• Beginning on October 1, 2022, plant-based meat alternative products in France will face new labeling challenges. The decree (in French) prohibits manufacturers of plant-based products from using “sector-specific terminology traditionally associated with meat and fish.” Notably, this law applies exclusively to products made in France and not to imports.
  • Under this decree, terms like “steak,” “sausage,” or “chicken” will not be allowed to describe meatless, plant-based products. However, terms like “burger” will remain permissible because it does not specifically refer to meat.
  • France is the first country in Europe to ban this “meaty” language for plant-based foods; although, the European Union has prohibited plant-based products from using labels like “milk,” “cheese,” and “butter” if they do not include dairy ingredients. On an international scale, South Africa recently passed a similar restriction on the use of “meaty” language for plant-based products.  Keller and Heckman will continue to monitor changes in plant-based labeling requirements.
  • On July 6, 2022, FDA announced it had finalized its Guidance for Industry (GFI) #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. The guidance aims to help food facilities develop a food safety plan to prevent or significantly minimize hazards in food for animals that could cause illness or injury to people or animals. Additionally, it provides detailed information to help animal food facilities anticipate possible food safety hazards, identify risk-based preventive controls to prevent or minimize those hazards, and create and implement a plan to keep unsafe animal food from entering the marketplace.
  • The document details:
    • How to recognize biological, chemical (including radiological), and physical agents that are known or reasonably foreseeable hazards in manufacturing, processing, packing, and holding of animal food;
    • Ways to identify and implement preventive controls for hazards that require preventive controls in animal food;
    • Components of preventive control management (e.g., monitoring, corrective actions, and verification (including validation); and
    • Recordkeeping requirements associated with the food safety plan and the implementation of the food safety plan.
  • By way of background, FDA released draft GFI #245, a draft of this guidance in January of 2018. One of the most notable changes in response to stakeholder feedback is the clarification that not all the hazard examples in the guidance are applicable to all animal food or all facilities.
  • Animal food facilities with questions about how this guidance applies to them can contact AskCVM@fda.hhs.gov for further assistance. Comments can be submitted here.
  • On June 10, 2022, the Food Safety and Standards Authority of India (FSSAI) issued a notification regarding the definition and regulation of vegan foods. Most notably, a food product cannot be considered “vegan” if the creation of the product required “animal testing for any purpose, including safety evaluation, unless provided by any Regulatory Authority.” This requirement also applies to food product imports that are labeled vegan and requires a certification by an appropriate authority of the exporting country.
  • The notification defines “vegan food” as “food or food ingredients” that are free from animal origin which means that “at no stage of production or processing” can ingredients of animal origin be used. Vegan food packaging must also display a logo indicating vegan compliance under the FSSAI regulations.
  • For comparison, the United States Food and Drug Administration (FDA) does not define or provide criteria for use of “vegan” claims on food labeling.  Rather, vegan claims are governed generally by the Federal Food, Drug, & Cosmetic Act § 403(a)(1).  This section requires that claims be truthful and not misleading.  Vegan certification claims on food products in the U.S. can be third-party certified, although this is not required by the FDA.  Keller and Heckman will continue to monitor and report on regulations regarding vegan foods.
  • On June 27th, the People for Ethical Treatment of Animals (PETA) submitted a petition to the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA-FSIS) requesting that the Agency initiate rulemaking to remove animal raising claims from the Agency’s label approval process.
  • Currently, labels bearing “special statements and claims,” including “claims regarding the raising of animals,” must be approved by FSIS’s Labeling Program and Delivery Staff prior to use. (See 9 CFR 412.1 for a full list of labels, including other special statements and claims, that must be approved by FSIS.) In 2019, FSIS published a guidance document which describes the documents that are needed to substantiate animal raising claims for label submissions. These include documentation describing the manner in which the animals are raised, a written description explaining the controls for ensuring the claim is valid, a description of product tracing and segregation (including for non-conforming product), and a current copy of any applicable third-party certificates.
  • In the petition, PETA argues that USDA exceeds its authority by approving animal raising claims because the Agency’s authorizing statues (the Federal Meat Inspection Act and the Poultry Products Inspection Act) do not authorize it to regulate on-farm raising activities, and instead limit its jurisdiction to slaughterhouses, packing facilities, and other processing and distribution facilities. Therefore, without any jurisdiction to conduct on-farm inspections, PETA argues that FSIS is unable to adequately substantiate these claims. Furthermore, PETA argues that animal raising claims including (but not limited to) “humanely raised,” “animal friendly,” and “raised with care” are inconsistently defined by animal producers and certifying entities, and that consumer expectations of these claims often differ significantly from company claims. As a result, and citing to several prominent examples, PETA argues that many of the animal raising claims that FSIS approves are in fact not truthful and/or misleading, and yet allow for significant price premiums to be charged. Accordingly, the petition requests that FSIS amend 9 CFR 412.1 to no longer allow for the review and approval of animal raising claims, and that the Agency rescind its guidelines regarding substantiation of animal raising claims. Keller and Heckman will monitor and report on the Agency’s response to the petition and whether it sparks any class action lawsuits.
  • As part of Canada’s comprehensive “Healthy Eating Strategy” aimed at helping Canadians make more healthful food choices, Health Canada has published new front-of-pack (FOP) nutrition labeling regulations covering pre-packaged foods that meet certain dietary thresholds.  See Front-of-Package Nutrition Labeling.
  • The new FOP features a magnifying glass and a dual language warning if a product is “high” in saturated fat, sugars, and/or sodium.
  • For small reference amount foods (foods with a reference amount of no more than 30g), the triggering threshold is 10% of the daily value per reference amount or per serving, whichever is greater.  For foods with a reference amount of greater than 30g, the triggering percentage is 15%.
  • Enforcement of the new regulation begins on January 1, 2026, although the effective date of the regulation is July 20, 2022.  Accordingly, the symbol is likely to begin appearing on foods sold in Canada in the relatively near future.  Keller and Heckman will closely monitor these and other Canadian regulatory initiatives issued as part of its Healthy Eating Strategy.
  • On June 27, 2022, FDA’s Center for Veterinary Medicine (CVM) announced that it had published a pre-recorded animal biotechnology case study webinar. The webinar addresses the agency’s risk-based review process for intentional genomic alterations (IGAs) in animals that may pose a low risk.
  • As previously reported, on March 7, 2022, FDA announced its first low-risk determination for the marketing of products from genome-edited beef cattle and their offspring, following a safety review. CVM’s webinar uses this evaluation as a case study to provide insight into how the agency reached its determination that the IGA did not raise any safety concerns.
  • By way of background, IGAs in animals are changes to an animal’s genomic DNA that are produced using modern molecular technologies, such as random or targeted DNA sequence changes. The intended uses for IGAs in animals include applications in human health (e.g., reducing allergenicity), improved animal health (e.g., disease resistance), and enhanced production of food quality (e.g., feed efficiency).  FDA’s draft guidance notes that FDA will exercise enforcement discretion where it determines that alterations present a low risk of harm.
  • CVM will accept feedback and questions regarding the webinar at FDA-CVM-Animal-Biotechnology-Feedback@fda.hhs.gov. Additional resources on IGAs can be found here.
  • On June 24, the Court of Appeals of Georgia held that Plaintiff Shawn Smith’s deceptive product labeling case raised questions best left to the FDA.
  • By way of background, in 2016, the FDA issued warning letters to seven companies stating that methylsynephrine used in the companies’ dietary supplements does not meet the definition of a “dietary ingredient” under the Federal Food, Drug, and Cosmetic Act (FDCA), rendering any product containing this ingredient and labeled as a “dietary supplement” misbranded. Relying on these letters, Smith sued Hi-Tech Pharmaceuticals under the District of Columbia Consumer Procedures and Protection Act for misleading consumers by “omitting that methylsynephrine is an unapproved drug that has been linked to adverse health events.” The state trial court dismissed the case with prejudice on grounds that the claims were preempted by the FDCA and raised issues within the FDA’s jurisdiction.
  • On appeal, a panel of judges found that the claims were not subject to preemption. However, they affirmed the trial court’s determination that the claims fall within the FDA’s primary jurisdiction because the questions require the agency’s expert determination of dietary ingredients.  The plaintiff argued that the warning letters describe the FDA’s final position that methylsynephrine does not qualify as a dietary ingredient; however, holding that the warning letters are only “regulatory letters [that] do not constitute final agency action,” the Court of Appeals remanded to the trial court to decide whether a stay or dismissal without prejudice is appropriate.
  • An attorney for the plaintiff reports that there is no indication the FDA plans to reconsider the questions at issue because there is no “pending agency action.” Keller and Heckman will continue to monitor this litigation.
  • On June 14, 2022, the Senate Health, Education, Labor, and Pensions (HELP) Committee passed the FDA Safety and Landmark Advancements (FDASLA) Act (S. 4348) which proposes various changes to the regulation of dietary supplements and cosmetics. The legislation was originally introduced by Sen. Patty Murray (D-WA) on May 26, 2022 and would amend Chapter IV of the Federal Food, Drug, and Cosmetic Act.
  • Specifically, in regard to dietary supplements, the Act would require that companies list their products with the FDA.  The information required to be submitted in connection with the listing includes the name of the supplement; the name and address of the manufacturer, packer, or distributor appearing on the label, and contact information for the owner or operator; the business name and mailing address of all locations in which the dietary supplement is manufactured, packaged, labeled, or held; a list of all ingredients in each supplement; the number of servings per container; directions for use; warnings, notice, and safe handling statements; allergen statements; any health or structure/function claims; and the dietary supplement product listing number. Subject to limited exceptions, this information would be made publicly available in a searchable electronic database.
  • The Act also proposes changes to the regulation of cosmetics. These include (1) adverse event reporting requirements; (2) the establishment of good manufacturing practices (GMPs) for cosmetics facilities; (3) registration and product listing requirements; (4) requirements to maintain records supporting the safety of the cosmetic product; (5) a labeling requirement to include contact information for adverse event reporting; (6) requirement to have records accessible to FDA if there is a reasonable belief that the product (or ingredients therein) presents a threat of serious adverse health consequences; and (7) a mandatory recall authority. In establishing GMP regulations, FDA is directed to consider the size and scope of the cosmetics manufacturer, the risks to public health, and to provide flexibility for different types of facilities. Currently, there is a GMP checklist for cosmetics manufacturers to follow for inspections, but no regulations have been promulgated.
  • Mandatory listing requirements for dietary supplement companies and strengthening of dietary supplement regulation have previously been considered by the FDA. Keller and Heckman will continue to monitor this legislation and report on any further updates.
  •  The Food Safety Modernization Act (FSMA) established the Accredited Third-Party Certification Program, also referred to as the Third-Party Program (TPP).  The voluntary TPP allows accreditation bodies (ABs) to apply for recognition by FDA. Recognized ABs have the authority to accredit certification bodies (CBs), otherwise known as third-party auditors. In turn, the CBs (1) conduct consultative and/or regulatory food safety audits and (2) issue certifications to eligible entities that produce food for humans and animals. FDA can require certification as a condition of entry for imported food products in limited circumstances when specific, risk-based criteria are met. Importers can use a certification to establish eligibility to participate in the Voluntary Qualified Importer Program (VQIP).
  • In a June 24, 2022 Constituent Update, FDA announced that it has recognized Jamaica National Agency for Accreditation (JANAAC), as an AB under the Accredited Third-Party Certification Program for a period of five years.  JANAAC joins three other ABs that are currently recognized in various scopes of accreditation, i.e., ANSI National Accreditation Board (ANAB), Thailand’s National Bureau of Agricultural Commodity and Food Standards (ACFS), and International Accreditation Services (IAS).  FDA has recognized JANAAC as having the authority to accredit CBs with the ability to conduct food safety audits under ten of the eleven possible scopes of accreditation:
    • Acidified Foods (AF)
    • Dietary Supplements
    • Juice Hazard Analysis and Critical Control Points (Juice HACCP)
    • Low-Acid Canned Foods (LACF)
    • Medicated Feed Current Good Manufacturing Practices (Medicated Feed CGMPs)
    • Preventive Controls for Animal Food (PCAF)
    • Preventive Controls for Human Food (PCHF)
    • Produce Safety
    • Seafood Hazard Analysis and Critical Control Points (Seafood HACCP)
    • Shell Eggs
  • JANACC is the only recognized AB whose scope of authority includes Medicated Feed CGMPs and Shell Eggs.  No AB is yet recognized with the authority to accredit CBs with the ability to conduct safety audits for Infant Formula.
  • As previously reported on this blog, Health Canada published proposed Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Nutrition Symbols, Other Labelling Provisions, Partially Hydrogenated Oils and Vitamin D) in 2018.  A key part of Health Canada’s proposed rule is Front-of-Package (FOP) labeling requirements aimed to assist consumers in making healthy eating choices by highlighting foods that contain “high” levels of sodium, saturated fat, or sugars.  According to the proposed rule, a prepackaged food product is “high” in sodium, saturated fat, or sugar if the amount of the nutrient meets or exceeds 15% of the daily value per serving.
  • The proposed rule provides exemptions to the FOP requirement for raw single ingredient meat products and meat by-products, but it specifically notes that this exception does not apply to ground meat.  Health Canada justifies the exemptions on the basis of technical, nutritional, or practical reasons, and the agency notes that the exemptions align with those for Health Canada’s Nutrition Facts table rules.
  • On June 3, 2022 the Canadian Cattlemen’s Association, Canadian Pork Council, and National Cattle Feeders’ Association issued a position statement asserting that Health Canada should exempt ground beef and ground pork from the proposed FOP labeling rules.  The statement asserts that since ground meats are nutritiously similar to exempt foods and relatively less processed than non-exempt foods, withholding the exemption from ground meats “contradicts the foundational principles of healthy eating” that the proposed rule seeks to effectuate.