This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape.
FDA publishes RFI on ultra-processed foods. FDA/HHS and USDA issued its long-awaited Request for Information (RFI) requesting data and information to assist in developing a uniform definition of ultra-processed foods. Defining UPFs is the first step to implementing regulatory requirements and recommendations around these foods, consistent with the Administration’s MAHA agenda to decrease the incidence of childhood chronic disease by improving the US diet. The RFI seeks information and data in response to a series of questions that focus on:
- Existing classification systems used to define UPFs (eg, NOVA)
- Types of ingredients that may be used to characterize a food as ultra-processed, including consideration of the relative amounts of an ingredient, as well as whether flavors and colors should be considered separately
- Whether and how the processing of ingredients, including physical (eg, cutting, extracting juice), biological (eg, fermentation), and chemical (eg, pH adjustments) should be considered when characterizing a food as ultra-processed
- Whether “ultra-processed” is the best terminology to use or whether there are other terms that should or should not be used to characterize a food in this category
- Research on nutrition and other attributes (eg, energy density, palatability) relating to health outcomes associated with UPFS
- How all of these factors can be integrated into a classification system that can be systematically measured and applied to foods, including how such a classification should be used in food and nutrition policies and programs
The comment period will remain open for 60 days until September 23, 2025.
FDA seeks to end 52 standards of identity. The FDA has announced its intention to eliminate 52 standards of identity (SOIs) for food products that it considers obsolete or unnecessarily burdensome. According to HHS Secretary Robert F. Kennedy, Jr., this effort is part of a broader push to “eliminate outdated food regulations that no longer serve the interests of American families” and to “remove regulations that have outlived their purpose.” This SOI elimination initiative will be implemented through three separate rulemakings: one direct final rule and two proposed rules. The direct final rule targets 11 SOIs for canned fruit and vegetable products that the FDA states are no longer sold in the United States, including seven standards for saccharin-sweetened canned fruits, one for canned preserved figs, and another for canned seedless grapes. This rule is set to take effect on September 22, 2025, unless significant adverse comments are received by August 18, 2025. The two proposed rules would revoke an additional 41 SOIs. One would eliminate 18 standards for dairy products such as milk, cream, cheeses, and frozen desserts (among them acidified milk, low sodium cheddar cheese, cream cheese with other foods, high-moisture jack cheese, and goat’s milk ice cream). The other would remove 23 standards covering bakery products, macaroni and noodles, canned fruit juices, fish and shellfish, and certain food dressings and flavorings. These 23 SOIs include but are not limited to milk bread, rolls, and buns; enriched macaroni products with fortified protein; wheat and soy noodle products; vegetable noodle products; frozen concentrate for artificially sweetened lemonade; orange juice with preservatives; frozen raw lightly breaded shrimp; and vanilla-vanillin extract, flavoring, and powder. Both proposed rules are open for a 60-day public comment period ending September 15, 2025. The FDA emphasizes that these actions are intended to reduce redundant regulatory requirements, increase transparency, and support the production and innovation of healthier food options. Elimination of these 52 SOIs could pave the way for 5 new regulations or policy documents under the Trump Administration’s 10 for 1 de-regulatory approach.
Texas and Louisiana move ahead with MAHA agenda for ultra-processed foods. State legislatures are taking action to regulate what they consider ultra-processed foods. Two state bills that will impact manufactured food companies and their suppliers have recently been signed into law. Texas enacted sweeping legislation, requiring warnings on food products containing any of 44 listed food additives. Louisiana also enacted a law imposing food-ingredient restrictions in school meal programs, disclosure requirements for 44 listed food additives for manufactured foods (not the same list as the Texas law), and disclosure requirements for 8 listed seed oils on the menu or “other clearly visible location[s]” of food-service establishments. These legislative actions reflect a growing trend toward local oversight of food composition and labeling, presenting significant compliance challenges for the food industry. See our alert.
Reminder from FDA about VQIP applications. The FDA is reminding importers that the application window for the Voluntary Qualified Importer Program (VQIP) for fiscal year FY 2026 benefits will close on September 1, 2025. VQIP, the agency notes, is “a fee-based program that offers importers an opportunity to expedite the review and importation process of human and animal foods into the United States by demonstrating and maintaining control over the safety and security of their supply chains.” To participate in the program, importers must meet certain conditions – among them, having their foreign suppliers audited and certified under FDA’s Accredited Third-Party Certification Program by an accredited third-party certification body. FDA is urging importers to submit their applications early to avoid delays. For more information about the application process, please visit this FDA page. VQIP benefits will start on October 1, provided the application has been approved and the user fee has been paid.
Proposed revisions to the SNAP food stocking standards are on the way. Before retailers can be approved to sell to Supplemental Nutrition Assistance Program (SNAP) recipients, they must show that they comply with SNAP’s staple food stocking standards. On July 11, the USDA submitted a proposed rule to OIRA for review that would update those standards. Little information is currently available about the proposed rule; some sources surmise that it will likely add requirements for stocking fresh produce, fresh meats, and whole milk to the standards.
Wildfire smoke poses new challenges for Canadian food producers. As wildfire smoke becomes a recurring issue across Canada, it’s adding another layer of uncertainty for the agricultural sector. Fires burning across northern Saskatchewan, Manitoba, and Ontario are creating smoky conditions that complicate crop growth and food production. The smoke’s effects on crops are complex and inconsistent, varying by crop type and growth stage. Smoke can block sunlight and hinder photosynthesis, while ozone formed from pollutants can damage plant tissues and reduce yields. Beekeepers, furthermore, are seeing direct consequences from wildfire smoke: sensing danger, bees tend to respond to smoke by reducing their pollinating activities and honey production, as if they are preparing to flee. Some honey producers have reported a 30 to 40 percent drop in output this season, worsened by ongoing drought conditions.
New Senate bill to close the GRAS loophole. On July 15, Senators Edward J. Markey (D-MA), Cory Booker (D-NJ), Elizabeth Warren (D-MA), and Richard Blumenthal (D-CT) have introduced the Ensuring Safe and Toxic-Free Foods Act of 2025, a bill that aims to eliminate the “self-GRAS pathway and require re-assessments of safety not later than every 3 years. With respect to the GRAS pathway, the measure would deem a substance added to food unsafe unless:
- It is an approved food additive in compliance with section 409 of the FD&C Act
- It is the subject of a GRAS notification submitted prior to the enactment of this law, and FDA has either not responded or issued a “no questions” letter
- It is the subject of a GRAS notification submitted after the enactment of this law, and in compliance with the standards in the law, and FDA has determined that it is GRAS
For the new notifications, FDA would evaluate the new notices on numerous criteria set forth in the statute, including full information on methods; cumulative effects; hazard dose, response, and exposure; application of safety margins; and evidence that the substance is not a carcinogen and does not induce reproductive toxicity or developmental toxicity in humans. The bill also would explicitly exclude certain substances from being determined to be GRAS, including substances identified as being toxic by other named federal agencies, as well as the California Office of Environmental Health Hazard Assessment. The bill would require FDA to publicly post GRAS notices, with a 60-day public comment period. While the bill does not prescribe a timeframe for review, it would require FDA to review at least 50 GRAS substances annually. The bill would also amend section 402 of the FD&C Act to explicitly deem non-GRAS substances as adulterated, providing an enforcement hook for domestic and imported products. See the text of the bill here. As we reported in March, HHS Secretary Robert F. Kennedy, Jr. has also directed the FDA to explore a possible rulemaking that could eliminate the GRAS Final Rule.
Change to FDA imports review policy affects low-value imports. On July 15, the FDA announced that due to a Customs and Border Protection (CBP) policy change, “all entries of FDA-regulated products must be reviewed for admissibility by the FDA, regardless of their quantity or value.” The change will particularly affect low-value products valued at $800 or less that are being shipped into the US, which previously had been exempt from FDA imports review. FDA stated that it and CBP are able to broaden the reach of their assessments thanks to technological advances and that the new policy would “facilitate legitimate trade and prevent the importation of violative products.”
Canada: Agriculture ministers agree to changes to AgriStability for 2025. AgriStability, a program under the Sustainable Canada Agricultural Partnership. protects Canadian producers against large declines in farming income for reasons such as production loss, increased costs, and market conditions. Federal and provincial agriculture ministers have agreed to improve the AgriStability program for the 2025 program year by increasing the compensation rate from 80 percent to 90 percent and doubling the payment cap from CA$3 million to CA$6 million. While provinces must formally approve these changes, the Federal Minister of Agriculture, Heath MacDonald, said the provincial ministers were “receptive” during a July 17 virtual meeting. These enhancements aim to support farmers facing trade challenges, particularly with China and the US. Commencing in 2026, a new valuation method will be available for on-farm inventory like feed, and ministers are working to include feed costs for rented pasture as an eligible expense. Ministers will continue discussions at an in-person meeting in Winnipeg In early September. Trade issues and investment promotion were also discussed at the virtual meeting, with MacDonald highlighting the importance of agricultural investment and praising strong federal-provincial collaboration that he has seen since his appointment in May.
FDA receives 12,000 comments on proposed front-of-package label rule. The comment period for the FDA’s Front-of-Pack Nutrition Labeling proposed rule closed on July 15, with nearly 12,000 public comments submitted. The proposed rule would “require front-of-package nutrition labels on most foods that must bear a Nutrition Facts label,” supplementing the Nutrition Facts label with “standardized, interpretive nutrition information” focused on saturated fat, sodium, and added sugar to help consumers “quickly and easily identify how foods can be part of a healthy diet.” The comment period had been extended an additional 60 days due to the substantial volume of submissions. While consumer and public health groups have supported this regulation, the food industry has pushed back, believing that it may be confusing to consumers, would be costly to comply with, and is not necessary since many in industry are using “Facts Up Front” labeling to simplify nutrition information.
HHS comment period asking which regulations to eliminate closes. The comment period for commenting on the HHS Request for Information (RFI): Ensuring Lawful Regulation and Unleashing Innovation To Make American Healthy Again, asking the public which regulations should be eliminated, closed on July 14. While more than 13,000 comments were reportedly received, only 975 of those are visible on the docket, and, of those, only 20 mention food. Among those are calls for the FDA to simplify the Food Traceability Rule, withdraw the guidances on voluntary disclosure of sesame as an allergen and on the labeling of plant-based alternative foods, milk alternatives, and animal-derived food alternatives, and review of agency voluntary sodium reduction targets.
EPA establishes food tolerance levels for three pesticides. The EPA has published three final rules establishing food residue tolerance levels for three pesticides: triclopyr, which is used on certain citrus fruits, harmonizing the tolerance level with the European Food Safety Authority’s Maximum Residue Limit; cypermethrin, used on durian, harmonizing its tolerance levels with Codex Alimentarius limits; and acetamiprid, used in connection with various spices, also harmonizing its tolerance levels with Codex Alimentarius limits. EPA is authorized under the Federal Food, Drug and Cosmetic Act to set pesticide tolerances for foods, and FDA enforces these tolerances. The tolerances were established in response to a petition by a Chilean company, although the ultimate tolerance levels were different from those sought so as to better harmonize with regulatory tolerances in other jurisdictions.
FDA approves new blue color additive derived from gardenias. On July 14, the FDA announced it had granted Gardenia Blue Interest Group’s color additive petition to use the color gardenia blue in various foods, at levels consistent with good manufacturing practices. This is the fourth color derived from natural sources that has been approved by the FDA for use in foods in the last two months. The agency approved the color for use in sports drinks, flavored or enhanced non-carbonated water, fruit drinks, and ready-to-drink teas, as well as hard and soft candy. The FDA said that its action is in line with HHS Secretary Kennedy’s priority of working with industry to phase out the use of all synthetic petroleum-based dyes from the nation’s food suppl, part of the Administration’s broader effort to Make America Healthy Again. Since Kennedy announced a series of measures in April to work with industry to phase out petroleum-based synthetic dyes in food, about 40 percent of the food industry has committed to a voluntary phaseout of such dyes, the FDA said.
DOJ sues California over state Proposition 12. On July 9, the Department of Justice announced that it had filed suit against the State of California over a state regulation that it says raises the price of eggs, poultry, and pork. The suit, which also names California Governor Gavin Newsom and Attorney General Rob Bonta as defendants, focuses on several California laws, among them Proposition 2, which sets out requirements for housing covered farm animals, including egg-laying hens; AB1437, which regulates the quality of eggs sold for human consumption; and Proposition 12, which sets California standards for the sale of certain egg, veal, and pork products – most notably, it bans the sale of pork in California from farms anywhere in the country that confine pregnant pigs in “gestation crates” for almost their whole lives. The department said that the laws and regulations challenged by the complaint directly conflict with federal regulations and impose requirements on farmers that have the effect of raising food prices – and especially egg prices – for American consumers. As we reported in our previous issue, the US Supreme Court recently declined to hear a case brought by the Iowa Pork Producers Association that had challenged Proposition 12. See the DOJ’s compliant in USA v. the State of California here.
Major study suggests links in developed world obesity to ultra-processed foods. A sweeping new global study of the relationship between calorie intake, energy expenditure, and obesity finds that people around the world, regardless of where they live or their socioeconomic status, burn about the same number of calories in a day, which stands in contrast to conventional wisdom and other studies that link the obesity crisis to developed countries’ sedentary lifestyles. The study, published in the Proceedings of the National Academy of Sciences (PNAS), looked at data on more than 4,200 “economically diverse” adults in 34 countries, assessing a broad spectrum of possible contributors to obesity, such as sedentary habits or higher consumption of meats, in seeking to determine why obesity is more prevalent in developed nations. The study concludes that there may be a link between obesity and the availability/regular intake of ultra-processed foods, which the study defines as industrial formulations with five or more ingredients. But the study concedes that the “mechanisms involved are not clear” and may simply be attributable to “increased availability of calories” because UPF are “low cost and [have] long shelf” lives. The study’s conclusions, the nearly 70 authors state, “highlight the need to identify the factors that make foods in developed countries obesogenic.” The authors also note, “The central role of diet in the global obesity crisis does not mean that efforts to promote physical activity should be minimized.” See the study, Energy expenditure and obesity across the economic spectrum, here.
Avian flu update.
- At this writing, in the last 30 days the USDA has detected H5N1 at only one poultry operation and two dairy farms, a drop being attributed to seasonal factors. The June report from the World Organization for Animal Health, however, notes that H5N1 infections among wild birds appear to be rising worldwide.
- Because no new human cases of H5N1 have been detected since February, the CDC on July 7 announced that it is ending its emergency response to H5N1 bird flu. The CDC declared the H5N1 emergency on April 4, 2024, giving its additional financial support to develop its public health response. “CDC will continue to monitor the situation and scale up activities as needed,” a spokesperson stated. The CDC will no longer report avian flu data, but the USDA will continue offering that information on its website.
- Fate of BC ostrich farm in limbo as CFIA cull policy faces rare legal challenge. The Federal Court of Appeal has reserved judgment in a high-profile challenge to the Canadian Food Inspection Agency’s (CFIA) decision to cull 400 ostriches at Universal Ostrich Farms in Edgewood, BC, following an avian flu outbreak in December 2024. In May 2025, the Federal Court ruled that the CFIA’s decision – and its application of the stamping-out policy to the ostriches – was reasonable. On appeal, the farm’s counsel argued at a July 15 hearing that the CFIA applied the policy in an overly rigid, one-size-fits-all manner, ordering total depopulation within 41 minutes of receiving positive test results from only two birds. Counsel emphasized that no bird deaths had occurred since January, and the herd was showing signs of recovery. The CFIA defended its actions as consistent with international standards and necessary to protect animal health and trade, noting the novel virus strain found on the farm and the risk of re-emergence. As we reported last month, the court stayed the cull pending the decision and indicated it will rule quickly given the stakes. The case, believed to be the first test of stamping-out policy as applied to ostriches, has drawn international attention. US figures including HHS Secretary Robert F. Kennedy, Jr. and Dr. Mehmet Oz, the Administrator for the Centers for Medicare & Medicaid Services, have repeatedly lobbied Ottawa to preserve the birds for research purposes.
- Raising fresh alarm, the Center for Infectious Disease Research and Policy (CIDRAP) reported on July 18 on the discovery of H5N1 in house flies. Raj Rajnarayanan, MSc, PhD, a computational biologist with the New York Institute of Technology College of Osteopathic Medicine at Arkansas State University, who detected the virus in house fly sequence samples that had been uploaded to the Global Initiative on Sharing All Influenza Data, said in a post on X, “Detection of avian influenza in house flies shows these insects can mechanically move virus around farms.” Meanwhile, a study published on July 1 in the National Science Review reported another potential route for H5N1 virus transmission in dairy cattle – mouth-to-teat transmission during nursing.