On April 19, the U.S. Food and Drug Administration (FDA) announced in a Federal Register (FR) notice a request for comments on a proposed collection of information titled “Food Labeling: Nutrition Facts Label and Supplement Facts Label.” The information collection supports regulations in 21 CFR 101.9, which of interest to CCC, requires that, under certain circumstances, manufacturers make and keep certain records to verify the amount of added sugars when a food product contains both naturally occurring sugars and added sugars, isolated or synthetic non-digestible carbohydrates that do not meet the definition of dietary fiber, different forms of vitamin E, and folate/folic acid declared on the Nutrition Facts or Supplement Facts label. This collection of information does not specify what records are to be used to verify the amounts of these nutrients but does specify the information that the records must contain. The collection requires manufacturers to provide FDA, upon request during an inspection, the records that contain the required information for each of these nutrients to verify the amount of the nutrient declared on the label. These records may include analyses of nutrient databases, recipes or formulations, information from recipes or formulations, batch records, or any other records that contain the required information to verify the nutrient content in the final product. Tables 1, 2, and 3 in the FR notice indicates FDA’s estimates of the annual burden for recordkeeping, reporting, and third-party disclosure (respectively). FDA is seeking comments on:
As comments are due to FDA by June 18, 2019, please provide substantive feedback to staff by Thursday, May 9 if you would like CCC to submit comments. |
On April 17, FDA published a notice announcing the issuance of draft guidance on how allulose should be listed on Nutrition Facts labels. The guidance, titled “The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels” provides FDA’s current view of how to declare calories, total carbohydrates, total sugars, and added sugars for products that contain allulose. FDA’s 2016 Nutrition Facts label final rule required that allulose be counted towards the amount of total carbohydrates, total sugars, and added sugars in products. According to the updated guidance, FDA intends to exercise enforcement discretion which will allow manufacturers to exclude allulose from the declared amounts for total and added sugars, respectively. FDA’s guidance also allows manufacturers to use a caloric value of 0.4 kcal/g for allulose because, “based on the range of data [FDA has], such a caloric value would not underestimate the caloric contribution.” Manufacturers will still need to include allulose under total carbohydrates. CCC’s Allulose Working Group is working to respond to the draft guidance. |
On April 17, Food Navigator-USA published an article reporting on the effect that FDA’s new guidance on allulose may have on consumers and manufacturers. Despite the positive attributes of allulose, manufacturers and consumers initially shied away from using the product due to its association with traditional sugar. Industry experts believe FDA’s shift away from treating allulose like traditional sugar on the Nutrition Facts label will clarify to manufacturers and consumers that allulose is different from traditional sugar. |
FDA Grants Citizen Petition for Dietary Fiber On March 27, FDA released an announcement that it intends to propose “cross-linked phosphorylated RS4” (regardless of source) be added to the definition of dietary fiber in response to a citizen petition from MGP Ingredients Inc. Based on available evidence, FDA determined that cross-linked phosphorylated RS4 can help reduce insulin levels following a meal containing carbohydrates that raise blood glucose levels. Companies can submit citizen petitions requesting that additional fibers be added to the definition of dietary fibers. Petitions are reviewed on a rolling basis. |
On March 27, Phys Org published an article detailing the findings of a recent study conducted by researchers at the Stanford Business School, suggesting Philadelphia’s soda tax has fallen short of its intended goals.The researchers studied more than three years of sales information at over 1,200 retail locations. Overall, their findings suggest that while the soda tax seems to be reducing consumption, the reduction is minor and is placing more of the tax burden on lower-income communities. The researchers did caution against making broad assumptions about soda tax effectiveness, highlighting Philadelphia’s small size which makes it easier for residents to travel farther out to avoid taxes, and the fact that the city laid a blanket tax on all sodas, including diet drinks. Of interest to CCC, the researchers suggest that taxing only regular soda and not their diet counterparts might encourage consumers to avoid sugar, as was the intention of the tax. |
On March 27, Politico Pro (subscription required) published an article reporting on the Sustainable Food Policy Alliance’s (SFPA) call for the federal government to consider climate change when drafting future editions of the Dietary Guidelines. The alliance released a high-level framework outlining several principles it believes should be considered in the 2020 update to the Dietary Guidelines for Americans (DGA). These principles include environmental impact, public health, and cultural concerns. As noted in the framework, SFPA recommends the 2020-2025 DGA should:
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On March 25, Forbes published an article reporting on a Citizen Petition filed earlier last month by KIND Healthy Snacks. The petition urges the FDA to change its regulations on nutrient content claims to reflect the overall nutrient quality of food, rather than the quantity of a specific nutrient. KIND states its concern that while products can claim they are a good source of fiber, vitamins, calcium, etc., they can also be very high in salt, sugar, saturated fat, or other excesses. KIND Founder and CEO, Daniel Lubetzky, explains, “Dressing up empty calorie products by emphasizing a singular nutrient, like protein or fiber, versus the overall quality of the food is unfair to consumers.” FDA has not responded to this petition. |
On March 28, Policy & Medicine published an article reporting on now-former Commissioner Gottlieb’s announcement that details FDA’s reorganization plan. According to his announcement, the Office of Medical Products and Tobacco, the Office of Foods and Veterinary Medicine, and the Office of Global Regulatory Operations and Policy will be realigned to new offices under the Office of the Commissioner. This move is intended to establish a direct line between the Commissioner’s office, Center Directors, and Office leadership. |
On March 27, the U.S. Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) announced the appointment of Michael Durando as Deputy Administrator and James Ivy as Associate Deputy Administrator of the Fair Trade Practices Program (FTPP). Michael Durando has held several significant roles in the USDA, including Associate Deputy Administrator of the FTTP and Director of the AMS Marketing Order and Agreement Division. James Ivy will be joining AMS from the Animal and Plant Health Inspection Service where he served as the Associate Deputy Administrator for Legislative and Public Affairs with USDA’s Animal and Plant Health Inspection Service (APHIS). |
On March 28, the Center for Science in the Public Interest (CSPI) released an article reporting on new legislation passed in New York City that restricts restaurants from defaulting to sugary beverages on children’s menus. More specifically, the law designates that restaurants default to healthier beverage options, such as water, low-fat milk, or 100% juice. The bill garnered support from the American Beverage Association who also offered support to restaurants that would like to remove sugary beverages from their children’s menus voluntarily. |
On March 28, a local California news station reported on a new bill in the California state legislature that would require safety labels on sugar-sweetened soda and juice drinks. Senate Bill 347 passed the Senate Health Committee on March 27 by a 5-1 vote with three Senators abstaining. If passed, the new bill, titled the Sugar-Sweetened Beverages Safety Warning Act, would require retailers and distributors to include a warning label on containers or points-of-purchase that states, “Drinking beverages with added sugar(s) may contribute to obesity, type 2 diabetes, and tooth decay.” This bill is not expected to include diet drinks as part of its mandate. |
Proposed Statewide Soda Tax in California On April 9, CNBC published an article reporting on the proposed statewide soda tax in California. The proposed bill would tax sugar-sweetened beverages and use the revenue to fund programs to combat diabetes and other chronic health conditions. The bill’s author, Assemblyman Richard Bloom of Santa Monica, has introduced similar legislation in the past, but each attempt was voted down. According to a poll funded by the American Beverage Association (ABA), 60% of likely 2020 voters in California oppose new state soda taxes. The tax is not expected to include diet drinks as part of its mandate. |
On April 2, EurekAlert! published an article reporting on a study that analyzed food and drink purchases at UC Berkeley-owned dining facilities and Berkeley drug stores before and after residents voted in favor of the new soda tax. The study’s findings indicate that the “Berkeley vs. Big Soda” campaign, which advocated in favor of the soda tax may have contributed to the consumption change before the price change. |
On March 29, PoliticoPro (subscription required) published an article reporting on the Dietary Guidelines Advisory Committee’s (DGAC) new subcommittee structure. This structure will help the DGAC address the major scientific topics being considered in the 2020 update of the Dietary Guidelines. The newly established subcommittees will function as working groups focused specifically on a particular topic and are as follows:
The subcommittees will post monthly updates of their work on the Dietary Guidelines website. |
U.S. Supreme Court to Consider Whether Courts Must Defer to Agency’s Interpretation of its Regulations On April 1, The National Law Review published an article reporting on a current Supreme Court case that could overturn the principle of judicial review over federal agency actions. On March 27, the Supreme Court heard arguments on whether a federal court should yield to an agency’s interpretation of its own regulations. This precedent, known as ‘Auer deference’ from the 1997 case Auer v. Robbins, was the basis for dismissal of several class action suits concerning ‘No Sugar Added’ claims on 100% juices. These cases permitted juice with no added sugar to be considered a substitute for juice with added sugar. A ruling is expected at the end of June. |
FDA’s Nutrition Innovation Strategy Updates to Labeling and Standards of Identity On April 5, Food Navigator-USA published an article reporting that FDA will continue to push forward with its Nutrition Innovation Strategy despite Commissioner Gottlieb’s departure. During the Grocery Manufacturers Association’s recent Science Forum, Claudine Kavanaugh, senior advisor for nutrition policy at FDA’s Office of Food Policy and Response, stated, “We are going to keep moving on with the innovation strategy. There are not changes.” Kavanaugh provided updates on a few projects relating to the Strategy, noting that FDA intends to reopen a public comment period on a 2000 proposed rule modernizing the standards of identity. She also reminded attendees that the new Nutrition Facts label will go into effect for major manufacturers in January 2020. |
FDA to Consider a ‘Healthy’ Icon for Food Packaging On April 1, Pacific Standard published an article reporting on FDA’s pending decision on how to define ‘healthy’ labeling on food packaging. Based on a recent Hagstrom Report interview with now-former Commissioner Gottlieb, FDA is still debating the appearance of the icon, but a rule regarding this new regulation is predicted to be issued this summer. Currently, FDA bases its definition of ‘healthy’ on a food’s nutrient and fat content but Gottlieb has noted that, “People don’t eat nutrients. They eat foods. And foods need to be assembled into diets that give people proper nutrition.” |
Innovators Capitalizing on Consumer Interest in Keto On April 2, Food Business News published an article analyzing industry innovations that are catering to the popular ‘keto’ dieting trend. Keto was identified as the most popular consumer diet for 2019 in Pollock Communications’ annual “What’s trending in nutrition” survey. According to the article, industry is looking to develop products that are in line with keto branding while also staying relevant long term. Of interest to CCC, some companies have started marketing a range of non-sugar sweeteners as being keto-friendly products, including stevia and monk fruit blends, as well as 100% erythrtiol sweetener. |
Nonprofits Sue Panera Bread for Marketing Foods as ‘Clean’ On April 2, The Corporate Social Responsibility Newswire published an article reporting on a lawsuit filed against Panera Bread. Nonprofits Clean Label Project and GMO Free USA are alleging that Panera used deceptive marketing and sales practices of certain bread products, sandwiches, and other goods as “clean,” after these products tested positive for contaminants including glyphosate. According to GMO Free USA’s report on glyphosate in restaurant foods, samples from Panera Bread contained the highest glyphosate levels of the fifteen restaurants tested. |
On April 3, the University of Washington (UW) Health Sciences Department posted an announcement regarding grant funding awarded by the Robert Wood Johnson Foundation. This funding will be utilized to undertake studies focused on sugary drinks. One study will examine the extent to which taxes on sugar-sweetened beverages are regressive and whether progressive investments of those revenues will affect net economic impact on households. The other study will develop and test counter-marketing and health-beverage social media messages among parents of Latin children ages 0-5. |
States Sue Trump Administration Over Rollback of School Lunch Standards On April 3, The New York Times published an article reporting on a lawsuit filed by a coalition of states and advocacy organizations against the Trump administration over its rollback of school nutritional standards. The administration’s new rules would weaken requirements that school lunches must contain less salt and more whole grains. The lawsuit alleges that the administration violated the Administrative Procedure Act by issuing its rules with little public notice and no reasonable explanation. |
FDA’s ‘Absence Claim’ Guidance Could Change Labeling Practices On April 12, the American Council on Science and Health published an article reporting on how non-binding guidance revised by FDA in March 2019 could change ‘GMO absence’ claims on labels. The guidance, titled “Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants” can be found here. The “Non GMO Project” is a non-profit organization known for placing its ‘Non-GMO Project verified’ labels on items that traditionally wouldn’t contain bioengineered ingredients in the first place, like salt and water. These types of labels are misleading to consumers and if FDA’s non-binding guidance were to become enforceable, it would change how organizations like the “Non-GMO Project” conduct business. |
On April 15, PoliticoPro (subscription required) published an article reporting on a study sponsored by the American Heart Association published April 15 in the journal Circulation. The study found that the FDA’s new requirement to disclose added sugars on the Nutrition Facts labels could prevent a substantial amount of diet-related diseases which would ultimately save billions in health care costs. Specifically, researchers found that the additional information on sugar labeling and the reformulation of more products could prevent 708,000 cardiovascular disease cases, and 1.2 million diabetes mellitus cases over a twenty year time frame. |
FDA Announces Intentional Adulteration Inspections to Begin in March 2020 On April 17, FDA published a notice announcing that routine inspections to verify compliance with the Intentional Adulteration (IA) final rule will begin in March 2020. FDA also announced that it will not provide an extension for the July 2019 compliance date despite industry requests. FDA believes the March 2020 inspection date will allow industry time to fully develop and implement the resources available to become fully compliant with the rule. The IA final rule is meant to prevent acts of intentional adulteration that would cause wide-scale public health harm. It will apply to both foreign and domestic companies that are required to register with FDA as food facilities under the Federal Food, Drug, and Cosmetic Act (FD&C). Covered entities will be required to develop and implement a food defense plan that outlines how that facility will prevent acts of intentional adulteration. |
International Policy and Regulatory Updates On April 18, BioMed Central journal published a new study that analyzed the potential correlation between the affordability of sugar-sweetened beverages with the prevalence of overweight and obesity in a cross-section of countries. The study found that a 10% increase in sugar-sweetened beverage affordability was associated, on average, with approximately 0.4 more overweight/obese adults per 100 inhabitants. Of interest to CCC, the study also mentions industry efforts to respond to public health concerns by replacing sugar with alternative sweeteners and notes that, “this marketing strategy could simply replace one problem with another, because of the potential harmful effects of these chemical additives on human health.” |
The 2019 Rare Sugar Congress will take place in Takamatsu, Kagawa, Japan from December 3-5. The agenda is set to include a keynote session, special program, oral presentations, and reception banquet. Early bird registration goes until August 31. More information can be found on the International Society of Rare Sugars’ website. |
Consumers View Nutrition and Health Claims Differently than Regulators On March 28, EurekAlert! published an article reporting on a study published in the journal Nutrients on March 2 that suggests consumers view nutrition and health claims differently than regulators. The study’s researchers sampled consumers from the United Kingdom, Slovenia, Germany, Spain, and the Netherlands and tested whether consumers were able to differentiate between ‘healthy’ and ‘nutritious’ claims, respectively, the way that EU regulators intended under the Nutrition and Health Claims Regulation EC No 1924/2006. This regulation seeks to eliminate unsubstantiated and misleading claims about food in order to provide consumer protection. It requires that more extensive evidence be provided in order to label a product as ‘healthy.’ Despite this protection mechanism, the study’s evidence suggests consumers may not consciously differentiate between a nutrition claim and a health claim the way that regulatory experts are able to. The researchers suggested that regulators consider consumer research when developing such labeling policies. |
On March 29, Food Navigator-USA published an article reporting on a recent study conducted by Cancer Research UK that suggests a link between special offers on junk foods and obesity. Cancer Research UK found that shoppers who purchase most of their goods on promotion specials are 28% more likely to be obese than low promotional shoppers. The research looked at the habits of more than 16,000 British households and according to its findings, almost half of all junk food items were purchased while on sale. Based on these findings, Cancer Research UK has called on the UK, Scottish, and Welsh governments to introduce restrictions on price promotions for less healthy food and drink items. According to the Director of Cancer Prevention at Cancer Research UK, Alison Cox, the problem is multifaceted, “There isn’t one magic fix for the problem, but removing these incentives to buy unhealthy food is key to changing it.” |
On April 1, Food Navigator-Asia published an article reporting on new labeling regulations from the Sri Lankan Ministry of Health. The new regulations will implement a color-coded ‘traffic light’ system on packaged foods and beverages that target high levels of sugar, salt, and fat content. This regulation follows the success of a similar regulation applied to soft drinks in the country in 2016. However, there are a number of food products that will be exempt from the rule, including primary agricultural products (cereals, vegetables, fruits, etc.) and single ingredient products (packaged/bottled drinking water, tea, and coffee). The regulation is expected to go into effect on June 1, 2019. |
On April 1, Food Navigator-LATAM published an article reporting on a recent change in leadership at the Brazilian Association of Food Industries (ABIA). Nestlé Brazil’s legal vice president, Flavio de Souza, is the new chair of the trade association until 2020. As Brazil continues to debate between warning and ‘traffic-light’ labels, respectively, on food packaging, de Souza perceives warning labels as misleading. De Souza will instead continue to advocate for ‘traffic-light’ labeling regulations, which is in line with ABIA’s prior policy. |
On April 3, Health Canada’s Food Directorate published a Notice of Modification enabling the expanded use of steviol glycosides from Stevia rebaudiana Bertoni in canned fruit products. Steviol glycosides from Stevia rebaudiana Bertoni are already permitted for use in Canada as a sweetener in a variety of unstandardized foods. The use of this sweetener was enabled by modifying the List of Permitted Sweeteners. |
Researchers Demand Stricter FSANZ Governance of Food-Health Relationship Claims On April 10, Food Navigator-Asia published an article reporting a call by Australian researchers for stricter standards from Food Standards Australia New Zealand (FSANZ) regarding the food-health relationship claims system on the FSANZ notification website. In a study published in March in the journal Public Health Nutrition, researchers examined 67 of the food-health relationship claims posted on the FSANZ website. Through their independent assessments, the researchers found that 27 of these claims (40.3%) were ‘concerning’ and lacked evidence to substantiate a food-health relationship. |
Brand Trust as a ‘Shield’ Against Unhealthy Nutrition Warnings On April 15, Food Navigator-LATAM published an article reporting on a study released on March 15 in the Journal of Business Research analyzing the effect that brand familiarity has on a consumer’s nutrition choices. The researchers focused their study on consumers in Ecuador, the United Kingdom, and Chile which are countries known for their widely-used labeling systems. The study shows that the stronger the brand familiarity and trust a consumer has with a product, the less likely that the presence of traffic light or warning sign nutrition labels will stop a consumer from purchasing the product. The researchers emphasize that nutrition labels are still useful tools but that brand trust and familiarity continues to play a strong role in consumer purchasing choices. |
On April 17, Food Manufacture UK published an article discussing how 3D printing could be incorporated into the food industry. The article outlines pros and cons of the emerging technology, pointing out that while printed food might require further processing after production, some benefits would include waste reduction and sustainability. |
On April 17, Food Navigator-Asia published an article reporting on a recent debate in Australia regarding enforcement of the government’s Health Stars Rating (HSR) System. The Australian government commissioned a five-year review of the HSR system and a draft release of the report includes a recommendation that the HSR system be continued as a voluntary front-of-pack label scheme. The draft was released ahead of the deadline for accepting public comments and, in response, consumer and health groups submitted comments opposing this recommendation, claiming that “no amount of consumer education will help overcome the challenges that consumers face when comparing products with inconsistent labelling.” The Australian food and beverage industry disputes these comments and supports the review’s recommendation to keep the labeling voluntary. The Australian Food and Grocery Council’s communications director, James Matthews, stated that that HSR program, “has proved its potential as a successful public health intervention with monitoring, demonstrating it has the support and trust of consumers with many using it to guide their food and diet choices.” |
On April 17, Food Navigator-USA published an article reporting on the European Parliament’s recent decision to make food safety assessments more transparent. This decision comes in response to European citizens voicing concern over the lack of transparency in the European Food Safety Authority’s (EFSA) risk analysis. Some significant changes include the creation of a common European Database of commissioned studies and a new requirement for applicants for food safety approval to disclose all relevant information for assessing safety. However, as it relates to information disclosure, some information such as manufacturing or production process, may be kept confidential to protect intellectual capital. |
On April 19, FoodNavigator-LATAM published an article reporting on Brazil’s progress with its front-of-pack nutrition labeling decision. Brazil’s regulatory agency, ANVISA, published a report that incorporated over 33,000 contributions in an open call for data. The report is currently only available in Portuguese but a more detailed version will be released in August and a final publication will be released in September. The report is meant to provide regulators with information to help them decide which labeling model should be implemented. |
Council Updates Last month, CCC staff and several members attended the 51st session of the Codex Committee on Food Additives (CCFA51), which took place March 25-29 in Jinan, China. A follow-up email with key outcomes of CCFA51 was shared separately. Please let staff know if you did not receive this. |
On March 28 and 29, staff attended the first of five public meetings held for the 2020 Dietary Guidelines Advisory Committee (DGAC). The attached document includes topline notes from the meeting. Of interest to CCC, the DGAC discussed beverage consumption patterns during various stages of life, and took questions on added sugar related to beverages. |
On April 2, CCC signed on to the attached letter to Congress authored by the Grocery Manufacturers Association (GMA). The letter requests that language be included in the Fiscal Year 2020 National Defense Authorization Act to protect a process ensuring all stakeholders are able to provide input if the Department of Defense (DOD) attempts to restrict or ban an ingredient that is widely used and considered safe by civilian regulatory agencies. Staff is still awaiting receipt of the final letter. |
Communications Update Sweetener-Specific Activities
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