• On February 3, 2023, USDA Secretary Tom Vilsack announced several initiatives to improve the nutritiousness of meals served through the school meal programs, including updates to the nutrition standards for meals served under these programs, as well as updates to the Buy American provisions. The proposed rule detailing these proposed changes was published in the Federal Register today.  See 88 Fed. Reg. 8050 (Feb. 7, 2023).
  • The updates to the nutrition standards will be phased in over a multi-year period and include proposed changes to the following:
    • Added Sugars: Inclusion of limits for certain common sources of added sugars (breakfast cereal, flavored milks, grain-based deserts, and yogurt) in fall 2025 followed by an overall added sugars limit across the weekly menu (<10% calories per meal) in fall 2027. There currently is no added sugars limit in the school meal program.Milk: Two options, one which would maintain the status quo and allow either fat free or low fat (1%) flavored or unflavored milk, and the other of which would allow flavored milk only for high school children starting in fall 2025. Both options include the proposed added sugars limit for flavored milk.Sodium: Reduced sodium limits for the school lunch and school breakfast programs. There are three proposed reductions for the school lunch program (to go into effect in July 2025, 2027, and 2029) and two proposed reductions for the school breakfast program (to go into effect July 2025 and 2027).
    • Whole Grains: Two options, maintain the status quo—80% must be whole grain and any other grains must be enriched—or require that the school breakfast and lunch programs offer only whole grains at last 4/5 day a week.
  • Comments to the proposed rule are due by April 10, 2023.  

  • On June 14, 2018, the Kellogg Company voluntarily recalled impacted packages of Honey Smacks cereal following an announcement by the FDA and the Centers for Disease Control and Prevention (CDC) of a multistate outbreak of salmonellosis that could be traced to Kellogg’s Honey Smacks cereal produced at Kerry Inc’s Gridley, Illinois facility.  According to the CDC outbreak summary, 135 people, in 36 states, were infected with Salmonella Mbandaka and 34 of these people were hospitalized.  No deaths were reported. 
  • In a February 3, 2023 press release, the United States Department of Justice (DOJ), announced that Kerry Inc. pled guilty to a misdemeanor count of distributing adulterated cereal marketed as Kellogg’s Honey Smacks.  According to the plea agreement, Kerry’s routine environmental testing detected Salmonella in its Gridley facility on approximately 81 times between June 2016 to June 2018 and employees at the Gridley facility routinely failed to implement corrective and preventative actions (CAPAs) to address positive Salmonella tests.  Per the plea agreement, Kerry has agreed to pay a criminal fine and forfeiture amount totaling $19.228 million.  If the guilty plea is accepted by the court, Kerry’s fine and forfeiture will overtake the penalty of $17.25 million from the Bluebell ice cream listeriosis settlement, discussed here, as the largest-ever criminal penalty following a criminal conviction in a food safety case. 
  • In a related federal action, as we previously reported, Kerry’s former Director of Quality Assurance, Ravi K. Chermala, pleaded guilty on October 21, 2022 to three misdemeanor counts of causing the introduction of adulterated food into interstate commerce.  Chermala admitted that he directed subordinates to not report certain information to Kellogg about conditions at the Gridley facility and to alter the plant’s program for monitoring for the presence of pathogens in the plant, limiting the facility’s ability to accurately detect insanitary conditions.  Sentencing dates for Chermala and Kerry Inc. are set for February 16, 2023 and March 14, 2023, respectively. 
  • On February 3, FDA announced in a letter of enforcement discretion that it does not intend to object to the use of certain qualified health claims regarding the consumption of cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease for conventional foods.  However, the qualified claim must be appropriately worded so as not to mislead consumers and other factors for the use of the claim must be met. FDA CFSAN reported on the letter here.
  • A health claim characterizes the relationship between a substance and a disease or health-related condition. FDA responded to a 2018 health claim petition submitted on behalf of Barry Callebaut AG Switzerland which requested FDA to review a qualified health claim about the relationship between the consumption of cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease. 
  • After its review, FDA determined that there is limited scientific evidence for a qualified health claim for cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease. Accordingly, FDA intends to exercise enforcement discretion for the following qualified health claims regarding cocoa flavanols in high flavanol cocoa powder when used in the labeling of conventional foods consistent with the letter of enforcement discretion:
    • “Cocoa flavanols in high flavanol cocoa powder may reduce the risk of cardiovascular disease, although the FDA has concluded that there is very limited scientific evidence for this claim.”
    • “Cocoa flavanols in high flavanol cocoa powder may reduce the risk of cardiovascular disease. The FDA has concluded that there is very limited scientific evidence for this claim.”
    • “Very limited scientific evidence suggests that consuming cocoa flavanols in high flavanol cocoa powder, which contains at least 4% of naturally conserved cocoa flavanols, may reduce the risk of cardiovascular disease.”
    • “Very limited scientific evidence suggests that consuming cocoa flavanols in high flavanol cocoa powder, which contains at least 4% of naturally conserved cocoa flavanols, may reduce the risk of cardiovascular disease. This product contains at least 4% of naturally conserved cocoa flavanols. See nutrition information for_____ and other nutrients.”
  • Please note that the qualified health claim only applies specifically to cocoa flavanols in high flavanol cocoa powder and foods that contain high flavanol cocoa powder.
  • Keller and Heckman will continue to monitor and report on developments regarding health claims and related FDA enforcement in this important area.
  • As part of legislation updates to the rate of official controls and emergency measures for food of non-animal origin imported into Europe, the European Commission (EC) has added controls for vanilla extract from the United States. 
  • Decisions are based on notifications made in the Rapid Alert System for Food and Feed (RASFF) portal and information from documentary, identity, and physical checks by member states in 2022.
  • Consignments of vanilla extract from the US will need to be accompanied by an official certificate stating that sampling results show compliance with EU maximum residue levels for ethylene oxide.  However, shipments dispatched before February may enter the EU until October 16, 2023 without a certificate and they will be subject to checks at a 20% frequency.  Other products with new ethylene oxide checks include botanical food supplements from South Korea, locust bean products from Morocco and Malaysia, tomato ketchup and sauces from Mexico, and calcium carbonate from India.
  • Currently, there is a 20% frequency for checks on peanuts, peanut butter, and peanut paste for aflatoxins from the US as well.
  • In light of the findings and recommendations of the external evaluation conducted by an expert panel at the Reagan-Udall Foundation (summarized here), FDA Commissioner Califf announced a proposed redesign to create the FDA Human Foods Program.
  • Under the proposed redesign, the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR), and certain functions of the Office of Regulatory Affairs (ORA) will be unified into a new organization called the Human Foods Program, which will be overseen by a Deputy Commissioner for Human Foods. The Deputy Commissioner will report directly to the FDA Commissioner and will be charged with “leading a unified Human Foods Program that keeps the foods we regulate safe and nutritious, while ensuring the agency remains on the cutting edge of the latest advancements in science, technology, and nutrition.” The Deputy Commissioner will have authority over policy, strategy, and regulatory program activities within the Program, as well as resource allocation and risk-prioritization. FDA is currently recruiting for the new Deputy Commissioner of the Human Foods Program. FDA’s visual depictions of the reorganization are provided below.
  • The proposed new Human Foods Program will also include
    • (1) The creation of a Center for Excellence in Nutrition to help consumers make more informed food choices. The Office of Critical Foods, which will be responsible for foods like infant formula and medical foods as directed by the 2023 Consolidated Appropriations Act, will fall within the Center for Excellence in Nutrition.
    • (2) The establishment of an Office of Integrated Food Safety System Partnerships to focus on coordinating and integrating the FDA’s food safety and response activities with state and local regulatory partners to meet the vision of an Integrated Food Safety System, as per FSMA.
  • Additionally, a Human Foods Advisory Committee will be established to help support the Agency and will consist of external experts to advise on challenging and emerging issues in food safety, nutrition, and innovative food technologies.
  • As for ORA, its operating structure will be transformed into an enterprise-wide organization that supports the Human Foods Program and all other FDA regulatory programs which will allow ORA to be focused on inspections, laboratory testing, import, and investigative operations.
  • As stated in the announcement, the next step will be for FDA to develop the vision into a concrete reorganizational proposal in close coordination with external stakeholders. The development of a detailed plan and the execution of the proposed redesign will be led by a recently formed Implementation and Change Management Group. As the redesign continues to take shape, CFSAN, ORA, and OFPR will continue to operate under their current structures with direct oversight by the FDA Commissioner.
  • On January 26, 2023, FDA issued a 60-day notice in the Federal Register of its intention to conduct an experimental study on consumer responses to front-of-package (FOP) labeling. Any collection of information conducted or sponsored by an agency requires such notice and solicitation of public feedback prior to submission to the Office of Management and Budget (OMB) for approval.  44 U.S.C. 3506(c)(2)(A)
  • FDA continues to explore options to create a healthier food supply and to empower consumers to make healthier choices including through FOP labeling. FOP labeling has already been adopted in both Canada and Mexico and the development of FOP labeling was included as part of the White House’s Hunger, Nutrition, and Health Strategy. In 2022 FDA conducted a review of the literature on FOP nutrition-related labels and conducted a set of focus groups to test FOP concepts and draft FOP schemes, and the results of this work will inform the experimental study.
  • The experimental study will test 3,000 adult consumer responses to a set of draft FOP schemes over 3 mock food products without providing any explanation of the FOP scheme. Further details regarding the study are available in the Federal Register notice.
  • As required by statute FDA is seeks comment on:
  1. whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility;
  2. the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
  3. ways to enhance the quality, utility, and clarity of the information to be collected; and
  4. ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
  • Comments are due by March 27, 2023. 
  • While FDA’s Center for Veterinary Medicine (CVM) accepts that absolute avoidance of all batch-to-batch drug carryover may not be possible in the production of animal feed, CVM’s “Current Good Manufacturing Practice for Medicated Feeds” regulations require the establishment of equipment cleanout procedures that are adequate to avoid unsafe contamination of animal feeds with drugs.  “Unsafe” contamination of an animal feed refers to a degree of contamination, by a drug approved for a medicated feed use, that poses an unacceptable risk to human health (from consumption of milk, meat, or eggs containing drug residue) or animal health (for example, horses consuming feed contaminated with ionophore drugs like monensin can result in severe illness or death).
  • On January 30, 2023, FDA published notice of the availability of a final guidance for industry that provides information on some ways to comply with the CGMP requirements at 21 CFR §§ 225.65 and 225.165 to help prevent unsafe contamination of animal feed from drug carryover.  Guidance for Industry #272, titled, “Practices to Prevent Unsafe Contamination of Animal Feed from Drug Carryover,” contains details and factors to consider in designing cleanout practices to protect the health of the animals consuming the animal feed and, in the case of food-producing animals, protect human health from unsafe contamination of animal feed from drug carryover.  Factors outlined for consideration in developing physical cleanout, flushing, and sequencing procedures include:
    • risks to human and/or animal health;
    • types of animal feed that are manufactured (such as medicated requiring a license);
    • animal species consuming the feed;
    • production stages of the animals;
    • the drugs being used and their levels; and
    • the types of equipment used in the facility.

The guidance also notes that alternative, equally effective practices other than physical cleanout, flushing, and sequencing are permitted to prevent unsafe contamination of animal feed from drug carryover. 

  • FDA has concurrently withdrawn Compliance Policy Guides Sec. 680.500 “Unsafe Contamination of Animal Feed from Drug Carryover” and 680.600 “Sequencing as a Means to Prevent Unsafe Drug Contamination in the Production, Storage, and Distribution of Feeds” because the new guidance, #272, contains much of the information found in the older CPGs as well as updates and additional information. 
  • Yesterday, Janet Woodcock, M.D., the Principle Deputy Commissioner for the Office of the FDA Commissioner, released a statement regarding the Agency’s approach towards cannabidiol (CBD) and its application in the food and drug industry.
  • The statement provided that FDA convened a high-level internal working group to explore potential regulatory pathways for CBD products.  The working group examined studies related to the CBD-based drug Epidiolex, as well as published scientific literature and information submitted to a public docket. Following review, the working group concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage potential long-term risks from frequent exposure. FDA is expecting to collaborate with Congress on this matter; however, the timeline for action remains unknown.
  • Woodcock, on behalf of FDA, stated: “[s]ome risk management tools could include clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children. In addition, a new pathway could provide access and oversight for certain CBD-containing products for animals.”
  • FDA also denied three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.
  • Keller and Heckman will continue to monitor and report on matters impacting the CBD industry.
  • On January 17, a California federal judge denied Costco Wholesale Corp.’s motion to dismiss a class action complaint that alleged the “dolphin-safe” claim on Costco’s canned tuna is false, deceptive, and misleading (subscription to Law360 required). U.S. District Judge William Orrick held that plaintiff Melinda Wright’s claims are not preempted by the Dolphin Protection Consumer Information Act (DPCIA) because Costco made its own, heightened promises that go above what the DPCIA requires.
  • According to the order, Costco’s Kirkland Signature brand of canned tuna features a “dolphin-safe” logo and also represents that it does not use tuna that was caught in a manner harmful to marine life. Other alleged promises include statements on product packaging that it is “100% traceable from sea to shelf” and uses “100% monofilament leaders & circle hooks.” However, plaintiff Wright argues that monofilament leaders are not sustainable or dolphin-safe because they are hazardous to marina mammals which become entangled in or ingest the almost invisible wire.
  • Judge Orrick denied Costco’s motion to dismiss because Wright’s claims do not focus on whether Costco abided by the DPCIA labeling requirements, but rather on whether its tuna products are indeed dolphin-safe and if Costco’s label representations are misleading in violation of California’s consumer protection statutes, or rise to a warranty breach and unjust enrichment. Indeed, Judge Orrick stated “[t]he question is whether Costco violates its own promises to consumers, not the DPCIA.”
  • Keller and Heckman will continue to monitor this case and report on any updates.
  • This morning the FDA announced the release of draft guidance entitled “Action Levels for Lead in Food Intended for Babies and Young Children.” The draft guidance, which is part of the Agency’s effort to reduce levels of heavy metals in food, especially in food consumed by babies and young children (the “Closer to Zero” action plan), establishes the following action levels for lead in food intended for babies and children less than two years of age:
    • 10 parts per billion (ppb) limit for fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain and meat-based mixtures), yogurts, custards/puddings, and single ingredient meats;
    • 20 ppb for root vegetables (single ingredient); and
    • 20 ppb for dry infant cereals.
  • These action levels reflect the levels of lead at which FDA may regard the food as adulterated. However, FDA considers on a case-by-case basis whether a food that contains a contaminant is adulterated and, when considering whether to bring an enforcement action, the Agency will also consider other factors, including its confidence in measured analytical values. Furthermore, the action levels are not the intended to be the lowest levels for industry to achieve and, consistent with its Closer to Zero action plan, FDA expects industry to “strive for continual reductions [of heavy metals] over time.” 
  • In related news, on January 19, 2023, the U.S. District Court in the Northern District of New York dismissed (Law360 subscription required) a lawsuit against Beech-Nut Nutrition which had made various claims related to allegedly dangerous levels of heavy metals in Beech-Nut’s baby food. The decision, which relies on the primary jurisdiction doctrine, is consistent with dismissals of similar lawsuits against Sprouts Foods and Gerber Products by federal courts in New Jersey and Virginia, respectively, but runs contrary to a decision by a California federal court which refused to dismiss similar claims against Plum Organics.
  • The primary jurisdiction doctrine allows a court to dismiss or stay a lawsuit when it finds that a decision is within “the special competence of an administrative body.” Applying a multi-factored test, the Court held that application of primary jurisdiction was appropriate because (1) the claims were not “garden variety” false advertising cases, but rather required the Court to make a determination as to what constituted dangerous levels of heavy metals, (2) such questions of safety were “within FDA’s authority and discretion,” and (3) a Court’s resolution of the issue without FDA guidance would result (and indeed, has resulted) in inconsistent rulings. 
  • We will continue to monitor and report on news related to heavy metals. Comments to the draft guidance are due by March 27, 2023.