This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape.
Comment on proposed FDA method for ranking chemicals in food for post-market assessments. The FDA is seeking public comment on a proposed method for ranking chemicals in the food supply. The proposed approach, similar to one already used by the EPA, would use Multi-Criteria Decision Analysis (MCDA) to score chemicals through a pre-determined set of criteria similar to the FDA’s Risk Ranking Model for Traceability. This method, FDA states, “provides a transparent, systematic, and science-based approach to determine which chemicals the agency would prioritize for post-market assessments through the agency’s post-market chemical review program.” For Public Health criteria, a chemical would be scored based on its toxicity, changes in the ways people are exposed to the chemical, its presence in food intended for vulnerable subpopulations, the emergence of concerning new scientific data. For Other Decisional criteria, chemicals would be scored based on three marketplace factors – attention paid to it by external stakeholders, actions being taken by other agencies, and the need to maintain consumer confidence in the safety of the food supply. The comment period is open through July 18.
HHS to launch Take Back Your Health campaign. HHS has issued a solicitation calling for advertising firms to pitch strategies in support of the Take Back Your Health campaign, the purpose of which is “to alert Americans to the role of processed foods in fueling the diabetes epidemic and other chronic diseases, inspire people to take personal responsibility for their diets, and drive measurable improvements in diabetes prevention and national health outcomes.” HHS solicits contractors to pitch a strategy that acts as “a wake-up call to Americans that eating processed foods dramatically increases the risk of diabetes and chronic disease.” It is seeking “a bold campaign tailored to diverse geographic, demographic, and socioeconomic audiences.” advancing its coming initiative that, HHS says, will “challenge individuals to adopt disciplined, lifelong habits – centered on eating real food, physical fitness, and spiritual growth – to build a healthier, stronger nation.” See the solicitation here.
Texas will require warnings on foods containing 44 listed chemicals. On June 22, Texas Governor Greg Abbott signed the Make Texas Healthy Again Act, SB 25, the latest state-level legislation seeking to enact aspects of the MAHA agenda. In addition to public school requirements regarding physical activity and nutrition education, SB 25 would require warning labels to be placed on food products sold in Texas that contain any of 44 listed chemicals which are "not recommended for human consumption" in such jurisdictions as Australia, Canada, and the European Union. Ingredients regulated by the FDA or federal law are excluded from this requirement. The labeling requirement goes into effect January 1, 2027; however, it “applies only to a food product label developed or copyrighted on or after January 1, 2027” – manufacturers of products that already exist by that date would be allowed to keep using existing packaging without the Texas warning label for up to another ten years. SB 25 also restores a requirement for physical education and recess for students through middle school – even students in detention – and adds new requirements that all public high school students take a half-credit of nutrition education and that nutrition be taught in premed programs and medical schools.
FDA will soon issue RFI on definition of ultra-processed foods. FDA is working with the USDA and other government agencies to establish a consistent definition of ultra-processed foods, FDA Deputy Commissioner for Human Foods Kyle Diamantas said, and will issue a request for information on such a definition “by the end of the month.” His remarks came during a June 17 Association of Food and Drug Officials webinar.
FDA budget request includes ask for authority to destroy refused FDA-regulated imports. Among FDA’s FY 2026 budgetary requests is a proposal to amend the Federal Food, Drug and Cosmetic Act’s S 801 “to give the agency the authority to require an importer to destroy any FDA-regulated product(s) refused entry into the U.S. that presents a significant public health concern” and that importers be required to pay the cost of destruction up front. In the proposal, FDA states that it has found that some importers attempt to reimport shipments of unapproved products, and it cites such examples as foods contaminated with carcinogenic animal drugs and adulterated contact lenses. Giving FDA these additional powers, the proposal said, would serve as a deterrent in such cases and would also “increase efficiency by reducing the need to involve the Customs and Border Protection in the seizure of unsafe FDA-regulated products.”
Webinar on Food Traceability Rule. A July 20 webinar hosted by the Reagan-Udall Foundation for the Food and Drug Administration, along with the FDA, will continue the agency’s ongoing discussion of the Food Traceability Rule. After hearing from industry about challenges posed by the final rule, FDA extended the compliance date of the rule until July 20, 2028. The webinar will examine lessons learned from various pilot initiatives as well as such traceability topics as approaches to outbreak investigations. Register for the webinar here.
FSIS updates allergen testing process. As part of the USDA’s Food Safety and Inspection Service’s work to harmonize allergen screening with the FDA, the service has released updates to its Chemistry Laboratory Guidebook method for testing allergens in ready-to-eat products. The method reportedly uses the XMAP multiplexing immunoassay technology to analyze 13 types of allergens.
The return of Am I regulated? Confirming that it will not appeal a December 2024 court decision vacating a rule governing the movement of certain genetically modified organisms, the USDA’s Animal Plant Health Inspection Service announced on June 16 that it will amend the Code of Federal Regulations to conform it to the court’s vacatur. The US District Court for the Northern District of California found that USDA had violated the Administrative Procedure Act when it updated the rule. APHIS is reportedly reverting to the Am I regulated? method and its pre-2020 framework for determining the regulatory status of new biotech products.
Agricultural groups criticize MAHA Report. In the latest expression of backlash against the Make Our Children Healthy Again Assessment, an open letter signed by more than 250 agricultural groups and sent to HHS Secretary Robert F. Kennedy, Agriculture Secretary Brooke Rollins, and EPA Administrator Lee Zeldin strongly criticizes the report and calls on the Trump Administration to “correct” the activities of the Make America Healthy Again (MAHA) Commission. The report, the farm groups charge, contains “numerous errors and distortions that have created unfounded fears about the safety of our food supply.” POLITICO reports that the letter also asks the MAHA Commission to hold a public comment period for all future actions and reports and to include agriculture and food stakeholders in its processes. The organizations signing the letter represent millions of farmers, ranchers, and food producers.
Bill would require funding for research into PFAS, microplastics on farms. On June 12, Representative Marie Gluesenkamp (D-WA) introduced HR 3991, “to amend the Food, Agriculture, Conservation, and Trade Act of 1990 to include as a high-priority research and extension area research on microplastics and per- and polyfluoroalkyl substances on farmland.” At this writing, the bill’s text is not yet available.
Public health groups urge continuity in federal Dietary Guidelines. In a June 10 letter, 55 public health and medical organizations called on HHS Secretary Robert F. Kennedy, Jr. and US Secretary of Agriculture Brooke Rollins to adopt the advice of the 2025 Dietary Guidelines Advisory Committee as their agencies finalize the final 2025-2030 Dietary Guidelines for Americans. The Dietary Guidelines, which are published every five years by HHS and USDA, generally recommend that people eat whole, nutrient-dense foods. Besides representing the government’s basic nutrition advice to its citizens, the Guidelines shape important federal food programs like the school meals program. The groups said they saw it as a high priority that the Guidelines should continue to recommend that people limit saturated fat, which is commonly found in higher amounts in beef, full-fat dairy products, and butter.
Newfoundland and Labrador: Repeal of sugar-sweetened beverage tax, effective July 1. The government of Newfoundland and Labrador has officially announced the repeal of its controversial sugar-sweetened beverage (SSB) tax, effective July 1. The province’s Department of Finance has amended the Revenue Administration Regulations, allowing retailers to apply for refunds on any remaining taxed inventory held after June 30, 2025. Finance Minister Siobhan Coady stated that this measure aims to alleviate financial burdens on consumers and retailers amid broader economic pressures. Retailers are encouraged to begin preparations for refund applications, with the provincial government committed to streamlining the refund process to ensure swift reimbursement. Further legislative changes formally removing the tax from the Revenue Administration Act will be introduced when the provincial legislature reconvenes later this year.
Abbott vetoes SB 3, calls special legislative session to discuss regulating THC. Also on June 22, Texas Governor Gregg Abbott vetoed SB 3, a bill that would have banned most intoxicating hemp-derived cannabinoids in the state. The measure would have made it a misdemeanor to sell, possess, or manufacture consumable products in edible, vape, and flower form containing tetrahydrocannabinol (THC) or related chemicals such as Delta-8 and Delta-9. Products containing cannabidiol (CBD) would have remained legal but would have been more tightly regulated. In his veto, Governor Abbott also called for a special session of the Texas legislature, slated to begin July 21, to discuss the issue. This year, a number of other US states have also sought to ban or regulate sales of THC products. On June 13, the California Department of Public Health proposed making permanent Governor Gavin Newsom’s 2024 emergency ban on sales of foods, beverages, and dietary supplements containing any detectable amounts of THC “or any comparable cannabinioid.”
California Senate approves disclosure bill for allergens on restaurant menus. On May 28, the California state Senate approved by a 32-0 vote SB 68, a bill that would require restaurants in the state to declare the presence of any of the nine federally defined major allergens in their menu items. The legislation is now under consideration by the state Assembly. It would require restaurants to notify customers when a menu item contains any of the nine allergens -- milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. Restaurants would be required to inform customers about the presence of allergens by placing labels directly on printed menus, using digital menus with labels, or by providing a separate allergen information menu. Food trucks and carts would be exempt from these requirements. Federal law already requires packaged foods to include labels for the nine allergens, which are responsible for 90 percent of allergic reactions to food, according to the FDA.
Santa Cruz’s beverage tax is challenged in California state court. The American Beverage Association, joined by a group of grocers, retailers, and restaurateurs, has filed suit in Sacramento Superior Court against the city of Santa Cruz, seeking to end Measure Z, its recently enacted tax on sugar-sweetened beverages. Asserting that the tax violates state law and the California Constitution, the plaintiffs are calling on the court to declare it unenforceable and to require the city to refund all money collected from the tax since it went into effect. The tax of two cents per fluid ounce is paid by distributors of sugar-sweetened beverages and is estimated to generate about $1.3 million annually for the city. It includes an exemption for companies with less than $500,000 in gross annual revenues. Although the California state legislature in 2018 prohibited most such local soda taxes via the Keep Groceries Affordable Act, that ban has been held by courts not to apply to “charter cities” such as Santa Cruz.
Canada launches its own foot-and-mouth disease vaccine bank to safeguard the livestock industry. Canada is taking a major step to protect its livestock sector with the launch of a national foot-and-mouth disease (FMD) vaccine bank. Built on a $57.5 million commitment over five years (with $5.6 million in ongoing annual funding), the effort was officially announced on June 9. FMD is a highly contagious viral disease that strikes cattle, pigs, sheep, and goats, causing painful sores, debilitating weakness, and loss of milk production. For the agricultural sector, it poses the threat of significant trade disruptions. FMD is reportable to the World Organisation for Animal Heath. Canada has been FMD free since 1952, but it is estimated that an outbreak could have an economic impact between $22 billion and $75 billion. The national vaccine bank will bolster Canada’s access to FMD vaccine. It is estimated that 1.9 to 2.7 million doses would be needed in the event of a large outbreak.
Consumer study identifies preferred FDA “Healthy” labels. A study assessing consumers’ preferences about “healthy” labeling symbols, published on June 16 by the Cambridge University Press, has identified two candidates that stood out as clear favorites. The study, carried out in a controlled laboratory setting in the US, offered test subjects – more than 300 American “adult consumers who are primary household shoppers without dietary restrictions” – 15 proposed front-of-package “Healthy” label candidates, asking them to identify their favorites via Best-Worst Scaling. The two labels that emerged as test subjects’ favorites – labels 8a and 12a – may be found here.
Avian flu update.
- According to the Wisconsin State Farmer, in the 30 days before this writing, the USDA has confirmed 9 cases of H5N1 in poultry flocks in Arizona, South Dakota, Idaho, New Jersey, and Pennsylvania, and 18 cases in dairy cows in California and Idaho.
- Canada is enjoying a relative lull in new avian influenza cases on farms this month. No new poultry outbreaks were reported in the first week of June, leaving just nine infected premises nationwide as of mid-June, down from dozens earlier this year. Nevertheless, the import of bird byproducts is still being closely restricted. As of May 30, authorities have tested thousands of raw milk samples from dairy farms across all provinces – none showed any avian flu contamination, reassuring consumers that Canada’s milk supply remains safe. Even so, farmers are still urged to maintain enhanced biosecurity through the summer downtime. The unprecedented scale of H5N1 has already claimed over 14 million birds in Canada since 2022 and officials caution that the virus could surge again with the change in seasons.
- Domestic poultry in Canada’s territories remain largely unaffected by H5N1, but recent wildlife cases show the virus remains active. On June 6, the Northwest Territories (NWT) confirmed H5N1 in two wild birds – a raven and a ring-billed gull found in the Yellowknife area. This incidence brings the territory’s confirmed total to nine wild birds since the virus arrived in North America. In the NWT, the primary is not poultry farms but the need to monitor wild bird populations and advise the public on sanitary measures and safe handling of birds. Yukon, for its part, has not yet detected any avian flu in 2025, in neither wild birds nor domestic flocks. Territorial officials in Yukon intensified surveillance during the spring migration and provided testing kits to communities and First Nations. Authorities continue to caution residents – especially hunters and bird handlers – to exercise care. The goal is to protect both wildlife and food security in northern communities.
- On June 20, the World Organisation for Animal Health (WOAH) stated that it considers the outbreak of H5N1 at a Brazilian poultry operation “resolved.” Last week, Brazil’s agricultural ministry informed WOAH that the country’s 28-day quarantine period had passed without detection of any new commercial cases of H5N1 and that Brazil is now free of bird flu. Agriculture Minister Carlos Favaro said there will be a “gradual resumption” of chicken exports. Brazil is the world’s leading exporter of chicken meat, primarily selling to China, the EU, and other Latin American countries.
- HHS Secretary Robert F. Kennedy, Jr.’s decision to end funding for development of an avian flu vaccine for humans is “a grievous mistake that threatens to leave the country unprepared for what experts fear might be the next pandemic,” Senators Elizabeth Warren (D-MA) and Tammy Duckworth (D-IL) stated in a letter released on June 18. In the letter, the Senators reportedly demand that Kennedy explain his rationale for cancelling Moderna’s $590 million award to develop a candidate mRNA vaccine for humans against H5 avian influenza. “There appears to be no rationale for this decision other than your ill-informed and dangerous war on vaccines,” the letter states. When the award was cancelled in May, an HHS spokesperson said the decision was the result of an internal review that concluded Moderna’s research was not meeting appropriate scientific standards. The senators are calling on Kennedy to make that review public and to release information on the decision to cancel a separate $258 million grant for HIV vaccine research. They stated, “You have failed to justify either of these moves to cripple vaccine research. Furthermore, these decisions appear to be part of your larger, unfounded vendetta against mRNA technology.”
- The president of a major US egg-laying operation blames the US federal ban on vaccination of chickens for the deaths of 6 million of his birds. Glenn Hickman heads Hickman’s Family Farms, one of the country’s largest egg producers, which earlier this month lost about 95 percent of its flock due to an outbreak of H5N1. While an H5N1 vaccine for chickens is available (and is manufactured in the US), USDA regulations forbid vaccination of birds in commercial operations because many countries prohibit imports of vaccinated chickens and their meat. Hickman told NBC affiliate 12News, "I can't vaccinate my birds, but we import eggs from Mexico to help with our egg shortage, and they vaccinate their birds.”
- The USDA is reportedly working with federal, state, and industry officials as well as international trade partners to develop a plan for vaccinating poultry against avian flu. Many US trading partners ban the import of vaccinated birds because vaccination can hide the presence of the virus. A plan recently proposed by the United Egg Producers recommends an initial vaccination for baby chicks, then a later booster shot and ongoing, routine testing. The proposal would require culling for flocks that still test positive.
- Canada’s Federal Court of Appeals has granted Universal Ostrich Farms a stay of the Canadian Food Inspection Agency’s order to cull the farm’s 400 remaining ostriches, survivors of a December outbreak of H5N1. The farm’s owners had also sought an order permitting them to conduct additional diagnostic tests on the surviving birds, but the court denied that request. Meanwhile, the CFIA has not revised its stance, stating that the flock remains a risk to public health and to Canada’s trade reputation. The case remains controversial, with protesters continuing to camp around the farm in hopes of protecting the birds. On June 24, the Federal Court of Appeal announced it will hear the farm owners’ appeal in July.
- Cornell University’s Cornell Feline Health Center is launching an initiative to track H5N1 in cats. Its CFHC Feline H5N1 Surveillance Consortium will begin its surveillance work by testing cats for H5N1 at clinics, vet hospitals, and shelters in New York state, then go on to expand surveillance across the country. A press release from Cornell University states, “In addition to testing for current infections, the team will look for the presence of antibodies indicating a previous infection, perform genomic analysis of H5N1 viral samples obtained from cats, and study the virus’ hemagglutinin protein, which plays a role in how viruses enter and infect the body.” The fatality rate for cats infected with H5N1 is about 90 percent. This year, three raw pet food manufacturers issued recalls for certain lots of their products due to H5N1 contamination and the USDA warned such manufacturers to reassess their food safety plans.
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