This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape.
- FDA issues proposed rule on front-of-package nutrition labeling. The FDA has released its proposed rule on front-of-package nutrition labeling which, if enacted, would add a requirement to include an informational box that highlights information on saturated fat, sodium, and added sugars – described as “nutrients to limit” – on the principal display panel of most food labels, or on the labeling of foods sold to consumers from bulk containers. It also seeks to update certain nutrient content claim regulations to better align with current science and avoid within-label inconsistencies related to the three nutrients at issue. Find out more in our alert.
- Newsom issues EO on ultra-processed food, access to healthy food. On January 3, California Governor Gavin Newsom issued an executive order (EO) aiming to increase Californians’ access to healthy, affordable food and limit the harms associated with “ultra-processed foods.” Among the actions set out in the EO, it directs the California Department of Public Health to provide recommendations to Governor Newsom “regarding potential action to limit the harms associated with ‘ultra-processed foods’”; directs the Office of Environmental Health Hazard Assessment to continue its work investigating “adverse health effects of food dyes to individuals”; and directs the California Department of Social Services to provide recommendations on actions the state may take “to reduce the purchase of soda, candy, other ultra-processed foods and/or foods with synthetic food dye or other additives.” The EO also addresses potential improvements to the state’s universal school meal program and calls on several agencies to report on ways to improve public health through better access to healthy foods.
- FDA revokes authorization for Red 3. The FDA has revoked its authorization for the use of FD&C Red No. 3, also known as Red Dye No. 3 and Red 3, in response to a petition by Center for Science in the Public Interest and other organizations. The FDA took this action under the “Delaney Clause,” a provision of the Federal Food, Drug, and Cosmetic Act adopted in 1958 that essentially prohibits the use of food and color additives found to cause cancer in humans or animals regardless of the risk to humans. Because the petition presented evidence that Red 3 induced cancer in some rat studies, the FDA had no discretion to allow its continued use, even though the agency did not find evidence that the substance poses a risk to humans. The ban will go into effect for foods (including dietary supplements) and ingested drugs on January 15, 2027 and for topicals and ingested medications on January 18, 2028. Find out more in our alert.
- FDA rolls out strategy to prevent enteric virus contamination in berries. On January 17, the FDA released a summary of a new strategy to prevent the contamination of fresh and frozen berries with enteric viruses – RNA viruses that are transmitted through the human intestine. Outbreaks of enteric virus infections, including hepatitis A and human norovirus, have been linked to fresh and frozen berries in the US and globally for years, the FDA said. Over 35 years of tracking, notably, enteric virus outbreaks in the US have entirely been linked to imported fresh and frozen berries. The new strategy outlines actions to help identify preventive measures and ensure their consistent application, as well as knowledge gaps in the ability to detect and characterize enteric viruses, to link the source of contamination using advanced laboratory methods, and to identify research to understand how these viruses affect berries and other fresh produce operations.
- Tariffs and Trump: Preparing your business to mitigate duties. With the new presidential Administration, significant, fast-moving changes may be on the way for US tariff policy. President Donald Trump has said he may impose further tariffs on China as well as 25 percent tariffs on imports from Canada and Mexico. While some proposals may never materialize, others could result in significant changes to tariff rates. These evolving policies could create opportunities for proactive businesses that have a thorough understanding of tariff rules. Our alert tells you more.
- FSIS announces change in its Salmonella sampling procedures for poultry. On January 17, the USDA’s Food Safety and Inspection Service (FSIS) announced a key change in the way in which it samples poultry establishments for Salmonella. It said that to more accurately sample poultry establishments based on volume, it has chosen to modify its Salmonella sampling task assignment procedures to set sampling frequency based on monthly production volume rather than daily production volume. Currently, FSIS may sample establishments that produce a larger amount of product in a single day more frequently than establishments that produce smaller volumes over many production days, even when an establishment with lower daily volume produces more product overall – an anomaly that FSIS wishes to change.
- FDA’s actions regarding poppy seeds. On January 14, the FDA denied a citizen petition from Center for Science in the Public Interest to issue regulations and guidance “establishing a maximum permissible threshold of opiate alkaloid contamination of poppy seeds sold in the US and describing current good manufacturing practices to reduce the presence of opiate alkaloids in poppy seeds,” as well as import testing requirements for these products. On the same day, however, the FDA issued a Request for Information on industry practices related to poppy seeds, seeking information on the growing, harvesting, and post-harvest procedures used for poppy plants. This comes in the wake of multiple reports of serious adverse events, including death, connected to the use of some poppy seed products and the use of poppy seeds to produce homemade “poppy seed tea.” Comments on this notice are due on April 15, 2025. The FDA will use this information, along with other data, to determine whether additional action is needed.
- FDA issues RFI on high-protein yogurt. The FDA has issued a Request for Information on ingredients used and manufacturing processes for high-protein yogurt, Greek yogurt, or Greek-style yogurt, partially in response to industry concern that the current standard of identity (SOI) for yogurt does not capture the manufacturing processes and ingredients used to produce these products, which include Greek yogurt and Greek-style yogurt. Industry has previously noted that a new SOI for strained high-protein yogurt should include language describing the authentic straining process, the characteristics of high-protein yogurt, and the distinguishing compositional nutritional elements of the product. The FDA is requesting this information to determine whether there is a need to either update the current SOI for yogurt or to establish a new SOI for it. Comments on this notice are due on April 15, 2025.
- GAO criticizes FDA for not living up to its food-inspection mandates. On January 8, the Government Accountability Office (GAO) issued a report saying that the FDA is not conducting enough inspections of food-production facilities, both domestically and internationally. The report found the FDA is falling short of the inspection mandates Congress set for the agency in 2011 under the Food Safety Modernization Act and has not met its targets since 2018. The FDA has responded that it has not been given the resources to meet these inspection mandates. The GAO has criticized the FDA on and off for the past 15 years for not conducting enough inspections.
- Leading citrus producer to end Florida production this year. Stating that “we must now reluctantly adapt to changing environmental and economic realities,” Alico, one of Florida’s leading citrus producers, has announced it is ending its citrus-growing operations in the state after the 2025 growing season. This decision was made in response to production decline across Florida as a result of years of citrus greening disease and the impacts of severe weather events, such as hurricanes, on their trees. The company said it is now undergoing “a strategic transformation to become a diversified land company with each of its properties now expected to create profitable agricultural revenue opportunities that are not citrus-related, until the highest and best use for these acres can be realized." It hopes to keep about 75 percent of its acreage in agriculture and says it is pursuing residential and commercial development of the remaining land.
- Nebraska governor endorses state legislation against lab-grown meat. On January 14, Nebraska Governor Jim Pillen announced he is supporting LB 246, a bill recently introduced in that state’s legislature that would keep lab-grown meat from being manufactured, distributed, or sold in Nebraska. Under the proposed bill, “cultivated food protein” would be labelled an “adulterated food product” as set out in the Nebraska Pure Food Act. In 2024, Florida and Alabama each enacted legislation banning the manufacture, sale, or distribution of lab-grown meat. “It’s important we get on the offense so that Nebraska farmers and ranchers are not undermined,” the governor said. “Most of us want government out of our hair, but there are places where government needs to step in and protect us.”
- Study links global rise of T2 diabetes, cardiovascular disease to sugary drinks. A new study published this month in Nature Medicine by researchers at Tufts University’s Friedman School of Nutrition Science and Policy estimates that, every year, 1.2 million new cases of cardiovascular disease and 2.2 million new cases of type 2 (T2) diabetes arise globally due to consumption of sugar-sweetened beverages. While the link between these diseases and sugary drinks has been well researched, studies examining the global burden have been rare. The researchers reviewed data from the years 1990 and 2020 in 184 countries, defining a sugar-sweetened beverage as a drink with added sugars and more than 50 kcal per 8-ounce serving. They found that the situation is especially concerning in the developing world: in Latin America and the Caribbean, for instance, such drinks contribute to 24 percent of new T2 diabetes cases and more than 11 percent of new cardiovascular cases. “These findings emphasize the need for targeted interventions, accounting for social inequities and aligned with global health objectives,” the researchers concluded, expressing hope that their research “could assist in shaping effective policies and interventions” around the world. See the study here.
- Avian flu update.
The US Bureau of Labor Statistic’s Consumer Price Index reported on January 18 that, over the past year, egg prices have risen 38 percent across the US. An early January report from the Agricultural Marketing Service said the record-high price of eggs and local scarcities are being driven by "significant outbreaks of highly pathogenic avian influenza (HPAI) in commercial table egg layer flocks through December." In 2024, more than 40 million laying hens were culled in the US due to bird flu – 17.2 million of those in November and December. A USDA report released in mid-January stated, “Unlike in past years, in 2024, all major production systems experienced significant losses including conventional caged, cage-free, and certified organic types.”
Overall, in the 30-day period up to January 16, 49 US commercial flocks and an additional 40 backyard flocks have been confirmed to be infected with H5N1, the CDC reports. In that same time period, 48 additional dairy herds have been confirmed to be infected, all of those in California and Michigan. Since the virus was first found to have crossed into US cattle in 2024, 928 dairy herds have been affected.
The Georgia Poultry Laboratory Network and the USDA have confirmed the first outbreak of H5N1 in a commercial flock in in Elbert County, Georgia – before this, the virus had been detected in that state only in a few backyard flocks. The state Department of Agriculture has suspended all poultry shows, meets, swaps, sales, and exhibitions in Georgia until further notice. On January 21, the Department announced that Georgia is joining the USDA’s National Milk Testing Strategy, which monitors the presence of avian influenza among dairy cows. The state already routinely tests commercial chickens – thousands a week – for bird flu through the National Poultry Improvement Program, a voluntary state-federal-industry partnership originally established in the 1930s to combat salmonella pullorum in commercial poultry.
Confirming the presence of H5N1 in the flock, the Canadian Food Inspection Agency (CFIA) has ordered the owners of an ostrich farm to cull its population of birds – 400 in all. CFIA said it is following the World Organization for Animal Health classification of ostriches as poultry.
The Louisiana patient hospitalized with “severe” H5N1 infection contracted from a backyard flock has died. The Louisiana Department of Health said that its “extensive public health investigation” of the patient’s contacts identified no additional H5N1 cases nor evidence of person-to-person transmission. On January 16, the CDC said all patients hospitalized with flu should be tested for H5N1 within 24 hours. On January 19, scientists at the Texas Biomedical Research Institute reported in Emerging Microbes & Infections that their study of a strain of bird flu isolated from a human patient in Texas carries a distinctive set of mutations that make it more adept at replicating in human cells. On January 21, Modena received a $590 million grant from the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) to accelerate development of an H5N1 mRNA influenza vaccine “well matched to strains currently circulating in cows and birds” for humans.
On January 21, the FDA said that at least a dozen house cats have been killed or sickened by H5N1 spreading in raw food products. Felines are especially vulnerable to the virus. Earlier in January, an FDA spokesperson told CBS News, “All recent detections of H5N1 in cats had these things in common: the infected cats ate wild birds, unpasteurized milk, raw poultry, and/or raw poultry pet food.” After one cat’s infection was linked to raw pet food containing turkey, APHIS said it is increasing its oversight of turkey slaughter. The strain of H5N1 in the turkey product was B3.13, the same as the bird flu virus fueling the dairy outbreaks across the US and Canada.
As of January 22, 2025, the CFIA reported that there are 50 infected poultry farms in British Columbia with an estimated 8.6 million birds impacted, as well as 8 infected premises in Ontario, 2 in Alberta, 1 in Manitoba, and 1 in Saskatchewan.