• On November 29, the FDA issued an updated draft guidance document about food allergen labeling requirements: Questions and Answers Regarding Food Allergens, Including Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5); Guidance for Industry. The draft guidance includes the following updates:
    • New questions and answers about food allergen labeling requirements, including the labeling of sesame, milk, and eggs, the labeling of major food allergens on dietary supplement labels, and other technical issues;
    • Revised questions and answers to update and clarify information included in earlier editions of the guidance, such as the labeling of tree nuts, fish, and crustacean shellfish; and
    • Example images of labeling requirements.
  • The draft guidance is an update to the previous version (Edition 4). In addition to the update, the Agency also issued a final guidance with the same title (Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5)) to preserve the questions and answers from the previous Edition 4 from 2006 that were not changed, except for editorial changes such as renumbering the questions and reorganizing the information in the guidance.
  • The FDA is accepting comments on the new and revised questions in the Edition 5 draft guidance until January 30, 2023. Keller and Heckman attorneys are well-versed in food allergen labeling requirements and are available to assist interested parties with submitting comments. For assistance, please email: fooddrug@khlaw.com.
  • On November 24, 2022, Health Canada updated the Table of Reference Amounts for Food based on new consumption data and market trends, and to address gaps in certain food categories.
  • In particular, the update (1) modifies or adds new reference amount categories and product examples, (2) provides additional instructions for the serving of stated size declaration for different food formats, and (3) for foods requiring further preparation, adds a serving of stated size declaration based on instructions for the amount to make the reference amount of the food.
  • The reference amounts in the table are used in a variety of regulatory determinations, including determining what constitutes a single-serving prepackaged product and the serving size of multiple-serving pre-packaged products. They are also relevant to nutrient content and health claims and front of package nutrition symbol labeling. The previous version of the table can continue to be used until January 1, 2026.

 Nurture Says Heavy Metal Baby Food Claims Aren’t Realistic (Law360 Subscription Required)

  • Multiple consumer-protection lawsuits against Nurture, LLC were consolidated in the Southern District of New York on September 1, 2021.  Plaintiffs in the Consolidated Class Action Complaint (CAC) allege that Nurture’s organic baby food products are contaminated with dangerous levels of heavy metals.  We have reported on the dismissal of similar claims in actions against Gerber, Plum, and Sprout that were among numerous putative class action lawsuits filed in the wake of a Congressional report on heavy metals in baby food.  Summaries of the report and subsequent events are available here and here.
  • In a memorandum filed November 21, 2022 in support of a motion to dismiss the CAC, Nurture disputes whether the plaintiffs have stated a single plausible claim that the company’s baby food products are unsafe, are inaccurately labeled, exceed any applicable regulatory standard, or have otherwise caused any harm to any consumer.  While acknowledging that its finished products may contain trace levels of lead, arsenic, cadmium, or mercury, Nurture points to an authoritative statement by FDA that “low levels of these elements are naturally occurring, are unavoidably present in many baby food products, and, importantly, do not pose a health risk to babies and toddlers.”
  • Personal injury claims against Nurture that are also based on allegations of tainted baby food have been consolidated in a separate proceeding with no new developments thus far.  Keller and Heckman will continue to monitor and report on any developments in the Nurture cases or other heavy metal baby food-related lawsuits.
  • The U.S. Government Accountability Office (GAO) has issued a report critiquing the premarket authorization programs handled by the U.S. Food and Drug Administration (FDA). The report, Food Safety: FDA Oversight of Substances Used in Manufacturing, Packaging, and Transporting Food Could Be Strengthened, GAO-23-104434, makes two recommendations to FDA for its consideration. These are: (1) Request from Congress specific legal authority to compel companies to provide the information needed to reassess the safety of substances already on the market; and (2) Track the dates of the last pre- and postmarket reviews for all food-contact substances to allow FDA to readily identify substances that may warrant postmarket review.
  • The report, which GAO published on November 8, 2022, identifies the primary means companies use to bring food-contact substances (FCSs) to the market and describes FDA’s premarket safety review process. It also examines FDA’s postmarket safety review actions, along with the limitations of those reviews. Concerning the first recommendation, the report points out that FDA does not have legal authority to compel companies to provide information and data on substances’ safety and extent of use. Yet, this information is needed to prioritize and conduct postmarket reviews. With respect to the second recommendation, the report states that while FDA can search its information system for each FCS and find the date of the last premarket review, the system cannot readily identify all substances that may warrant additional review based on their last review date. The report notes that FDA neither agreed nor disagreed with the first recommendation and agreed with the second recommendation, which the Agency has indicated, it has begun to implement.
  • In preparing the report, GAO interviewed FDA officials and stakeholders and reviewed, among other things, FDA documents and the Agency’s website for actions it took from January 2000 (when the Food Contact Notification program became effective; for more information, see the Packaginglaw.com article, What is the Best Approach to Obtain FDA Clearance for Food Contact Substances?) to May 2022 to stop the use of potentially unsafe substances. FDA noted in particular that advancements in toxicological science may raise new questions not addressed in FDA’s premarket review.

GAO will update this report to relay the actions that FDA has taken in response to these recommendations.

  • On November 21, 2022, FDA posted warning letters that had been issued to 11-11-11 Brands, Naturally Infused LLC, Newhere Inc dba CBDFX, Infusionz LLC, and CBD American Shaman, LLC for illegally selling CBD-containing products. Collectively, the warning letters raised several legal objections to the sale of CBD in human and animal food and drugs, and dietary supplements, including the following:
    • The sale of a CBD-containing food or animal food renders that food or animal food adulterated because CBD has not been authorized for use by a food additive regulation, subject to a prior sanction, and does not satisfy the criteria for GRAS. On the contrary, FDA noted that the “available data raises serious concerns about potential harm from CBD added to conventional food,” including potential for livery injury, harmful interaction with certain drugs, and interference with sexual development, function, and behavior.
    • The sale of CBD in a human or animal product intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body, and that has not been approved by FDA, is an unlawful introduction into interstate commerce of an unapproved new human drug or animal drug. The only CBD-containing drug approved by FDA is Epidiolex, which is approved to treat severe epilepsy.
    • It is unlawful to market any CBD-containing product as a conventional food or dietary supplement because CBD has been approved for use as a drug.
    • When a drug is used to treat a condition which is not amenable to self-diagnosis or treatment (e.g., sleep apnea), as was the case with many of the products at issue, that drug is misbranded if it does not include adequate directions for use. FDA-approved prescription drugs are exempt from this requirement, but none of the products at issue have been approved by FDA.
  • FDA was particularly concerned with some of the products at issue that appeal to children (e.g., candies, cookies, and gummies) as children may be at greater risk to adverse effects from consumption of CBD. Additionally, in the Naturally Infused LLC Warning Letter, FDA objected to the presence of Delta-8 THC, noting that its use in food renders that food adulterated because it is not authorized by a food additive regulation, the subject of a prior sanction, or GRAS. Indeed, FDA noted that the available data raises “serious concerns” about its use, including “potential for adverse effects on the central nervous and cardiopulmonary systems” and gestational neurodevelopment interference.
  • FDA has already issued a number of warning letters to companies using CBD in various products this year (see here and here) and the safety concerns raised by the Agency suggest that it will be a continuing enforcement priority. Keller and Heckman will continue to monitor and report on regulatory developments related to CBD.
  •  On November 17, 2022, FDA posted warning letters to 7 companies for selling different dietary supplements with claims that caused the products to be “drugs” in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).  Under the FD&C Act, products intended to diagnose, cure, treat, mitigate, or prevent disease are drugs and are subject to the requirements that apply to drugs, even if they are labeled as dietary supplements.
  • The claims were found on the 7 companies’ websites, social media pages, and/or Amazon or Walmart storefronts, and included a variety of statements regarding the products’ claimed abilities to cure, treat, mitigate, or prevent cardiovascular disease (or related conditions, such as atherosclerosis, stroke, or heart failure).  Six of the companies at issue sell a product(s) containing one or more dietary ingredients identified as Vitamin B3, red yeast rice, pine bark extract, EPA and DHA omega-3 fatty acids, magnesium, zinc, bergamot, Hawthorn berry, Hawthorn extract, Coleus forskohlii, hops, taurine, garlic powder, amino sulfonic acid, Co-Q-10, and/or octacosanol.  The seventh company does not list a dietary ingredient but identifies its product as a “glycocalyx regenerating product” and notes various “pathologies associated with impaired endothelial glycocalyx.”  As noted in the warning letters, FDA has not evaluated whether the unapproved products are effective for their intended use, the proper dosage, potential interaction with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns.  Further, in addition to characterizing the products as unapproved “new drugs,” FDA’s letters note misbranding charges based on the impossibility of writing adequate directions for a layperson to use the products safely for the intended purpose of treating one more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner.
  • FDA requested that the companies respond to the warning letters within 15 working days and describe how they will address the issues, or provide reasoning and substantiation as to why they believe the products are not in violation of the law.  Failure to adequately address could result in legal action, such as product seizure and/or injunction.
  • On November 16, 2022, the U.S. Food and Drug Administration (FDA) announced the completion of its first pre-market consultation for a human food made from cultured animal cells.
  • UPSIDE Foods uses animal cell culture technology to take living cells from chickens and grow the cells in a controlled environment to create the cultured animal cell food.  FDA conducted a pre-market consultation with UPSIDE Foods to evaluate its production process and cultured cell material and concluded that it has no further questions about UPSIDE Foods’ safety conclusion.
  • Following FDA’s approval and facility registration for the cell culture portion, the company will also need a grant of inspection from the United States Dept. of Agriculture Food and Safety Inspection Service (USDA FSIS) for the manufacturing establishment.  USDA FSIS must inspect the product before it enters the market.
  • Keller and Heckman will continue to follow developments in this rapidly emerging market.
  • On November 15, FDA announced a finalized rule to more effectively trace contaminated food through the food supply sourced both domestically and internationally. Foodborne illness affects millions of Americans each year. FDA’s action progresses its commitment to better protect the public by ensuring a safe and wholesome food supply through enhanced recordkeeping requirements which will allow for fast identification and removal of contaminated food from the US market.
  • The final rule, entitled “Requirements for Additional Traceability Records for Certain Foods,” establishes additional traceability recordkeeping requirements for entities that manufacture, process, pack, or hold certain food types.
  • Working closely with industry, FDA will be able to more effectively identify the origin and route of travel of certain contaminated foods to prevent or mitigate foodborne illness outbreaks, address credible threats of serious adverse health consequences or death, and minimize overly broad advisories or recalls that implicate unaffected food products.
  • “This rule lays the foundation for even greater end-to-end food traceability across the food system that we’re working on as part of the New Era of Smarter Food Safety initiative,” shared Frank Yiannas, FDA’s duty commissioner for food policy and response.
  • The traceability recordkeeping requirements purport to create a universal and harmonized approach to tracing certain foods included on the Food Traceability List (FTL). In determining what foods to include on the FTL, FDA has developed a risk-ranking model for food tracing based on the factors that Congress identified in Section 204 of the FDA Food Safety Modernization Act. Examples of identified food categories include, but are not limited to, fresh leafy greens, melons, peppers, nut butters, fresh fruits, and crustaceans.
  • The final rule, which will go into effect on November 21, 2022, includes the following key features:
    • Tracking specific points in the supply chain – such as the harvesting, cooling, initial packing, receiving, transforming, and shipping FTL foods;
    • Instituting traceability plans that contain information essential to help regulators understand an entity’s traceability program, including a description of the procedures used to maintain required records, descriptions of procedures used to identify foods on the FTL, descriptions of how traceability lot codes are assigned, a point of contact for questions regarding the traceability plan, and a farm map for those that grow or raise a FTL product;
    • Requiring industry to maintain records as original paper or electronic records, or true copies, provide requested records to the FDA within 24 hours of a request (or within a reasonable time to which the FDA has agreed), and offer records in an electronic spreadsheet when necessary to assist the FDA during an outbreak, recall, or other threat to public health.
  • Keller and Heckman will continue to provide updates on this final rule and its applications to the food industry
  •  Thirty-six leaders in the cellular agriculture industry in the Asian region signed a memorandum of understanding (MOU) agreeing to the use of the English language term “cultivated” to describe animal products grown from animal cells. Many other terms including “cultured,” lab-grown,” and “cell-based” have also been used to describe such products. The MOU was announced at Singapore’s International Agri-Food Week (SIAW) at the end of last month.
  • The MOU does not have the force of law and could be impacted by future national laws and regulations but does reflect agreement from regional industry leaders that the term “cultivated” should be used because it is a scientifically accurate term that distinguishes from traditional animal products and it elicits the most positive responses from consumers. The MOU indicates that more research is needed to determine how to translate the term into various Asian languages.
  • It is unclear whether this agreement will have any impact in the U.S., but it is noteworthy that some signatories, including Cargill, have an international presence. There are no commercially available “cultivated” animal-based products in the US, but in 2019 FDA and USDA signed a MOU regarding their respective jurisdiction over cultivated meat and poultry products (the MOU did not use the term “cultivated”). Per the agreement, FDA will regulate the early stages of development while USDA will regulate post-harvesting steps, including labeling. FDA has exclusive jurisdiction over cultivated seafood products, although the agencies have indicated that they will work jointly to ensure consistent labeling. In that regard, in 2021 USDA issued an advanced notice of proposed rulemaking (ANPR) on labeling of cultivated meat and poultry products (the ANPR used the term “cultured”), but no regulatory action appears to be forthcoming. Similarly, in 2021 FDA issued a request for information (RFI) regarding cultivated seafood (the RFI also used the term “cultured”), but the agency has also not yet taken any regulatory action.
  • We also note that several states have tried to enact bans on the use of animal-based terms (e.g., meat) on products that are not derived from animals (cultivated meat products and plant-based meat products), although courts have found such bans to be unconstitutional. See e.g., Enforcement of Arkansas Law Enjoined. We will continue to monitor and repot on any developments in the commercialization and regulation of cultivated animal products.

 Nestle Dumps Boost Beverage False Ad Suit For Good (Law360 Subscription Required)

  • Earlier this year, a California federal judge dismissed without prejudice the second amended complaint in a proposed class action lawsuit, originally filed on December 20, 2021, against Nestle HealthCare Nutrition, Inc. (“Nestle”), holding that Boost Glucose Control and Boost Glucose Control High Protein product labels would not lead reasonable consumers to believe that the drink would treat or cure diabetes, a chronic disease for which there is no known cure.  Plaintiffs alleged that the Boost products are deceptively labeled because the statements, “glucose control,” “helps manage blood sugar,” and “designed for people with diabetes” misleadingly imply that the products would have some affirmatively therapeutic impact on their blood glucose levels or otherwise mitigate, treat, or prevent pre-diabetes or diabetes.
  • On November 7, 2022, the lawsuit over Boost glucose control drinks was permanently dismissed.  Regarding new allegations in the third amended complaint that were added to address earlier deficiencies regarding whether a reasonable consumer would be deceived, the court found:
    • Allegations that the products are sold in the health and nutritional supplement sections of stores, rather than in the grocery aisles, were added to address the point that “no reasonable consumer of the targeted consumer group would expect a novel diabetes treatment to simply appear on grocery shelves out of the blue,” but are not persuasive because the plaintiffs failed to plausibly allege that Nestle held control over placement of the products;
    • FDA and FTC (Federal Trade Commission) cease-and-desist letters regarding sham diabetes treatments, bearing statements such as “keep blood sugar at an optimum level” and “diabetes support supplement,” were intended to support the inference that similar representations on the Boost labels advertise an unproven treatment but have the contrary effect because no such letter was likewise sent to Nestle; and
    • Claims that these individual plaintiffs were duped by the alleged misrepresentations on the Boost labels does not lead to the conclusion that a significant portion of persons with prediabetes or diabetes would similarly believe that a nutritional drink would control a chronic disease.

On the issue of whether the plaintiffs adequately alleged standing based on a price-premium theory, the judge acknowledged the plaintiffs’ evidence that Boost glucose control drinks are priced higher than other nutritional drinks but noted that the plaintiffs still did not allege specific facts relevant to their particular purchases.

  • It is not clear if the statements on Nestle’s Boost glucose control drinks may have been deemed misleading for the general public as opposed to the targeted consumers with diabetes to whom the court attributed some level of savviness in understanding “clear designations of the nutritional contents on the front of the label,” which together with descriptions of the products as nutritional drinks, the court found “demonstrate that the products are a food that will necessarily impact glucose levels, not a health supplement or a drug that would treat the chronic disease.”