2021 Regulatory Update – August

U.S. Topline Regulatory Issues

Food Labeling Modernization Act Introduced in Congress

The Food Labeling Modernization Act was introduced to both Houses of Congress on August 3. The 35-page legislation co-sponsored by Representative Frank Pallone (D-N.J.) and Senator Richard Blumenthal (D-Conn.) proposes additional information and updates to food labels. While existing food labels provide nutrition and ingredient information for consumers to make informed food choices, the legislation claims that today’s food labeling standards do not provide adequate information for consumers to make healthy lifestyle decisions. FLMA’s largest initiative calls upon the FDA to establish a standard front-of package labeling system for all FDA-regulated food products. Similar systems are in use in various countries throughout the world and have been credited with prompting the food industry to decrease levels of sugar, sodium and saturated fat in foods.

Although FLMA was first introduced in 2018, the shift towards online grocery shopping during the COVID-19 pandemic has increased the need for nutrition information requirements to be available at the online point of sale. The current version of the FLMA requires nutrition information including Nutrition Facts, ingredients and allergen information to be displayed for online grocery items. The updated version of the FLMA also encourages the use of substitutions for overconsumed nutrients, such as sodium. By amending the “standards of identity,” which currently require minimum levels of salt in some food products, to allow for the use of salt substitutes, this change could lead to lower rates of heart disease, hypertension and high blood pressure.

Additionally, FLMA aims at eliminating marketing practices that mislead consumers. It requires products making claims about healthy ingredients like fruits, vegetables and whole grains to list the amount per serving or include percentages of these ingredients. It also creates uniform definitions of popular marketing terms like “natural,” and it will provide important information to consumers regarding caffeine content and gluten-containing grains. NCA will continue to monitor and report on any developments regarding FLMA.

CDC Updates Mask Guidance for Vaccinated Individuals

On Tuesday, July 27, the Centers for Disease Control updated its mask guidance for vaccinated individuals. In May, CDC changed its mask guidance to state that fully vaccinated individuals could resume most pre-pandemic activities without wearing a mask. However, due to the recent rise of COVID-19 cases due to the Delta variant, CDC has changed course. The new guidance states that even fully vaccinated individuals should wear a mask in indoor public places if they are “in an area of substantial or high transmission.” The agency has a detailed, searchable map of the U.S. to help determine whether an area is one with “substantial or high transmission” on a state and county basis. The classification for a particular county will be fluid and will change based on the number of cases recorded on a weekly basis. In addition to these guidelines, businesses should also pay attention to state and local guidance, which could provide more restrictions due to the uptick in COVID-19 cases because of the Delta variant.

Cannabis Administration and Opportunity Act lands in Congress

On July 14, Senators Chuck Schumer (D-N.Y.), Cory Booker (D-N.J.), and Ron Wyden (D-Ore.) released draft legislation titled the Cannabis Administration and Opportunity Act. Although cannabis use currently remains illegal under federal law, adult use of cannabis, which is classified as Schedule 1, is legal in 18 states, and the medical use of cannabis is legal in 37 states. CAOA would expunge federal non-violent marijuana crimes to petition a court for resentencing, reinvest federal cannabis tax revenue into communities historically afflicted by the “War on Drugs” and ultimately end the federal prohibition of cannabis while allowing states to continue to determine their own cannabis laws. The bill includes several provisions for additional research to investigate the impact of legalization on public health, driving safety and similar areas. Senators Schumer, Booker and Wyden are currently seeking feedback from the public as the proposal is finalized, encouraging stakeholders to submit comments by September 1, 2021. More details on FAOA are available to NCA members.

Consumer Brands Association Calls on FDA to Regulate CBD Products

In late July, the Consumer Brands Association renewed its call for government action on cannabidiol regulation in order to ensure consumer safety. In letters sent to Acting FDA Commissioner Janet Woodcock and Senator Ron Wyden (D-Ore.), CBA endorsed Senator Wyden’s Hemp Access and Consumer Safety Act to establish uniform CBD regulations and argued that a federal regulatory framework should empower federal regulators to:

• Identify the data that is needed to support the safe marketing of foods and dietary ingredients that contain CBD;
• Establish the infrastructure and processes to review safety data and allow the lawful marketing of CBD-containing ingredients that are safe;
• Ensure products are made in full compliance with existing and applicable manufacturing, processing, distributing and product claim requirements;
• Provide guidelines to protect trademark and intellectual property; and
• Align on how the current marketplace will transition to meet the requirements established through the new federal regulatory framework in partnership with stakeholders.

CBA also advocated for federal funding of federal regulators to establish such a system. CBA proposed a two-pronged approach for Congress to clarify the CBD marketplace: (1) Congress should ensure adequate funding for federal research on the health and safety of CBD products in order to allow regulators to make informed decisions; and (2) Congress should ensure that FDA has the resources to engage in market surveillance and undertake enforcement activities. CBA expressed support for the House Appropriation Subcommittee’s decision to allocate an additional $5 million to FDA’s CBD enforcement capacity in FDA’s 2021 budget.

CBA recently published the report “Unregulated and Exploding: How the CBD Market Is Growing Amid a Labyrinth of State Approaches and Rampant Consumer Confusion,” which explores consumers’ lack of understanding of the CBD market. For instance, the report found that on a scale of one to ten, consumers regarded their knowledge of CBD at an average of 3.3. Additionally, while 28% of Americans have used CBD, 74% of consumers were unsure if CBD is federally regulated. CBA asserts that while FDA’s use of warning letters may curb bad actors, a clear regulatory framework is needed to address consumer confusion created by the multitude of state approaches.

NCA is exploring its own approach to cannabis regulation as it relates specifically to the confectionery industry.  A working group has been formed to develop industry principles, especially regarding marijuana edible products.

Department of Justice Says Vaccine Mandates Not Prohibited by EUA

On July 6, the Department of Justice Office of Legal Counsel released a memo that discusses vaccine mandates and the OLC’s position that the Food, Drug, and Cosmetic Act’s Emergency Use Authorization provisions do not prohibit employer vaccine mandates. The opinion comes at an inflection point as employers debate whether to mandate the now widely-available COVID-19 vaccine for their employees or simply recommend it. The OLC opinion states that the language of the FDCA EUA provisions specify only that certain information be provided to potential vaccine recipients and does not prohibit entities from imposing vaccination requirements. In addition to the DOJ’s memo, at least two federal courts have ruled in favor of vaccine mandates.

U.S. State & City Governments Trend Toward Mandatory Vaccines

California will require all state employees and healthcare workers to be vaccinated or be subject to weekly COVID testing and mask requirements in order to remain in the workplace. All employees of the City of New York will also be similarly required to be vaccinated or be subject to weekly testing. The mayor of New York City asked that all businesses in the City think about mandating vaccines for their employees. The Department of Veterans Affairs also issued a vaccine mandate for all of its healthcare workers. On July 31, President Biden announced federal workers would be required to sign forms attesting they’ve been vaccinated against the coronavirus or else comply with new rules on mandatory masking, weekly testing, distancing and more.

At this point, it seems that a challenge to a vaccine mandate based on the vaccine’s EUA status is unlikely to be successful. It could also be that these arguments become moot should the vaccines receive full FDA approval in the near future. However, some states have barred “vaccine passports,” so businesses should continue to monitor laws, guidance and cases related to these issues and update their policies to ensure the measures taken are appropriate in the jurisdiction in which they operate.

Consumers Allegedly Deceived by Sugar Claims

A class-action lawsuit – filed on behalf of consumers in California, New York and nationwide –alleges that Campbell Soup Company and Pepperidge Farm, Inc.’s Goldfish-brand snack products (the “Goldfish Products”) are misleadingly labeled.  Plaintiffs allege that the Goldfish products do not comply with 21 C.F.R. § 101.60 (“Nutrient content claims for the calorie content of foods”) because they claim “0g Sugars” or “0g Total Sugars” (i.e, sugar free claims) without disclosing that they are “not a low calorie food,” “not a reduced calorie food” or “not for weight control.” Plaintiffs further allege that the sugar free claims misled consumers into thinking they were purchasing low calorie foods and gave defendants a competitive advantage over similarly-positioned products in the market. 

Among other criteria, Section 101.60 requires that foods claiming to be “sugar free,” “free of sugar,” “no sugar,” “zero sugar,” “without sugar,” “sugarless,” “trivial source of sugar,” “negligible source of sugar” or “dietarily insignificant source of sugar” contain less than 0.5 g sugar per serving and be labeled with a “not a reduced calorie food,” “not a low calorie food” or “not for weight control” disclaimer if the foods do not also meet the “low calorie” or “reduced calorie” criteria. The regulation does not reference the quantitative claims “0g Sugars” or “0g Total Sugars,” although plaintiffs allege that they are substantively identical to the claims delineated in the regulation. The court instead must decide whether a “reasonable consumer” would be deceived by the labeling. 

FSIS and FDA Sign New MOU Regarding Dual Jurisdiction

Some food establishments are referred to as dual jurisdiction establishments because they fall under the jurisdiction of both the U.S. Department of Agriculture Food Safety and Inspection Service and the U.S. Food and Drug Administration. In January 2018, FSIS and FDA signed a memorandum of understanding (MOU) to streamline the oversight of food establishments and bolster more effective and efficient coordination between the two agencies. This August, FSIS announced via a Constituent Update that a new MOU had been signed with FDA to further facilitate the exchange of information on DJEs. The DJEs that fall under this MOU are limited to human food operations and exclude animal food operations regulated by FDA. Ways in which this agreement builds upon previous information exchange include:

• Adding headquarters-level contacts for FSIS and FDA to improve the overall awareness of findings or emerging issues that would require more coordination than at the regional or local level.
• Updating the types of findings that should be shared between jurisdictions to reflect advances in microbiological food hazards. This could include microbiological and/or other environmental sampling findings in DJEs or food products that can provide important information about sanitary conditions of such establishments or the potential hazardous nature of contaminated food products under either agency’s jurisdiction. The results from these findings will also include microbe characteristics where applicable, as well as any other information related to the categorization and tracking of foodborne pathogens.

FDA Plans Fall Virtual Summit on E-Commerce and Food Safety

FDA announced that it would be hosting a three-day virtual summit on October 19-21, 2021. The summit will be part of the agency’s ongoing outreach to stakeholders on its New Era of Smarter Food Safety. Each day the program will run from 11:30 a.m. – 5 p.m. ET. The agency seeks to discuss and exchange perspectives with industry stakeholders and other interested parties on e-commerce and ensure the safety of both human and animal foods ordered online and delivered directly to consumers. FDA is particularly interested in the role of e-commerce in food, including how foods produced, manufactured, sold and delivered directly to consumers may fit into current regulatory frameworks and the new challenges for tracking and tracing food products they may present. These considerations will be key components of FDA’s New Era of Smarter Food Safety initiative and recommendations to industry to modernize the agency’s approaches to food traceability and improve its response to foodborne illness outbreaks. More information on registration and event times will be available on FDA’s website and in the Federal Register.

U.S. House of Representatives Passes PFAS Bill

The U.S. House of Representatives passed the PFAS Action Act on July 21 to regulate the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS). The passing of the bill was in response to FDA’s published update on the testing of PFAS in foods to better understand the presence of PFAS substances in the food supply. The PFAS Action Act would require the following:

• The Environmental Protection Agency must add two PFAS, perfluorooctanoic acid (PFOA) and perfluoroactanesulfonic acid (PFOS), to the list of hazardous substances within one year and assess all other PFAS within five years to determine whether they should be designated as hazardous substances;
• EPA must determine whether PFAS should be designated as toxic pollutants under the Clean Water Act; and
• The EPA Administrator must monitor PFAS in drinking water and permit a “PFAS-free” indication on nonstick cookware.

The bill passed 241-183, and it will now move to the Senate. 

FDA Issues Letter to Industry on Fluorinated Polyethylene Food Contact Containers

On August 5, FDA issued a letter to industry emphasizing only certain fluorinated polyethylene containers are authorized for food contact use. The letter is a result of recent testing results from EPA that indicate certain PFAS substances can form and migrate from some fluorinated high-density polyethylene containers. While EPA’s testing was conducted on containers that are not regulated by FDA, the agency still expressed concerns that such containers could also be used in contact with food. The letter states: “Fluorinated polyethylene food containers that are not manufactured in compliance with 21 CFR 177.1615 are adulterated within the meaning of section 402(q)(2)(C) of the FD&C Act.” FDA encourages manufacturers and distributors to consult with FDA moving forward about the regulatory status of any substances used in contact with food to ensure compliance.

FDA Releases TechTalk Podcast Episode 2 on Whole Genome Sequencing

FDA released the second episode of its TechTalk podcast. Each episode of the podcast touches one of the Core Four Elements of the New Era of Smarter Food Safety initiative. This second episode focused on whole genome sequencing as part of Core Element 2: Smarter Tools and Approaches for Prevention and Outbreak Response. Mark Moorman, Ph.D., director of FDA’s Office of Food Safety, and Eric Brown, Ph.D., director of the Division of Microbiology in the Office of Regulatory Science at FDA’s Center for Food Safety and Applied Nutrition, led a discussion with expert panelists in food safety and public health on how whole genome sequencing could transform food safety, including ideas to increase its use throughout the supply chain and create more opportunities for its use in the laboratory community. The experts included Shari Shea, Director of Food Safety at Association of Public Health Laboratories; Afreen Malik, Science Programs Director at Western Growers; and William Wolfgang, Division of Infectious Diseases at New York State Department of Health. The last two episodes of the FDA’s TechTalk Podcast series will focus respectively on Core Element 3: New Business Models and Retail Modernization and Core Element 4: Food Safety Culture.

Legal Victory for “Vegan Butter”

On August 10, the Northern District Court of California ruled that California regulators cannot prevent Miyoko’s Kitchen, a vegan dairy alternative company, from using terms like “butter,” “lactose free,” “cruelty free” and “revolutionizing dairy with plants” on its labels. In December 2019, Miyoko’s Kitchen received a letter of complaint from the California Department of Food and Agriculture that ordered the company to stop calling its products “butter” and claiming they are “cruelty and animal free.” The vegan dairy company then sued the state in February 2020, alleging the state violated its First Amendment rights. As part of its defense, California presented a 2018 study that found 26% of consumers misidentified plant-based cheese products; however, U.S. District Judge Richard Seeborg noted that 19% of its participants were also confused by animal-based cheeses. The court ruled in favor of the California Department of Food and Agriculture with respect to the “hormone free” claim, stating that Miyoko’s cannot make this claim because its products contain plant hormones. Overall, the case represents a victory for the dairy alternative industry, which faces challenges on nomenclature and claims in many states.

Malic Acid Flavoring Case Allowed to Proceed Sans Injunctive Relief

In Hayes vs. General Mills, the plaintiff brought a class action lawsuit against General Mills, alleging that it falsely and intentionally misled consumers with claims that its various fruit flavored snacks contained no artificial flavors when the products contained DL-malic acid to contribute to the flavor of the products. Malic acid is a compound typically used as a food ingredient for flavoring, flavor enhancement and pH control. While L-malic acid is naturally occurring in many foods, mainly fruits, DL-malic acid is commercially manufactured and considered by some to be artificial. Many food products with natural flavors or “free of artificial flavor” claims have been targets of class action lawsuits for use of DL-malic acid. In Hayes vs. General Mills, General Mills moved to dismiss the complaint because DL-malic acid was not used as a flavor, and therefore, the flavor statement on the label was not deceptive. General Mills notes that it uses the compound as a flavor enhancer, not a flavor agent, and therefore, the products cannot be artificially flavored by DL-malic acid. The court held that the distinction between a “flavor” and a “flavor enhancer” was a factual dispute that could not be resolved on a motion to dismiss, and thus allowed the plaintiff’s deceptive advertising claims to proceed. However, the Court denied the plaintiff’s request for injunctive relief because there was no immediate threat of the future violation of the plaintiff’s rights. The court also rejected the argument that there was imminent harm to other unaware consumers. This case demonstrates the ongoing difficulty of making natural flavor or “free of artificial flavor” claims for products containing DL-malic acid and/or other ingredients that serve similar functions in foods, such as flavoring agents.

International Regulatory Issues

EFSA Dietary Sugars Opinion

The European Food Safety Authority has published a draft opinion on a tolerable upper intake level for dietary sugars. This was based on a request to update a 2010 safety assessment from Denmark, Finland, Iceland, Norway and Sweden. EFSA undertook a comprehensive review of the scientific literature that examines the link between intake of dietary sugars and the development of diseases such as Type 2 diabetes, cardiovascular diseases, obesity, gout and dental caries.

Although EFSA was unable to provide specific guidance on how much dietary sugar is ‘safe’ to consume, they did confirm that to varying degrees of certainty, there was a link between various sugars in the diet and risk of disease. Across all of the diseases that were examined, the highest degree of risk certainty was associated with consumption of sugar-sweetened beverages. EFSA stressed that this information is intended to be viewed as scientific advice, not a policy recommendation. It is to assist EU Member States in setting dietary goals for populations and/or recommendations for individuals in their country. There is a public consultation period until September 30, and EFSA plans to hold a public meeting to discuss the draft opinion on September 21.

EU Revises Lead and Cadmium Limits for Some Food Products

The European Commission is aiming to further reduce the presence of heavy metals in foods by setting new limits on cadmium and lead in certain food products. The Commission considered the European Food Safety Authority’s (EFSA) 2010 opinion on lead in food as well as recent data from the Codex Alimentarius Commission to determine that limits for infant food, salt and wild fungi merited revision. For cadmium, the Commission considered a 2009 EFSA opinion about health risks of cadmium in food and other new data showing that cadmium levels for certain foods could be further reduced. The revised limits for cadmium cover products such as beetroots, garlic, berries, nuts, fish and salt. These measures will apply beginning August 30 for limits on lead and August 31 for limits on cadmium. Food products that exceed newly revised limits, which are placed on the market before implementation of the new rules, may continue to be sold until February 28, 2022.

Always A Treat,