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
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.”
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:
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.
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.”
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.
General Program
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.
