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 the last week of September through the third week of October 2018.
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
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:
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.”
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.
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:
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).
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.
General Program
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
Do you have questions about low-calorie sweeteners? Want to learn more about maintaining a healthy lifestyle? You asked and we listened. Our resident Registered Dietitians answered the most popular questions about low-calorie sweeteners.
