This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape.
FDA rolls out Phase II of long-term sodium reduction plan. FDA has released new, voluntary targets for sodium reduction in foods – Phase II in its broad campaign to cut sodium in Americans’ diets. The draft guidance, issued August 15, sets out sodium reduction targets for 163 food categories. Both manufacturers and food service establishments are affected. FDA says that the targets set out in the draft guidance aim to provide new goals for industry to work toward by three years after the guidance is finalized. See the draft guidance here, and submit comments on it here.
Warning letter to Austrofoods over failures in its supply chain program. FDA has issued a warning letter to Austrofoods, the Ecuadorian manufacturer of apple cinnamon fruit puree pouches recalled in 2023 after they were found to be contaminated with harmful levels of lead and chromium. This warning letter, dated August 9 and released to the public on August 17, arose from an inspection of the Austrofood facility that had produced the pouches. In the letter, FDA cited the facility for failure to identify all known or reasonably foreseeable biological, chemical, and physical hazards that may require a control, including lead in cinnamon. In addition, the agency found the facility failed to implement appropriate verification activities and that its Certificates of Analysis were not adequate. This year, FDA has increased its scrutiny of spices used in products consumed by infants and young children. As part its ongoing investigation into the contaminated apple products, the agency has placed Negasmart, the distributor of the contaminated cinnamon used in the apple purees, on multiple import alerts.
Health Canada expands list of permitted sweeteners. Health Canada has expanded its List of Permitted Sweeteners to allow the use of sucralose in ready-to-serve liquid protein modular supplements for adults. The modification responds to a food additive submission from a petitioner seeking authorization for the use of sucralose as a sweetener in its supplements. The petitioner requested a maximum sucralose level of 0.08 percent to improve the taste of the product. Health Canada's Food and Nutrition Directorate completed a premarket safety assessment taking into account allergenicity, chemistry, nutrition, and toxicology. The results confirmed that the requested maximum level of use is within the range of permitted levels for sucralose in other foods.
FDA reevaluates its policies on new animal food ingredients. On October 1, 2024, FDA’s Memorandum of Understanding (MOU) with the Association of American Feed Control Officials (AAFCO) will expire. AAFCO’s official Publication contains, among other things, a comprehensive list of animal food ingredients, many including definitions established through the AAFCO ingredient definition request process for which FDA has historically provided scientific and technical review. Industry relies heavily on this publication to determine the safety of ingredients in its products. With the expiration of this MOU with AAFCO, the agency has issued three documents that reexamine its policies around animal food ingredients. First, the agency has issued a Request for Comments in the Federal Register on the agency’s pre-market animal food ingredient review programs; FDA plans to use these comments to shape its future reviews. Second, the agency has issued a Draft Guidance on FDA's Animal Food Ingredient Consultation (AFIC) to establish an interim consultation process for new animal food ingredients while the agency determines the future of the program. Third, FDA issued a Draft Guidance on FDA's Enforcement Policy for AAFCO-Defined Animal Feed Ingredients that describes the conditions under which an animal food ingredient listed in the 2024 AAFCO OP will receive enforcement discretion in the interim.
NACMPI to hold virtual meeting in September. In mid-September, USDA’s Food Safety and Inspection Service will hold a virtual meeting of the National Advisory Committee on Meat and Poultry Inspection, which advises the Secretary of Agriculture on state and federal meat and poultry inspection programs, food safety, and other matters. This meeting will discuss whether the USDA should change its definitions of establishment sizes to better reflect current business operations. The committee will also discuss how technology could enhance FSIS inspection activities. The virtual meeting will take place 10 am - 4 pm September 16 and 17. Register for the meeting here.
Injunctive relief granted to Canadian kosher meat processors. A Federal Court ruling means that the Canadian Food Inspection Agency (CFIA) is required to suspend the enforcement of three indicators of unconsciousness mandated for slaughtering food animals in compliance with Judaic and Islamic law. The three indicators had been set out in 2019 in Guidelines as best practices under the Safe Food for Canadians Regulations (SFCR) but were not enforced. In 2023, the CFIA made the use of at least one of these three indicators mandatory. As a result, kosher meat production in Canada slowed - kosher beef production in Canada fell by 55 percent and kosher veal by 90 percent - and prices rose. This year, the Kashruth Council of Canada, among other interested entities, filed an application for judicial review, seeking interlocutory injunctive relief from the application of the Guidelines. They argued that the three indicators are inappropriate and go further than what is required under the SFCR. They highlighted the religious importance of kosher meat and that the strict enforcement of the Guidelines violated their Charter rights as Jewish Canadians. The Federal Court accepted the applicants’ arguments, ruling that the CFIA standards were unnecessary and that the applicants’ rights under the Charter of Rights and Freedom had been impaired. It has suspended enforcement of the three indicators of unconsciousness until a final decision is reached.
Microplastics allegations “don’t hold water”: Illinois district court tosses claims against BlueTriton Brands. A recent opinion from the Northern District of Illinois may dampen the prospects of plaintiffs seeking to challenge the labeling of bottled water and other beverages based on the alleged presence of microplastics. The opinion is notable for its thorough analysis and its colorful dissection of the plaintiffs’ case. See our alert.
Appeals court rejects poultry-labeling complaint on standing grounds. On August 9, the US Court of Appeals for the DC Circuit unanimously rejected on the grounds of lack of legal standing a lawsuit filed by the Animal Legal Defense Fund against the USDA concerning its approval of labels for Perdue's “Fresh Line” chicken and turkey products. The nonprofit group alleged that while the poultry were raised strictly indoors, the USDA-approved product labels depict birds freely roaming outside a barn. This imagery, the group said, misleads consumers into thinking the birds were raised in pastures, when they in fact spent the entirety of their lives in warehouses. The appeals court, however, ruled that the nonprofit group did not have associational standing to pursue the case, and that although the harm suffered by one group member “when she purchased Fresh Line chicken breasts is sufficiently concrete and particularized, ALDF fails to show that the harm is ongoing or substantially likely to recur.”
Testing finds perchlorate is present in the food supply. Consumer Reports reported on August 7 that its latest tests show that detectable amounts of perchlorate, a chemical that is used in such products as rocket fuel, explosives, adhesives, airbags, and cleaning agents, may be found in a wide variety of fast foods and grocery items. The highest perchlorate levels that the nonprofit group found in its testing were in foods popular with babies and children. “Our new findings come decades after perchlorate was first identified as a contaminant in water and food,” the group said. “Yet the problem remains largely neglected by the federal regulators tasked with keeping our food and water supply safe.” Indeed, the CDC web page about perchlorate states: “We do not know the exact amount of perchlorates produced or used in the United States or around the world.” That page also notes, “We have learned only recently that perchlorates may last in the environment unreacted for several years.”
Avian flu update.
- Starting September 16, FSIS will begin monitoring dairy cows at slaughter for H5N1. The additional testing will be rolled into the service’s extant national surveillance programs for pathogens and chemical contaminants. Dairy cows make up about 10 percent of US beef production, primarily as ground beef. If a sample tests positive, USDA will purchase that carcass to carry out further tests and ensure the carcass does not enter the food supply.
- Following a second round of peer-reviewed testing, FDA is reiterating that dairy products, including milk, that undergo pasteurization are safe for human consumption and free of the H5N1 virus. Consuming raw milk, the agency emphasized, remains risky. Working with the USDA, the agency tested 167 dairy products that had been collected at retail locations across the US for viable H5N1 virus.
- On August 16, the CDC said it is continuing to work with health officials in Michigan and Colorado conducting H5N1 seroprevalence investigations among dairy farm workers who may have been exposed to infected cattle. The CDC is looking for the presence of neutralizing antibodies to these viruses, a sign of prior infection. This year, 13 human cases of H5N1 have been reported in the US - four associated with exposure to sick dairy cows and nine with exposure to H5N1-infected poultry.
- Meanwhile, as the virus continues its grim march through commercial bird flocks, egg prices are again on the rise. The Consumer Price Index found that July was the third straight month this year in which egg prices rose. Egg prices in July 2024 were 19.1 percent higher than in July 2023.
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