Buyers Want An End To 7-Year Pause In Kix Cereal Suit – Law360 (subscription to Law360 required)

  • In 2015, when now ubiquitous “natural” lawsuits first began proliferating, FDA solicited comments on the use of the term “natural” in the labeling of human food products, including foods that are genetically engineered or contain ingredients produced through the use of genetic engineering.  As reported here, action was stayed in numerous lawsuits challenging “natural” claims on various bases.  Although the comment period closed in May 2016, FDA has not taken any further action to define “natural.” 
  • In an April 4, 2023 letter (see Law360), consumer plaintiffs claiming General Mills lied about Kix cereal made with genetically modified (GM) corn being “all natural” asked a New Jersey federal judge to end a nearly 7-year old stay of the proposed class action, arguing that food regulators are no closer today to adopting rules on bioengineered food being labeled “natural” than they were when the litigation was first stayed in 2016.  Aside from a brief period in 2021 when both sides requested a stay while pursuing a deal to end the litigation, the plaintiffs have vigorously opposed the stay, which has nevertheless been continued at least 10 times since it was imposed on June 13, 2016.  The plaintiffs project that the case may quickly settle if the stay is lifted. 
  • As significant time has passed without further movement since FDA signaled potential activity in 2015, stays have been lifted in some “natural” class action litigation that had been paused pending FDA action.  For example, in the Chobani litigation discussed here, the judge explained in lifting a 2-year stay in 2019 that the court “cannot sit idly by on an illusory assurance that something is likely to happen.”  In the General Mills lawsuit, however, the court may be again willing to wait for FDA due to a lack of urgency where the phrase “natural” was discontinued on Kix boxes in 2016. 
  • In November 2022, B&G Foods Inc.’s Polaner “All Fruit” jelly spreads were challenged by a proposed class action suit in New York federal court for allegedly misleading consumers into believing the products are sweetened only with fruit juice when they also contain citric acid and natural flavors. See Indiviglio v. B&G Foods Inc., case number 22-cv-09545, in the U.S. District Court for the Southern District of New York. The original compliant argued that the product label claims that the jellies are “Sweetened Only With Fruit Juice” and only contain “All Fruit” are misleading because the ingredient lists indicate the presence of not only juice concentrates and fruit pectin which meet the definition of fruit, but also citric acid and natural flavors, which allegedly do not qualify as fruit ingredients.
  • Plaintiff maintains that “fruit” means “the seed-associated fleshy structures or produce of plants that are sweet or sour and edible in the raw state.” Although citric acid is an organic acid naturally occurring in various fruits, plaintiff argues that it is industrially produced via fermentation from a fungus when used as an ingredient in other foods. Further, plaintiff argues that natural flavors are defined as the “essential oil” or extractive with “flavoring constituents derived from” fruits and other plant material, whose significant function in food is for flavoring, rather than nutritional, purposes. Due to the inclusion of citric acid and natural flavors, plaintiff alleges that the products’ labels are false and misleading, contending that consumers value fruit ingredients for generally being less processed, more natural and healthier than non-fruit ingredients and pay a premium price for products labeled as containing only fruit.
  • On March 20, B&G Foods Inc. filed a motion to dismiss, arguing that the fruit label is neither false or misleading and that the plaintiff makes generalized allegations about the food industry regarding the sources and uses of citric acid and natural flavor ingredients in foods. On Monday, April 3, plaintiff filed a memorandum to court requesting the case be preserved, arguing that the “all fruit” claim is synonymous with “nothing but, or only” fruit and maintaining that citric acid and natural flavors do not meet the a typical consumer’s understanding of the definition of “fruit.”
  • Keller and Heckman will continue to monitor consumer class actions regarding challenges to food label claims.
  • In 2020 FDA established a collaborative partnership, i.e., “Statement of Intent” (SOI), with its Mexican counterparts (SENASICA and COFEPRIS) to improve the safety of food that is traded between the countries. The SOI expanded upon a 2014 SOI which had been limited to produce and minimally processed foods.
  • On March 31, 2023, FDA held a joint meeting with SENASICA and COFEPRIS to discuss the progress on food safety issues. Progress on identifying food contaminated with Cyclospora cayetanensis was particularly noteworthy and FDA shipped Cyclospora DNA sequences to SENASCIA and COFEPRIS and delivered a training on Chapter 19B of the Bacteriological Analytical Manual (BAM), which relates to FDA’s preferred methods for testing for Cyclospora cayetanensis.
  • Other accomplishments of the partnership can be found at the FDA webpage for the partnership where they are listed under one of the four content-specific working groups which worked on the issue: (1) the Strategic Priorities Work Group (focused on improving communication on important food safety issues), (2) the Laboratory Collaboration Work Group (focused on sharing lab data including whole genome sequencing, (3) the Outbreak Response Work Group (focused on enhancing effectiveness and timeliness of responses to food born illness outbreaks), and (4) the Food Safety Training Work group (focused on training to improve compliance with food safety requirements). 
  • We will continue to monitor and report on any developments in the partnership as well as other food safety issues.

Coca-Cola’s Juice Boxes Not Actually Healthy, Class Suit Says (subscription to Law360 required)

  • We have reported on FDA’s proposed rule for when foods can be labeled with the claim “healthy” on their packaging.  The proposed definition would permit the “healthy” claim on food products that contain a meaningful amount of fruit (or another specified food group) and adhere to specific limits for certain nutrients, including added sugars.  Under FDA’s proposed rule, the fruits group can include 100% fruit juice with no added sugars. 
  • On March 28, 2023, a proposed class action lawsuit was filed against Coca-Cola Co. over Minute Maid juice boxes bearing the statements “Good for You!” and “Part of a Healthy, Balanced Diet” and featuring images of whole fruit.  The plaintiff alleges that while a piece of whole fruit may be healthy, it is transformed into an unhealthy food when the natural food matrix is destroyed in producing juice, which concentrates and releases sugar from the fruit’s fiber.  The plaintiff asserts that Coca-Cola’s “health and wellness” messaging on these 100% juice products (e.g., Apple, Mixed Berry, et al.) preys on existing misconceptions that juice is healthy and the messages are false and misleading because scientific evidence (presented in the complaint) demonstrates that juice, like the Juice Boxes, increases risk of serious chronic diseases—such that authoritative bodies recommend avoiding or limiting its consumption.  The complaint also alleges that the juice box labeling violates FDA’s nutrient content regulations and fortification policy.
  • This new lawsuit involves complex issues, including the role of a single product in the total diet and whether sugar from fruits should be distinguished from “added sugars.”  In this regard, the Centers for Disease Control and Prevention (CDC), while recommending against juice for infants and stating that “juice after 12 months is not necessary,” also states that “4 ounces or less of 100% juice can be provided” for children over 12 months and recommends checking to be sure a juice product is 100% juice.  FDA’s proposed rule for “healthy” is in the early stages and some comments argue the definition should not apply to 100% juices that typically contain less dietary fiber than the whole fruit or vegetable. 
  • On March 24, the U.S. Food and Drug Administration (FDA) proposed changes to the standards of identity (SOIs) for foods that include salt to permit the use of safe and suitable salt substitutes.  The proposed rule, “Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods,” is part of the Biden-Harris Administration’s National Strategy on Hunger, Nutrition, and Health and complements the goals of the FDA’s voluntary sodium reduction targets for processed, packaged, and prepared foods.
  • Most SOIs that feature salt as a required or optional ingredient would preclude the use of salt substitutes.  The proposed rule uses a “horizontal” approach to updating the SOIs.  Specifically, it would amend the 80 relevant SOIs.  Because these 80 SOIs are referenced in other SOIs, 140 of the 250 SOIs currently established would be affected.
  • The proposed rules does not list permitted salt substitutes, but defines them as safe and suitable ingredients used to replace some or all of the salt in a standardized food.  The extent to which salt can be replaced depends on the ability of salt substitutes to replace the functions of salt without compromising the food safety or essential characteristics of the food.  Salt substitutes are subject to the same labeling requirements as other ingredients.
  • FDA will be accepting comments to the proposed rule 120 days after it is published in the Federal Register.  Specifically, FDA requests comments on potential salt substitutes that may be used as a result of the new flexibility provided by the proposed rule.  Keller and Heckman will continue to monitor this area and relay any developments.
  • On March 28, FDA released an Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market. The strategy follows a months-long infant formula shortage sparked by the temporary shutdown of Abbot’s facility in Sturgis, Michigan in February 2022 due to positive test results in the facility for Cronobacter sakazakki and an outbreak of food-borne illness among infants who had been exposed to infant formula produced at the facility. To view our past blog posts regarding FDA’s response to last year’s infant formula crisis, please follow this link.
  • As directed by Congress in the Food and Drug Omnibus Reform Act of 2022, FDA devised a national strategy describing the immediate actions the Agency took to address the infant formula shortage and detailing the Agency’s plans for improving the resiliency of the infant formula supply. Among other things, FDA is working to conduct surveillance food safety inspections of all infant formula manufacturers at least annually, use remote regulatory assessments, expand and improve infant formula training for investigators, monitor the infant formula supply and supply chain, expedite review of premarket submissions for new infant formula products to mitigate or prevent shortages, and build a consumer education program.
  • This strategy represents a first step toward issuing, with input from the National Academy of Science, Engineering and Medicine (NASEM), a long-term national strategy in 2024 to improve preparedness against infant formula shortages by outlining methods to improve information-sharing, recommending measures for protecting the integrity of the infant formula supply chain, and preventing contamination.  The long-term strategy will also explore new approaches to help facilitate entry of new infant formula manufacturers to increase supply and mitigate future shortages and recommend other necessary authorities to gain insight into the supply chain and risks for shortages.
  • Keller and Heckman will continue to monitor and report on any developments in this area.
  • Earlier this month, USDA’s Food Safety and Inspection Service (FSIS) issued a proposed rule which would significantly narrow the scope of voluntary U.S. origin claims on FSIS-regulated products (meat, poultry, and eggs).
  • Currently, FSIS’s Food Standards and Labeling Policy Book allows “Product of USA” or similar claims to be made if the product was processed in the U.S., even if the source animals were born, raised, or slaughtered abroad. FSIS received serval petitions requesting revisions to this standard in the last few years and in response commissioned a study which found that most consumers did not understand and were misled by the current U.S. origin claims.
  • Accordingly, FSIS is proposing to authorize “Product of USA” and “Made in USA” only if all FSIS-regulated components of the product are derived from animals born, slaughtered, raised, and processed in the U.S. and (2) all additional ingredients, except for spices and flavoring, are of domestic origin. The proposed rule also allows for qualified origin claims to be made provided that they describe the processing steps which occur in the U.S. (e.g., “Sliced and packaged in the United States using imported pork”). Furthermore, the same criteria would apply to state origin claims (e.g., a “Made in Maryland” meat product would have to be born, raised, slaughtered, and processed in the Maryland).
  • The proposed rule notes that it does not conflict with the country of origin labeling (COOL) regulations for certain imported commodities sold at retail in 7 CFR Part 65 and that such products should continue to comply with those requirements.
  • Comments to the proposed rule are due by May 12, 2023.
  • FDA has long recognized the use in food labeling of Dietary Guidance Statements (e.g., fruits and vegetables are part of a nutritious dietary pattern) as a tool that could help consumers improve their health and decrease the risk of diet-related diseases by making sound dietary decisions.  On November 25, 2003, FDA issued an advance notice of proposed rulemaking (ANPRM) that solicited information and comments on alternatives for regulating qualified health claims and on the appropriateness and nature of dietary guidance statements.  More recently, as covered extensively on our blog, FDA announced a new Nutrition Innovation Strategy (NIS) in March 2018 and held a public meeting on July 26, 2018 to receive input on topics including (1) what types of claims or other nutrition-related labeling statements are most helpful in facilitating product innovation to promote healthful eating patterns and (2) what types of claims and other labeling statements are most helpful to consumers in selecting foods consistent with recommendations in the “Dietary Guidelines for Americans.” 
  • On March 27, 2023, FDA published notice on the availability of a draft guidance for industry titled, Questions and Answers About Dietary Guidance Statements in Food Labeling.  The draft guidance defines Dietary Guidance Statement as “written or graphic material, based on key or principal recommendations from a consensus report, in food labeling that represent or suggest that a food or a food group may contribute to or help maintain a nutritious dietary pattern.”  Dietary Guidance Statements focus on a food or food group in contributing to or maintaining nutritious dietary patterns (e.g., “Eat broccoli as part of a nutritious dietary pattern”) and do not undergo review by FDA prior to use in the marketplace.  They are distinguishable from Health Claims, which focus on the relationship between a particular food substance and reduced risk of a disease or health-related condition (e.g., “Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors”) and which generally undergo review by FDA through a petition process, and Nutrient Content Claims which expressly or implicitly characterize the level of a nutrient in a food (e.g., a claim that a food is “low” in fat content or is “healthy”).  
  • The guidance includes recommendations on how to use Dietary Guidance Statements as follows:
    • Identifying an appropriate source of the Dietary Guidance Statement;
    • Ensuring that a product bearing a Dietary Guidance Statement contains a “meaningful amount” of the food or food group or “food group equivalent” that is the subject of the statement;
    • Maximum levels that should be present per Reference Amount Customarily Consumed (RACC) for individual foods bearing a Dietary Guidance Statement, i.e., 15% of the daily value (DV) for sodium (345 milligrams), 10% of the DV for saturated fat (2 grams), and 10% of the DV for added sugars (5 grams), with an exception for saturated fat in seeds and nuts. 
    • Maximum levels that should be present for main dishes bearing a Dietary Guidance Statement, i.e., 30% the saturated fat and sodium DVs per RACC and 20% of the DV per RACC for added sugars.
    • Maximum levels that should be present in meals bearing a Dietary Guidance Statement, i.e., 40% of the saturated fat and sodium DVs per RACC and 30% of the DV per RACC for added sugars. 
  • FDA specifically invites comments on:
    • Use of Dietary Guidance Statements on refined grains that are staples of cultural cuisines that are not high in added sugars, saturated fat, and sodium (since consumption of whole grains is encouraged in the guidance); 
    • Alternative options for calculating “meaningful amounts” or “food group equivalents” of a food or food group that is the subject of the Dietary Guidance Statement;
    • Disclosure statement requirements for situations when a food is recommended by a consensus report as part of a nutritious dietary pattern and the food has a nutrient profile that exceeds the recommended nutrient levels set forth in the guidance;
    • Use of Dietary Guidance Statements on bottles or containers of plain water and other calorie-free beverages ( e.g., flavored carbonated water, coffee, and tea).
  • Comments on the draft guidance that are submitted by June 26, 2023 will be considered before FDA begins work on the final version of the guidance.  FDA will also consider comments received from the 2003 ANPRM that are deemed relevant to the current dietary recommendations. 
  • In February 2023, California Assemblymembers Jesse Gabriel and Buffy Wicks introduced legislation (AB 418) that would prohibit the manufacture or distribution In California of foods containing the additives red dye No. 3, potassium bromate, brominated vegetable oil, titanium dioxide, and propyl paraben.
  • The color additives are commonly found in candies, drinks, and baked goods, including items marketed to children, though some have claimed that they have been linked to cancer, behavioral health problems, and harm to the reproductive system.
  • In the U.S., red dye No. 3 was previously banned in cosmetics in 1990, after studies suggested that it caused thyroid cancer in rats at high doses.  It is already banned in foods in the European Union.  However, industry groups have argued that there is insufficient scientific evidence linking synthetic colors in food to negative health or behavior effects.
  • In October 2022, Consumer Reports, the Center for Science in the Public Interest, and other groups and individuals wrote to the U.S. Food and Drug Administration (FDA) petitioning to “remove Red No. 3 from the permanent list of color additives approved for use in food and dietary supplements… and for use in ingested drugs… because the FDA has found that the additive induces cancer and is unsafe.”  FDA has stated that it will “continue to engage in the scientific and regulatory review of color additives.” 
  • Given that the targeted color additives have been approved by FDA, enactment of the proposed California legislation almost certainly would trigger legal challenges.
  • Keller and Heckman will continue to monitor the developments of AB 418 and will update accordingly.
  • On March 21, the FDA released Activities for the Safety of Imported Seafood, a report which details the approach the Agency’s is taking to ensure that imported seafood consumed in the U.S. meets food safety requirements and the standards of domestically produced seafood. For background on the FDA’s “Strategy for the Safety of Imported Food,” see our February 2019 blog and September 2022 blog regarding FDA’s report for imported produce. 
  • The reports details how established FDA regulation and innovative programs and technology are employed to support each of the four goals that were established in the 2019 strategy document as they relate to imported seafood safety:
    • Goal 1 – Food Offered for Import Meets U.S. Food Safety Requirements
      • FDA objectives include relying on international inspections, using verified foreign suppliers, auditing such as those conducted under FDA’s Accredited Third-Party Certification Program or other programs aligned with FDA produce safety requirements, incentivizing importers to use verified suppliers through the Voluntary Qualified Importer Program (VQIP), leveraging oversight efforts of regulatory counterparts with strong food safety systems, and increasing awareness and training of seafood safety requirements.
    • Goal 2 – FDA Border Surveillance Prevents Entry of Unsafe Foods
      • FDA objectives include enhancing and refining FDA’s import screening and entry review process, optimizing use of sampling of imported seafood, utilizing import alerts and import certifications, improving testing methods and tools to determine admissibility of seafood offered for import, and maximizing surveillance from state and other partnerships.
    • Goal 3 – Rapid and Effective Response to Unsafe Imported Food
      • FDA objectives include maximizing the effectiveness of Agency responses to events involving imported seafood, such as recalls.
    • Goal 4 – Effective and Efficient Food Import Program
      • FDA objectives include a better understanding of the global inventory of seafood facilities and farms and conduction of performance assessments of the effectiveness of import activities.
  • Keller and Heckman will continue to monitor and report on any developments that impact seafood safety requirements.