Food and Beverage News and Trends - January 9, 2025
This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape.
FDA issues final guidance on lead in baby food. FDA has issued its Final Guidance on Action Levels for Lead in Processed Food Intended for Babies and Young Children as part of its Closer to Zero initiative to reduce dietary exposure to unavoidable environmental contaminants in foods, while maintaining access to a broad range of nutritious foods. This final guidance covers packaged processed foods that are represented or purported to be for babies and young children less than two years of age. This includes foods in jars, pouches, tubs or boxes and may include ready-to-eat foods such as purees, as well as semi-prepared foods such as dry infant cereals. The agency did not change the draft action levels when it finalized the following:
- 10 ppb for fruits, vegetables (excluding single-ingredient root vegetables), mixtures, yogurts, custards/puddings, and single-ingredient meats
- 20 ppb for single-ingredient root vegetables
- 20 ppb for dry infant cereals
The guidance does not cover infant formula, beverages (including toddler drinks), or snack foods (including grain-based or freeze-dried snacks, like puffs and teething biscuits). These action levels represent the levels of lead that may render a food adulterated under the FD&C Act. Although not binding on industry, the FDA would consider action levels, in addition to other information, when considering whether to bring enforcement action in a particular case. The agency states that the guidance is not intended to direct consumers in making food choices and that parents and caregivers should not throw out processed or packaged baby foods or stop feeding certain foods to babies and young children because these foods are important to meeting nutritional needs.
FDA revises fifth edition of Q&A on food allergen labelling requirements. FDA recently revised the fifth edition of its guidance document on Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act. This revised final guidance consolidates both the draft and final guidance that FDA issued on November 30, 2022. More specifically, this updated guidance contains questions and answers about food allergen labeling requirements, including the labeling of sesame, milk, eggs, incidental additives, highly refined oils, dietary supplements, and some specific packaging and labeling situations, such as individual units within a multiunit package. FDA also clarifies its expanded interpretation (for allergen labeling purposes) of the terms “milk” (to include milk from cows, goats, sheep, or other ruminants) and “eggs” (to include eggs from domesticated chickens, ducks, geese, quail, and other fowl) for the purposes of defining and complying with the food allergen labeling requirements under the Food, Drug, and Cosmetic Act. Additionally, the final guidance revises the list of tree nuts that FDA considers as major food allergens and revises several questions and answers to clarify previous guidance-based information pertaining to the labeling of fish and crustacean shellfish.
FDA publishes final guidance on public health importance of non-listed food allergens. FDA recently published its Final Guidance on Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act. This guidance is intended for FDA staff who are responsible for evaluating the public health importance of a non-listed food allergen, as well as interested parties who are either focused on how FDA evaluates the public health importance or who intend to submit a citizen petition asking FDA to establish related regulatory requirements. A non-listed food allergen for purposes of the guidance is a food allergen other than a major food allergen (ie, milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame). This guidance finalizes FDA’s recommended approach to evaluating the public health importance of a non-listed food allergen. The guidance specifies the scientific factors and other information relevant to the labeling and production of food that contains a food allergen and describes FDA recommendations for identifying and evaluating applicable evidence to evaluate the public health importance of a non-listed food allergen. At a high level, key changes to this final guidance include (1) clarifying that evidence of non-IgE-mediated reactions can be useful as supplemental data in an evaluation of the public health importance of a food allergen; (2) incorporating updated text and a revised reference to reflect the recent publication of the Food and Agricultural Organization of the United Nations and World Health Organization’s Expert Committee meeting report; and (3) expanding the discussion regarding prevalence data when a food is not regularly consumed in the US.
FDA releases guidance on LMRTEs. FDA has released its Draft Guidance on Establishing Sanitation Programs for Low-Moisture Ready-to-Eat (LMRTE) Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event to help LMRTE food manufacturers comply with the requirements for current good manufacturing practices (CGMPs), hazard analysis, and risk-based preventive controls to ensure a safe and sanitary food supply for these foods in part 117, as well as help infant formula manufacturers comply with the CGMP requirements in part 106. LMRTE foods include powdered infant formula (PIF), peanut butter, nut butters, powdered drink mixes, chocolate, medical foods in powdered and paste forms, processed tree nuts, milk powders, powdered spices, snack foods such as chips and crackers, granola bars, and dry cereal. The guidance recommends following GMPS to minimize the risk of pathogen growth. These include recommendations for controlling water in dry production environments, routine cleaning and sanitation, and equipment design and maintenance. In addition, the guidance specifically identifies Salmonella spp. and Cronobacter spp. if the food is exposed to the environment prior to packaging and the packaged food does not receive a treatment or otherwise include a preventive control. Therefore, the guidance recommends, in addition to CGMPs, that a food safety plan for LMRTE foods include sanitation controls that are written, monitored, and documented that they were followed. Moreover, the guidance recommends that the written sanitation controls are verified through an effective environmental monitoring program, as well as effective corrective actions and remediation techniques that include conducting a root cause analysis and characterization of isolates obtained. Comments on this draft guidance are due May 7, 2025.
FDA releases draft guidance on labeling of plant-based alternatives to animal derived foods. On January 6, 2025, FDA released a Draft Guidance for Industry: Labeling of Plant-Based Alternatives to Animal Derived Foods. The draft guidance is intended to provide FDA’s recommendations and best practices for naming and labeling of certain plant-based foods that are marketed and sold as alternatives for animal-derived foods (plant-based alternative foods). Such products would include products marketed, as alternatives to eggs, seafood, poultry, meat, and certain dairy products (such as cheese and yogurt) that fall under FDA jurisdiction. Importantly, this draft guidance does not address the naming and labeling of plant-based milk alternatives and excludes animal proteins produced by microflora. Generally speaking, FDA’s intent is to ensure consumers are provided sufficient information to understand the plant source of the animal alternative product, and that the composition of the product is different from animal-derived products. These products do not have definitions or standards of identity and thus must be labeled with their common or usual names, or, in the absence thereof, a statement of identity that accurately describes the food. While referring to “plant-based” is relevant in notifying consumers that the food is derived from plants instead of animals, FDA recommends that common or usual names or statements of identity of subject products specifically describe the plant source at issue (eg, soy, cashew, almond); simply stating “plant-based” alone is insufficient. While the draft guidance clarifies that names or statements of identity are not precluded from using the names or standards of identity of animal derived foods (eg, “burger”), use of such terms should clearly identify the plant source, and the name of the standardized food should be qualified by the type of plant source (eg, “soy-based cheddar cheese”). FDA also reiterates that the statement of identity must be in bold type on the principal display panel in a size reasonably related to the most prominent printed matter. FDA is requesting comments on the draft guidance by May 7, 2025.
US: Scientific Report of the 2025 Dietary Guidelines Advisory Committee addresses “ultra-processed foods” – public meeting slated for January 16. The Dietary Guidelines Advisory Committee has submitted its 2025 Scientific Report to the USDA and the Department of Health and Human Services (HHS). This Report, in conjunction with public comments and federal agency input, will inform the 2025-2030 Dietary Guidelines. The Dietary Guidelines set nutrition standards for federal nutrition programs, inform the FDA’s nutrition policy, and provide frameworks for state health and disease-prevention initiatives. As part of the process, the Committee systematically reviewed existing studies that linked “ultra-processed foods” (UPFs) to chronic diseases. However, the Report did not include any recommendations related to UPFs, concluding that the body of evidence was difficult to assess, largely because of the lack of clear definition of ultra-processed foods. Consequently, the Committee advises that future committees examine the association of UPF with growth, body composition, and risk of obesity, noting in particular that future conclusions may change if a more rigorous definition of ultra-processed foods is developed and further studies are conducted. The public is invited to submit written comments on the report by February 9, 2025. Additionally, USDA and HHS will hold a public meeting on the Report on January 16, 2025, from 1:00 pm to 4:30 pm EST. Both those wishing to attend the January 16 meeting and those wishing to provide comments at the meeting must pre-register. Registration for oral comments opened in December and will close once capacity has been reached. Those wishing to attend the meeting but not to provide oral comments may pre-register here any time until January 16, 2025.
FDA warns industry about toxic mushrooms. In December, FDA wrote to food manufacturers to advise them that the toxic mushroom Amanita muscaria, popularly nicknamed the fly agaric, as well as its extracts and certain chemicals derived from it (muscimol, ibotenic acid, and muscarine) are unapproved food additives in the US. The letter to industry notes that “the toxic consequences of consumption of A. muscaria mushrooms are well known” and include “cardiovascular effects, hallucinations, respiratory depression, and even death.” The FDA letter reminded recipients that, under the food additive provisions of the Food, Drug, and Cosmetic Act, it is the responsibility of manufacturers, processors, distributors, and other facility operators to ensure that their food products are safe and lawful.
US Surgeon General issues an Advisory on Alcohol and Cancer Risks, calling for cancer warning on alcoholic drinks. On January 3, US Surgeon General Vivek Murthy issued an advisory, which calls for policy changes that include alcohol labels to be more visible and include a warning about the increased risk of cancer on alcohol packaging. The advisory asserts that there is a “direct link between alcohol consumption and cancer risk” and that alcohol use is a “leading preventable cause of cancer in the U.S.” While the advisory states that the risk increases as the level of consumption increases, it notes that, for certain cancers, the risk may start to increase at low levels of consumption (ie, 1-2 drinks/day). Additionally, the advisory notes that women’s risk of cancer increases at a higher rate than men’s when the amount and frequency of alcohol consumption is held equal. The report cites a general lack of consumer awareness of the connection between alcohol consumption and risk of cancer. Consequently, the report recommends increasing consumer education, including updating the existing health warning label on alcohol-containing beverages to include a warning about the risk of cancer, and making changes to the characteristics of the warning label to make it more visible, prominent, and effective in communicating this risk.
35 PFAS food contact notifications no longer effective. The FDA announced its determination that, as of January 6, 2025, 35 food contact notifications (FCNs) concerning certain per- and polyfluoroalkyl substances (PFAS) are no longer effective because manufacturers have ceased production, supply, or use of those substances. Back in 2020, manufacturers voluntarily committed to end sales of these PFAS for food contact use in the US, and in February 2024 the agency announced that this voluntary market phaseout was complete and all these PFAS were no longer being sold. The PFAS covered in the now-abandoned notifications had been used in food contact materials, like paper and paperboard packaging, for grease proofing.
FDA announces uniform compliance date for 2025 and 2026 food labeling regulations. January 1, 2028, will be the uniform compliance date for final food labeling regulations published on or after January 1, 2025 and on or before December 31, 2026. Uniform compliance dates for new food labeling requirements are periodically announced to reduce the need to respond separately to each labeling change. The agency advises that food products subject to the January 1, 2028 uniform compliance date must comply with the appropriate labeling regulations when initially introduced into interstate commerce on or after January 1, 2028. The announcement does not affect existing requirements for compliance dates in final rules published before January 1, 2025.
Agencies extend comment period for government study of date labeling. On January 3, the USDA’s Food Safety and Inspection Service and the FDA announced that they are extending by 30 days the comment period for their joint Request for Information on industry practices and preferences concerning date labeling, research results on consumer perceptions of date labeling, and any impact that date labeling may have on food waste and grocery costs. The comment period will now end on March 5, 2025. The Request for Information was published in the Federal Register on December 4, 2024.
Comment period is open on FDA’s collection of information on animal food. The FDA has called for comments on its proposed collection of certain information pertaining to its authority over food additives used in animal food. Comments are welcome on an array of topics: food additives intended for use in animal food, food additive petitions, investigational food additive files exemptions, and declarations of color additives on animal food labels. The comment period closes on February 18, 2025.
Canada: Bill C-368 moves forward. Bill C-368 has completed consideration in committee and is moving to its third reading with amendments in the House of Commons. Bill C-368 aims to amend the Food and Drugs Act to provide that certain natural health products are not therapeutic products within the meaning of that Act and therefore are not subject to the same monitoring regimes as other drugs. Bill C-368 will purportedly reduce regulatory red tape on the availability and affordability of natural health products in Canada.
Virginia bill would block minors from purchasing supplements for weight loss, muscle building. On January 8, the first day of the new legislative term, Virginia Delegate Baxter Ennis (R-89) introduced HB 1585, which if enacted would prohibit the sale to minors of over-the-counter diet pills or dietary supplements for weight loss or muscle building. HB 1585 targets supplements containing “(i) an ingredient approved by the U.S. Food and Drug Administration for weight loss or muscle building; (ii) a steroid; or (iii) creatine, green tea extract, raspberry ketone, garcinia cambogia, or green coffee bean extract” and with labeling or advertising that labeling or marketing bears statements or images that suggest the product will help “modify, maintain, or reduce body weight, fat, appetite, overall metabolism” or “maintain or increase muscle or strength.” It is the latest such piece of legislation being considered in US statehouses – similar bills were pre-filed in the Texas and New Hampshire state legislatures in late 2024 and will likely be formally introduced in the coming days, and New York’s version was enacted in October 2023.
Canadian Federal Court releases its decision in Paradis Honey Ltd. The Federal Court issued a decision in the class action, Paradis Honey Ltd. v. Canada (Agriculture and Agri-Food), 2024 FC 1921, in which commercial beekeepers alleged damages as a result of Minister of Agriculture and Agri-Food and Canadian Food Inspection Agency restrictions on importing honeybees from the United States. These restrictions were implemented to address concerns about a tracheal mite bee pest. The class alleged that the restrictions impacted the beekeepers’ ability to replenish their bee colonies. Among other claims, the plaintiffs alleged they were owed a duty of care and that the defendants had been negligent in allowing an improper continuation of a prohibition on US bee imports. The Court found that no duty of care arises from statements of regulatory intent or undertakings to consult with specific industries. The Court held that the regulations and policies implemented under the Act do not give rise to a private law duty of care owed to the beekeepers, and that the alleged private duty is foreclosed by the relevant legislation (the Health of Animals Act and its regulations) as the purpose of the Health of Animals Act is to protect human and animal health. The Court also held that the communications and interactions between the CFIA and the class properly fall within the regulator’s role and do not give rise to a private law duty of care to protect the plaintiffs’ economic interests. Even had sufficient proximity been identified, “policy immunity” would apply. Furthermore, indeterminate liability, the effect on government consultations, and a potential conflict between public and private duties would negate the duty of care. Canada currently allows the import of “packages” of bees (containers holding a small colony, including a queen bee) from Italy, Chile, Australia, and New Zealand, as well as the import of individual queens from the US, Chile, Australia, New Zealand, Denmark, Italy, and Malta.
Lawsuit aims to push FDA to act on phthalates in food packaging and food production. A group of health advocates represented by the nonprofit Earthjustice sued the FDA in December to force it to reevaluate its decades-old authorizations for the use of certain phthalates in food packaging and food production materials. Phthalates are a group of chemicals that are used to make plastics more flexible and transparent; they have been widely used in food-contact materials. The FDA’s authorizations are based on safety assessments that are at least 40 years old, Earthjustice said, and the agency has not responded to advocates’ calls to update them. “The FDA is knowingly putting millions of people in the U.S. at risk of life-altering health problems by continuing to green-light uses of phthalates that contaminate our food,” said Earthjustice Attorney Katherine O’Brien. “FDA’s decision defies decades of science and the agency’s core purpose of keeping the food supply safe.” The lawsuit was filed in the US Court of Appeals for the DC Circuit.
Avian flu update.
- Working with the USDA, the Centers for Disease Control and Prevention, and state partners, on January 2 the FDA began collecting and testing samples of aged raw milk cheeses for H5N1. Cheeses may be made from raw milk in the US provided they are aged at least 60 days to mitigate pathogenic risks.
- H5N1 continues its spread through US and Canadian farms. In California, where the virus has spread across more than a quarter of the state’s dairy herds, Governor Gavin Newsom declared a state of emergency, describing it as "a targeted action to ensure government agencies have the resources and flexibility they need to respond quickly to this outbreak." On December 30, the USDA’s Animal and Plant Health Inspection Service (APHIS) confirmed 12 more H5N1 avian flu detections in California dairy herds, then confirmed detections in four more herds on January 3. For commercial flocks, in December and early January, APHIS confirmed the virus in 61 commercial flocks in 17 states. As of January 7, 2025, the Canadian Food Inspection Agency reported that there are 61 infected poultry farms in British Columbia with an estimated 8.6 million birds impacted, as well as 7 infected premises in Ontario, 2 in Alberta, 2 in Quebec, 1 in Manitoba, and 1 in Saskatchewan.
- Also on December 30, APHIS announced an interim final rule updating the conditions for poultry facilities to receive indemnity and compensation after testing positive for H5N1: before farmers can restock and be eligible for future indemnity on that restock, they will be required to undergo a biosecurity audit. The update, APHIS said, acknowledges the importance of strong biosecurity measures as a tool for battling the virus. Producers who don’t put in place sanitary corrections recommended in APHIS’s biosecurity audit will not be eligible for indemnity payments if their premises experience future infections within the same outbreak.
- The Consumer Price Index reports that the price of a dozen large Grade-A eggs in the US rose about 45 percent between January and November 2024, primarily due to the ongoing outbreak. In addition to surging prices, in many parts of the country eggs are sporadically in short supply or even unavailable.
- The spread of H5N1 among felines is raising concerns. The Los Angeles Times reported on January 3 that since December 1, at least 11 California house cats have died of H5N1 as a result of consuming contaminated raw milk and raw pet food, stating, “Experts say this is likely a vast undercount, as many veterinarians and pet owners are unaware of the connection of raw milk and meat to H5N1 bird flu and the unique sensitivity of cats to this particular virus.” Following the death of a house cat in Oregon, on December 26, Portland, Oregon-based Northwest Naturals announced it has voluntarily recalled a batch of its Feline Turkey Recipe raw frozen pet food which tested positive for H5N1. The implicated batch of raw food - two-pound plastic bags with “best if used by” dates of May 21, 2026, and June 23, 2026 - has been sold across the US and in British Columbia. The owner of three cats infected with H5N1 after drinking raw milk is seeking compensation from Raw Farm LLC for the medical bills incurred in treating his sole surviving pet. We reported on the Raw Farm LLC raw milk recall in our previous issue.
- The previously reported 13-year-old BC teen infected with Canada’s first human case of avian flu has been transferred out of intensive care. Her case was published in the New England Journal of Medicine on December 31, 2024.
- In December, an elderly Louisiana resident hospitalized in critical condition became the first US case classified as "severe." The patient had been exposed to sick and dead birds in a backyard flock suspected of being infected with H5N1. On December 28, the CDC stated that genetic analysis suggests the virus mutated inside that patient into a more severe form. It called this finding "concerning" but said there is no indication the patient infected anyone else.
- On January 2, the Biden Administration announced it is committing an additional $306 million toward averting a potential H5N1 pandemic in humans. The new federal funds – which are already being disbursed – will primarily address hospital preparedness, early-stage research on therapeutics, and research on diagnostics and vaccines. About a third of the funding will go to state and local governments to support efforts to test and track human exposure to infected animals and to further outreach to high-risk workers, such as farm laborers. Before this additional funding, in 2024 the Biden Administration had already spent more than $1.8 billion to combat the virus, most of it disbursed by the Department of Agriculture to address farm outbreaks.