This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape.

FSIS moving to strengthen oversight of food processing facilities with focus on Listeria monocytogenes. On December 17, the USDA’s Food Safety and Inspection Service (FSIS) announced it is taking several steps to strengthen its oversight of food processing facilities, particularly focusing on improvements and initiatives that can be implemented quickly to address Listeria contamination and overall food safety. Within the next 30 days, FSIS will implement changes in three areas: enhancing its regulatory and sampling approach to Listeria – for instance, by adding broader Listeria species testing to all samples, starting in January 2025; equipping FSIS inspectors with updated training and tools – among these, in 2025, FSIS will prioritize completion of Food Safety Assessments at ready-to-eat meat and poultry facilities that rely exclusively on sanitation measures to control for Listeria; and tightening oversight of regulated establishments, including by revising establishment-review alert triggers.

FDA may soon act to ban Red 3. Jim Jones, FDA’s deputy commissioner for human foods, recently told a Senate health committee that the agency may act in coming days to revoke approval for FD&C Red No. 3, commonly known as Red 3. Pressure has been growing on the FDA all year to eliminate Red 3 from foods. In 2023, California banned it and three other chemicals from use in food. In the EU, Red 3 has been prohibited for almost all food uses for more than 30 years, and it is also banned in Australia, China, Japan, New Zealand, and the UK. In the US, it has been banned for use in cosmetics and externally applied drugs since 1990, but is still authorized for use as a color additive in foods and ingested drugs. Just last month, a bipartisan group of legislators, led by Representative Rosa DeLauro (D-CT), sent an open letter to the agency urging the ban. That letter stated, “A ban on Red 3 is not only statutorily required, but it is also feasible – alternatives are widely available. Thirty-four years of inaction is far too long.” At this writing, a petition from 24 food safety and consumer protection organizations and scientists calling on the FDA to review its approval of Red 3 is with the White House Office of Management and Budget (OMB) for review and approval; however, the agency could move to grant the petition on its own, without OMB approval. During the hearing, Jones stated that the FDA was “hopeful” that it would “be acting on that petition” in the “next few weeks.”

The Robinson-Patman Act: Pricing considerations for US retailers. Companies are facing increasing scrutiny and challenges involving pricing and other antitrust issues. The latest episode of our podcast series Pricing Rules explores the Robinson-Patman Act, a significant antitrust law that continues to serve as a legal safeguard against anti-competitive pricing strategies. Most recently, the FTC deployed the Act in suing the largest alcohol distributor in the US, alleging it unjustifiably charged higher prices to small businesses, limiting their ability to compete with big chains. Listen to the podcast here.

FDA: New inventory of voluntary premarket meetings on genome-edited plants. FDA announced that it has released a new inventory of voluntary premarket meetings that have been held between the FDA and developers of foods from new genome-edited plant varieties. Industry can request a voluntary premarket meeting before marketing food from genome-edited plants when the genome-edited plant does not raise food safety questions or regulatory considerations based on risk characteristics outlined in the agency’s February 2024 Guidance Document. In contrast, the agency recommends voluntary premarket consultations when the food presents those risks. This inventory, which will continue to be updated, provides additional transparency for stakeholders around the plant, the developer, and the intended use of the plant variety.

FDA’s food safety culture webinar series to continue. FDA has announced the continuation in 2025 of its webinar series promoting food safety culture. These webinars, which are done in partnership with Stop Foodborne Illness, feature industry experts who address critical aspects of food safety culture, with the goal of providing actionable strategies for the food industry. You may register for these webinars here.

Califf defends FDA’s work on food, says lack of funding is the problem. On December 5, outgoing Food and Drug Administration chief Robert Califf, who has led the agency since 2022, gave US senators a blunt assessment of the nation’s problems with obesity, ultra-processed foods, and chemicals in the nation's food supply. Califf told the senators at a hearing of the Senate Committee on Health, Education, Labor and Pensions that there remains a great deal of research to do before the FDA can definitively know which ingredients are safe and which are not. He said that one problem is that the agency’s funding requests to Congress have not been fulfilled, leaving the FDA unable to conduct necessary research.

New York City bill would expand nutrition requirements for restaurant kids’ meals. This month, the New York City Council heard testimony on Bill 0641-2024, which would require New York City restaurants that offer children’s meal packages on their menus to serve at least two meals that meet nutrition standards. The city already requires that kids’ meal bundles include a healthy beverage – nonfat milk, water, or juice. Should the bill be enacted, New York City would become the fourth jurisdiction in the US with such requirements. The other three are all in Maryland – in Prince George’s, Montgomery, and Charles counties.

Bill in Texas legislature would keep certain dietary supplements away from kids. During the 2025 legislative session, the Texas legislature will consider HB 1474, which would prohibit the sale of weight loss and muscle building dietary supplements to persons younger than 18. The bill, containing language similar to that in a bill passed by the New York state legislature last year, would go into effect on September 1, 2025, and compliance would begin on December 1, 2025. HB 1474 defines a weight-loss or muscle-building dietary supplement as one that contains “creatine, green tea extract, raspberry ketone, garcinia cambogia or green coffee bean extract.” A similar bill was recently “pre-filed” in New Hampshire for consideration in the 2025 session, and nine other state legislatures – in California, Colorado, Illinois, Massachusetts, Michigan, Missouri, New York, New Jersey and Rhode Island – are also considering legislation to restrict minors’ access to certain dietary supplements. The New York state legislation was signed into law in October and goes into effect in April. It is being challenged in court by the Council for Responsible Nutrition.

Cucumber and cucumber product recalls continue during ongoing salmonella outbreak. On December 11, Sprouts Farmers Market recalled Gyro Family Kits sold at its stores in 24 states, with use-by dates running through January 7, 2025, because of the possibility of salmonella contamination. The tzatziki sauce was made with cucumbers potentially contaminated with the bacteria, the company said. This action followed other recalls due to possible salmonella contamination in cucumbers. As a general matter, the Food and Drug Administration and other federal agencies are urging people not to eat recalled cucumbers, as well as salads, wraps, party trays and meal kits that could contain the product, amid an investigation into an outbreak of salmonella that has sickened at least 68 people in 19 US states and sent 18 to the hospital.

Bill C-280, Financial Protection for Fresh Fruit and Vegetable Farmers Act, passes third reading in the Canadian Senate. On December 10, 2024, Bill C-280 passed its third reading in the Senate. The passage of the Bill marks a significant step towards enhancing financial protection for produce sellers in Canada and was welcomed by the industry. The Bill introduces a deemed trust financial protection mechanism for fresh produce sellers and aims to secure payments in the event of buyer bankruptcy. The Bill is similar to the US Perishable Agricultural Commodities Act (PACA) and will create a reciprocal protection for Canadian sellers. Under the current system, Canadian sellers must pay double the bond required for PACA’s dispute resolution mechanism. This Bill will allow the USDA to restore Canadian produce sellers' preferential access to PACA protections.

Avian flu update.

• Testing of raw or unpasteurized milk from dairy farms and processors nationwide for the H5N1 virus began on December 16 in California, Colorado, Michigan, Mississippi, Pennsylvania, and Oregon. Under the USDA's National Milk Testing Strategy, announced December 6, dairy farmers and those who handle raw milk intended for pasteurization must provide samples on request for testing. Positive test results, including those conducted by private labs, must be reported to the USDA; herd owners must provide basic information that will allow tracing. The strategy, announced on December 6, complements the April mandate required testing of lactating dairy cows before they are shipped across state lines.
  
  The H5N1 virus, which has spread through wild bird and mammal populations worldwide, continues to move through US poultry and dairy operations. APHIS reports that in the 30-day period up to December 16, 2024, H5N1 has been confirmed in 51 commercial flocks and 33 backyard flocks, affecting 14.43 million birds in the US. The virus’s leap to US dairy cattle has now involved more than 710 dairy herds across 15 states. California has reported the highest number of such infections. On December 13, the Fresno Bee reported that statewide, about half of the industry’s 1,100 dairies have herds with the virus. Public health officials in California stated this month that the virus is now widely circulating among poultry, wild birds, and livestock across California.
  
  Across the US, at least 60 people are confirmed to have been infected, most of them agricultural workers exposed to sick animals. On December 6, health officials in Arizona confirmed the first human cases in that state, in two people who had worked with infected poultry at a facility in Pinal County. On December 7, public health officials in Marin County, California announced a possible case of H5N1 in a child. At this writing, it remains unclear how the child was exposed. On December 13, a person in Louisiana was hospitalized with what may be the state’s first case of bird flu. The Louisiana Department of Public Health stated, “The individual had exposure to sick and dead birds that are suspected to have been infected with H5N1.” No cases of bird flu spreading between people have been detected in the US.
  
  The British Columbia teen who was the first human in Canada to domestically acquire H5N1 infection remains in stable but critical condition in BC Children’s Hospital. Public health investigators have conducted extensive contact tracing of animals and people whom the teen may have come into contact with and have taken several environmental samples but have been unable to determine the source of the exposure. As of December 20, the Canadian Food Inspection Agency (CFIA) report that there are 73 infected poultry farms in British Columbia with an estimated 8,335,000 birds impacted, as well as 4 infected premises in Alberta, 4 in Quebec, 2 in Saskatchewan, 1 in Manitoba and 1 in Ontario.
  
  In recent days, the Iowa Department of Agriculture has reported outbreaks of avian flu in commercial poultry facilities – egg operations in Sioux and O’Brien Counties and a turkey flock in Palo Alto County. Iowa Governor Kim Reynolds has extended the disaster proclamation for Sioux and Palo Alto counties and enacted one for O’Brien County. On December 17, APHIS confirmed the presence of H5N1 in two South Dakota commercial meat turkey flocks.
  
  Epidemiologists have expressed concerns that H5N1 could spread to humans through unpasteurized milk. This month, two dairies providing raw milk to California consumers – Raw Farm, of Fresno, which is California’s largest supplier of raw milk, and Valley Milk Simply Bottled, of Modesto – were subject to recalls after the California Department of Food and Agriculture found the virus in their products during routine testing. The CFDA is warning consumers, “Drinking raw milk containing bird flu virus may lead to infection with this rare, emerging flu virus.” On December 12, the Los Angeles County Department of Public Health announced it is investigating the deaths of two cats that consumed recalled raw milk from Raw Farm. Also this month, California news media reported that Mark McAfee, CEO of Raw Farm, is being considered for a position in the next Trump Administration as a “raw milk adviser” for the FDA.