In this Issue

US Policy and Regulatory Updates
• Industry Comments on FDA’s Nutrition Innovation Strategy
• West Coast Voters Show Split on Soda Taxes
• FDA Announces Plant and Animal Biotechnology Innovation Action Plan
• USDA/FDA Funding Still Uncertain During Lame Duck Congress
• Physicians Urge FDA to Implement Strict Labeling of High-Sugar Foods
• Federal Court Urged Not to Dismiss GMO Labeling Suit
• FDA Extends Comment Period on Use of Names of Dairy Foods in Plant-Based Substitutes

International Policy and Regulatory Updates
• U.S. Signs WTO Statement on Harmonized Biotechnology
• Australia-New Zealand Share Notification Circular (63-18)
• Key Players Suspend Evolved Nutrition Label Involvement Over Portion Size Concerns

Publication Updates
• Marion Nestle Publishes Unsavory Truth
• Report Recommends Modifying Dietary Guidelines to Reduce Diabetes
• Microbiome Changes Impacting Obesity Linked to Immigration
• Academy of Nutrition and Dietetics and The Obesity Society Announce Collaboration on Treatment of Obesity and Weight Management
• Study Published on How a Low-Carb Diet Might Help You Maintain a Healthy Weight

Council Updates
• CCC Holds its 2018 Annual Meeting in Arlington, Virginia
• CCC Thanksgiving and National Diabetes Month Coverage
• Additional Communications

US Policy and Regulatory Updates

Industry Comments on FDA’s Nutrition Innovation Strategy
On October 26, the National Law Review published an article reporting on industry’s comments regarding the U.S. Food and Drug Administration’s (FDA) Nutrition Innovation Strategy (NIS). Of the 1,357 comments submitted, most addressed the definition of “healthy,” a “healthy” symbol, consumer education, and standards of identity. Most companies focused on specific areas of interest to them, but all expressed interest in supporting greater consumer understanding and public health, while also increasing the ability to innovate. Several companies expressed interest in broadening standards of identity. For example, Chobani is requesting the ability to market Greek yogurt under a standard of identity as a high protein food. In addition, Campbell Soup Company reportedly believes that “a significant liberalization of qualified health claim language would help drive innovation and be beneficial to consumers,” but warns that “an approved claim that is so laden as to render the claim entirely unappealing to consumers” will suppress research and innovation.

The article does not discuss comments submitted by industry organizations, such as CCC and the Food & Beverage Issue Alliance.

West Coast Voters Show Split on Soda Taxes
On November 6, voters in Oregon and Washington State had the chance to decide whether new soda taxes have a future in the Pacific Northwest. In Washington, a ballot measure that makes it impossible for cities and counties to enact new soda taxes was passed, although an existing soda tax in Seattle will still stand. Beverage companies donated more than $20 million to support the measure, Initiative 1634. According to a November 7 article published by Vox, this substantial funding may have resulted in voters not realizing they were voting against soda taxes. This is because the industry-backed, heavily promoted campaign “Yes! To Affordable Groceries” described the measure as “opposing new taxes on everyday grocery items, such as meat, dairy and beverages.”

On the other hand, a similar initiative in Oregon, Measure 103, was voted down. In this case, industry spent a much smaller sum of $5.7 million supporting the measure to prohibit future soda taxes. Laura MacCleery, policy director at the Center for Science in the Public Interest (CSPI), claimed that the difference in outcomes in the two states, “is a difference where advocacy groups had the resources to stand up and explain to voters what the measure was about.”

FDA Announces Plant and Animal Biotechnology Innovation Action Plan
On October 30, FDA published a statement from Commissioner Scott Gottlieb and Deputy Commissioner Anna Abram on the agency’s new plan to advance plant and animal biotechnology innovation. In an effort to implement modern regulations that foster innovation in this emerging field, the statement includes an announcement of the Plant and Animal Biotechnology Innovation Action Plan. The three priorities are as follows:

1. Advancing public health by promoting innovation
2. Strengthening public outreach and communication
3. Increasing engagement with domestic and international partners

As a first step in implementing this plan, FDA is focusing on animal biotechnology, with an upcoming public webinar on genome editing in animals and a veterinary innovation pilot program. CCC does not plan to participate in this webinar.

USDA/FDA Funding Still Uncertain During Lame Duck Congress
An article published in Food Chemical News (FCN) (subscription required) on November 12 noted that, while the midterm elections confirmed democratic control of the U.S. House of Representatives, Congress must still address several legislative action items during the lame duck session which lasts until January. One of these items is the Fiscal Year 2019 funding of the FDA and the U.S. Department of Agriculture (USDA). Although several government spending bills were rolled into “minibus” funding bills and signed into law ahead of the November 6 elections, Congress was unable to strike deals for the remaining seven measures, including USDA/FDA funding.

Funding for FY 2019, which started in October, has been sidelined. Both House and Senate spending bills would cut the USDA Food Safety and Inspection Service (FSIS) budget by $7.5 million to $1.049 billion. The House bill is more generous with USDA’s Agricultural Research Service (ARS) with a $52.6 million increase, while the Senate bill would reduce ARS funding by $42.4 million.Those in favor of boosting FDA’s budget in FY 2019 prefer the higher budget of the House appropriations bill, but favor some provisions in the Senate bill, including the $15 million increase proposed for food safety. Notably, the House committee-passed bill provided no extra funding to helps states ramp up Food Safety Modernization Act (FSMA) implementation efforts.

In addition to settling FDA funding differences between the House and the Senate, several food policy issues need to be addressed which were tucked into the spending bills. For example, both bills would prevent FDA from writing final guidance on sodium reduction actions until a dietary reference intake report is completed, and from moving ahead with requiring added sugars labeling for certain single-ingredient foods such as honey and maple syrup in the Nutrition Facts rule. However, in June, FDA announced it was rethinking its approach about added sugars labeling to make key information available to consumers.

Physicians Urge FDA to Implement Strict Labeling of High-Sugar Foods
On November 13, the American Medical Association (AMA) released a statement announcing it has adopted a new policy aimed at increasing consumer awareness of the amount of added sugars, as well as the type of allergens, in food products. In the statement, AMA urges FDA to ramp up the labeling of high-sugar foods. The association, which represents U.S. physicians, is calling on FDA to develop front-of-package (FOP) warning labels for foods high in added sugars, and is also asking FDA to limit the amount of sugar that can be added to products making health claims.

Federal Court Urged Not to Dismiss GMO Labeling Suit
As reported by FCN (subscription required), a California consumer is urging a federal judge not to dismiss a class action against Nestle, arguing the company has failed to disprove her claims that the company’s “No GMO Ingredients” seal is deceptive. The plaintiff contests that the seal misleads the consumer to believe it is that of a third party, when in fact, it is Nestle’s own creation and “self-endorsement.” The lawsuit alleges the seal mimics the Non-GMO Project’s certification, but Nestle’s products would not comply with the Non-GMO Project standard as they contain dairy ingredients that come from cows raised on genetically engineered grains. Nestle says the lawsuit is preempted by federal law, as its labels comply with FDA and USDA regulations, noting that its “No GMO Ingredients” claim is verified by SGS, a testing and certification firm based in Switzerland. In its motion to dismiss, the company says the product label references the SGS website and provides consumers with the ability to obtain complete information about its standard.

FDA Extends Comment Period on Use of Names of Dairy Foods in Plant-Based Substitutes
On November 15, FDA announced its intention to extend by 60 days the comment period on modernizing standards of identity (SOI) and the use of dairy names for plant-based substitutes. While FDA is primarily seeking comments on the labeling of plant-based products, this call for public comments signifies a primary step in FDA’s NIS. CCC does not intend to submit comments. If you would like to do submit comments please inform staff by Friday, December 7.

International Policy and Regulatory Updates

U.S. Signs WTO Statement on Harmonized Biotechnology
As reported by Politico Pro! (subscription required) on November 2, the U.S. joined twelve other World Trade Organization (WTO) members in signing a non-binding statement spearheaded by Argentina that promotes synchronized regulatory approaches on agricultural biotechnology. The statement supports the use of biotechnology as an essential tool in combating food insecurity, as well as environmental and food safety issues. Other signatories included Australia, Brazil, Canada, Colombia, the Dominican Republic, Guatemala, Honduras, Jordan, Paraguay, Uruguay, Vietnam and the Secretariat of the Economic Community of West African States.

Australia-New Zealand Share Notification Circular (63-18)
As an industry stakeholder, CCC staff received notice from Food Standards Australia New Zealand (FSANZ) that Notification Circular (63-18) was published on November 13. This circular notifies of the approval of several additives, including A1129 Monk Fruit Extract and A1157 Enzymatic production of Rebaudioside M to the Australia and New Zealand Ministerial Forum on Food Regulation (convening as the Australia and New Zealand Food Regulation Ministerial Council).

Key Players Suspend Evolved Nutrition Label Involvement Over Portion Size Concerns
As reported by Food Ingredients 1st on November 21, five major food and beverage companies have abandoned a project called the Evolved Nutrition Label (ENL) Initiative, aimed at creating traffic light nutrition labels to help EU consumers better understand what is in their food. The ENL proposal is similar to the traffic light labels used in the UK. It is a color-coding system based on individual ingredients such as sugar, salt and fat in food and drink items. The main difference is under the ENL initiative the colors would be allocated for smaller portions (below 60g) on a “per portion basis” rather than “per 100g.”

After two years of working together, the five companies, some of which are CCC members, have decided to suspend ENL trials for food because of a lack of EU-defined portion sizes which has led to insufficient understanding and support of the industry’s proposed scheme. For example, there are concerns over the misleading nature of refraining from placing a red light on Nutella, a high-fat, high-sugar product. The companies continue to advocate for harmonization of interpretative labeling at EU level and call on the European Commission and member states to take the necessary steps.

Publication Updates

Marion Nestle Publishes Unsavory Truth
On October 30, Marion Nestle, an acclaimed consumer activist, nutritionist, and academic who specializes in the politics of food and diet, published her new book titled Unsavory Truth: How Food Companies Skew the Science of What We Eat. The book details how industry-funding of nutrition research affects public health. Nestle explains that these studies are more about marketing than science, and are often paid for by the companies and associations that sell foods. Along with greater Kellen staff, CCC staff received and reviewed this book in detail and worked with public affairs staff on a strategic, coordinated approach to respond to attention on the book’s accusations on behalf of the broader industry if necessary.

Report Recommends Modifying Dietary Guidelines to Reduce Diabetes
A report titled “The Cost and Impact of Type 2 Diabetes: Policy Recommendations for a Growing Public Health Epidemic” was published on November 1 in the journal Food & Nutrition. The report was sponsored by Atkins Nutritionals and authored by Paul Keckley, President of the Keckley Group, a healthcare advisory firm. Two of the five major factors experts and policy makers have identified as responsible for increased costs associated with Type 2 diabetes highlighted by Keckley are confusion about healthy food choices amongst American consumers, and low prioritization of nutrition, pricing policies, and income inequality amongst policymakers. Although a public health crisis, simple treatments of proper nutrition therapy and exercise can be effective in causing remission of type 2 diabetes. The report includes the following suggestions for immediate next steps:

• The U.S. Dietary Guidelines should give nutrition recommendations instead of a “one-size-fits-all” approach to nutrition.
• A major public education campaign to educate consumers about nutrition therapies and healthy choices, and to help them avoid misleading marketing and health advice.
• Updating of diagnostic screening measures used by primary care clinicians, retail clinics and other primary care venues to diagnose pre-diabetes and Type 2 diabetes. It is noted the American Diabetes Association’s recent recognition that low carb diets may serve as an appropriate nutrition therapy is a step in the right direction.
• Improvements in medical education to emphasize nutrition therapies.
• Inclusion of explicit nutrition therapy outcomes in alternative payment programs including The Medicare Shared Savings Program and others.
• Appointment of a blue-ribbon commission on nutrition therapy to modernize policies, regulations and food supply chain considerations.

Microbiome Changes Impacting Obesity Linked to Immigration
On November 1, a study titled “US Immigration Westernizes the Human Gut Microbiome” was published in the journal Cell. The study, conducted by researchers at the University of Minnesota and the Somali, Latino, and Hmong Partnership for Health and Wellness, measured gut microbiomes and dietary intake from immigrants moving from Southeast Asia to the United States. Second-generation immigrants were also included to determine if the effects of U.S. immigration were compounded across generations by birth in the U.S. Researchers measured the short-term effects of immigration by following a group of 19 Karen refugees for their first six to nine months upon arrival in the U.S. In that time period, researchers found the Western strain Bacteroides began to displace the non-Western bacteria strain Prevotella. This Westernization was also observed in the first decade in the U.S. as overall microbiome diversity decreased the longer the immigrants had been in the country. Although this study cannot be used to establish a cause-and-effect relationship between the microbiome changes in the guts of immigrants and the rise in obesity, it does suggest that greater microbiome westernization is linked to greater obesity.

Academy of Nutrition and Dietetics and The Obesity Society Announce Collaboration on Treatment of Obesity and Weight Management
On November 14, the Academy of Nutrition and Dietetics (AND) and the Obesity Society announced a three-year collaboration to develop materials, programs and other activities related to evidence-based treatment of obesity and weight management. The collaboration will feature educational, scientific or clinical sessions or presentations at each organization’s annual meetings; workshops, programs or presentations at other conferences; and live or recorded webinars or other online programs and presentations. According to the collaboration agreement, the two organizations “will leverage their respective brands and communication assets, including social media channels and digital platforms, to promote the activities and contribute to the advancement of the shared commitments envisioned by this agreement.”

Study Published on How a Low-Carb Diet Might Help You Maintain a Healthy Weight
On November 14, a study was published in the British Medical Journal (BMJ) titled “Effects of a low carbohydrate diet on energy expenditure during weight loss maintenance: randomized trial” that sought to determine the effects of diets varying in carbohydrate to fat ratio on total energy expenditure. In the study, 164 adults with a body mass index of 25 or more were randomly assigned to one of three test diets according to carbohydrate content (high, 60%, n=54; moderate, 40%, n=53; or low, 20%, n=57) for 20 weeks. Test diets were controlled for protein and were energy adjusted to maintain weight loss within 2 kg.

Researchers found that overweight adults who cut carbohydrates from their diets and replaced them with fat sharply increased their metabolisms. After 20 weeks on the diet, their bodies burned approximately 250 calories more per day than people who ate a high-carb, low-fat diet. This suggests that restricting carb intake could help people maintain their weight loss more easily. It also represents evidence to support a shift in guidelines and government policies away from focusing on calories and low-fat and toward better diet quality.

Council Updates

CCC Holds its 2018 Annual Meeting in Arlington, Virginia
Thank you to all who participated in CCC’s 2018 Annual Meeting, which took place November 7-9 at the Hyatt Regency Crystal City in Arlington, Virginia. Staff will be circulating meeting minutes and related materials shortly. Presentations shown during the meeting are located here under 2018 Meeting just below the agenda shown. Password is “cccinfo.”

Communications Update

General Program 

CCC Quoted in More Than 500 Media Outlets for Thanksgiving Calorie Story
The Calorie Control Council’s Thanksgiving Calorie Meal media outreach was well received with the story picked up by 500 media outlets, including several national outlets — Inside Edition (syndicated TV), USA Today, CNBC and Health in a Heartbeat syndicated radio program airing on 55 National Public Radio (NPR) radio stations — and hundreds of local TV segments and newspaper outlets. (For context, Inside Edition gets more viewers than any of the following syndicated programs: Live with Kelly and Ryan, Ellen, Rachael Ray Show, The Dr. Oz Show and The Doctors). Media stories and segments included Calorie Control Council’s messaging on what is a typical high-calorie count Thanksgiving dinner. The Council offered ways to keep the count in check while still enjoying the holiday.

National Diabetes Month
Staff developed, posted and promoted a temporary page created in honor of National Diabetes Month on CalorieControl.org. New content was developed by staff, social media advisors, and scientific advisors, and old content was repurposed, for example, diabetes-friendly recipes. Staff wrote “Five Tips for Managing Diabetes” and pitched it via media outreach, securing placements with Healthy magazine, Black Enterprise magazine and VIPortal Health, among others. In addition, staff arranged an interview of Sylvia Melendex Klinger (a past advisor to the Council) with CNN En Espanol for a segment surrounding diabetes. Staff will share the recording if aired in a future update to members.

High Intensity Sweetener (HIS) Committee
Staff further edited talking points, a statement and other material in preparation for the upcoming announcement related to LCNS from the World Health Organization (WHO) Nutrition Guidance Expert Advisory Group (NUGAG).

Working Groups 

• Polyols:
  • Staff has completed a new infographic for food scientists outlining the technical specifications of individual polyols. Staff is planning promotion of infographic to food scientists.
• Fiber: 
  • Staff re-themed, re-designed and is in the process of re-launching the Spanish and Portuguese language versions of FiberFacts.org.
• Sucralose:
  • Staff re-themed, re-designed and re-launched the Spanish, Portuguese and Italian websites of Sucralose.org based on the new look and feel of the English site.
• Stevia:
  • Staff promoted the “How-To” recipe videos for stevia via Council’s social channels garnering 240,000 views, promoting usage of stevia throughout the holiday cooking season.
    • Sweet & Spicy Snack Mix – 110,000 views
    • Homemade Blueberry Pie with Stevia – 70,000 views
    • Strawberry Shortcake Trifle – 61,000 views

In this Issue

US Policy and Regulatory Updates
• DHHS/FDA Fall 2018 Unified Agenda Released
• FDA Invites Public Comments on Labeling of Plant-Based Products Using Dairy-related Terms
• FDA Commissioner Releases Statement on Standards of Identity and Dairy Names for Plant-Based Substitutes
• US Codex Program Announces Notice of Public Meeting and Request for Comments
• FDA Deputy Commissioner for Foods and Veterinary Medicines Retires and Organizational Change Awaits
• Media Analyzes State of Sugar-Sweetened Beverage Taxes
• Popular Beverage Brand Faces “All Natural” Lawsuit
• Former Executive Director of US Dietary Guidelines Accused of Dispensing Mistaken Dietary Advice
• Congress Asked to Establish National Institute of Nutrition
• American Diabetes Association Launches Online Recipe Platform Including LNCS

International Policy and Regulatory Updates
• Mexico Requested to Replace FOP System with Warning Labels
• Denmark Discusses Climate Impact Labels for Foods
• Malaysia Considers Graded Sugar Tax Model

Publication Updates
• Carb Cycling Increases in Popularity as a Low-Carb Diet Alternative
• New Survey Shows Most Americans Remain Confused About GMOs
• British Medical Journal Study Recommending Low-Calorie Foods Gains UK Attention
• Reported US Consumption of LNCS from All Sources Published

Council Updates
• CCC Submits Nominations for 2020 DGAC
• CCC Submits Comments on FDA’s Nutrition Innovation Strategy
• CCC Staff Attends FNCE
• CCC to Hold 2018 Annual Meeting
• Communications

US Policy and Regulatory Updates

DHHS/FDA Fall 2018 Unified Agenda Released
On October 17, the federal government published the Fall 2018 Unified Agenda, which serves to share the government’s top regulatory priorities with the public. To access a particular agency’s agenda, click on the drop-down menu and select the desired agency (e.g., Department of Health and Human Services).

Regarding the US Food and Drug Administration (FDA), the Unified Agenda reflects the four priorities included in FDA’s 2018 Strategic Policy Roadmap unveiled at the beginning of 2018. To “[empower] consumers to make better and more informed decisions about their diets and health and expand the opportunities to use nutrition to reduce morbidity and mortality from disease,” the agency is working to modernize nutrition claims, labels and standards of identity. As noted by Commissioner Scott Gottlieb in a statement announcing the Agenda, “[FDA’s] Fall 2018 Unified Agenda includes key actions that will improve labeling and nutrition. [FDA believes] it’s important to maintain the basic nature and nutritional integrity of products while allowing industry flexibility for innovation to produce more healthful foods.” Commissioner Gottlieb also stated that in order to modernize food standards, reduce regulatory burden, and remove barriers to innovation, FDA will reopen the comment period on a proposed rule, seeking to establish general principles to update the framework for standards of identity.

The Unified Agenda also includes the US Department of Agriculture’s (USDA) intent to revise regulations concerning the “importation, interstate movement, and environmental release” of genetically engineered organisms. USDA has not determined costs and benefits of the new rules, but said it anticipates they will affect international trade and investment.

Furthermore, FDA notified of its intent to publish a notice of proposed rulemaking in March of 2019 to update the definition for the implied nutrient content claim “healthy” and revise the requirements for its voluntary use in labeling. FDA intends to update the definition to be consistent with current nutrition science and modern federal dietary guidelines that focus more on dietary patterns, and less on specific nutrients Americans were not getting enough of in the early 1990’s.

In addition, the Unified Agenda includes an announcement that FDA is proposing to amend its food additive regulations to allow a Food Contact Substance Notification (FCN) to become no longer effective for reasons other than safety. Further, under the proposed rule, FDA would provide manufacturers or suppliers an opportunity to address any safety concerns earlier in the determination process.

FDA Invites Public Comments on Labeling of Plant-Based Products Using Dairy-Related Terms
On September 28, FDA kicked off their first step in addressing the agency’s broad Nutrition Innovation Strategy (NIS) by publishing a notice in the Federal Register (FR) announcing a request for comments on the labeling of plant-based products with names that include dairy foods such as “milk,” “cultured milk,” “yogurt” and “cheese.” FDA is interested in learning how consumers use these plant-based products and how they understand terms such as “milk” or “yogurt” when included in the names of plant-based products. FDA is also interested in learning whether consumers are aware of and understand differences between the basic nature, characteristics, ingredients, and nutritional content of plant-based products and their dairy counterparts. Comments are due November 27, 2018. CCC does not plan to submit comments unless otherwise advised by Friday, November 9.

FDA Commissioner Releases Statement on Standards of Identity and Dairy Names for Plant-Based Substitutes
On September 27, FDA published a statement from Commissioner Gottlieb on modernizing standards of identity (SOI) and the use of dairy names for plant-based substitutes, as one component of the agency’s multi-year NIS. While Dr. Gottlieb’s statement primarily addresses the above mentioned request for comments on the labeling of plant-based products, he also incorporated FDA’s efforts to increase transparency on products, and broadly noted that the agency is “working on modernizing [its] standards of identity, which define through regulation certain characteristics, ingredients and quality of specific foods. These standards of identity help to ensure that consumers know ‘vanilla extract,’ for example, will always be made from vanilla beans and not artificial flavorings.”

US Codex Program Announces Notice of Public Meeting and Request for Comments
In a FR notice published October 18, it was announced the US Codex Office is finalizing its FY-2019-2023 Strategic Plan and is sponsoring a public meeting to provide additional information and receive public comments on the plan. The meeting took place November 2, where it was expected the program’s goals and objectives will be discussed. Written comments may also be submitted by November 6. CCC does not intend to submit comments.

FDA Deputy Commissioner for Foods and Veterinary Medicine’s Retires and Organizational Change Awaits
As reported by Politico (subscription required) on October 18, Stephen Ostroff is set to retire as FDA deputy commissioner for foods and veterinary medicine,a significant food safety and nutrition role at the agency. Frank Yiannas will join FDA and fill a similar role as deputy commissioner for food policy and response. Yiannas is a well-known food safety executive from Walmart and vocal proponent of blockchain technology for improving food safety. As Yiannas’s new title signifies, his new role reflects an ongoing effort to reorganize FDA so that heads of centers, such as the Center for Food Safety and Applied Nutrition (CFSAN), report directly to the commissioner instead of to deputy commissioners.

FDA is also planning to create a new office focused on food safety called the Office of Food Policy and Response (OFPR), which will partially replace some of the work the Office of Foods and Veterinary Medicine has been leading. The OFPR will aim to continue advancing Food Safety Modernization Act (FSMA) work, while also coordinating foodborne illness outbreak response.

Media Analyzes State of Sugar-Sweetened Beverage Taxes
On October 4, PBS published an article titled “How taxing sugary drinks affects a community’s health and economy” which assessed the state of sugar-sweetened beverage (SSB) taxes, the first of which was implemented in 2014 in Berkeley, California. Still, supporters and opponents of similar measures across the country have debated their effectiveness. The article reports that currently, seven cities tax sugary drinks, and cites the Center for the Public Interest’s (CSPI) chart comparing each of the city’s taxes.

Several new studies are also referenced that strengthen conclusions that SSB taxes lead to changes in behavior, such as “The Impact of the Philadelphia Beverage Tax on Purchases and Consumption by Adults and Children” published in September by the National Bureau of Economic Research (NBER) which showed that the taxes succeeded in reducing consumption of sugary drinks. The research, however, showed only a slight reduction (approximately 23.6 calories per day) in Philadelphia’s population’s overall sugar consumption. Further, another NBER study published the same month titled “The Impact of the Philadelphia Beverage Tax on Prices and Product Availability” showed that the taxes are also driving shoppers away from cities that charge more for sugary drinks and into surrounding suburbs.

In addition to debating the economic and health impacts of the taxes, there is focus on how revenue from SSB taxes is being used. In Illinois’ Cook County, the tax was used to solve a major budget shortfall, which encouraged public backlash that resulted in repealing the tax five months after its implementation. In Philadelphia, city officials have said the tax was implemented primarily to fund early education, libraries and public parks, and considered health impact to be a secondary consideration. In many other cities, including Boulder, at least some of the tax revenue has been specifically earmarked for health initiatives.

Following are next steps for sugary drink taxes in different areas:

• In California, voters will decide in 2020 whether to overturn a ban on SSB taxes. The ban was implemented after four California cities (Albany, Berkeley, Oakland and San Francisco) passed SSB taxes in the past four years.
• In Washington state, voters will consider a similar ban during the 2018 General Election. The ban, known as Initiative 1634, would bar any local governments from adding a tax to groceries, including sodas.
• In Boulder, Colorado, voters will decide in November whether to scale back the city’s SSB tax, which is generating millions of more dollars than originally estimated. Residents will have the opportunity to decide whether to let the city keep the money or reduce the tax rate.
• Globally, countries like the United Kingdom (UK) and Mexico have implemented nationwide soda taxes. In the UK, companies have responded by creating new beverages that have fewer added sugars.

Popular Beverage Brand Faces “All Natural” Lawsuit
As reported on October 5 by CBS News and several other news outlets, LaCroix sparkling water is facing a lawsuit alleging its claims of “all natural” and “100 percent natural” are misleading because the brand’s beverages contain artificial ingredients. According to Food Navigator, the complaint filed in Cook Country, Illinois on October 1 alleges that LaCroix sparkling waters, which have two ingredients: carbonated water and natural flavor, are “manufactured using non-natural flavorings and synthetic compounds,” but are marketed as “all natural” on boxes and on LaCroix’s website. LaCroix maker National Beverage Corp has publicly refuted this allegation, stating that the “natural flavors in LaCroix are derived from the natural essence oils from the named fruit used in each of the flavors. There are no sugars or artificial ingredients contained in, nor added to, those extracted flavors.”

While “natural flavors” are defined by law, there is no detailed definition of “natural” or “all natural” on food labels. Further, as noted by Dr. Kantha Shelke, food scientist and principal at research firm Corvus Blue LLC, “A definition of ‘natural flavors’ is the only promulgated regulation concerning the term ‘natural.’ The regulation contains a list of substances that a natural flavor ingredient may contain, as well as a list of sources in which the chemical substance may originate…the rule only refers to ingredients affecting flavor as natural; it doesn’t specify the extent to which an ingredients that does not affect flavor is natural or unnatural.”

Former Executive Director of US Dietary Guidelines Accused of Dispensing Mistaken Dietary Advice
On October 9, the Los Angeles Times published an article written by Nina Teicholz, science journalist and the executive director of the Nutrition Coalition, which covered the downfall of Cornell University’s Brian Wansink, former executive director of the US Dietary Guidelines for Americans (DGA) from 2007-2010. In September, Wansink had many of his papers retracted and resigned from his professorship. The article claims “Wansink’s fall is not just the tale of a single scientist gone astray. It is, instead, an indictment of an entire type of nutrition science that has led to mistaken dietary advice dispensed to Americans for decades.”

Under Wansink’s leadership, the DGA shifted to be based more on weak observational data he produced in his own lab. Wansink’s 2010 guidelines turned the recommendations away from a focus on food groups and toward dietary patterns. The problem with this change was not the change itself, but rather the evidence used to support the new guidelines.

As Teicholz notes, each study published in 2015 cited by the 2010 dietary guidelines advisory committee (DGAC) to support the recommendations were “astonishing.” The government’s three recommended food patterns (US-style, Mediterranean, and Healthy Vegetarian) were supported only by a few truly rigorous trials. A single Mediterranean-diet trial of just 180 people was cited to demonstrate that the pattern could produce significant weight loss, and evidence to show the diet’s impact on diabetes and heart disease was deemed insufficient. The large clinical trial cited to claim cardiovascular benefits for the Mediterranean diet was recently retracted and reissued, due to doubts about its basic reliability. Furthermore, the government’s review of the Healthy Vegetarian diet concluded that the evidence for any disease-prevention potential of this diet was “limited,” which is the lowest rank given for available data.

In its notice of retraction of Wansink’s papers, the Journal of the American Medical Association (JAMA) said their primary reason for doing so was that his data could not be confirmed because the original dietary surveys had been thrown out. The article adds that the country’s largest observational nutrition study, funded by the National Institutes of Health (NIH), is one of the most highly cited studies in the DGA evidence base, yet Harvard, who ran the study, does not publicly disclose its data, making its findings impossible to confirm. Teicholz concludes, “Observational studies are supposed to be exploratory work, hardly ready for prime time. Yet the pressure to publish, the reality that media coverage drives grant making, and that these both drive the professional trajectory of researchers, push scientists like Wansink and others to oversell their results.” Although updated guidelines were issued in 2015 under a different director, reliance on weak data has still remained.

Congress Asked to Establish National Institute of Nutrition
On October 9, The Hill published an article suggesting the time has come to explore the merits of creating a federal agency dedicated to nutrition science, and recommends establishing a National Institute of Nutrition (NIN) under the United States Department of Health and Human Services (HHS). The article argues that nutrition science is not the primary focus of any federal agency, or any of the 27 institutes and centers that comprise the NIH. Although the FDA and USDA deal in food, the FDA’s oversight is limited to food labeling and safety, and the USDA’s research funding is predominantly dedicated to farming and food manufacturing, not nutrition science and the effect of food on humans.

The establishment of the NIN would provide robust, independent, and new evidence on health effects of foods as well as independence in translation of evidence-based nutrition science into national dietary guidelines.

American Diabetes Association Launches Online Recipe Platform Including LNCS
As reported by the Washington Informer on October 24, the American Diabetes Association (ADA) went live on October 22 with its Diabetes Food Hub, an online cooking and recipe platform aiming to assist people with diabetes and their families. The platform includes hundreds of recipes for breakfast, lunch, dinner, snacks, and desserts that are suitable for people with diabetes, several of which call for low- and no-calorie sweeteners (LNCS). Sacha Uelmen, director of nutrition at the ADA, stated, “Diabetes Food Hub makes it easy to find healthy recipes that fit your lifestyle, and includes shopping lists, meal prep tips from nutrition experts, and more.”

International Policy and Regulatory Updates

Mexico Requested to Replace FOP System with Warning Labels
As reported in a September 26 article in Food Navigator, a group of researchers formed by the National Institute of Public Health put together a position paper on front-of-pack (FOP) labeling (as requested by Mexico’s Ministry of Health) to help inform future developments and guidance. The group has concluded that Mexico’s more complex System of Frontal Labeling of Food and Beverages (SEFAB), which is based on the European model, is not clear and is in fact difficult to understand. The group is recommending the best option would be a simpler warning label for critical ingredients similar to the system used in Chile, which features triangular black labels on products high in sugar, sodium, total fats, saturated fats, or trans fats. The group claims their position to use warning labels is consistent with international efforts, and says suggestions for including other ingredients like vitamins, fiber, and other nutrients in FOP labels must be ignored, stating, “Given the importance of simplifying the system and making it easy for the population to understand, we consider it fundamental to keep only emphasis on the components that the World Health Organization (WHO) recommends paying attention to.”

The article concludes by acknowledging the larger Mercosur region of Argentina, Brazil, Paraguay, Uruguay, and Venezuela is in the midst of debating the best way forward with its FOP labeling. The Brazilian Health Regulatory Agency (ANVISA) is currently reviewing proposals for an industry-backed traffic light system and a consumer group-supported warning label system similar to that of Chile. It is predicted ANVISA will make a final decision by the end of this year, which will lead to a mandatory nutrition label policy for the entire Mercosur region.

Denmark Discusses Climate Impact Labels for Foods
As reported by CNN on October 9, the Danish government began discussing proposals to require food manufacturers and supermarkets to put labels on their products that would rate their impact on the environment and climate. The main driver of this move is the Danish Agriculture and Food Council, which is the industry’s umbrella organization. Morten Hoyer, director of the council, stated, “Everyone knows that food production influences the climate, but if the rest of the world produced food the way we do in Denmark, the world would be a better place.” Although the article notes Denmark has been working with the European Union for the past ten years to develop a climate label, it is a complex undertaking. Hoyer explains, “It may be necessary to compare the climate effect of a product with how nutritious it is. A soda might only have a small impact on the climate, but it will not sustain you.”

Malaysia Considers Graded Sugar Tax Model
On October 22, Food Navigator published an article featuring an analysis of potential sugar or soda taxes in Malaysia by expert Dr. Lim Chee Han, a Penang Institute Senior Analyst. Dr. Lim suggests that Malaysia expand and transform its soda tax proposed last December to a sugar tax based on a graded multi-tier excise tax model, that could be either volumetric-based (e.g. per 100 ml of beverage) or content-based (e.g. per gram of sugar content of beverage), as seen in the UK and Thailand. This would be more applicable to the dietary habits of Malaysians, who have a high consumption of many sweetened foods and drinks not currently subject to a soda tax, such as malted milk, traditional cakes called kuih (eaten daily by 80 percent of the population), and raw sugar used to sweeten drinks. In addition, given that production costs for soda in Malaysia are lower than that of alcoholic beverages, Dr. Lim expressed concerns that a soda tax “may not do enough to deter people from purchasing and consuming high-sugar content beverages” and, while it might be effective on the lower 40 percent of household income class, “it does not extend to the rest of the population.”

Regarding public education around sugar reduction, Dr. Lim suggests that a health promotion campaign launched by the government would need to incorporate comprehensive strategies that align with the tax implementation, and cited Singapore’s ‘Healthier Choice‘ symbol as an example.

Publication Updates

Carb Cycling Increases in Popularity as a Low-Carb Diet Alternative
On September 25, the Washington Post published an article highlighting carb cycling as an increasingly popular alternative – especially amongst athletes – to low-carb diets such as the ketogenic diet, which the author reports can result in low energy levels and headaches. In addition, the article references a study presented at the European Society of Cardiology’s 2018 Congress in August, which found that participants who ate a low-carb diet had a 32 percent higher risk of premature death.

With carb cycling, consumers alter the amount of carbohydrates eaten on daily, weekly, or monthly basis. The article also provides recommendations for carb cycling, noting that on higher-carb days consumers should try to get about half of calories from carbohydrates, and on lower-carb days, consumers should try to get about 25 percent of your calories from carbs.

Proponents argue that compared to low-carb diets, carb cycling could put the body under less stress and ensure consumption of nutrients like fiber that are found in carbohydrate-rich foods. However, the benefits of carb cycling are theoretical, because it is mostly based on research on the effects of low-carb diets or high-carb diets, not on alternating between the two. Supporters of carb cycling reference research that shows carb loading can temporarily raise metabolism and increase leptin, which could help promote weight loss. In addition, athletes believe carbohydrate-rich foods boost athletic performance and recovery, and that carbohydrates burned for energy spare protein that can be used for muscle growth rather than fuel. Therefore, carb cycling allows for higher-carb days that, in theory, prevent metabolic slowdown that occurs when restricting calories. Then, lower-carb days encourage the body to burn fat for fuel. Ultimately, as the article acknowledges, there is not enough research and information about carb-cycling to recommend them. The author concludes by stating, “The best diet is one that’s sustainable and doesn’t require endless calculations.”

New Survey Shows Most Americans Remain Confused About GMOs
On October 2, GMO Answers, an initiative committed to responding to consumer questions about how their food is grown, released the findings of a new YouGov survey which show that a majority of Americans aren’t confident they definitely know what genetically modified organisms (GMOs) are, and that this lack of knowledge may be driving overall uncertainty and discomfort. The survey, which comes shortly before the USDA plans to publish its final bioengineered food disclosure labeling standard, includes the following findings:

• 69 percent of consumers are not confident they know what GMOs are, and only 32 percent say they are comfortable with the use of GMOs in their food products.
• Roughly 3 in 5 Americans are interested in learning more about GMOs overall. 74 percent want to learn more about GMOs’ impact on their overall health, and 67 percent are interested in learning more about the overall safety of GMOs.
• 43 percent of consumers believe that food sold in the US is, in general, safe for consumption. This means there is widespread distrust as a whole when it comes to food production, despite the US having the safest food supply in the world.

British Medical Journal Study Recommending Low-Calorie Foods Gains UK Attention
As reported by BBC News on September 27, a new study published September 26 in the British Medical Journal (BMJ) strengthens the suggestion that diet replacement programs made up of low-calorie soups, shakes, and regular counseling should be a recommended National Health Service (NHS) treatment for obesity. The original objective of the study was to test the effectiveness and safety of a total diet replacement (TDR) program for routine treatment of obesity in a primary care setting. The study of 278 obese adults took place in ten primary care practices in Oxfordshire, UK, over the course of 24 weeks. Of the 278 adults studied, 138 were assigned to the TDR program of weekly behavioral support for 12 weeks and monthly support for three months, with formula providing 810 calories per day as the sole food during the first eight weeks, followed by reintroduction of food. The remaining 140 adults were assigned to usual care, comprised of behavioral support and a diet program with modest calorie restriction.

Not surprisingly, at every stage of the study, people following the diet replacement program lost more weight. After a year, they had lost on average approximately 23.6 lbs. compared with 6.8 lbs. for those in the usual weight loss group. Furthermore, for those in the TDR group, there were noticeable improvements in blood pressure and cholesterol, and those with type 2 diabetes were able to radically reduce their medication. The results of this study corroborates a 2017 trial of patients with type 2 diabetes who were fed a low-calorie diet of shakes and soups. The trial results, which were published in the Lancet medical journal, found that half were able to lose enough weight to reverse their type 2 diabetes.

As noted in the BBC article, TDRs are designed for those who are obese or seriously obese, who have been unable to lose weight after attempted changes to diet and lifestyle. TDRs are currently only available privately, although NHS England has reportedly said it is considering the diets as part of a long-term plan for the NHS.

Reported US Consumption of LNCS from All Sources Published
A study was published in September in the journal Current Developments in Nutrition that assessed the reported consumption amongst US adults of low-calorie sweeteners (LCS) in foods, beverages, and food and beverage additions (FBAs), unlike prior studies that strictly focused on LCS consumption through beverages. In this cross-sectional study, two nonconsecutive 24-hour dietary recalls from NHANES 2007-2012 and the National Cancer Institute usual intake method were used to estimate the prevalence of LCS intake from foods, beverages, and FBAs, and macronutrients among over 14,000 US adults aged 19 and older. The prevalence of LNCS consumption from reported foods, beverages, and FBAs among US adults was examined by sociodemographic characteristics and body mass index (BMI).

Researchers found that 47.8 percent of adults reported intake of at least one food, beverage, or FBAs containing LCS over a two day period. Intake was found to be higher among non-Hispanic white women, college graduates, and those with higher income and obese BMIs. Intake of beverages containing LCS was higher for ages 51-70 compared to ages 19-30. Calories, carbohydrate, and sugar intake were lower and fiber was higher in LCS-consumers than they were in non-consumers. Specifically, calories from beverages were lower in those who reported LCS intake. The authors concluded that although the main source of LCS in the US adult diet was beverages (31.9 percent), they found that FBAs also present a significant contribution (25.2 percent), which surpassed food (9.3 percent).

Council Updates

CCC Submits Nominations for 2020 DGAC
“On October 6, CCC submitted five nominations in response to USDA’s announcement of intent to establish the 2020 Dietary Guidelines Advisory Committee (DGAC) and Solicitation of Nominations for Membership. Attached is a copy of CCC’s letter.

In addition, CCC signed onto the attached comments from the Food & Beverage Issue Alliance (FBIA) regarding DGAC nominations. Although the comments do not nominate a particular individual, they contain several recommendations to ensure the DGAC represents appropriate experience, balance, and diversity.

Communications Update

General Program

• A new page has been created in honor of National Diabetes Month on CalorieControl.org. This page serves as an aggregate platform for all of the new content staff and Council’s Scientific and Social Media Advisors have created for the month-long campaign. Staff is now promoting the content in conjunction with both National Diabetes Month and World Diabetes Day.

Council Social Media Advisor, Jen Haugen, RDN, LD, completed her third and final video for 2018, focusing on the benefits of using LNCS in savory applications.

Working Groups 

• Aspartame: 
  • Council Social Media Advisor (SMA) Rosanne Rust, MS, RDN, produced new content covering diabetes, carb counting and LNCS, entitled “Managing Diabetes & Carb Counting.”
  • Council Social Media Advisor (SMA) Neva Cochran, MS, RDN, LD, completed a new article for healthcare professionals on the benefits of aspartame in managing diabetes, entitled “Low and No Calorie Sweeteners,
    Glycemia and Diabetes: What Does the Science Say?”
  • Staff rethemed, redesigned and is poised to relaunch the Aspartame Japanese language site once all quality checks are performed.
• Polyols:
  • Staff has completed an infographic covering the basics of polyols for consumers. This infographic has been translated into Spanish and Portuguese. Staff is planning promotion of infographic.
  • A second infographic for food scientists has also been completed outlining the technical specifications of individual polyols. Staff is planning promotion of infographic.
  • Staff is currently in the process of creating a third infographic outlining updates to the Nutrition Facts Label for a consumer audience.
• Fiber: 
  • Council’s Scientific Advisor, Robyn Flipse, has completed the second piece of her two-part series on Addressing the Fiber Gap. The first article, “Closing the Fiber Gap,” addressed the growing fiber deficiency. The second article outlines where individuals can find added fiber, entitled “Finding Fiber in the Grocery Store.” Staff will post then promote both pieces of new content through advertising.
  • Staff re-themed, re-designed and re-launched FiberFacts.org based on the look and feel used in other Council websites (Aspartame, Sucralose, Polyols) to provide a common platform.
• Sucralose:
  • Staff is readying Spanish, Portuguese and Italian websites for re-launch. Those three sites are being re-themed as well, using the new Sucralose.org look and feel with the new copy (which was translated this year). 

• Stevia:
  • Council’s Scientific Advisor, Keith Ayoob, recorded an episode of Melissa Joy Dobbins’ podcast, Sound Bites, discussing stevia, its benefits and the processing of steviol glycosides. The episode is set to air in early November.
  • Four new recipe “How-To” videos for stevia have been created and about to be posted on the Councils social channels, and then promoted, especially during the busy holiday cooking season.

In this Issue

US Policy and Regulatory Updates
• Amended Prop 65 Regulations Likely to Prompt Increased Litigation
• FDA Commissioner States Support for Exempting Another Product from Prop 65
• FDA Announces Fee Structure for Export Certification for Certain Foods
• Commissioner Gottlieb Releases Statement on Added Sugar Labeling of Maple Syrup and Honey
• Federal Judge Certifies Classes in Added Sugar Case
• New Senior Policy Advisor Appointed to USDA’s Food and Nutrition Service
• CSPI Urges Trump Administration Not to Use Trade Talks to Thwart Nutrition Labeling
• USDA Sets December 1 Target Date for GMO” Final Rule
• California Law Signed to Limit Soda in Kids’ Meals, Washington D.C. Could Be Next
• Court Allows Case to Proceed on NGO Lawsuit on GRAS Rule
• New CDC Data Shows Adult Obesity Rates Present Need for More Prevention Programs

International Policy and Regulatory Updates
• New Updates Reported for Foods Marketed to Children in North America
• Japan Holds Meeting to Discuss Genome Editing Technology
• English Treasury Warns Against Calories on Menus
• UK to Consider Relaxing Gene Editing Ban
• Consumer Organization Challenges EU Law Protecting Intellectual Property
• Industry Questions WHO’s Evidence for Support of Sugar Taxes

Publication Updates
• Study Published on Alternative Sweeteners in Schools
• Study Published on Impact of Three Different Nutrition Labels
• Legislative Analyst Office Finds CA Soda Tax Initiative Would Generate Billions for Health Care
• CDC Report Shows 1 in 7 Americans Has Diabetes

Council Updates
• CCC Signs on to Letter of Support for Biotech Education
• CCC Signs on to Letter on Trade Secret and Confidential Commercial Information
• CCC 2018 Annual Meeting Reminder
• Communications Update

US Policy and Regulatory Updates

Amended Prop 65 Regulations Likely to Prompt Increased Litigation
As reported in an August 31 article in Food Navigator, California’s Proposition 65, which requires firms selling products in the state to provide warnings if their products expose consumers to chemicals that have been determined by the Office of Environmental Health Hazard Assessment (OEHHA) to be linked to cancer or reproductive toxicity, includes new rules that came into effect August 30. The new rules have to do with how the warning label is displayed and now address products sold online. As described by Nutritional Outlook, the new rules require on-product labels for food to contain a warning symbol of a yellow triangle with an exclamation point at its center. Further, the content of the written warning has changed, and must name at least one chemical in the product that is on the Prop 65 list, and specify whether it can cause birth defects, reproductive harm, or cancer. In addition, whereas before companies were allowed to show warnings after the point of sale, consumers must now also be shown the warning before the point of sale.Companies do have the option of using a shortened warning statement on products, although they must use the long-form warning on signage and online.

With the new rules, attorneys expect an uptick in lawsuits against firms providing inadequate warning labels on packages and on websites. OEHHA has issued guidance on how internet retailers can comply with the new regulations. Specifically, website warnings must either be (1) placed on the product’s display page, (2) given via hyperlink using the word ‘WARNING’ placed on the product display page, or (3) displayed with a tie to the product for which the warning is being given to the consumer before the purchase is completed (such as having the warning appear when the shopper enters a California zip code at the checkout). A warning does not satisfy Proposition 65’s requirements if the purchaser is required to search for it.

The law has long been heavily criticized by industry for creating consumer confusion and fear, and imposing unnecessary and costly regulatory and legal burdens. According to a report by Chemical Watch (subscription required), the American Chemistry Council (ACC) called the confusing law an “unmitigated disaster” at Chemical Watch’s Safer Chemicals in Products conference in Boston. ACC’s senior director of regulatory and technical affairs, Karyn Schmidt, said problems with the law are “rife and it’s time to put it to bed.”

FDA Commissioner States Support for Exempting Another Product from Prop 65
Weeks after a California appeals court ruled a Proposition 65 cancer warning would not be required on breakfast cereals, the US Food and Drug Administration (FDA) released a statement on August 29 noting Commissioner Scott Gottlieb’s support for exempting coffee from Prop 65 listing as well. The Commissioner explained FDA’s mission is to ensure safe food and truthful labeling, and stated, “…[this] also includes statements that may be compelled under state law… Simply put, if a state law purports to require food labeling to include a false or misleading statement, the FDA may decide to step in… That’s why we were deeply concerned when a court recently ruled that a California law – known as Proposition 65 – may require coffee sold in California to be labeled with a cancer warning because of the presence of a chemical called acrylamide… But requiring a cancer warning on coffee, based on the presence of acrylamide, would be more likely to mislead consumers than to inform them… [However],the California agency that administers Proposition 65 has proposed a regulation to exempt coffee from a Proposition 65 cancer warning. The FDA strongly supports this proposal.”

FDA Announces Fee Structure for Export Certification for Certain Foods
On August 31, FDA published a Federal Register (FR) notice announcing the fees the agency will assess for issuing new export certifications for certain foods which were authorized under the Food Safety Modernization Act (FSMA). On October 1, the agency plans to begin issuing and collecting fees for two new types of food certificates pursuant to this new FSMA authority, the “Certificate to a Foreign Government” and “Certificate of Exportability.”

Also starting October 1, FDA will assess fees for issuing export certificates for food for human consumption, with the exception of dietary supplements, medical foods, and foods for special dietary use. A “Certificate of Free Sale,” which is free of charge, will continue to be used for dietary supplements, medical foods, and foods for special dietary use.

Commissioner Gottlieb Releases Statement on Added Sugar Labeling of Maple Syrup and Honey
On September 6, FDA published a statement from Commissioner Gottlieb on the application of the listing of “added sugars” under the final rule to update the Nutrition Facts label (NFL) to honey and maple syrup. Commissioner Gottlieb explains, “[FDA] recognized that this new labeling information on “packaged as such” products may inadvertently lead consumers to think their pure products, such as a jar of honey or maple syrup, may actually contain added table sugar or corn syrup because there are “added sugars” listed on the label.”

FDA previously issued draft guidance for industry to clarify the added sugars declaration on pure maple syrup and honey. The draft guidance advised food manufacturers about our intent to allow the use of an obelisk symbol immediately after the added sugars percent daily value information that would direct consumers to language that provides information about what “added sugars” actually mean for these specific products. Commissioner Gottlieb reported “…more than 3,000 comments we received on the draft guidance indicate that there are further opportunities to update [FDA’s] proposed approach.” It is noted the agency is currently drafting final guidance that is expected to be issued in early 2019.

Federal Judge Certifies Classes in Added Sugar Case
As reported by Food Navigator on August 27, a federal judge has certified three classes of consumers in an added sugar-related false advertising lawsuit versus Kellogg. Plaintiffs argue that Kellogg’s use of “lightly sweetened,” a term not defined by FDA regulations, on products that contain up to 40 percent of calories from added sugar is misleading.

Judge Lucy Koh’s order that sided with consumers begs the question of what the broader repercussions are to industry given the current environment around added sugar. Attorney Allan Zackler advises that while “Kellogg may ultimately prevail if the case proceeds to judgement, this is a good illustration of the risks of making any claim not specifically authorized by FDA regulations.” Dale J. Giali of law firm Mayer Brown added, “As far as what this means going forward, food companies should be able to reduce this type of litigation risk by re-doubling their efforts to refrain from positioning as better-for-you or healthy a food product with excess added sugar.”

New Senior Policy Advisor Appointed to USDA’s Food and Nutrition Service
On September 5, U.S. Secretary of Agriculture Sonny Perdue named Pamilyn (“Pam”) Miller to serve as Senior Associate Administrator for Policy at the U.S. Department of Agriculture’s (USDA) Food and Nutrition Service (FNS). Miller previously spent twenty years working on nutrition policy and funding on Capitol Hill, including time on the House Agriculture and Appropriations Committees.

CSPI Urges Trump Administration Not to Use Trade Talks to Thwart Nutrition Labeling
On September 6, the Center for Science in the Public Interest (CSPI) published a statement urging the Trump administration to accelerate progress on front-of-package labeling in the U.S. and to “not undermine public health efforts around the world.” CSPI argues U.S. trade negotiations should support the types of public health initiatives such as Chile’s front-of-package labeling requirements that spurred reformulation of many packaged foods so companies could avoid placing “high in sugar” on packages. However, the Trump administration appears to still be using trade negotiations with Mexico and Canada to block similar progress.

USDA Sets December 1 Target Date for “GMO” Final Rule
According to a September 13 Politico update, the USDA is aiming to publish its final rule to implement the National Bioengineered Food Disclosure Standard (NBFDS) by December 1, 2018. Greg Ibach, undersecretary for marketing and regulatory programs said USDA wants to line up enforcement of the rule with the implementation of the FDA’s updated NFL to ease the burden on manufacturers. FDA Commissioner Scott Gottlieb told Politico the agency is not considering a delay of the January 1, 2020 NFL compliance deadline to account for USDA’s timeline.

As a reminder, CCC submitted comments to the proposed rule in July, which acknowledged the importance of developing a regulatory framework that supports the aims and principles of the NBFDS and provides consumers with accurate, science-based information about food, and took the position that refined ingredients should not be included in the definition of bioengineered food and thus should not be required to be labeled. CCC also signed on to comments from the Coalition for Safe and Affordable Food.

California Law Signed to Limit Soda in Kids’ Meals, Washington D.C. Could Be Next
As reported by CBS, on September 20, California Governor Jerry Brown signed a law that will take effect January 1, 2019 and will require milk, a non-dairy milk alternative, or sparkling, still or flavored water to be provided as the default beverage and advertised on the menus for children’s meals. However, soda and juice can still be purchased upon request.

A statement published by CSPI on September 18 announced its support for similar new legislation introduced called the “Healthy Kids’ Meal Bill,” which replicates California’s initiative to require children’s meals at restaurants to come with a healthy beverage.

Court Allows Case to Proceed on NGO Lawsuit on GRAS Rule
On September 14, the National Law Review reported on a court-filed opinion released September 12 holding that the Center for Food Safety and the Environmental Defense Fund do in fact have standing to sue FDA regarding the agency’s final 2016 Generally Recognized as Safe (GRAS) rule. This ruling follows FDA’s previous motion to dismiss the suit on the basis that the organizations lack standing to sue. Therefore, it is now possible that the Court will eventually rule on the substantive issues raised by the plaintiffs that FDA’s GRAS rule finalized in 2016 “(1) violates fundamental principles of separation of powers, (2) exceeds FDA’s statutory authority, (3) does not accord with the law, (4) is arbitrary and capricious, and (5) is an abuse of discretion.”

As a reminder, CCC is a member of the Safe Food Ingredients Coalition (SFIC), an industry coalition that was formed several years ago to address challenges by PEW and other advocacy organizations regarding the U.S. food additive and GRAS processes. SFIC is meeting soon to discuss this development and consider actions to support FDA and the existing regulatory framework. You may also recall CCC joined the Joint Committee to develop a Publicly Available Standard for demonstrating the safety of GRAS substances per the Grocery Manufacturers Association’s (GMA) “GRAS Modernization Initiative.” This work was stalled recently, but has been resumed and CCC plans to continue to actively participate through the Chemistry Task Group.

New CDC Data Shows Adult Obesity Rates Present Need for More Prevention Programs
On September 12, non-profit health policy organizations Trust for America’s Health and the Robert Wood Johnson Foundation published the 15th annual State of Obesity: Better Policies for a Healthier America report. The report, based on 2017 data from the U.S. Centers for Disease Control and Prevention (CDC) reveals obesity rates have topped 35 percent in 7 states, which is up from 5 states reported two years ago. States with obesity rates of 35 percent or more now include Iowa and Oklahoma. The others are Alabama, Arkansas, Louisiana, Mississippi and West Virginia. Furthermore, no state showed notable improvement in its obesity rate over the previous year. The report offers recommendations for government policymakers, restaurant and food industries, and the health care system, including that “Food and beverage companies should follow the American Heart Association’s guidance concerning children’s intake of added sugars as they develop, reformulate, and market foods and beverages intended for children…” and “Food and beverage companies should eliminate children’s exposure to advertising and marketing of unhealthy products.”

International Policy and Regulatory Updates

New Updates Reported for Foods Marketed to Children in North America
In September, the Council of Better Business Bureaus’ Children’s Food and Beverage Advertising Initiative (CFBAI), comprised of business bureaus across the U.S., Canada and Mexico, announced their initiative to strengthen the Category-Specific Uniform Nutrition Criteria that apply to foods advertised to children, and have agreed to an implementation date for its updated criteria of January 1, 2020 to coincide with FDA’s NFL regulations. CFBAI published a white paper that explains the revisions, including stepwise progress toward lower sodium and added sugars. Highlights from the revised criteria include the following:

• More transparent and descriptive food categories – the revised criteria include new categories for foods that were previously bundled together in one broad category. The new categories have more rigorous requirements that better recognize the different dietary roles of the foods and their varied nutrient or ingredient compositions.
• To align with the new NFP, CFBAI has adopted an “added sugars” criteria. The new criteria replaces “total sugars” used in the 2011 criteria.
• Stricter sodium and added sugars limits in key categories – in response to Dietary Guidelines and other global recommendations, CFBAI has reduced sodium limits in thirteen of the seventeen categories, and estimates that the new added sugar limits represent at least a 10% reduction in key categories such as Milks, Cereals, Savory Snacks, Sweet Snacks and Exempt Beverages.
• The food group and positive nutrient requirements have been strengthened.

Low and no-calorie sweeteners are not addressed in the revised criteria. However, CFBAI concludes its white paper by stating they “also must assess whether new or different categories or subcategories are necessary to reflect innovation and new foods in the marketplace. CFBAI will continue to evaluate whether changes to the revised criteria are warranted in order to ensure that the program remains dynamic and responsive.”

As a reminder, CCC has also been following and previously commented on Health Canada’s proposed regulations on restricting marketing of unhealthy foods and beverages to children. Staff has been in contact with the Canadian Beverage Association (CBA), which reported that Health Canada’s latest proposal was that any food/beverage containing more than 5 percent Daily Value of either sugars, sodium or saturated fat could not be marketed to children, but did not propose to restrict marketing of products containing low- or no-calorie sweeteners.

Japan Holds Meeting to Discuss Genome Editing Technology
On August 27, a USDA Global Agricultural Information Network (GAIN) report was released that includes information on the second technical meeting held by Japan’s Ministry of Environment (MOE) to discuss the handling of genome editing technology under the Cartagena Protocol on Biosafety. It was agreed that as long as a product does not contain nucleic acids from a foreign source, it should not be categorized as genetically engineered (GE) under Japan’s existing GE regulations. Similarly, the modification of the genome and the introduction of genes, which could occur naturally or conventional cross breeding, won’t be regulated as GE either. The report notes the MOE plans to have an “Advisory Panel on GMOs” meeting in the near future to discuss this conclusion with legal experts.

English Treasury Warns Against Calories on Menus
On September 5, BBC News reported that England’s Treasury has warned against the Department of Health’s efforts to implement calorie labeling requirements as part of its childhood obesity strategy. Chief Secretary to the Treasury Liz Truss has said the policy would burden 26,000 small businesses and could lead to job cuts. The Federation of Small Businesses’ chairman Mike Cherry explained, “Businesses will have to spend hundreds to work out a precise calorie count and when recipes change, which could well incur additional costs unless regulations are written with small business in mind.” The Department of Health and Social Care is expected to launch a public consultation on restaurant calorie labeling soon.

UK to Consider Relaxing Gene Editing Ban
As reported by Food Navigator on September 14, the UK has confirmed it will consider relaxing the EU’s decision in July to include gene editing techniques within its regulatory framework that restricts the use of GMOs. The EU ruled that crops obtained by mutagenesis are GMOs, as the techniques and methods of mutagenesis alter the genetic material of a plant in a way that does not occur naturally. In opposition, the UK had backed exempting gene editing from EU’s GMO regulations.

Considering Brexit, scientists are asking the government to provide clarity on the future of gene edited crops in the UK. A letter signed by 33 scientists stated “We feel there are significant questions that must be addressed urgently by government if the UK is to retain its strength in plant genetics, to use innovation to boost productivity and competitiveness…” In response, a spokesperson for the Department of Environment, Food and Rural Affairs (DEFRA) said that the government would “consider” the points raised in the letter and issue a reply “in due course.”

Consumer Organization Challenges EU Law Protecting Intellectual Property
According to an August 31 article in Food Navigator, a non-profit environmental law organization ClientEarth with offices in London, Brussels and Warsaw, is requesting the European Commission’s (EC) proposal on the transparency and sustainability of the EU risk assessment in the food chain. According to the law organization, the wording of the proposal is “highly problematic” and compromises food safety since it contains provisions that guarantee intellectual property rights and data exclusivity, allowing food companies to withhold certain information. The proposal does however allow confidential information to be disclosed when urgent action is needed to protect public, animal, or environmental health, or when the information is part of the conclusions to the European Food Safety Authority (EFSA) opinion and relates to probable health effects. However, ClientEarth lawyer Dr. Apolline Roger pushes that this is not enough, and that the proposal must not allow broad confidentiality claims and must not restrict the right of the public and NGOs to request access to confidential information when disclosure is of public interest.

Industry Questions WHO’s Evidence for Support of Sugar Taxes
In September, Euractiv, a European media publication, published a special report titled “Reducing sugar consumption: Is taxation effective?” which analyzes challenges policymakers face regarding sugar taxes in the EU and several related initiatives such as food reformulation. As part of this report, Euractiv published an article on September 11 discussing industry’s position that the World Health Organization (WHO) has no evidence to support its claim that sugar taxes effectively improve public health.

As the next European Health Interview Survey is scheduled to be published in 2019, focus is increasing on whether or not the taxation of sugar-sweetened beverages “may contribute to a reduction in overweight and obesity” as WHO said it would. However, industry argues there is no concrete evidence proving this outcome. Still, a WHO spokesperson argues, “Evidence from Europe and worldwide shows that when countries introduce taxes, purchase and consumption of SSBs goes down, industry reformulates to remove sugar, and awareness of the health harms of excess sugar intake goes up – thus contributing to the prevention of obesity and diabetes,” and further added that taxes can also cut healthcare costs and increase revenues to invest in health services.

The industry argues that product reformulation isn’t necessarily the answer, and may lead consumers to cheaper brands with similar or even higher calorie content. According to an older study commissioned by the EC, taxes on high sugar products can reduce their consumption but not necessarily the consumption of the targeted ingredients, and can even increase the consumption of other products. While, industry has already achieved a 12 percent sugar reduction between 2000 and 2015 and has made an additional 10 percent framework commitment across Europe, Unesda, the EU soft drinks trade association, claims reformulation and sugar reduction lead to taste changes that are too radical. As such, there is a risk consumers may switch to other beverages and continue to consume the same or even higher levels of sugars.

Publication Updates

Study Published on Alternative Sweeteners in Schools
On September 10, Cambridge University Press published a study on alternative sweeteners in food and beverage products in schools. The cross-sectional study (PDF attached) aimed to provide a baseline assessment of the extent to which state laws and school district policies address restrictions on the use of alternative sweeteners.

Data was collected from the 2014-15 school year on all fifty states and Washington, DC. State laws and local school wellness policies (LWP) were rated based on their strength of restrictions on alternative sweeteners, and prevalence of state laws and LWP nationwide was computed. According to the study’s results, only six states’ laws (AR, DC, IN, MA, RI and TX) addressed alternative sweeteners for both competitive foods and beverages (CF&B). Nine states’ laws (AR, DC, IN, MA, NC, NM, RI, TX and WV) addressed alternative sweeteners in competitive foods. Ten states’ laws (AR, CA, CT, DC, IN, LA, MA, OH, RI and TX) addressed alternative sweeteners in competitive beverages. Across all districts and grade levels, only 23.9 percent of the LWP addressed any restrictions on alternative sweeteners for CF or CB.

School district sweetener policies most frequently applied to beverages in elementary schools’ vending machines and were more likely to address alternative sweeteners if state laws addressed alternative sweeteners. However, the authors conclude most state laws and LWP do not address alternative sweeteners and further note this is not surprising since the FDA has approved eight alternative sweeteners for consumption and the Smart Snacks in School regulation does not limit alternative sweeteners.

Study Published on Impact of Three Different Nutrition Labels
On September 8, the journal Nutrients published a study titled “Impact of Front-of-Pack Nutrition Labels on Portion Size Selection: An Experimental Study in a French Cohort.” In the study, researchers compared the impact of three nutrition labels – the Evolved Nutrition Label (ENL) developed by the food industry based on the Traffic Light logo but uses different nutrition thresholds; Nutri-Score which has been adopted in France and Belgium and assigns one color for the whole product; and the Traffic Light label used extensively in the UK and Ireland that gives separate colors for the sugar, salt, fat and saturated fat content in a product.

For the study, over 25,000 French participants were asked to view product images of sweet biscuits, cheeses and sweet spreads, and select the portion they would like to eat. The researchers found that the Nutri-Score label led to the lowest portion size, followed by Traffic Lights, while the ENL showed “inconsistent” results across food categories. They conclude “With the ENL, consumers are potentially misled about the real nutritional quality of the product and would feel less restraint, resulting in the selection of larger portion sizes, which contradicts the initial objective of the ENL.”

Legislative Analyst Office Finds CA Soda Tax Initiative Would Generate Billions for Health Care
On September 5, the California Dental Association (CDA) published an article highlighting the Legislative Analyst Office’s (LAO) analysis of the California Sugar-Sweetened Beverages Tax Act of 2020, a ballot measure filed in July by CDA and the California Medical Association to implement a 2-cents-per-ounce tax on sugar-sweetened beverages. The LAO concluded that the tax would generate an estimated $2-3 billion annually, $1.6 to $2.5 billion of which would be dedicated exclusively to health care. In addition to this projected annual revenue from the soda tax initiative, CDA adds California could double its health care investment through federal matching funds, making between $3 billion and $5 billion available for improving health care in California. CCC staff will continue to monitor and keep members informed of progress with this initiative.

CDC Report Shows 1 in 7 Americans Has Diabetes

On September 19, the CDC’s National Center for Health Statistics (NCHS) published a data brief showing that 1 in every 7 Americans has diabetes. Of the 14 percent of US adults who have diabetes, more than 4 percent are undiagnosed. According to the American Diabetes Association, about 95 percent of diabetes cases are type 2, which is often tied to overweight or obesity. About 5 percent of diabetes cases are type 1, which can arise early in life and is not linked with lifestyle factors. Lead CDC researcher Mark Eberhardt stated “Diabetes remains a chronic health problem in this country, affecting some 30 million people.”

Council Updates

CCC Signs on to Letter of Support for Biotech Education
CCC signed onto the attached letter sent to the Chairs and Ranking Members of the US House and Senate Agriculture Committees on behalf of the Coalition for Safe and Affordable Food (CFSAF) in support of biotech education language that was included in the House version of the Farm Bill. The letter notes comments from CFSAF (which CCC co-signed) on the proposed rule to implement the National Bioengineered Food Disclosure Standard included a recommendation that USDA conduct an educational campaign to help ensure that consumers possess a reasonable understanding of the various disclosure options, including what they mean with respect to whether a product is produced with bioengineered ingredients.

CCC Signs on to Letter on Trade Secret and Confidential Commercial Information
CCC signed on to the attached Food & Beverage Issue Alliance (FBIA) letter shared with the US House and Senate Appropriations staff regarding management of trade secret and confidential commercial information (TS/CCI) by the FDA, as required under FSMA. The letter urges Congress’s support in requesting the overdue detailed description of FDA’s systems to ensure protection of TS/CCI, which has been flagged as a potential gap by FBIA member associations.

CCC 2018 Annual Meeting Reminder
As a reminder, the CCC 2018 Annual Meeting will take place November 7-9 at the Hyatt Regency Crystal City just outside Washington, DC. The Board and all CCC Committees and Working Groups will meet, and the Educational Symposium will feature regulatory updates and other presentations focusing on carbohydrates and LNCS. If you need information about the meeting, please contact Judy Rogers.

Communications Update

General Program

• Council’s Medical Advisor, Dr. Keri Peterson, is writing a series of articles highlighting data from the CCC/Harris Poll survey. Dr.Peterson completed a four-part series on weight loss, including “Top 5 Lifestyle Changes People are Making to Achieve Weight Loss,” “After Losing Weight, Many Americans Struggle To Keep The Weight Off,” “What’s Your Why? The Top Reasons Why Americans Want to Lose Weight,” and “What’s Your Why Part Two: The Top Reasons Americans Feel They Have Gained Weight.” Staff is now set to promote to audiences through advertising.
• Council Social Media Advisor (SMA) Rosanne Rust, MS, RDN, completed new content covering the many benefits of low- and no-calorie sweeteners, entitled “Safety and Benefits of Low or No Calorie Sweeteners.” Staff is set to post and promote through advertising.
• Council Social Media Advisor, Jen Haugen, RDN, LD, completed a video describing how to cut calories while cooking savory dishes with low- and no-calorie sweeteners. Staff is preparing to promote video with advertising.

Working Groups 

• Sucralose: Council Social Media Advisor, Jen Haugen, RDN, LD, completed a video outlining the benefits of baking and cooking with sucralose. Staff is preparing to promote video with advertising.
• Aspartame: Staff created and posted “Healthcare, Patients, and Social Media” to Aspartame.org. This article discusses the role social media plays in advising patients on health and nutrition.   This content is geared toward a health care provider audience.
• Polyols: Staff is in the process of creating an infographic on the basics of polyols, geared towards the consumer audience. Once completed, this infographic will be translated into Spanish and Portuguese.
• Fiber: Council’s Medical Advisor, Dr. Keri Peterson, has completed an article on the benefits, sources and tolerance of fiber. Additionally, Council’s Scientific Advisor, Robyn Flipse, completed “Closing the Fiber Gap,” addressing the majority of the populations fiber deficiency and where to find fiber. Staff will post then promote both pieces of new content through advertising.
• Allulose: Staff developed advertising targeted to healthcare professionals (registered dietitians, diabetes educators) via Today’s Dietitian, which will run in October.
• Stevia: Healthcare Professionals: Four EatRight Pro SmartBriefs paragraph ads are running, beginning Sept. 25th and going through October, as part of the CCC/ISC collaboration promoting the Keith Ayoob paper, timed right before the Academy of Nutrition and Dietetics’ FNCE.

In this Issue

US Policy and Regulatory Updates
• USDA Releases Food and Nutrient Database for Dietary Studies 2015-2016
• FDA Pushed to Revise Redbook to Modernize Food Additive Evaluations
• California Court Rules Against Cancer Warnings on Breakfast Cereal Packaging
• FDA Commissioner Gottlieb Releases Statement on Modernizing SOI for Dairy
• FDA Announces Information Collection Submitted to OMB on Proposed New Food Safety, Health, and Diet Survey
• FDA Requests Comments on Voluntary Labeling of Products Derived from GE Plants
• FDA to Host Monthly Webcast on BPA
• Washington State To Decide on Anti-Soda Tax Measure
• Boulder, Colorado to Vote on Sugary Drink Tax in November
• California Governor Expected to Sign Bill on Restaurant Beverages for Children

International Policy and Regulatory Updates
• EFSA Launches Public Consultations on Draft Guidance on Methodologies for Human Health Risk Assessment and Draft Statement on Genotoxicity
• CRISPR Plants Now Subject to EU GM Laws
• Europe’s Top Beet Producer to Make Lower-Sugar Sweetener
• India Publishes Draft Notification on Calorie Displays in Food Service Establishments
• India Sets up Expert Panel to Review Proposed Packaged Food Labeling Rules
• Poland Releases Draft GE Labeling Legislation
• Brazil Debates Best Option for Mandatory Labeling Policy
• Belgium Launches NutriScore Labeling

Publication Updates
• New Report Indicates Promise for Sugar Reduction Techniques in Dairy Products
• Canada Releases New Report – Counting the Calories

Council Updates
• CCC Staff Attends FDA Public Meeting to Discuss Nutrition Innovation Strategy Implementation
• CCC Responds to FSSAI Request for New Data on Polyols/Sweeteners
• CCC 2018 Annual Meeting Reminder
• Communications Update

US Policy and Regulatory Updates

USDA Releases Food and Nutrient Database for Dietary Studies 2015-2016

On July 30, the U.S. Department of Agriculture (USDA) released the Food and Nutrient Database for Dietary Studies 2015-2016. This database is released every two years and is used to convert foods and beverages in What We Eat in America (WWEIA), National Health and Nutrition Examination Survey (NHANES) into gram amounts and to determine their nutrient values. FNDDS is made available for researchers using WWEIA, NHANES to review the nutrient profiles for specific foods and beverages as well as their associated portions and recipes. Such detailed information makes it possible for researchers to conduct enhanced analysis of dietary intakes.

FDA Pushed to Revise Redbook to Modernize Food Additive Evaluations
According to a July 30 article in Food Chemical News (subscription required), Tom Neltner, chemicals policy director at the Environmental Defense Fund (EDF), is calling on the U.S. Food and Drug Administration (FDA) to update its roadmap for food safety assessments commonly referred to as the Redbook.

In 2014, FDA held a public meeting and gathered public input to modernize the Redbook which serves as a resource to help guide industry on evaluating the safety of food additives and color additives. (As a reminder, CCC submitted comments and co-signed a Safe Food Ingredients Coalition comment to FDA in May 2015.) The article notes that in 2015, FDA stated their interest in “expanding the scope of the Redbook to emphasize the principles of safety and risk assessment that are shared across different regulatory contexts for foods and cosmetics, while still providing specific guidance for applying these principles in particular contexts…” But Neltner contests that the agency has not followed up or provided an update on this initiative and is requesting that FDA keep track of food additives in a way that allows stakeholders to monitor the cumulative effects of substances on human health. He argues that, FDA should implement a process similar to the Environmental Protection Agency (EPA), which requires companies to report every five years on the amount of chemicals they make whenever it goes into children’s products.

When asked for an update on the agency’s work to update its Redbook, FDA refrained from speculating on the timing of any changes.

California Court Rules Against Cancer Warnings on Breakfast Cereal Packaging
As reported by Legal Newsline on July 25, the Los Angeles Superior Court ruled against a doctor’s attempt to force cereal companies to display cancer warnings on products sold in California. Dr. Richard Sowinski alleged that breakfast cereals from several global CPG brands must have cancer and reproductive health warnings on their packaging because they contained acrylamide, a chemical included on the Proposition 65 list of harmful substances. However, the three-judge panel unanimously ruled in favor of the cereal companies’ petition which stated that such warnings are preempted by federal law that encourages “federal policy objectives to increase Americans’ consumption of whole grains.” Though this case does not directly address low- and no-calorie sweeteners, it indicates California’s move to exercise enforcement discretion with regard to Proposition 65 when considered in the context of potentially discouraging healthy choices that are encouraged by federal authorities.

FDA Commissioner Gottlieb Releases Statement on Modernizing SOI for Dairy
On July 26, FDA published a statement addressing a key pillar of the agency’s Nutrition Innovation Strategy – modernized standards of identity, specifically for dairy products. The statement addresses the current proliferation of products made from soy, almond or rice calling themselves milk. However, these alternative products are not the food that has been standardized under the name “milk” established by the Federal Food, Drug, and Cosmetic Act (FD&C Act), and may therefore mislead consumers and promote unintended nutrient deficiencies and related public health consequences. However, Gottlieb confirms that, “While dairy has received a lot of attention, there are many other standards of identity that need to be revisited and potentially modernized. After all, there are nearly 300 of these standards of identity on our books, some of which were created in my grandparents’ generation.” The statement includes a call to action for stakeholders to submit comments to the related NIS docket on the following considerations related to statements of identity:

• How the FDA should assess whether a standard of identity reflects consumer expectations about that food.
• Changes in food technology, nutrition science, fortification practices and marketing trends that should be considered.
• It is noted that FDA has “heard concerns that these standards of identity can sometimes cause industry to avoid reformulating products to reduce things like fat or sodium content because of the limitations of these standards…” Therefore, the agency wants to hear about how modifications in FDA standards can facilitate the production of more healthful foods.

FDA Announces Information Collection Submitted to OMB on Proposed New Food Safety, Health, and Diet Survey
On August 14, FDA announced in a Federal Register (FR) notice that a proposed collection of information related to the agency’s proposed “FDA Food Safety, Health, and Diet Survey” has been submitted to the Office of Management and Budget (OMB) for review and clearance. The survey would combine the “Food Safety Survey” and the “Health and Diet Survey” which have been conducted since the late 1990’s. Since there are many related topic areas included in both surveys, FDA has decided to combine them. The newly proposed survey will contain many of the same questions and topics as the previous surveys, and measure trends in food safety, diet knowledge, attitudes, and behaviors over time. This survey’s focus will be on three major themes: Eat, Shop, and Prepare. Information gathered using the survey will be used by FDA to monitor and evaluate its programs and policies relating to menu labeling, use of the Nutrition Facts label, and food safety education activities.

Original requests for comments on the proposed collections of information for OMB for the separate “Food Safety Survey” and “Health and Diet Survey” were published in July of 2017 (CCC did not submit comments). The current notice presents a consolidated estimated annual reporting burden for both surveys under one OMB control number. This type of FR notice is largely administrative and seeks to collect feedback on the estimated reporting burden. However, CCC may also use the comment opportunity to include other feedback related to the proposed new survey.

Public comments are due September 13. If you would like CCC to submit comments, please notify me by Friday, September 7.

FDA Requests Comments on Voluntary Labeling of Products Derived from GE Plants
On August 9, FDA published an FR notice announcing an opportunity for public comment on the information collection associated with the guidance to assist manufacturers who wish to voluntarily label their foods (human and animal) as being made with or without bio-engineering, or the use of bio-engineered ingredients, to ensure that labeling is truthful and not misleading. With respect to this collection of information, FDA invites comments on these topics:

(1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility;

(2) the accuracy of FDA’s estimate of the burden of the proposed collection of information (see Table 1 in the notice), including the validity of the methodology and assumptions used;

(3) ways to enhance the quality, utility, and clarity of the information to be collected; and

(4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Public comments are due October 9. If you would like CCC to submit comments, please notify me by Friday, September 14.

FDA to Host Monthly Webcast on BPA
This month, FDA announced it will be hosting its monthly Grand Rounds webcast on September 13 from 12 -1 pm US ET. FDA’s Grand Rounds webcasts highlight research underway across the Agency and its impact on protecting public health. The September webcast lecture is entitled “Bisphenol A: Toxicology and Pharmacokinetic Data to Inform On-Going Safety Assessments,” and will summarize the results of studies FDA has undertaken with other U.S. Government agencies over the past decade to address alleged data gaps identified by FDA’s Science Board. For more information on the presentation and presenter, visit here. Pre-registration is required (register here).

Washington State to Decide on Anti-Soda Tax Measure
According to an August 14 article published by Food Chemical News (subscription required), Washington state voters will be asked to weigh in on a proposal (Initiative 1634) to prohibit communities in the state from enacting their own sweetened-beverage taxes. However, only days after the statewide anti-soda tax proposal was placed on the November ballot, new data was released suggesting that Seattle’s soda tax, which was implemented six months ago, is on track to raise more money than projected. In an August 8 article, city officials told the Seattle Times they have collected more than $10.5 million from payments from the tax, which includes $5.8 million from the first quarter of the year and $4.7 million in the second quarter.

While I-1634 would not affect the existing 1.75-cents-per-ounce soda tax in Seattle, it would close the loophole used by the city to pass a tax on beverages and prevent other cities from doing the same. “Yes! To Affordable Groceries” – a coalition of citizens, community organizations, and businesses, specifically soda companies – will have to battle against groups such as the Childhood Obesity Prevention Coalition, who plans to educate voters about the true impact of such a proposal.

Boulder, Colorado to Vote on Sugary Drink Tax in November
According to an article published August 14 by a local news source, voters in the city of Boulder, Colorado, will get the chance to decide on a measure that, if passed, would allow the city to keep extra revenue raised by the city’s 2-cents-per-ounce tax on sugar-sweetened beverages. According to Colorado’s Taxpayer’s Bill of Rights, the revenue collected over the originally estimated $3.8 million would be required to be refunded. While the most obvious recipient of the returned funds would be distributors, small business owners and consumers say much of the costs have been passed onto them.

In 2016, a majority of voters (54.7 percent) approved the city tax. The article notes that since the tax was implemented, over $3.2 million of the revenue has been given to groups working to improve the health of Boulder’s low-income residents and those with diet-related diseases. The tax is now expected to bring in $5.2 after its first full year in place. This would mean if the measure is not passed in November, upwards of $2 million will have to be returned to businesses.

California Governor Expected to Sign Bill on Restaurant Beverages for Children
On August 20, The San Diego Union Tribune published an article highlighting a highly publicized California Senate Bill (SB-1192) aiming to address the state’s childhood overweight and obesity problems by introducing a policy to discourage restaurants from serving soda to children. News of this bill passing on the state Assembly floor on August 16 was picked up by several major online, print, and TV outlets who stirred up opposition and falsely reported that SB-1192 would ban restaurants from serving soda to children. However, this is not the case. The bill would require restaurants to offer water, sparkling water, flavored water or unflavored milk or a nondairy milk alternative as the “default beverage.” The bill defines “default beverage” as a beverage automatically included or offered as part of a children’s meal unless a costumer asks for a different drink. It would not prohibit a restaurant’s ability to sell, or a customer’s ability to purchase, an alternative beverage such as soda. Many expect Governor Jerry Brown to sign the bill into law shortly.

International Policy and Regulatory Updates

EFSA Launches Public Consultations on Draft Guidance on Methodologies for Human Health Risk Assessment and Draft Statement on Genotoxicity
On July 26, the European Food Safety Authority (EFSA) launched the following two public consultations which present new approaches to risk assessment:

• Draft guidance on harmonized methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals (link here; comment deadline September 15)
• Draft Statement on genotoxicity assessment of chemical mixtures (link here; comment deadline September 9)

If you would like CCC to submit comments please notify staff by Friday, September 7.

CRISPR Plants Now Subject to EU GM Laws
On July 25, the Court of Justice of the European Union released a ruling that organisms created using relatively new gene-editing technologies such as CRISPR-Cas9 are subject to the same stringent 2001 directive as conventional genetically modified (GM) organisms. An article in Nature notes the ruling is likely to hinder investment in crop research using these tools in the EU, and that while gene-editing techniques will still be used as a research tool in developing crops, there is doubt that companies in Europe will have much appetite to develop them.

Europe’s Top Beet Producer to Make Lower-Sugar Sweetener
On July 31, Reuters published an article featuring Suedzucker, Europe’s largest beet producer, as the next industry resource to help companies cut the amount of sugar in foods. The company is underway developing a sweetener that provides the same level of sweetness but with 40 percent less sugar. The product, which uses a mineral molecule to bind with sugar molecules to reduce the need for as much sugar, has already received regulatory approval in the EU.

India Publishes Draft Notification on Calorie Displays in Food Service Establishments
On July 24, the Food Safety and Standard Authority of India (FSSAI) notified the World Trade Organization (WTO) of a draft notification relating to the display of calorie information in food service establishments. The notice, which can be viewed here, required the display of the following information in food service establishments at the point of purchase:

(a) any warning/statutory declarations required under these regulations;
(b) information relating to allergens in the food;
(c) logo for veg or non-veg;
(d) information relating to gluten free and low gluten status in food; and
(e) information relating to organic food or ingredients.

Public comments are due September 21. If you would like CCC to submit comments, please notify me by Friday, September 7.

India Sets up Expert Panel to Review Proposed Packaged Food Labeling Rules
As reported by Food Navigator on August 21, based on concerns FSSAI received by stakeholders on the authority’s proposed labeling regulations, “an expert panel of experts with health and nutrition backgrounds” have been convened to “look into the draft regulations”, despite the draft already being sent to the Health Ministry for finalization.

FSSAI’s proposed labeling regulations for packaged foods include placing a mandatory red-colored mark on the front-of-pack label for foods high in fat, sugar or salt. FSSAI may also introduce a color coding system in addition to marking certain foods as “red”. Further, foods high in fat, sugar, or salt would not be allowed to be advertised to children.

While the industry will continue to lobby against FSSAI’s plans, several major health groups, regulators, and manufacturers have recently joined a broad coalition called the “Eat Right Movement” which aims to encourage consumers to make healthy food choices while pushing firms to promote healthier food options, provide better nutritional information, and reformulate products to reduce sugar and salt content in packaged foods.

Poland Releases Draft GE Labeling Legislation
According to a July 30 USDA Global Agricultural Information Network report, the Polish Ministry of Agriculture (MinAg) issued new draft voluntary labeling standards for food products free from genetic engineering (GE). The draft standard would include a “non-GMO” label. According to MinAg, the draft legislation is in response to Polish public requests, as well as calls from consumer organizations and food industry groups to differentiate between products containing GE and non-GE ingredients. Eligible products under the draft Act would include processed and unprocessed foods of plant and animal origin. Products that are not produced using GE and products without any EU GE approvals (e.g. apples) would not be eligible to use the “non-GMO” label.

Poland currently implements EU GE labeling regulations for labeling food products. Packaged foods and packaged feeds are required to be labeled if GE-derived ingredients exceeds 0.9-percent of the products total composition. Poland’s MinAg will take public comments into consideration and plants to submit the draft labeling standards to Polish parliament in early September, 2018.

Brazil Debates Best Option for Mandatory Labeling Policy
As reported by Food Navigator LATAM on August 15, the Brazilian Health Regulatory Agency (ANVISA) is debating between front-of-pack traffic light labels supported by the country’s food and beverage industry, and a warning label supported by the country’s leading consumer protection organization. The traffic light labels would display percentages of sugar, total fat and sodium in the product and assign colors for high, medium, or low levels. The warning label would feature separate triangular black labels on products high in sugar, sodium, total fats, saturated fats or trans fats.

The president of Brazil’s Association for Soft Drinks and Non-Alcoholic Beverages (ABIR), Wilson Mello, explains the traffic light system is the industry’s preferred option because it is universally recognized and leaves room for consumer choice. Mello states that the warning sign model being evaluated, which is similar to the one implemented in Chile, would “alarm consumers” and “create the wrong idea that food in any quantity will be bad for their health.” On the other hand, Ana Paula Bortoletto, food program leader for the Brazilian Institute of Consumer Protection (IDEC) argues, “The excess of data, numbers, or colors with different connotations, such as the traffic light labels, leads the consumers to confusion or misleading interpretations.”

The article reports that ANVISA will likely finalize its decision on the look of mandatory front-of-pack labels by the end of 2018. It is also noted that the food and beverage sector has expressed support for the joint agreement to introduce new front-of-pack compulsory labeling across the entire Mercosur region (Argentina, Brazil, Paraguay, and Uruguay).

Belgium Launches NutriScore Labeling
As reported by Food Navigator on August 23, Belgium has announced it is introducing the NutriScore voluntary labeling scheme to promote healthy eating. NutriScore ranks foods from -15 for the ‘healthiest’ products to +40 for those that are ‘less healthy.’ Based on this score, the product is assigned a corresponding color code and letter from dark green (A) to dark red (F). Belgium’s public health minister Maggie De Block said the NutriScore system was the preferred choice over other labeling systems, such as the UK’s traffic light scheme, because tests in France – where it has already been adopted – show it has “greater impact” on purchasing habits.

The article reports that reaction by the Belgian food industry has been “more muted.” Although Fevia, the umbrella trade association of the Belgian food industry, has expressed concern that the system over-simplifies nutritional guidance, and fails to distinguish between various nutritional requirements of different consumer groups.

Publication Updates

Gallup Poll Reveals Americans Divided on Leaving Sugar Off the Plate
On August 10, Gallup published an article highlighting key generational and demographic differences between Americans when choosing to minimize fat, salt, or sugar intake. Gallup polled Americans on 13 different food categories in its 2014, 2015 and 2018 Consumption Habits surveys, asking whether they actively try to include or avoid items in their diet. Combined results show that while 51 percent of all Americans actively avoid sugar, there are differences among subgroups. For example, 62 percent of college graduate try to keep sugar out of their diets, compared with 47 percent of those without a degree. The article also reports that young people are least likely to actively avoid salt, sugar or fat, likely because they are the age group most likely not to make an effort to decide whether to avoid or include those items in their diet. For example, the percentage of adults ages 18-24 who said they actively try to avoid sugar was found to be 12 percent less than those 65 and older.

Pinto App Modernizes Diet-Specific Food and Beverage Recommendations
On August 14, Fortune published an article featuring a new phone app that went live this month called Pinto, which aims to provide specific, tailored nutrition information to consumers. While the app was developed by a startup comprised of one designer, two programmers, three dietitians, and one food scientist, Pinto’s nutritional database contains 100,000 food items from major grocery stores, companies, and the nation’s 200 most popular fast-food and fast-casual restaurants. The app harnesses this data to analyze if products or ingredients comply with certain dietary profiles, and provide a brief description of why. Of interest to CCC, if a consumer selects the “Diabetes Friendly” profile, diet soda will pop up as “A good choice for your food profile” and “Fits with Diabetes Friendly.” The same diet soda for the “Healthy Eating” profile shows up as “A good choice for healthy eating” and “Low Sodium.” However, other foods with LNCS are not recommended for profiles such as Low FODMAP. The article notes that the team is already working on its next version which will include a filter for pregnancy and the ability to merge two profiles together for the purposes of couples who shop and organize meals together.

While the app is free to consumers, Pinto makes money by providing intelligence to food retailers on what customers are seeing in their purchases. For example, CEO and founder Sam Slover explains, “A restaurant [or store] can learn how much of its menu is Whole30-compliant and shift marketing around that…The share of Americans with specific dietary needs and wants isn’t going anywhere. [Pinto] is a way to lock in a relationship with them.”

New Report Indicates Promise for Sugar Reduction Techniques in Dairy Products
On August 19, the Journal of Dairy Science published a report (PDF attached) in which researchers reviewed recent studies assessing the role of sugar, alternative sweeteners, and sugar reduction in products such as ice cream, yogurt, and flavored milk. Further, the report discusses options available to the dairy industry to reduce sugar without compromising flavor. An article published on August 20 by EurkaAlert highlights the importance of this report, noting that many dairy products are potentially high in added sugar, which has recently come into negative focus.

In the case of ice cream, studies have shown that reducing sugar and fat is likely to induce a bitter aftertaste and less creaminess. Researchers found that of the possible solutions, calorie-reduced ice creams sweetened with sorbitol and sucralose were most accepted compared with other “light” vanilla ice creams or ice cream with a minimum reduction of 25 percent of the total energy, sugar, or fat. Erythritol is also noted to be commonly used for sugar reduction in ice cream because of its ability to provide volume and texture with a fraction of the calories from sucrose. For frozen yogurt, a study determined that substituting inulin and isomalt for sugar and fat led to a similar sweetness and a reduction in fat with no added sugar.

Within the yogurt category, several studies found that blends of nonnutritive sweeteners have been very successful in reducing sugar content of yogurt. One study is referenced that reported it was possible to produce a probiotic yogurt successfully using a sweetener blend (sucrose, aspartame, saccharin, and sucralose) without affecting the viability of the probiotic microorganisms. This same study found the addition of nonnutritive sweeteners did not negatively affect the yogurt-making process because the sweeteners did not break down over time.

Finally, flavored milk was considered. Since reducing sugar in chocolate milk can be costly, many directors of school meal programs choose the higher sugar alternative to reduce cost or choose to eliminate chocolate milk entirely. However, one study showed that withdrawing a chocolate milk option meant that three or four additional foods needed to be added into the diet to replace the nutrients from milk, adding additional calories and cost. Therefore, sugar-reduced chocolate milk should be considered.

Canada Releases New Report – Counting the Calories
As announced in an August 21 release provided by the Canadian Beverage Association (CBA), the Conference Board of Canada published a report August 9 that explores how the contribution of liquid refreshment beverages (LRBs) to Canadians’ diets is changing over time. Highlights from the report are as follows:

• According to data from the latest Canadian Community Health Survey, between 2004 and 2015, all provinces are following the general trend towards fewer calories/day from non-alcoholic beverages including regions where obesity rates have increased.
• Despite the fact that obesity rates continue to rise in Canada, overweight Canadians reduced their beverage calorie consumption by 45% and obese Canadians by 41% between 2004 and 2015.
• Calories from non-alcoholic beverages in diets of children (1-13yrs) have decreased by 47% (to 95 kcal/day) and for adolescent (14-18yrs) diets calories have decreased by 46% since 2004 (to 140 kcal/day)
• The contribution of non-alcoholic beverages to the average 2,000 kcal diet went from 7.4% of daily calories in 2004 down to 4.1% of daily calories in 2015.

There has been a greater than 30% reduction in calories consumed by Canadians overall from non-alcoholic beverages due to changing tastes and product innovation in the beverage industry.

Council Updates

CCC Staff Attends FDA Public Meeting to Discuss Nutrition Innovation Strategy Implementation
On July 26, FDA held a public meeting to begin discussing various aspects of the agency’s multi-year Nutrition Innovation Strategy (NIS), which it hopes will encourage consumers to make informed decisions about their diets and health, support the development of healthier food options and expand opportunities to use nutrition as a tool to reduce morbidity and mortality due to chronic disease. Specific tactics include developing a standard symbol for the claim “healthy,” creating a more efficient review strategy for the FDA to use when evaluating qualified health claims, allowing for labeling statements or claims on food products that could facilitate innovation to promote healthful eating patterns, modernizing standards of identity, considering changes that could make ingredient information more consumer friendly, and implementing the FDA’s educational campaign for consumers about the updated Nutrition Facts Label.

CCC staff attended the meeting and provided a detailed report and relevant insights in a separate email to members. Staff has gathered initial member feedback and is developing a first draft of CCC comments to circulate for additional member feedback prior to submitting to the NIS docket.

CCC Responds to FSSAI Request for New Data on Polyols/Sweeteners
In follow up to its proposed label declarations for foods containing polyols and sweeteners, FSSAI requested new data on regulatory approvals and studies to support the safety of these materials, especially for children. FSSAI proposed these label warnings in April, which included a warning that children should not consume products containing polyols and high intensity sweeteners, and CCC, along with other organizations responded that such warnings are not supported by the science. FSSAI apparently determined they based their recommendations on old data, so in August requested that stakeholders submit the latest data and scientific information which will be reviewed by a Working Group on Sweeteners. CCC submitted information on the safety of acesulfame potassium, aspartame, saccharin, steviol glycoside and sucralose, which is available upon request. CCC also coordinated with the European Association of Polyol Producers, which worked with its members to submit requested information for all the polyols.

Save the Date: CCC Annual Meeting 2018
The CCC 2018 Annual Meeting will be held at the Hyatt Regency Crystal City from November 7 – 9, 2018. The negotiated room rate is $199.00 plus applicable tax. Room reservations can now be made online, please reserve as early as possible as there are a limited number of rooms. Further meeting information will be available in the near future.

Communications Update

General Program

• Council’s Medical Advisor, Dr. Keri Peterson, is writing a series of articles highlighting data from the CCC/Harris Poll survey, including “Top 5 Lifestyle Changes People are Making to Achieve Weight Loss.” Staff is now set to promote to audiences through advertising.
• Council Social Media Advisor (SMA) Neva Cochran MS, RDN, LD wrapped up seven studies in her article, “The State of the Science on Sweet Taste Preference,” debunking the myth that low- and no-calorie sweeteners cause a sweet taste preference. Staff now set to promote through advertising.

Working Groups 

• Sucralose: In response to research by Bornemann et al. published in the Journal of Toxicology and Environmental Health, staff posted “Research Claims of Accumulation of Sucralose in Lab Rats Fails to Establish Safety Concern.”
• Aspartame: Council Social Media Advisor (SMA) Rosanne Rust contributed new content for Aspartame.org as part of a two part series, debunking myths around the no-calorie sweetener. The next part is set to be posted and promoted in September. This content is geared toward a health care provider audience.
• Polyols: Staff began development of a checklist, comparing the various polyols across a range of characteristics. This content will be helpful when promoting to healthcare professionals and food scientists, especially in line with Nutrition Labeling.
• Fiber: Council’s Medical Advisor, Dr. Keri Peterson, is now writing two articles targeted to healthcare professionals around fiber – one regarding tolerance and the other regarding benefits/sources. Once finished, staff will promote through advertising.
• Allulose: Staff created and launched advertising targeted to healthcare professionals (registered dietitians, diabetes educators) through Today’s Dietitian e-newsletter. Those who clicked the ad spent 37% more time reading the site and visited 40% more pages than the website’s average. The campaign continues in October with a print ad and banner advertising on TodaysDietitian.com.
• Stevia: Healthcare Professionals: To increase the awareness of stevia research presented by Dr. Keith Ayoob at the October 2017 IUNS International Congress of Nutrition, CCC Staff continued running an ad in the print magazine of Today’s Dietitian (click for magazine, ad on page 4, which was also the magazine’s AADE Conference issue). Those who visited the Dr. Ayoob page summarizing the research spent 33% more time on site than the average visitor to the site.  Food Scientists: Staff ran website advertising on IFT.org, which clicks to Dr. John Fry’s research (Sensory Analysis and Mathematical Modelling) also originally presented at last year’s IUNS.

CCC’s Monthly Digest serves to inform its members of developments from the previous month concerning topics of interest to the Council. Below are highlights which cover past, current, and on-going regulatory updates, industry & consumer issues, and Council activities from July 2018, along with more information on the Annual Meeting in November.

*PLEASE NOTE: Requests for member feedback are included below to assess whether CCC should address certain topics. CCC will only pursue comment opportunities if substantive member feedback is received.

In this Issue

US Policy and Regulatory Updates
• FDA Seeking Comments on Proposed Rule for Vending Machine Calorie Labeling
• FDA Announces Public Meeting to Discuss Nutrition Innovation Strategy Implementation
• FDA Launches New Substances Added to Food Inventory
• The Obesity Society Calls for More Research on SSB Tax
• California Bans Local Soda Taxes
• California Doctors Respond to Soda Tax Ban with New Ballot Measure
• Pennsylvania Supreme Court Upholds Philly’s Soda Tax
• Assembly member Bloom Announces Plan to Introduce SSB Fee in 2019
• Industry Forms New Sustainable Food Policy Alliance
• Trump Nominates New USDA Undersecretary for Research, Education and Economics
• Disagreements Persist Over Threshold for GMO Disclosure Threshold
• CFS Sues OMB for Records on GMO Disclosure Rule
• FDA Proposes to Restructure

International Policy and Regulatory Updates
• Australia and New Zealand Forum Investigate the Labeling of Sugars on Packaged Foods and Drinks
• Australia Seeks Comments on Use of Monk Fruit as High Intensity Sweetener
• EFSA May Recommend Limits for Kaurenoic Acid in Stevia
• Macau Implements New Sweetener Regulations
• Philippines Announces Potential Plans for Warnings on SSBs
• Philippines Opposes Proposed Rules on Required Sugar Declaration
• Scotland Publishes Plans to Restrict Marketing of Foods High in Salt, Sugar and Fat

Publication Updates
• Aspartame Poses No Negative Effects on Health: RCT
• Prebiotic fibers show gut and immune health benefits for children: RCT
• Chile’s sugar tax has led to consumption decreases: Observational Study
• Consumer Research Supports FDA’s Work on “Healthy” Claim
• NASEM Publishes Report on Science Breakthroughs to Aid in Research by 2030
• Study Highlights Effectiveness of 5:2 Diet for Controlling Diabetes and Calorie Intake
• American Academy of Pediatrics Calls for Reform of Regulation of Food Additives

Council Updates
• CCC Comments on USDA Biotech Labeling Proposed Rule
• Save the Date: CCC Annual Meeting 2018
• Communications Update

US Policy and Regulatory Updates

FDA Seeking Comments on Proposed Rule for Vending Machine Calorie Labeling
The U.S. Food and Drug Administration (FDA) is proposing to revise the front of pack (FOP) type size labeling requirements for packaged foods sold in glass-front vending machines, which were first issued in 2014. The proposed rule would apply only to those machines owned by operators with 20 or more vending machines, or those who voluntarily register with the FDA, and would require that the type size on these packages be at least 150 percent (1.5 times) the size of the net weight declaration on the front of the package. The agency notes that this action is in response to requests from the vending and packaged foods industries to reduce the regulatory burden and increase flexibility and would make the type size of calorie counts more consistent on food packages, while still ensuring that this important information is readable by consumers considering options in vending machines.

With the proposed rule, the FDA intends to allow manufacturers of glass vending machine products additional time to come into compliance, as they are proposing a compliance date of January 1, 2020 for any final rule that results from this proposed rule making. Stakeholders and the public can provide comments on this proposal by September 25. CCC does not plan to comment unless otherwise advised by Friday, August 17.

FDA Announces Public Meeting to Discuss Nutrition Innovation Strategy Implementation
On June 26, FDA announced it would be holding a public meeting on July 26 to begin discussing various aspects of the agency’s multi-year Nutrition Innovation Strategy, which looks to encourage consumers to make informed decisions about their diets and health, support the development of healthier food options and expand opportunities to use nutrition as a tool to reduce morbidity and mortality due to chronic disease. Specific tactics include developing a standard symbol for the claim “healthy,” creating a more efficient review strategy for the FDA to use when evaluating qualified health claims, allowing for labeling statements or claims on food products that could facilitate innovation to promote healthful eating patterns, modernizing standards of identity, considering changes that could make ingredient information more consumer friendly, and implementing the FDA’s educational campaign for consumers about the updated Nutrition Facts Label.

CCC staff attended the meeting and will separately provide relevant insights shortly.

FDA Launches New “Substances Added to Food” Inventory
On June 26, FDA announced the launch of the new Substances Added to Food inventory, which is an upgraded version of the original “Everything Added to Food in the U.S.” (EAFUS) inventory. The new inventory allows for the search of approximately 4,000 substances and includes information on food additives, color additives, and Generally Recognized As Safe (GRAS) and prior-sanctioned substances. In addition, the inventory includes users to search multiple related food ingredient and packaging inventories, direct links to any applicable regulations for a substance, and additional information such as other known names, common uses, and information by other entities when available.

The Obesity Society Calls for More Research on SSB Tax
Steven B. Heymsfield, MD, FTOS, President-Elect of The Obesity Society (TOS), professor and director of the Body Composition-Metabolism Laboratory at the Pennington Biomedical Research Center at Louisiana State University in Baton Rouge, says that the net outcome of sugar-sweetened beverage (SSB) taxes “may not necessarily decrease overweight and obesity rates in the United States or worldwide.” In the official press release, Heymsfield also notes that questions remain regarding the best way to structure these taxes and how any resulting dietary changes might influence health.

California Bans Local Soda Taxes
On June 28, California Governor Jerry Brown signed a law prohibiting cities and counties from enacting taxes on soda for the next 12 years. According to the Los Angeles Times, the fast-moving bill was the result of an agreement by legislators, industry and labor interests after they agreed to remove an initiative from the November 2018 statewide ballot that was initiated by the beverage industry and would have restricted cities and counties from raising any taxes without a supermajority vote of local citizens.

State legislators accused the beverage industry of “aiming basically a nuclear weapon at governing in California and saying if you don’t do what we want, we’re going to pull the trigger and you are not going to be able to fund basic government services.”

California Doctors Respond to Soda Tax Ban with New Ballot Measure
On July 2, the California Medical Association (CMA) and the California Dental Association (CDA) filed a new ballot measure that would implement a statewide 2-cents per ounce tax on sugar-sweetened drinks, providing at least $1.7 billion in revenue for critical health programs. Their actions follow passage of a ban on new soda taxes until 2031 in the state and would be up for consideration during the 2020 US election.

The CMA and CDA collectively represent more than 70,000 healthcare professionals in California. In a joint statement, Dustin Corcoran, CMA chief executive officer, and Carrie Gordon, CDA chief strategy officer cited “overwhelming evidence” linking sugar-sweetened beverages with obesity, diabetes and tooth decay.

Pennsylvania Supreme Court Upholds Philly’s Soda Tax
As reported on July 20 by Food Chemical News (subscription required), Pennsylvania’s Supreme Court delivered a 4-2 ruling to uphold Philadelphia’s 1.5 cent-per-ounce tax on soda and rejected a challenge to the tax from a group of industry, merchants, and businesses called the “Ax the Philly Beverage Tax” coalition, who argued that the tax is an illegal duplication of Pennsylvania’s state sales tax. The majority of judges on the panel, however, disagreed and said that the Philadelphia soda tax is different than the state’s sales tax, since it applies at the distribution level and is “independent of whether any retail sale actually occurs.”

Assembly member Bloom Announces Plan to Introduce SSB Fee in 2019
Richard Bloom, who represents California’s 50th Assembly District, has announced his intent to introduce a “health impact” fee on SSBs that would be used to fund obesity and diabetes prevention programs. Bloom’s announcement followed a press release in which CMA and CDA announced their goal to introduce a similar ballot measure in 2020.

In the official press release Bloom states, “The overconsumption of sugar sweetened beverages has led to a staggering rise in obesity and diabetes in California. Low income communities, communities of color, and children have been targeted by the soda industry and are facing increasingly dire health outcomes. We can’t wait until 2020. We need to act now.”

Industry Forms New Sustainable Food Policy Alliance
As reported on July 12 by Politico, four major food companies – Danone, Mars, Nestle and Unilever – have formed a new coalition called the Sustainable Food Policy Alliance (SFPA), which will lobby on five policy areas it believes are of top interest to modern consumers: product transparency, nutrition, the environment, food safety and a positive workplace for food and agriculture workers. SFPA reportedly will focus its initial efforts on nutrition labeling and carbon emissions. One of the group’s current priorities is to push the government to define “healthy” based on strong, science-based regulations. The Washington Post also reported the group is pressing the FDA to advance the implementation of the new nutrition facts panels proposed under the Obama administration, which more prominently highlights added sugar and calorie content. SFPA also submitted comments on the proposed rule to implement the National Bioengineered Food Disclosure Standard asking FDA to apply the disclosure requirements to a wider range of oils and sweeteners. Further, SFPA states their positions through several commitments to consumer transparency, including the statement “We are confident that currently approved gene-based technologies for food production are safe.”

Trump Nominates New USDA Undersecretary for Research, Education and Economics
As reported by Politico, on July 16 President Donald Trump nominated Scott Hutchins for the next Under Secretary for research, education and economics within the US Department of Agriculture (USDA), a position previously slotted for Sam Clovis before his controversial withdrawal. Hutchins is currently the global head of integrated field sciences for the agriculture division of DowDuPont. If confirmed by the Senate, Hutchins would serve as USDA’s top scientist.

Disagreements Persist Over Threshold for GMO Disclosure Threshold
On July 17, Food Chemical News (subscription required) reported on the public discourse in reaction to three options for the minimum threshold for exemption from USDA Agricultural Marketing Service’s (AMS) proposed rule to implement the Bioengineered Food Disclosure Standard. While two of the options allow the “inadvertent or technically unavoidable presence” of genetic material at either a 0.9 percent or 5 percent level by weight of specific ingredient, the third would permit the use of Bioengineered (BE) ingredients up to 5 percent of the total weight of the product.

Supporters of the 0.9 percent threshold for inadvertent presence include environmentalists and consumer advocates, including the Non-GMO Project and the Center for Food Safety, who stated that the 5 percent threshold is arbitrary and would exempt broad segments of the BE food market from disclosure. Major food companies also expressed support for 0.9 percent, noting this threshold is both feasible for industry and would meet consumers’ demand for transparency. In addition, 0.9 percent is supported by the Organic Trade Association (OTA), who rejected the American Soybean Association’s suggestion that a 5 percent allowance for GE material should be made because organic regulations allow for use of 5 percent non-organic ingredients.

However, the American Farm Bureau Federation (AFBF), and other groups representing growers of major agricultural products urged AMS to adopt a threshold of 5 percent, stating concerns that a lower level would “denigrate biotechnology” and could further encourage consumer distrust.

CFS Sues OMB for Records on GMO Disclosure Rule
On July 20, Food Chemical News (subscription required) reported that the consumer group the Center for Food Safety (CSF) filed a lawsuit on July 3 against the White House Office of Management and Budget (OMB) for failing to supply documents related to the review of the draft GMO disclosure rule. CSF submitted a Freedom of Information Act (FOIA) request with OMB on May 3 for all documents from December 2017 when AMS sent the agency the draft rule related to implementation of the National Bioengineered Food Disclosure Standard. According to the lawsuit, OMB acknowledged receipt of CSF’s request but has otherwise ignored it.

FDA Proposes to Restructure
On July 20, Politico reported that the FDA is planning to restructure in order to consolidate some operations. The proposed plan would create two new offices – the Office of Clinical Policy and Programs and the Office of Food Policy and Response – that would take over some of the duties now handled by offices dealing with medical products, tobacco, veterinary medicine, and food.

International Policy and Regulatory Updates

Australia and New Zealand Forum Investigate the Labeling of Sugars on Packaged Foods and Drinks 

The Food Regulation Standing Committee (FRSC), which is responsible for coordinating policy advice to the Australia and New Zealand Ministerial Forum on Food Regulation, is a facilitating stakeholder consultation on the labelling approaches for providing information on sugars to consumers. FRSC is inviting stakeholders including industry, public health and consumer organizations and other interested parties to make submissions on the Consultation Paper, which contains open questions regarding the labelling of sugars on packaged foods and drinks.

The deadline to comment on the consultation is September 19. If you are interested in CCC providing comments, please advise staff by Friday, August 17.

Australia Seeks Comments on Use of Monk Fruit as High Intensity Sweetener
On July 20, Food Standards Australia New Zealand (FSANZ) announced it is calling for submissions on an application to permit a new sweetener derived from monk fruit, or luo han guo. After conducting a thorough safety assessment, FSANZ concluded there are no public health or safety issues related to the use of monk fruit extract as a sweetener. FSANZ is accepting public comments on this matter until August 31. CCC does not plan to comment on this request unless otherwise advised by Friday, August 17.

EFSA May Recommend Limits for Kaurenoic Acid in Stevia
According to an article published July 12 by Food Navigator, Representatives from Cargill, DSM and the International Stevia Council (ISC), as well as Pure Circle, The Coca-Cola Company, SweeGen and Intertek, met with European Food Safety Authority (EFSA) scientists to discuss kaurenoic acid, an impurity in stevia sweeteners. In a presentation given on behalf of EFSA at the meeting, it was noted that, previously, the presence of the acid was not reported in application dossiers submitted by stevia producers. As a result, no limits are included in the specifications for food additive steviol glycosides.

DSM, Cargill, PureCircle and Sweegen submitted data from tests on commercially available samples. Out of 40 samples, the acid was not found at levels of detection ranging from <0.25 to <1 part per million (ppm). A DSM spokesperson states that the company has “no doubts about the safety of the acid at the very low levels in which it is present in steviol glycosides.” A SweeGen representative noted that it’s “very easy” to limit kaurenoic acid in stevia and doing so would not result in increases in cost.

Macau Implements New Sweetener Regulations
As noted in the attached World Trade Organization (WTO) notice, on June 4, new sweetener regulations were published by Macau, China. Although the regulation is only available in Chinese and Portuguese, it is noted that the regulation is administrative in nature. In this regulation, “sweeteners” are defined as a type of food additive that is used to replace sugar and impart sweet taste to food. It does not apply to foods intended for specific dietetic use, with the exception of certain products for infants and young children. There is not an opportunity for public comments.

Philippines Announces Potential Plans for Warnings on SSBs
According to a July 2 article in Food Navigator, the Philippines’ Department of Trade and Industry (DTI) announced it may be requiring health warnings on sugar-sweetened beverages (SSBs) within the next one to two months. However, the article notes the DTI will first consult stakeholders in order to select categories of products that will be required to display a health warning. In addition, DTI’s Secretary Ramon Lopez confirmed that the Philippine’s Department of Health (DOH) and its own Food and Drug Administration (FDA) will be the ultimate authorities for execution of the policy.

The Philippines has already taken steps to reduce consumption of SSBs under the Philippines’ Tax Reform for Acceleration and Inclusion (TRAIN) law. As a health measure, the law mandates a P6 per liter tax on beverages using caloric and non-caloric sweeteners and a higher P12 per liter on beverages using high-fructose corn syrup.

The Philippine Society of Endocrinology, Diabetes, and Metabolism (PSEDM) has supported such further steps to require warning labels on SSBs, calling the government’s anticipated move timely as diabetes rates are growing in the Philippines.

Philippines Opposes Proposed Rules on Required Sugar Declaration
As reported on July 10 by Business World, the Federation of Philippine Industries (FPI) has opposed the DTI’s proposed rules that would require companies to include sugar content per pack and per serving on front-of-pack labels for beverages in both liquid and powdered form. The DTI proposed requiring this labeling for amounts greater than 25 grams of sugar per 200 milliliter serving. FPI claims that the government is singling out sugar, which it claims is “a consumer good that has weathered its fair share of challenges at the expense of several concerned industries” and argues against the volumetric nature of the tax, instead insisting on the adoption of a content-based scheme which is in alignment with the SSB tax under the TRAIN law. The article reports that FPI urged the government to also consider exempting non-caloric sweeteners from the labeling and taxation scheme so as not to impose a financial burden to senior citizens and those wanting to cut their sugar intake.

Scotland Publishes Plans to Restrict Marketing of Foods High in Salt, Sugar and Fat
Earlier this month, Scotland’s government published a report entitled “A Healthier Future – Scotland’s Diet & Healthy Weight Delivery Plan” two months after Minister Nicola Sturgeon announced a new target to cut child obesity in Scotland by half by 2030. The newly-published strategy paper sets out measures to restrict the promotion and marketing of foods high in fat, sugar and salt. It is anticipated that more detailed plans will be released in the fall with an opportunity for public comment, which CCC staff plans to monitor for and provide more details on for members.

Publication Updates

Aspartame Poses No Negative Effects on Health: RCT
A recent study sought to assess the effects of aspartame on several health factors including glucose tolerance, weight and appetite. The 12-week trial included 100 lean adults aged 10-60 years of age who were randomized to consume 0, 350, or 1050 mg aspartame/day for the length of the study. Body weight and composition, appetite and selected hormones were measured at baseline and at week 12, in addition to the administration of a 240-minute oral glucose tolerance test (OGTT). Participants kept appetite logs, and body weight, blood pressure, heart rate and waist circumference was measured weekly. 24-hour urine samples were collected at weeks 4, 8 and 12.

With the exception of the baseline OGTT glucose concentration at 60 min (and resulting area under the curve value), there were no group differences for glucose, insulin, resting leptin, glucagon-like peptide 1, or gastric inhibitory peptide at baseline or week 12. There also were no effects of aspartame ingestion on appetite, body weight, or body composition.

Prebiotic fibers show gut and immune health benefits for children: RCT
A study funded by a member company reported that supplementing the diet of three to six year olds with chicory root fiber may improve the gut microbiota composition and strengthen their immune defenses. The study is said to be the first to examine the effects of chicory root extract in this age group, with previous data supporting benefits in infants and children up to the age of two years old.

A sample of 142 boys and 128 girls between the ages of 3 and 6 were randomly assigned to consume 6 grams per day of either prebiotic fiber or maltodextrin (control) for 24 weeks. The researchers found significant increases in the relative abundance of Bifidobacterium (20% increase) and Lactobacillus (8% increase) in those who received the chicory root fiber as compared to the control group. A reduction in the incidence of febrile episodes requiring medical attention and sinusitis were also observed in the prebiotic group.

Prebiotic fibers show gut and immune health benefits for children: RCT
A study funded by a member company reported that supplementing the diet of three to six year olds with chicory root fiber may improve the gut microbiota composition and strengthen their immune defenses. The study is said to be the first to examine the effects of chicory root extract in this age group, with previous data supporting benefits in infants and children up to the age of two years old.

A sample of 142 boys and 128 girls between the ages of 3 and 6 were randomly assigned to consume 6 grams per day of either prebiotic fiber or maltodextrin (control) for 24 weeks. The researchers found significant increases in the relative abundance of Bifidobacterium (20% increase) and Lactobacillus (8% increase) in those who received the chicory root fiber as compared to the control group. A reduction in the incidence of febrile episodes requiring medical attention and sinusitis were also observed in the prebiotic group.

Chile’s sugar tax has led to consumption decreases: Observational Study
According to a new study, the 2014 tax on sugar-sweetened beverages in Chile has led to an overall decrease in the volume of sugary soft drink purchases of almost 22%. Researchers from the University of York and the University of Chile also report that greater decreases in purchase volume were seen in the middle and high socioeconomic groups, with only a 12% reduction seen in the low SES group.

Co-author of the study, Professor Cristobal Cuadrado says the results “suggest an overall reduction of sugar consumption after the implementation of the tax in Chile. From a public health perspective, even a small reduction in sugar intake at the population level could lead to significant health gain.” It should be noted, however, that this study did not include a control group and therefore the true causal impact of the tax could not be assessed.

Consumer Research Supports FDA’s Work on “Healthy” Claim
According to consumer research reported in a July 5 article on Food Navigator, consumers are increasingly associating the term ‘clean’ with ‘natural’ and ‘healthy.’ However, the term ‘clean’ is also a cause for confusion, and while research showed that some liked a product because it is ‘clean,’ many asked what ‘clean’ meant. The lack of a clear definition of ‘clean’ and the increasing association with health by consumers has only furthered pressure on FDA to define ‘healthy.’

In March 2018, FDA Commissioner Scott Gottlieb released the FDA Nutrition Innovation Strategy, noting “‘Healthy’ is one claim that the FDA believes is ready for change and we have already signaled our intention to update the criteria for this claim. The Agency is considering how to depict ‘healthy’ on the package so that consumers can easily find it. Similarly, the FDA has also received requests for clarity on the use of ‘natural’ in labeling. Just like other claims made on products regulated by FDA, we believe the ‘natural’ claim must be true and based in science.” It is further stated that “Availability of information about nutrients [including] those we need to limit, such as added sugars and sodium…remain a core aspect of our role and nutrition strategy.” However, the article notes that another logo or symbol to indicate the healthy status of products may not be the answer, as research found that only 44% of consumers reported that they trust claims on food and beverage products.

In the meantime, consumers are tending to form their own perception of what ‘clean’ means by following ‘free-from’ claims and elimination diets such as vegan, diary-free, and gluten-free. Market intelligence agency Mintel advises that brands looking to appeal to ‘clean’ eating consumers should focus on the essential messaging that makes the product beneficial for them.

NASEM Publishes Report on Science Breakthroughs to Aid in Research by 2030
On July 18, the National Academies of Sciences, Engineering and Medicine (NASEM) published a report identifying the following five most promising scientific breakthroughs that are possible to achieve in the next decade to increase the U.S. food system’s sustainability, competitiveness, and resilience.

1. A systems approach to understand the nature of interactions among the different elements of the food and agricultural system can be leveraged to increase overall system efficiency, resilience, and sustainability.
2. The development and validation of highly sensitive, field-deployable sensors and biosensors will enable rapid detection and monitoring capabilities across various food and agricultural disciplines.
3. The application and integration of data sciences, software tools, and systems models will enable advanced analytics for managing the food and agricultural system.
4. The ability to carry out routine gene editing of agriculturally important organisms will allow for precise and rapid improvement of traits important for productivity and quality.
5. Understanding the relevance of the microbiome to agriculture and harnessing this knowledge will improve crop production, transform feed efficiency, and increase resilience to stress and disease.

The document intends to sway Congress and other funders to make additional investments in research, and encourages the involvement of non-agricultural professionals.

Study Highlights Effectiveness of 5:2 Diet for Controlling Diabetes and Calorie Intake
On July 20, the Journal of the American Medical Association (JAMA) published the first long-term clinical trial comparing the different diets of people with type 2 diabetes entitled “Effect of Intermittent Compared With Continuous Energy Restricted Diet on Glycemic Control in Patients With Type 2 Diabetes.” The study found that patients with type 2 diabetes are just as likely to control their blood glucose levels and lose weight by following what has been termed the ‘5:2 diet’ as they are on a calorie-restricted on every day.

The ‘5:2 diet’ entails restricting calories to 500 to 600 per day for 2 days of the week followed by the person’s usual diet for the other 5 days. After researchers conducted the year-long clinical trial of 137 adults with type 2 diabetes, half of whom followed a 5:2 diet while the rest maintained stable daily caloric intakes of 1,200 to 1,500 calories per day, findings showed that those on a 5:2 diet lost weight and achieved improved hemoglobin A1c levels. In a July 23 press release research affiliate Peter Clifton commented in support of the study findings, stating “Conventional weight-loss diets with daily energy restrictions are difficult for people to adhere to so we must look for alternative solutions.”

American Academy of Pediatrics Calls for Reform of Regulation of Food Additives

The American Academy of Pediatrics released a policy statement on July 23 (in print August 2) calling for “urgently needed reforms” at the U.S. Food and Drug administration to ensure the safety of food additives used in foods and packaging, arguing for more rigorous testing requirements and regulations. While AAP’s statement does not address alternative sweeteners, it questions the ability of FDA’s regulatory oversight to ensure the safety of the food supply for children, who, as the policy states, “may be particularly susceptible to the effects of these compounds, given that they have higher relative exposures compared with adults (because of greater dietary intake per pound), their metabolic (i.e. detoxification) systems are still developing, and key organ systems are undergoing substantial changes and maturation that are vulnerable to disruptions.” CCC staff is working with other associations to consider activities to address this statement.

Council Updates

CCC Comments on USDA Biotech Labeling Proposed Rule
On July 3, CCC submitted the attached comments to the USDA regarding AMS’s proposed rule to implement the National Bioengineered Food Disclosure Standard (NBFDS). CCC also co-signed comments from the Coalition for Safe and Affordable Food (CFSAF), which are also attached.

CCC acknowledged the importance of developing a regulatory framework that supports the aims and principles of the NBFDS and provides consumers with accurate, science-based information about food, and therefore took the position that refined ingredients should not be included in the definition of bioengineered food and thus should not be required to be labeled. CCC also endorsed the CFSAF comments, which support mandatory disclosure with a number of exemptions, including some refined ingredients, as well as a robust voluntary notification procedure for companies wishing to disclose of the presence of exempted refined ingredients.

Save the Date: CCC Annual Meeting 2018
The CCC 2018 Annual Meeting will be held at the Hyatt Regency Crystal City from November 7 – 9, 2018. The negotiated room rate is $199.00 plus applicable tax. Room reservations can now be made online, please reserve as early as possible as there are a limited number of rooms. Further meeting information will be available in the near future.

Communications Update

Working Groups 

• Allulose: Staff created and launched advertising targeted to food scientists through the Institute for Food Technologists (IFT) via its website, magazine and e-newsletter. As a result, July website traffic to Allulose.org is up 71% compared with June, with the ads generating page reads of 3 minutes compared with a website average of 1.5 minutes.Campaign continues in August with an e-newsletter, and in October with a print ad in Today’s Dietitian magazine and a digital ad on TodaysDietitian.com.

• Stevia: In collaboration with the International Stevia Council and to increase the awareness of stevia research presented at the October 2017 IUNS International Congress of Nutrition, CCC Staff created and launched new content and an ad campaign targeted to food scientists and registered dietitians. And the results were favorable – July website traffic to SteviaBenefits.org is up 63%.
  • Food Scientists: Staff developed and ran e-newsletter and website advertising on IFT.org, distributed a press release, and created website content featuring Dr. John Fry’s research (Sensory Analysis and Mathematical Modelling). Website visitors spent 9 minutes on Fry’s page, comparing very favorably to the typical 3 minute read time.
  • Registered Dietitians: Staff developed and ran print advertising in the July 2018 issueToday’s Dietitian and created website content featuring Dr. Keith Ayoob’s research (The State of the Science).  Website visitors spent 11 minutes on Ayoob’s page, compared to the 3 minute average. Campaign continues into August-October through Today’s Dietitian and EatRight Pro SmartBrief.