Consumer Fights Bid To Ax Kombucha Beer False Ad Claims (Law360 Subscription Required)

  • On October 24, 2021, a proposed consumer class action lawsuit was filed in the Northern District of Illinois alleging that the labeling of Fermented Sciences Inc’s Flying Embers brand Hard Kombucha and Hard Seltzer beverages deceives consumers about the health benefits of these alcoholic beverages.  As discussed here, the label statements at issue include “Antioxidant Vit[amin] C,” “Antioxidants,” “Real Botanicals,” and “Crafted with Live Probiotics,” among other claims like “Brewed with Benefits.”
  • According to the plaintiff’s memorandum filed April 11, 2022, the beverages’ label statements imply health benefits, thus changing what a reasonable consumer would otherwise glean from the federally required warnings on the alcohol products.  The plaintiff further asserts that the defendant’s March 18, 2022 motion to dismiss conflates her claim that the labeling leads a reasonable consumer to believe the “beers were more good than bad” with the absurd belief, not put forth in her complaint, that the products’ vitamins and antioxidants make her “immune” to the adverse effects of alcohol consumption.
  • FDA’s Q&A guidance on its fortification policy (discussed here) states that the agency does not consider it appropriate to add vitamins to alcoholic beverages.  Neither memorandum in this case, however, discusses in detail whether the kombucha and hard seltzer label statements (including “Antioxidant Vit C”) are consistent with the nutrient objectives of FDA’s food fortification policy under 21 CFR 104.20.
  • This week, a bipartisan group of House members moved forward with a proposal to federally regulate cannabis similarly to the regulation of alcohol.  Written by Reps. Dave Joyce, R-OH, Hakeem Jeffries, D-NY, and Brian Mast, R-FL, the PREPARE Act would establish a federal commission to advise Congress on the most effective means of regulating cannabis.
  • This particular bill would not legalize cannabis. Instead, within a year of passage, the Commission would be required to provide a report to Congress suggesting a system to develop safety standards for the manufacture and sale of cannabis products, with enforcement authority shared with the states.  The commission would also be required to generate new policies aimed at repairing damage to low-income, veteran and minority communities, which the proponents of the legislation believe have been disproportionately impacted by cannabis prohibition, as well as easing medical researchers’ access to cannabis.  The prospects for passage of the Act are unclear. However,  the Act appears to be receiving serious consideration, which suggests a movement toward regulation as opposed to prohibition of cannabis.
  • In a parallel move in the Senate, New York Senator Chuck Schumer has introduced the Cannabis Administration & Opportunity Act (CAOA).  The CAOA would end federal prohibition and criminalization of cannabis.  Senator Schumer aims to remove cannabis from the federal list of controlled substances.
  • It is unclear how these proposals may impact the regulation of cannabidiols (CBD). Keller and Heckman is following developments in this area and will report on them as they occur.
  • In September 2019, we reported that FDA had issued a draft guidance for industry titled “Reconditioning of Fish and Fishery Products by Segregation.” On April 13, 2022, FDA issued its final guidance on the topic.
  • The guidance is intended to clarify the steps that owners or representatives of fish and fishery products can take to segregate non-violative portions of fish and fishery products from portions that are adulterated due to pathogens, unlawful animal drugs, scombrotoxin (histamine), or decomposition. The document provides guidance for the reconditioning of fish and fishery products by:
    • segregation based on a production-related rationale, supported by production records identifying the cause of the adulteration and its restriction to only a portion of the article, along with sampling and testing to confirm that the segregation was successful; or
    • segregation based on the results of statistically significant sampling and testing, where the sampling and testing forms the basis for the segregation.
  • The guidance document emphasizes that proposals for reconditioning by segregation require sufficient evidence to demonstrate that the violative product can be reliably separated from the non-violative product. It provides transparency on the information sought by FDA for such proposals.
  • FDA will continue to accept comments on the guidance. Public comments can be submitted to www.regulations.gov using Docket ID: FDA-2019-D-3324.

 

  • On April 11, Senator Patty Murray (D-WA), who leads the Senate Committee on Health, Education, Labor, and Pensions, sent a letter to FDA Commissioner Robert Califf about her concerns over a report that described “longstanding, significant delays and dysfunction across food safety efforts” at the Agency and requests that the Commissioner make food safety issues a priority and take immediate action to ensure the FDA fulfills all aspects of its public health mission. Senator Murray goes further stating that “[t]he FDA’s failure over decades to regulate and enforce food safety standards, on issues ranging from bacteria in vegetables to arsenic in baby food, has put the health of Americans at risk.”
  • Referring to a recent report from Politico, Senator Murray states that the FDA’s predominant focus has been on drugs and devices, despite overseeing nearly 80% of the American food supply. In her letter, Senator Murray notes she is concerned the FDA has not yet imposed strict safety standards with regards to heavy metals found in baby food, finalized long-term voluntary reduction targets for sodium in food, or ensured timely inspections and recalls, which are “critical for ensuring food is free of bacteria and other harmful contaminants.”
  • By April 25, Senator Murray requests the Agency provide her with the following information:
    • Steps the FDA is taking or planning to take to improve food safety efforts, including the timeliness and rigor of regulatory and enforcement activities;
    • Whether the FDA has assessed the causes of delays in addressing water used to grow produce, heavy metals in baby food, and sodium levels in food. If so, what were the results of the assessments;
    • Steps the FDA is taking to ensure the Agency’s organizational structure supports timely and effective food-related decision-making; and
    • The number of food safety inspections conducted over the past 10 years, as well as the number of food and food packaging samples tested for toxic elements.
  • Senator Murray has not been the only Congress member with concerns. Representative Frank Pallone (D-NJ) tweeted that he is requesting a briefing from the Agency, and House Appropriations Chair Rosa DeLauro (D-Conn) also tweeted “The ‘F’ in FDA has come to mean ‘failure’ on food safety. We must greatly intensify the pressure to get the FDA to do its job and to keep American people safe and alive.”
  • On April 8, 2022, the U.S. District Court for the Northern District of Illinois Eastern Division dismissed a class action lawsuit which alleged that Whole Foods had deceptively advertised its “Organic Chocolate Ice Cream Bars” as a chocolate product even though, according to the ingredient list, it contained more palm kernel oil than organic chocolate.
  • The court held that the Plaintiff’s interpretation of the labeling was unreasonable. Specifically, the court noted that Whole Foods had accurately disclosed the ingredients in the ingredient list and had never advertised its product as exclusively or 100% chocolate, nor made any representation regarding the proportion of cacao ingredients to other ingredients in the chocolate coating. Interestingly, while the court accepted that definitions of chocolate, including FDA’s definition of “milk chocolate” in 21 CFR 163.130, “universally exclude fats from sources other than cacao ingredients,” it did not find this fact dispositive since plaintiff had not alleged that “consumers were aware of those definitions or would expect a chocolate coating on ice cream to conform precisely to those definitions.”
  • This case, along with other similar decisions (See e.g., Mars Chocolate Case and Kellogg Strawberry Pop-Tart Case) suggest that challenges to the addition of “other” ingredients (e.g., vegetable oils) into a product advertised and named according to another primary ingredient (e.g., cocoa) are unlikely to succeed where the defendant has (1) not made a claim about the relative proportions of the ingredients and (2) accurately disclosed the ingredients on the ingredient list.
  •  Plants produced through genetic engineering (GE) are subject to the same FDA safety standards as other plants.  Given the possibility for food from some GE plants to have new allergens, an unapproved food additive, reduced levels of important nutrients, or significantly increased levels of toxicants or anti-nutrients, FDA has established its voluntary Plant Biotechnology Consultation Program whereby companies may submit notices, which FDA reviews and responds to with respect to whether food derived from the new plant variety presents safety and regulatory issues.  We reported last year, before the completion of FDA’s review of two new GE canola seeds from BASF Agricultural Solutions (BASF) and Nuseed, on FDA’s April 13, 2021 response, which indicated no safety concern, on the inadvertent presence of low levels of genetic material in specific lots of canola seed and a small number of canola fields.
  • On March 28, 2022, FDA announced the completion of the voluntary pre-market consultations on BASF’s LBFLFK canola and Nuseed’s NS-B5ØØ27-4 canola, which are genetically engineered to produce long chain polyunsaturated fatty acids (LCPUFAs), including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and also to tolerate treatment with herbicides, i.e., imidazolinone and glufosinate ammonium, respectively.  As stated in FDA’s response letters to BASF and Nuseed, FDA has no questions about the safety of food from these canola varieties when used as described.  Specifically, oil from the GE canola seed is intended for use in human food subject to the limitations in the Generally Recognized As Safe (GRAS) affirmation regulation for menhaden oil (21 CFR 184.1472), which are related to the intake of EPA and DHA from menhaden oil; canola meal derived from the seeds is used in human food as a source of protein isolates; and solvent-extracted meal derived from the seeds will be used in animal feed in the same manner as compositionally equivalent canola meal from other canola seeds.
  • Issues preventing unintended spread to non-GE crops are not unique to BASF’s LBFLFK canola and Nuseed’s NS-B5ØØ27-4 canola, and are not addressed in FDA’s response letters.
  • On March 28, 2022, the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) jointly issued seven warning letters to companies marketing cannabidiol (CBD) products with COVID-19 related claims.
  • Specifically, the agencies warned the following companies regarding the promotion of their respective products with claims that they cure, mitigate, treat or prevent COVID-19: Cureganics, Heaven’s Organics LLC, Functional Remedies, LLC D/B/A Synchronicity Hemp Oil, Greenway Herbal Products LLC, CBD Social, UPSY LLC, and Nature’s Highway. Examples of claims include: “Our research suggest that CBD . . . can block SARS-Cov-2 infection at early and even later stages of infection. . .”, “Studies Show CBD Compounds Prevent COVID Cells From Replicating”, and “Can CBD Help with the Fight Against COVID? Some of the worst effects of COVID are caused by inflammation, and CBD is a potent anti-inflammatory.”
  • By way of background, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), products intended to cure, treat, mitigate, or prevent disease are considered drugs and are subject to the requirements that apply to drugs. Therefore, the agencies classified the products as unapproved and misbranded drugs that may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA.
  • The letters included a cease-and-desist demand from FTC, prohibiting the companies from making such COVID-19 related claims. The companies were provided with 48 hours to respond with specific steps that were taken to correct the violations.
  • On April 5, the USDA’s Agricultural Marketing Service (AMS) amended the Origin of Livestock (OOL) requirements for dairy animals under the USDA organic regulations. AMS amended the requirements to increase uniformity in OOL production practice for organic dairy animals, and reduce variance between the approaches taken by certifying agents.
  • The final rule governs how dairy producers can transition animals into organic production. The rule has two key provisions:
    • (1) It allows a dairy livestock operation transitioning to organic, or starting a new organic operation, to transition non-organic animals only once; and
    • (2) It prohibits organic dairies from sourcing transitioned animals. Once a dairy is certified organic, the animals must be under continuous organic management from the last third of gestation onward, except for newly certified organic livestock operations.
  • Critics of the prior rule argued it allowed producers to continuously integrate conventionally raised cows into organic operations and lacked clarity. In a press release, Agriculture Secretary Tom Vilsack stated “The Origin of Livestock final rule provides clear and uniform standards about how and when livestock may be transitioned to organic dairy production, and how transitioned animals are managed within the organic dairy system. Now, all organic dairy livestock producers will have the confidence and certainty they are operating in a fair and competitive market.”
  • The rule is effective June 6, 2022. Certified organic operations must comply with the final rule by April 5, 2023.
  • On March 31, 2022, the U.S. District Court for the District of Massachusetts held that Plaintiffs’ claims— which alleged that the labels on three of Vitamin Shoppe, Inc.’s dietary supplements included false and misleading statements— were preempted by the Federal Food, Drug, and Cosmetic Act (the “Act”). The Court therefore granted summary judgment in favor of Vitamin Shoppe. See Order (Subscription to Law360 required).
  • The challenged label statements were “structure/function” claims related to the benefits of glutamine, a major ingredient in all three products. Specifically, the labels of the three products stated that glutamine “has been shown to possess anti-catabolic properties to help preserve muscle,” “helps support muscle growth and recovery as well as immune health,” and that it “is involved in regulating protein synthesis.”
  • A structure/function claim “describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans” or “characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function.” 21 USC 343 (r)(6); 21 CFR 101.93(f). A structure/function claim may not claim that a nutrient or dietary ingredient diagnoses, treats, cures, or prevents disease (e., a disease claim) and must be accompanied by a disclaimer that states that the claim has not been evaluated by FDA and that it is not a disease claim. Furthermore, the manufacturer must have evidence to substantiate that the claim is truthful and not misleading.
  • While Plaintiffs did not contest that glutamine has been shown to produce the claimed benefits, they did allege that the dose of glutamine in the products was insufficient to deliver the claimed benefits. The Court held that the Act requires that a structure/function claim be substantiated by evidence of the ingredient’s function in the body, and that it does not require evidence that the product produces the claimed benefits. Thus, Plaintiffs were preempted from claiming that the glutamine structure/function label claims were false and misleading.
  •  We previously reported on FDA’s November 24, 2021 tentative response denying requests in two citizens petitions (June 1, 2021 Council for Responsible Nutrition (CRN) petition and August 18, 2021 Natural Products Association (NPA) petition) to change its position that N-acetyl-L-cysteine (NAC) products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).  At that time, FDA also requested information on the earliest date that NAC was marketed as a dietary supplement or as a food, in case there could be new evidence showing NAC was marketed as a dietary supplement before it was approved as a new drug.  Additionally, FDA requested data, research results, and other information related to the safe use of NAC in products marketed as dietary supplements and any safety concerns.
  • In a March 31, 2022 Constituent Update, FDA announced it has confirmed that NAC is excluded from the definition of a dietary supplement.  FDA’s response letter to CRN and NPA’s petitions outlines the legal background for its interpretation that the Dietary Supplement Health and Education Act of 1994 (DSHEA) provides only two exceptions from the exclusion from the dietary supplement definition of an article such as NAC that has been approved as a new drug, namely:  (1) the article was marketed as a dietary supplement or as a food before such approval (or its authorization for investigation as a new drug, if there were substantial clinical investigations that were made public), or (2) FDA issues a regulation to allow use of the article in a dietary supplement.  FDA noted that while acetylcysteine (another name for NAC) was approved as a new drug on September 14, 1963 for administration by inhalation, it is the same “article” for purposes of the exclusion clause as NAC for ingestion, which the earliest evidence FDA found of marketing as a dietary supplement or as a food is an August/September 1991 advertisement for an NAC-containing supplement.
  • While FDA’s response to the citizen petitions confirms that NAC is excluded from the definition of a dietary supplement, the agency has not yet reached a decision on the NPA citizen petition’s alternative request that FDA undertake rulemaking to allow the use of NAC in dietary supplements.  FDA’s March 31, 2022 response letter notes it has received comments supporting NPA’s rulemaking request and providing information on the safety of NAC in dietary supplements and, thus far, has not identified safety concerns for such use.  In the interim, until FDA proposes a rule, which the response letter characterizes as “likely,” the response letter states, “we think it appropriate to consider exercising enforcement discretion for products labeled as dietary supplements that contain NAC if such products would be lawfully marketed dietary supplements if NAC were not excluded from the definition of dietary supplement and are not otherwise in violation of the FD&C Act, and we intend to issue guidance on this topic.”