• FDA has issued food industry guidance for voluntary sodium reduction targets in foods.  The guidance is intended to provide voluntary short-term goals for food manufacturers, chain restaurants, and food service operators for 163 categories of processed, packaged, and prepared foods.
  • FDA acknowledges that sodium is widely present in the American diet and that approximately 70% of total sodium intake is from sodium added during food manufacturing and commercial food preparation.  Average sodium intake in the U.S. is approximately 3,400 mg/day, whereas the Dietary Guidelines for Americans and recommendations from the National Academies of Sciences, Engineering and Medicine advise individuals 14 years and older to limit their consumption to 2,300 mg/day.  The targets in the final guidance seek to decrease average sodium intake from 3,400 mg to 3,000 mg/day over the next 2.5 years.
  • The Agency recommends that the food industry work to meet both a target mean concentration and an upper bound concentration of sodium for various specified categories of foods as soon as possible.  In the future, FDA plans to issue revised targets to further lower the sodium content and continue to help reduce the sodium intake.  FDA notes that such voluntary and gradual approaches have been successful in other countries, such as Canada and the U.K.
  • The FDA guidance follows a petition and lawsuit filed by the Center for Science in the Public Interest (CSPI). CSPI now requests that FDA provide consumer education on the importance of sodium reduction, finalize long-term sodium reduction targets, and consider mandatory standards.
  • On October 7, the FDA announced that the Agency entered into domestic mutual reliance agreements with California, Florida, Utah, and Wisconsin. The mutual reliance agreements facilitate a coordinated effort between the FDA and the individual states with goals to reduce human foodborne illness outbreaks, reduce duplication of regulatory oversight, and increase public health protection by focusing on higher risk areas.
  • Through the mutual reliance agreements FDA and the states will coordinate and leverage one another’s work, data, and actions to achieve a safer food supply. The FDA stated that the mutual reliance agreements will enhance the existing relationships with states and government counterparts and move the country toward an Integrated Food Safety System.
  • The FDA will collaborate with partner states on data sharing, risk prioritization, inspections, outbreak investigations, development and monitoring of key metrics and laboratory capacity, among other areas. The partners will be able to jointly identify needs to better protect the public and leverage work from other regulatory programs. The agreements will also help build quality management systems and infrastructures to support national regulatory standards.
  • As per Michael Rogers, Assistant Commissioner for the Office of Human and Animal Food Operations in FDA’s Office of Regulatory Affairs, “A strong, integrated system is essential to a safe food supply. Mutual reliance between the FDA and individual states is one example of the many actions the agency is taking to address our nation’s increasingly complex food production and distribution systems. We expect that as more states sign mutual reliance agreements, it will help reduce redundancy and duplication of effort, optimize the impact of our collective oversight, and allow us to build on the long-standing relationships that we have with our state regulatory partners.”
  • On October 6, 2021, California Governor Gavin Newsom signed AB 45 into law, which allows for the inclusion of hemp and cannabinoids (e.g., CBD), extracts, or derivatives of hemp in food and beverages, dietary supplements, cosmetics, and processed pet food provided that they, among other things, contain less than 0.3% THC.
  • THC (or “THC and comparable cannabinoid”) is broadly defined to include (1) tetrahydrocannabinolic acid; (2) any tetrahydrocannabinol, including Delta-9 THC (the molecule traditionally recognized as THC), as well its isomers Delta-8 THC and Delta-10 THC; and (3) any other cannabinoid (except CBD), that the California Department of Health (the Department) determines causes intoxication. The Department may exclude from the definition of THC any THC isomer that does not cause intoxication.
  • Among other the things, the law:
    • Establishes a registration requirement for manufacturers of hemp products.
    • Requires testing by an independent laboratory of hemp extract in its final raw form (prior to being incorporated into a product) to ensure that the THC concentration does not exceed 0.3% and that no unsafe contaminants are present.
    • Requires that hemp products which are foods, beverages, or dietary supplements include:
      1. A label, scannable barcode, internet website, or QR code linking to certificates of analysis, providing, among other things, the THC content of the tested batches.
      2. The product expiration or best by date, if applicable.
      3. A statement indicating that children or those who are pregnant or breastfeeding should avoid using the product prior to consulting health professionals.
      4. A statement that cannabinoids should be kept out of reach of children.
      5. The statement, “THE FDA HAS NOT EVALUATED THIS PRODUCT FOR SAFETY OR EFFICACY.”
  • Prohibits the labeling, advertising, or marketing of any untrue “health-related statement,” which is defined as a “statement related to health . . . [that] suggests a relationship between the consumption of industrial hemp or industrial hemp products and health benefits or effects on health.”
  • The law, however, does not provide any guidance on maximum serving sizes, active cannabinoid concentration per serving size, the number of servings per container, and similar requirements for foods and beverages, although it provides the Department with the authority to issue regulations on these issues.
  • Finally, recognizing the potential future conflict with federal law, the AB 45 provides that when federal law authorizes hemp products, the Department “shall adopt new regulations either as necessary pursuant to the federal law or deemed necessary to protect consumers.”

Welch Inks $1.5M Deal To End Grape Juice False Ad Suit (Law360 Subscription Required)

  • Welch Foods Inc. (“Welch”) is seeking preliminary approval for a nationwide settlement of a class action lawsuit filed in US District Court for the Northern District of California by plaintiff Curtis Hansen in March of 2020.  Hansen alleged that the company falsely represented that its grape juice products, which contain a substantial amount of sugar, support heart health. The proposed settlement includes a $1.5M payout to class members who purchased the Welch’s grape juice products since March 23, 2016. In addition to the class payout, the settlement includes agreement for Welch’s to refrain from using heart healthy claims on some of its grape juice products for two years.
  • This is not the first time Welch’s has been the subject of litigation surrounding its heart health claims. A 2013 suit in the US District Court for the Central District of California challenged the company’s claim that its 100% grape juice “Helps support a healthy heart.”  Heart health claims made about cereal and snack products have been similarly targeted.
  • These and similar lawsuits challenge so-called structure function claims about the role of the advertised food in supporting or promoting heart health.  Unlike health claims, which associate a food or food ingredient with reduction of risk of a disease or health related condition, the Food and Drug Administration does not need to approve structure function claims, leaving them vulnerable to such class action challenges for their alleged false or misleading implications.
  • Keller and Heckman will continue to monitor and report on this and similar litigation outcomes.

 

  • As previously reported, FDA will host a three-day virtual meeting on October 19-21, 2021 to discuss the safety of foods sold online and delivered directly to consumers. FDA provides that there has been an increasing number of consumers ordering their food online, and that number has dramatically increased during the COVID-19 pandemic.
  • The Summit will address a variety of topics related to human and animal foods sold through Business to Consumer (B2C) e-commerce, including:
    • Types of B2C e-commerce models (e.g., produce and meal kit subscription services, ghost kitchens, dark stores);
    • Safety risks associated with foods sold through B2C e-commerce;
    • Standards of care used by industry to control these safety risks;
    • Types of delivery models (e.g., third-party delivery, autonomous delivery models);
    • Regulatory approaches to food sold through B2C e-commerce, including challenges and gaps that need to be addressed; and
    • Labeling of foods sold through B2C e-commerce.
  • There will be opportunities for public comment each day; however, participants who wish to speak during the public comment sessions must register with FDA by October 8, 2021 at 11:59 p.m. Eastern Time.
  • On October 1, Chobani asked an Illinois federal judge to dismiss a proposed class action lawsuit that accused the company of falsely claiming that its Complete Greek Yogurt provides “complete nutrition,” among other claims (subscription to Law360 required). Chobani argued that the plaintiff has not alleged any facts that plausibly suggest that the labeling of the product at issue makes any materially false or misleading representations. Further, Chobani argued that all of the claims that the plaintiff is attempting to challenge are literally true and the plaintiff does not allege otherwise.
  • In the complaint, the plaintiff alleged that the product’s name, “Complete Nutrition,” is false, deceptive, and misleading because it fails to provide “complete” nutrition. However, according to Chobani, the product is named “Chobani Complete,” not “Complete Nutrition,” and the phrase “complete nutrition” does not appear anywhere on the product label.
  • Chobani also argued that the plaintiff failed to include any nonconclusory allegations that demonstrated how she was injured by the product’s label claims, which, according to Chobani, terminates her claim under the Illinois Consumer Fraud and Deceptive Business Practices Act. Further, Chobani urged the court to reject the plaintiff’s claim for negligent misrepresentation because she did not demonstrate that Chobani violated any duty owed. Chobani also took issue with the plaintiff’s argument that using a plus symbol indicates that the product contains “more” probiotics and prebiotics, and is deceptive.
  • Keller and Heckman will continue to monitor this case and report on any updates.
  • Last month, FDA issued a final rule to approve a new blue color additive made from butterfly pea flower (clitoria ternaea) for use in (1) alcoholic beverages, (2) sport and energy drinks, (3) flavored or carbonated water, (4) fruit drinks (including smoothies and grain drinks), (5) carbonated soft drinks (fruit-flavored or juice, ginger ale, and root beer), (6) fruit and vegetable juice, (7) nutritional beverages, (8) chewing gum, (9) teas, (10) coated nuts, (11) liquid coffee creamers (dairy and non-dairy), (12) ice cream and frozen dairy desserts, (13) hard candy, (14) dairy and non-dairy drinks, (15) fruit preparations in yogurts, and (16) soft candy, at levels consistent with good manufacturing practice (GMP). See 86 Fed. Reg. 49230 (Sep. 2, 2021).  The principal coloring component of the new color additive is anthocyanins. The rule approving the new “butterfly pea flower extract” color additive is effective today (October 5, 2021).
  • FDA concluded that batch certification was not necessary to public health. As a reminder, while all color additives must be approved for their intended use, FDA may determine that, in addition, protection of the public health requires the Agency to analyze and certify a sample from each batch of the color additive (i.e, batch certification). See 21 CFR 71.20 (b). Color additives subject to batch certification are listed in 21 CFR, Parts 74 and 82, and color additives exempt from certification are listed in 21 CFR Part 73. The new color additive will be codified at 21 CFR 73.69.
  • Another blue color additive that is currently approved is spirulina at 21 CFR 73.530. Blue color additives derived from natural sources including jagua fruit pulp (Genipa americana) (filed July 31, 2020), gardenia (filed April 20, 2021), and unicellular red algae (Galdieria sulphuraria) (filed September 9, 2021) are also currently under review for use in food. See List of Food Additive and Color Additive Petitions.
  •  Many of our readers will recall a February 4, 2021 report by the U.S. House of Representatives subcommittee on Economic and Consumer Policy (summarized here) that raised alarm regarding the levels of heavy metals— including arsenic, lead, cadmium, and mercury— reportedly found in baby foods produced by seven of the largest baby food manufacturers in the U.S.  The Food and Drug Administration (FDA) issued a response on February 16, 2021, as discussed here, outlining the current regulatory activities for assuring that naturally occurring toxic elements in many crops do not reach dangerous levels in food.  Soon after, on March 5, 2021, FDA announced new activities, including a letter to baby food manufactures, increased sampling and other plans (as discussed here) that target reducing the levels of toxic elements in baby food.  On April 8, 2021, FDA released a new Closer to Zero action plan involving four stages: (1) Evaluate the science, (2) Propose action levels, (3) Consult with stakeholders, and (4) Finalize action levels for lead, arsenic, cadmium, and mercury.  As discussed here, FDA’s Closer to Zero action plan is scheduled to unfold in phases over several years, with the first phase (proposing action levels for lead in various categories of baby foods) scheduled for completion by April 2022.
  • On September 29, 2021, just seven months after its initial report, the same congressional subcommittee released a new report that adds test results the authors deem concerning for some Plum Organics and Sprout products (not reviewed in the first report), and new information from Walmart (also not discussed in the first report) which the authors characterize as showing a decrease in protective standards.  Summaries of the companies’ responses to the report’s claims are available here.
  • Recommendations in the new report, which is critical of all baby food manufacturers’ handling of toxic elements, as well as FDA’s timeline for publishing draft and final limits for lead, arsenic, cadmium, and mercury in baby foods, include:
    • For FDA to accelerate its proposed timelines for publishing final limits for toxic heavy metals and require baby food manufacturers to test their finished products, and
    • For industry to voluntarily adopt finished product testing, rather than attempt to control levels of heavy metals “based on inaccurate individual-ingredient tests,” and to use appropriate substitutes or phase out products that have high amounts of ingredients that frequently test high in toxic heavy metals, such as rice.
  • Keller and Heckman will continue to monitor and report on FDA’s regulatory activities, as well as congressional investigation and litigation involving heavy metals in baby food.

 

  • On September 29, 2021, the United Kingdom (UK) announced plans to pave the way for gene editing technologies to be used for crops raised in the UK.  While the European Union (EU) regulates organisms modified by gene editing as genetically modified organisms, the UK is choosing to take a different approach to gene editing.  As a first step, the government will change rules relating to gene editing to facilitate research and development.
  • The UK’s Department for Environment, Food, and Rural Affairs (DEFRA) noted that gene editing is different from genetic modification because it does not result in the introduction of DNA from other species, but rather creates new varieties that are similar to those that could be produced by natural breeding processes.
  • DEFRA takes the position that gene editing will make plant breeding more efficient and will be able to develop crops that are more nutritious, more resistant to pests and disease, and more beneficial to the environment.  To that end, DEFRA notes that gene edited foods will only be permitted to be marketed if they do not present a health risk, do not mislead consumers, and do not have lower nutritional value than their non-genetically edited counterparts.
  • On September 27, agriculture industry groups, including the National Pork Producers Council (NPPC) and American Farm Bureau Federation (AFBF), petitioned the U.S. Supreme Court to review the Ninth Circuit’s decision to uphold California’s Proposition 12, which is a ballot initiative that was passed by California voters in November 2018 and established new standards of confinement of certain farm animals and bans the sale of eggs, veal, and pork products that do not comply with those standards (subscription to Law360 required).
  • As our readers know, in July of 2021, the U.S. Court of Appeals for the Ninth Circuit ruled against the NPPC and AFBF in their challenge to Prop 12. In a unanimous decision, the Ninth Circuit affirmed the dismissal of the groups’ challenge to the law, stating that the law correctly regulates in-state and out-of-state actions in the same way. The panel also noted that precedent dictates a state law can only be found to violate the dormant commerce clause in “narrow circumstances” and the law’s alleged “upstream effects” on out-of-state producers do not qualify.
  • The NPPC and AFBF state that the district and appeals courts’ decisions should be overturned. NPPC President Jen Sorenson said “We’re asking the Supreme Court to consider the constitutionality of one state imposing regulations that reach far outside its borders and stifle interstate and international commerce.”
  • Notably, this is not the first challenge to Proposition 12 to go before the U.S. Supreme Court. The North American Meat Institute (NAMI) previously petitioned the Court to hear its case regarding the constitutionality of Prop 12, arguing that the Ninth Circuit’s decision in its case conflicts with holdings by other appellate courts and the U.S. Supreme Court. However, the Supreme Court denied the request for review on June 28 and offered no explanation for its decision.
  • Keller and Heckman will continue to monitor challenges to California’s Proposition 12 and report on any updates.