• This past summer Inner Mongolia Kingdomway Pharmaceutical Limited (“Kingdom”) submitted a new dietary ingredient (NDI) notification to FDA for β-Nicotinamide Mononucleotide (NMN), a compound that has been touted for its anti-aging properties. Under the Federal Food, Drug, and Cosmetic Act, an NDI is required to market dietary supplements that contain a “new dietary ingredient,” which means a dietary ingredient that was not marketed in the US prior to October 15, 1994. (21 USC 350b (d)).
  • In its initial October 11, 2022, response,  FDA reiterated that the definition of dietary supplement excludes articles “authorized for investigation as a new drug … for which substantial clinical investigation have been instituted and for which the existence of such investigations have been made public,” unless the article was marketed as a food or dietary supplement prior to the authorization. (21 U.S.C. 321(ff)). And, because FDA determined that such authorization for investigation as a new drug had taken place before NMN was marketed as a food or lawfully marketed as a dietary supplement, the agency concluded that NMN is excluded from the definition of a dietary supplement. 
  • Last month, and in response to a letter from Kingdom’s lawyers requesting that the agency withdraw its October 11th letter, FDA doubled down on its conclusion in a second letter which further explains the agency’s decision. Notably, in the second letter FDA:
    • Indicates that it will not disclose the date on which the authorization for investigation of NMN (or any new drug) occurred unless the investigational new drug application has been publicly disclosed or acknowledged.
    • Rejects the arguments that dietary ingredients marketed after January 7, 2016, the date on which NMN capsules were offered for sale in Japan, do not require an NDI notification. This argument is based on the exemption from an NDI notification for dietary ingredients which have been present in the “food supply” (21 USC 350b(a)). FDA interpreted “food supply” to include only food, and not dietary supplements. Furthermore, it found that only evidence of marketing in the U.S. was relevant.
    • Reaffirms that illegal marketing of NMN without an NDI notification is not relevant to the determination of whether it is a dietary supplement (or excluded because it has already been authorized for investigation as a new drug). 
  • FDA previously determined that N-acetyl-L-cysteine (NAC) was excluded from the definition of a dietary supplement for similar reasons, and yet ultimately determined that enforcement discretion was appropriate. We will continue to monitor and report on developments regarding the use of NMN in dietary supplements.

Trader Joe’s Beats Suit Over Cold-Pressed Juice Processing (Law360 Subscription Required)

  • FDA developed Hazard Analysis Critical Control Point (HACCP) regulations that require treatment of covered juice products due to bacteria that may be present in fresh-squeezed fruits and vegetables.  As we have discussed, FDA’s regulations allow only very limited exemptions from a requirement for a 5-log reduction of the pertinent microorganism that is achieved by pasteurization or other processing.  For example, grocery stores and other retail outlets may sell unpasteurized packaged juice that is made onsite.  Such products must be refrigerated and must carry a warning about harmful bacteria.  FDA has posted What You Need to Know About Juice Safety to educate consumers about packaged juice that has not been treated to ensure its safety. 
  • On December 9, 2022, an Illinois federal judge permanently dismissed a proposed class action lawsuit alleging that the grocery store chain, Trader Joe’s, deceived its customers about the freshness of its green juice by claiming “cold-pressed” on the front label and placing the juice in the refrigerated section of the produce department despite the juice having been high-pressure processed.  The judge found that the “cold-pressed” claim is factually accurate, as the juice is in fact cold-pressed before a high-pressure processing step, and that the plaintiff offered only conclusory allegations that other consumers would agree that the “cold-pressed” labeling implies the juice is free of processing or preservation, especially when the product’s side label expressly states that the juice is processed. 
  • In deciding on the motion to dismiss by Trader Joe’s, the court took judicial notice of FDA’s “What You Need to Know…” website and postulated whether reasonable consumers would be aware that most juice is routinely processed to avoid food borne illness.  Regardless of consumer awareness, the court concluded that the plaintiff’s interpretation of the “cold-pressed” claim is contrary to FDA’s guidance on juice manufacturing. 

Pepsi Falsely Touts ‘No Preservatives’ In Izze Drinks, Suit Says (Subscription to Law360 required)

  • On December 1, PepsiCo and the equity firm behind Tropicana, PAI Partners, Inc., were named defendants in a proposed class action suit in New York federal court for its Izze-brand sparkling juice products which contain the common ingredients ascorbic and citric acids.
  • In an 18-page complaint, plaintiff Taylor alleged that the companies “systematically misled” the public by purportedly claiming the popular Izze sparkling juice beverages contain no preservatives, which she claims is a marketing tactic aimed towards health-conscious shoppers looking for more options that don’t contain preservatives.
  • The Izze-brand drinks include the phrase “NO PRESERVATIVES” on the front label; however, the ingredient statements featured on the product labels list both citric acid and ascorbic acid. The Izze line of drinks includes a variety of flavors such as sparkling blackberry, blackberry lemonade, peach, apple, pomegranate, clementine and grapefruit.
  • According to the complaint, citric acid functions as a preservative by acting as an acidulant and indirect antioxidant. Citric acid infiltrates, then either weakens or kills microorganisms in a product through direct antimicrobial effect and can lower a product’s pH level, according to the suit. Citric acid is one of the most widely-used acidulants in the food and beverage industry.
  • The complaint similarly claims that ascorbic acid, like citric acid, functions as an antioxidant that helps prevent microbial growth and oxidation in food products, thereby preserving their color and freshness. The FDA regulates the use of ascorbic acid in the formulation of wine and juice “to prevent oxidation of color and flavor components of juice” pursuant to 27 C.F.R. § 24.246.  The complainant alleges that ascorbic acid, like citric acid, has preservative effects even when used in small amounts, which in turn supports the conclusion that the products contain preservatives.
  • Plaintiff Taylor asserts violations of state consumer protection statutes and violations of New York General Business Law sections 349 and 350, and seeks relief in the form of compensatory, statutory and punitive damages, along with attorney fees and costs.
  • The case is Tiffany Taylor v. PepsiCo Inc. and PAI Partners Inc., case number 7:22-cv-10219, in the U.S. District Court for the Southern District of New York, and is another in the line of class action challenges to the use of preservative claims for products containing multipurpose ingredients like ascorbic and citric acid.  Defendants typically respond that these ingredients are used to add tartness to the product and are not used for any preservative effect.
  • Keller and Heckman will continue to monitor this case and report on any notable developments.
  • The U.S. Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) and the U.S. Food and Drug Administration (FDA) continue to investigate and report recent food-related illnesses that have been plaguing the country.
  • FSIS has recently reported a November 2022 outbreak caused bythe pathogen Escherichia coli O157:H7 (E. coli) which the agency suspects was caused by contaminated beef, but has provided no additional information, including how many people have fallen ill and where the outbreak has occurred.
  • FDA has begun sample collection and analysis following an outbreak of Listeria monocytogenes linked to enoki mushrooms.  The investigators are currently trying to determine what food brands are involved.  FDA also continues to investigate the cause of an outbreak of Salmonella Typhimurium that infected 270 people, although the agency has determined that the outbreak is over.  Some other ongoing FDA investigations include a Listeria monocytogenes outbreak from Brie and Camembert cheese in September, Salmonella infections traced to Mariscos Bahia, Inc. seafood, and infections caused by Cronobacter that have been found in at least four infants.
  • FDA releases a public health advisory for investigations that have resulted in specific, actionable steps for consumers to take to protect themselves.  Outbreak and adverse event investigations do not always result in identification of a source or contributing factors, and FDA relies heavily on self-reported data in these cases.
  • Keller and Heckman will continue to update on outbreaks of food-borne illnesses.
  • As mentioned in July, FDA Commissioner Robert Califf commissioned an external evaluation of the FDA’s Human Foods Program (HFP), including the Office of Food Policy and Response (OFPR), the Center for Food Safety and Applied Nutrition (CFSAN), as well as relevant parts of the Office of Regulatory Affairs (ORA). The external evaluation was conducted by an expert panel facilitated by the Reagan-Udall Foundation, who was asked to assess the processes and procedures, resourcing, and organizational structure for the HFP.
  • On December 6, the expert panel released its findings and recommendations in the “Operational Evaluation of FDA’s Human Foods Program.” The report gives an overview of the HFP’s primary functions and provides recommendations regarding the Program’s culture, structure, resources, and authorities:
    • Culture – The Panel found that while the staff are dedicated to protecting public health, the current culture, structure, and governance model detract from the HFP’s effectiveness. Among other suggestions, the Panel recommended the establishment of an organizational structure with a clear leader that can identify, communicate, embrace, and promote a clear and compelling vision, mission, and value statement. The Program must also commit to transparency, timeliness, and predictability in decision-making, with a preference towards action.
    • Structure – Related to their recommendations regarding the culture, the Panel found the HFP lacked a clear leader or decision-maker, outside of the Commissioner. While the missions of CFSAN and OFPR are different on paper, according to the report, staff are often left wondering which program is responsible for decision-making. Similarly, neither CFSAN nor ORA have a direct stake in ensuring that their work and perspectives align. Thus, the Panel strongly recommended some sort of structural change to address these challenges. For instance, the Panel stated that FDA should increase the visibility and prominence of the Program, establish clear lines of authority, and the importance of nutrition should be elevated.
    • Resources – The Panel found that the HFP is significantly under-resourced and additional resources, in conjunction to other changes, are critical to future success. Congressional appropriations, the primary source of funding for the Program, have not kept pace with its needs, which is exacerbated by the imbalanced availability of user fee programs across the Agency. The Panel recommended the FDA secure the hiring authorities and salary flexibility of the 21st Century Cures Act to improve ability to recruit, hire, and retain personnel. FDA should move to a stronger, more cooperative relationship with states and other local authorities. However, FDA should give the highest priority to the formulation of an appropriations strategy that creates a clear case for why increased funding is necessary. FDA should also more fully implement the industry fee authorities provided by FSMA, as well as do more to support the HFP budget internally.
    • Authorities – The HFP is challenged in keeping up with the innovations in food and regulatory science. According to the Panel, the FDA should seek to amend the FDCA to allow for disclosure of non-public information to state, local, and US territorial government agencies with counterpart functions related to FDA-regulated products by preempting related state, local, or territorial disclosure laws. FDA should also seek authority to request records from food manufacturers in advance of or in lieu of an inspection, and also be notified when designated food categories are likely to experience shortages or when supply chain disruptions are anticipated. The FDA should also seek a substantial amount of “no-year” funding.
  • In a press release about the report, Commissioner Califf stated that he will be “making final decisions regarding the future of the FDA Human Foods Program after reviewing the report and consulting with stakeholders both externally and internally.” The Commissioner intends to form a group of agency leaders to determine how best to implement and operationalize the Panel’s findings.
  •  Any product under USDA jurisdiction “which was purchased by the importer outside the United States for his/her own consumption,” and in a quantity of no more than 50 pounds, can be imported into the U.S. without compliance with the regulations relating to imported products in 9 CFR, Part 327, which require, among other things, a foreign inspection certificate. See 9 CFR 327.16.  Such a product could, however, be subject to other import laws, including the regulations in 9 CFR, Part 94 relating to various animal diseases (e.g., BSE).
  • TopIceland, an Icelandic company which sells Icelandic food product abroad, filed a petition last month which requests that USDA amend the regulation to clarify that food products which are purchased online are eligible for this exemption. The petition follows the seizure of several shipments of their products for failure to comply with the regulatory requirements for commercial import.
  • In support of their petition, TopIceland cites FDA guidance on “personal importation” which does not distinguish between the mode of delivery and encompasses products which are “shipped by courier or international mail.”
  • USDA has acknowledged the petition, although it is unlikely to substantively respond anytime soon as there is no mandated time for its response, and it has a backlog of petitions to which it has not responded.
  •  In a December 16, 2003 petition, a coalition of consumer advocates asked the Alcohol and Tobacco Tax and Trade Bureau (TTB) to require allergen information on alcohol beverages and an “Alcohol Facts” panel similar to the “Nutrition Facts” panels on food.  In 2005, TTB published a notice of proposed rulemaking and subsequently issued an interim rule in 2006 on mandatory allergen statements.  Additionally, in 2007, TTB issued a proposed rule for new requirements for alcohol content labeling and a mandatory “Serving Facts” statement.  TTB did not issue a final rule on either mandatory allergen labeling or nutrient content labeling but did amend its rules in 2013 to allow voluntary labeling of major food allergens.  In 2017, TTB withdrew the rulemaking proposals for allergen and nutrient content labeling.
  • In a November 17, 2022 letter to consumer advocates that was issued just over a month after three consumer groups filed a lawsuit to compel TTB to act, the agency announced it has granted the December 2003 petition to “engage in a new rulemaking on the issues of nutrient content labeling, expanded alcohol content labeling, major food allergen labeling, and ingredient listing.”  As requested in the 2003 petition and supplemented by a February 24, 2021 letter to the Secretary of the Treasury, the “Alcohol Facts” panel would include information in a standardized format as follows:
    • The alcohol content, expressed as a percentage of volume;
    • The serving size for a standard drink that contains 0.50 ounce of ethyl alcohol;
    • The amount of alcohol in ounces and number of calories per serving;
    • The number of standard drinks (using 0.50 ounce of ethyl alcohol as a standard drink) per container;
    • An ingredients declaration, listing each ingredient (including food and color additives, and flavors) by its common or usual name (to appear immediately below the Alcohol Facts panel), and;
    • Current U.S. Dietary Guidelines definitions of moderate drinking for men and women.
  • TTB expects to issue notices of its proposed rules within the next year.  TTB will solicit comments on all nutrient content labeling, expanded alcohol content labeling, major food allergen labeling, and ingredient labeling issues, even though some of these issues already received comments from its 2006 and 2007 notices because those comments are now “stale.”

Kroger Hit With False Ad Suit Over ‘Naturally Flavored’ Water (Law360 Subscription Required)

  • On November 28, a putative class action suit filed in Ohio federal court alleges that The Kroger Company misleads shoppers by falsely advertising that its sparkling waters are “naturally flavored,” despite adding malic acid derived from petrochemicals, which the plaintiff alleges imitates the characterizing flavor of the names fruit in its beverage products.
  • Plaintiff Cameron claims she bought the beverages at Kroger locations over the course of five years between 2016 and 2021 in Ohio and Tennessee after relying on the statements made on the products’ labels.
  • Kroger labels and advertises its sparkling waters as containing different characterizing flavors like strawberry, white grape, mixed berry, kiwi strawberry, blueberry pomegranate, black cherry and pineapple coconut. Plaintiff Cameron alleges that the characterizing flavors are not exclusively derived from the named fruit ingredients.
  • Plaintiff seeks several forms of relief on behalf of fellow shoppers over Kroger’s allegedly deceptive marketing practices, including a court order compelling the grocery giant to stop packaging, distributing, advertising and selling the products that it alleges are in violation of U.S. Food and Drug Administration regulations.
  • The case is Mary Cathleen Cameron v. The Kroger Company, case number 1:22-cv-00694, in the U.S. District Court for the Southern District of Ohio.
  • Keller and Heckman will continue to monitor any developments in this case.
  • On November 17, 2022, FDA announced that it would be hosting an informational webinar on the recently released Food Traceability final rule.
  • As previously reported, the final rule was announced on November 15, 2022, and establishes additional traceability recordkeeping requirements for entities that manufacture, process, pack, or hold certain food types. The final rule includes traceability plans and recordkeeping requirements that aim to more effectively trace contaminated food through the food supply sourced both domestically and internationally.
  • The webinar will be held on December 7, 2022, from 1:00 – 5:00 pm ET. During the webinar, FDA will provide an overview of the rule, discuss recordkeeping requirements, and answer questions. Questions may be submitted during the registration process. The webinar will also be recorded and posted to the meeting page.
  • 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.