• 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.
  • The Senate Health, Education, Labor and Pensions (HELP) Committee has approved the FDA Safety and Landmark Advancements Act of 2022 (FDASLA) to introduce policies in response to the infant formula crisis. Sen. Patty Murray (D-WA), who chairs the HELP committee, introduced the bill in May.
  • The HELP Committee added sections 909 and 910 to address the breakdowns that led to a nationwide shortage of infant formula. Specifically, section 909 would require FDA to report to Congress on its mailroom policies and procedures, including quarterly reports on how the agency handles common carrier packages and correspondence. Section 910 would introduce a long list of requirements, including requiring FDA to monitor infant formula manufacturers more closely, increase the resiliency of the formula supply chain, work with other countries to “harmonize regulatory requirements” for formula, and provide flexibility in the infant formula premarket submission process during supply chain disruptions.
  • The formula shortage occurred due to food safety concerns that shut down a formula production plant in mid-February. The plant reopened June 4, but the shortage is expected to continue into the summer.
  • Keller and Heckman will continue to monitor this legislation.
  • On June, 6 2022, FDA released an online resource page for human and animal food producers who may be affected by flooding and severe weather incidents.  It identifies federal and state resources available to those who may be harvesting, mixing, storing, or distributing grains and other foods.
  • For example, FDA highlights that crops harvested from flood waters may be contaminated and unacceptable for consumption, as flood waters may contain sewage, pathogenic organisms, and chemical waste.  In addition, a concern for flood-impacted crops includes mold growth and the potential for the development of mycotoxins that have the potential to remain in the food throughout the production process and can cause serious illness or death when consumed by animals or humans.
  • FDA notes that some crops that are unsuitable for human use may be salvaged for animal food. FDA considers reconditioning requests on a case-by-case basis. FDA’s compliance policy guide for reconditioning requests can be found here.
  • A proposed consumer class action lawsuit was filed against Beyond Meat, Inc. on June 10, alleging that the plant-based meat manufacturer embellished the amount of protein contained in its line of plant-based sausages, breakfast patties, meatballs, ground beef, and chicken products. [Subscription to Law360 required].
  • In the complaint, plaintiff Mary Yoon alleges that Beyond Meat falsely labels and advertises its products as providing “equal or superior protein” to animal-derived meat. Her claim is based on the fact that “two different U.S. laboratories have independently and separately conducted testing on a wide range of Beyond Meat products. The test results were consistent with each other: the results of both tests show that Beyond Meat products contain significantly less protein than what is stated on the product packaging.”
  • Plaintiff Yoon alleges that Beyond Meat’s quantitative declaration of protein and percent Daily Value (%DV) are false and misleading because the quantitative amount was calculated using the nitrogen method. According to the complaint, “the nitrogen method is not the most accurate way to describe protein content” and that “[b]y law, Beyond Meat is required to use the PDCAAS calculation for the products rather than some other less-sophisticated method.”
  • In opposition to plaintiff Yoon’s claims, 21 CFR 101.9(c)(7) specifically provides for two different methods to determine protein values, including the nitrogen method. The FDA recently issued a clarifying Q&A supporting the use of either method to calculate protein content (i.e., nitrogen or PDCAAS), but noted that manufacturers are still obligated to include a %DV when protein claims are made and that %DV should be adjusted for protein quality.
  • Keller and Heckman will continue to monitor this litigation, as well as other protein related lawsuits.
  •  As many of our readers (and fellow peanut butter consumers) are likely aware, on May 20th J.M. Smucker Co. issued a voluntary recall of its JIF peanut butter products due to potential Salmonella contamination linked to a manufacturing facility in Lexington, Kentucky.
  • Class-action lawyers wasted no time in holding J.M. Smucker accountable and at least two class-actions have been filed against the company alleging various causes of action, including negligence and breach of warranties, for actions resulting in the production of potentially contaminated product that was sold to plaintiffs and other similarly situated consumers. The law firm of Akim represents the Plaintiff in both lawsuits and the complaints are substantially similar to one another.
  • The recall is still being investigated by FDA, CDC, and other state partners. It presents a particularly interesting question of legal liability since the Salmonella strain associated with illness in the current outbreak is the same one which was found in an environmental sample during a 2010 FDA inspection. Keller and Heckman will continue to monitor this litigation and the results of the outbreak investigation.