• 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.
  • As previously reported,  on March 28, 2022, the U.S. Supreme court granted a Writ of Certiorari petition submitted by the National Pork Producers Council (NPPC) and the American Farm Bureau Federation (AFBF) in National Pork Producers Council v. Karen Ross. The petitioners argue that California’s Proposition 12 places excessive burdens on interstate commerce in violation of the Commerce Clause. By way of background, California’s Proposition 12, also known as the Prevention of Cruelty to Farm Animals Act, establishes new standards for confinement of certain farm animals (breeding pigs, calves raised for veal, and egg-laying hens) and bans the sale of products from such animals not raised under minimum confinement standards in California.
  • On June 17th, the U.S. Government and the U.S. Solicitor General filed an amicus brief in support of the NPPC and AFBF’s challenge to California’s Proposition 12. The brief states that the U.S. Government has a substantial interest in this question because, under the Animal Health Protection Act and the Federal Meat Inspection Act, the federal government has the responsibility to guard against disease in interstate commerce, as well as to ensure the free flow of interstate commerce. To that end, the amicus brief argues that the state of California does not have a legitimate interest in protecting the welfare of animals outside of its borders and that it may not extend its police power beyond its jurisdictional bounds. The brief states that it is not taking a position on whether Proposition 12 is unconstitutional but rather that the petitioners have plausibly alleged that the measure will have substantial adverse impacts on the interstate pork market and that, if those assertions are proven, the burdens would be “clearly excessive.”  The brief concludes that the judgment of the court of appeals should be remanded for appropriate proceedings.
  • This filing comes after a coalition of representatives urged the Solicitor General to support Proposition 12. The Supreme Court case is set to be heard on October 11, 2022. Keller and Heckman will continue to monitor this matter and report on any updates.
  • On June 21, the FDA published a final guidance for FDA staff entitled “FDA Oversight of Food Covered by Systems Recognition Agreements” (SRAs). The guidance covers FDA’s regulatory oversight activities for food covered by SRAs between FDA and foreign regulatory counterparts. SRAs establish a regulatory partnership between the FDA and the Agency’s regulatory counterpart. At present, FDA has signed SRAs with food safety agencies in Australia, Canada, and New Zealand.
  • Systems Recognition (SR) take into account whether (1) another country’s food safety system provides a similar, though not necessarily identical, system of food safety protections as the US, and (2) another country’s food safety authority provides similar oversight and monitoring activities for food produced in their jurisdiction as FDA provides. In short, SRAs are based on the conclusion that food safety systems with similar levels of oversight lead to similar food safety outcomes.
  • SR allows FDA to avoid duplicating certain food safety-related work in countries with an SRA. For food imported from a country with an active SRA, FDA intends to adjust its regulatory oversight, including as follows:
    • FDA’s routine inspections of foreign food establishments for food covered by an SRA will be rare (except for certain situations), allowing FDA to allocate its risk-based foreign inspection resources more efficiently and effectively.
    • FDA intends to adjust its risk-based screening and targeting criteria for import entries of food covered by an SRA to reflect FDA’s determination of the comparability of the regulatory system covered by an SRA
    • FDA will not prioritize import samples and field examinations of food covered by an SRA.
    • With respect to imported foods covered by an SRA, FDA does not intend to prioritize inspections of importers for FSVP compliance or compliance with juice and seafood HACCP importer requirements.
  • As we have previously blogged, FDA announced a three-phase “Closer to Zero” plan in 2021 to reduce the levels of arsenic, lead, cadmium, and mercury that babies and young children are exposed to.
  • In regard to arsenic and cadmium, the plan requires FDA to: (1) develop an interim reference level (IRL) for arsenic in phase 1 of the plan (April 2021 to April 2022); (2) propose a draft action level for arsenic and develop an IRL for cadmium in phase 2 of the plan (April 2022 – April 2024); and (3) finalize the arsenic action level and develop a draft action level for cadmium in phase 3 of the plan (April 2024 and beyond).
  • At a June 14, 2022 webinar on the draft action levels for lead in juice that the Agency recently published (see April 29th post), Conrad Choiniere, Director of the Office of Analytics and Outreach at FDA’s Center for Food Safety and Applied Nutrition (CFSAN), indicated that the Agency has received additional resources to focus on its Closer to Zero plan and that it is likely to release IRLs for both arsenic and cadmium by early 2023 and that draft action levels for both heavy metals would follow in late 2023 to early 2024.  He also reported that an action level for lead in baby food is currently undergoing interagency review and is expected to be released soon.
  • Keller and Heckman will continue to monitor and report on updates to the Closer to Zero Plan.