This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape.
The leaked MAHA draft strategy. The Administration was expected to release its MAHA strategy document in August outlining policy initiatives as a follow-up to the Make Our Children Healthy Again Assessment released in May. While the final document has not yet been issued, a leaked draft outlines policies that echo statements and ideas made in the past by the Administration, with no significant surprises. That said, the MAHA draft strategy, as set out in reviews of the leaked text, sketches an ambitious but notably opaque nutrition-policy roadmap that would simultaneously tighten health-protective oversight and accelerate deregulatory “process efficiencies.” On the one hand, the draft text foreshadows FDA initiatives to modernize its post-market food-chemical assessment framework, revisit the GRAS program, finalize front-of-package nutrition labeling, craft a uniform definition of “ultra-processed foods,” overhaul infant-formula standards, issue streamlined Dietary Guidelines for Americans, curtail synthetic dyes (including within the National School Lunch Program) and align FTC marketing guidelines to curb kid-directed promotion of unhealthy products. On the other hand, the leaked document discusses offering greater flexibility for “no artificial color” and similar labeling claims. Parallel USDA efforts would streamline organic certification, digitize applications, expand financial assistance, remove barriers to whole milk in school meals, refine HACCP guidance for very small meat processors, broaden grocery access in food deserts, and revisit standards of identity with an eye toward manufacturing flexibility. Layered atop these regulatory pivots, the administration proposes a robust research architecture – including a MAHA Chronic Disease Task Force overseeing “Food for Health” studies, NIH-led randomized trials, and an FDA-NIH Joint Nutrition Regulatory Science Program – as well as a “Real Food First” public-awareness campaign designed to translate emerging science into practical dietary change. Although concrete timelines, funding mechanisms, and enforcement contours remain unclear, the draft unmistakably positions FDA, USDA, HHS, and allied agencies to recalibrate both the scientific and commercial parameters of the US food system in the coming years. It is not clear when the final document will be issued, but press reports speculate that the release date will be early September.
Former FDA Commissioner files petition to limit refined carbohydrates. Dr. David A. Kessler, who served as FDA Commissioner from 1990 to 1997, has filed a petition urging the FDA to revoke the “generally recognized as safe” (GRAS) status of refined carbohydrates that dominate ultra-processed foods. These ingredients are used in a broad array of snack foods, beverages, cereals, baked goods, and even some infant formulas. The petition contends that scientific studies conducted since these ingredients were determined to be GRAS demonstrate that they accelerate eating rates, spike insulin and blood glucose, promote visceral fat deposition, and drive a cascade of chronic illnesses such as obesity, type 2 diabetes, cardiovascular disease, and non-alcoholic fatty liver disease. The petition argues that the requisite expert consensus of safety no longer exists and that continued use violates the statutory requirement of “reasonable certainty of no harm” necessary for GRAS status. More specifically, the petition requests that FDA:
- Declare that the listed processed refined carbohydrates are no longer GRAS, based on the likelihood that they are contributing to metabolic harm
- Initiate rulemaking to revoke their existing GRAS regulations for use in industrial processing
- Require industry to notify FDA within 12 months of any intent to file food-additive petitions and to submit full petitions within 24 months
- Announce that these substances are legally classified as food additives and that continued use of these products depends on the industry notifying FDA within 12 months of its intent to file a food additive petition and submitting full petitions within 24 months
- Remove non-compliant products from commerce absent an approved food-additive regulation and
- Collaborate with industry to reduce reliance on these ingredients as rapidly as practicable.
Lindberg confirmed to USDA trade post. The Senate has confirmed Luke Lindberg as the USDA’s Under Secretary for Trade and Foreign Agricultural Affairs. Most recently, Lindberg served as president and CEO of South Dakota Trade, a public–private partnership focused on expanding international market access for regional exporters. Before that, he was chief of staff and chief strategy officer at the Export-Import Bank during the first Trump Administration.
Another cell-cultured animal product receives FDA no questions letter. On July 24, 2025, FDA completed its pre-market evaluation of Believer Meats’ cultured chicken cell material and expressed “no questions” regarding the company’s conclusion that the ingredient is generally recognized as safe (GRAS) for use in human food. This is the fifth cell-cultured animal product that has been reviewed by FDA and received a no questions letter. FDA confirmed that the harvested cells are compositionally and microbiologically comparable to conventional chicken. As a result, Believer may introduce foods containing its cultured chicken ingredient into US commerce without additional food-additive approvals, so long as it continues to produce the material in accordance with the specifications and cGMP controls. As we reported earlier this summer, FDA set a no questions letter to San Francisco-based Wildtype concerning its cell-cultured salmon, making it the first company to complete the US pre-market scientific and safety consultation process for a seafood product.
FDA confirms effective date for three natural colors in food. Following the May final orders allowing for the use of three natural food dyes, FDA issued three Federal Register notices confirming the June 26, 2025 effective date for galdieria extract blue, calcium phosphate, and butterfly pea flower extract. FDA issued these notices because the agency received no objections or requests for hearings in response to the final orders.
Save the date for FDA virtual public meeting on food allergen thresholds. FDA will host a three-day virtual public meeting in November to discuss food allergen thresholds and their potential applications. The agency states, “Recent scientific developments in food allergen thresholds have prompted FDA to explore how these thresholds can improve food safety, enhance labeling practices, and help consumers make more informed choices.” A day of presentations and panel discussions is slated for November 18; with November 19 and 20 dedicated to listening sessions. FDA will release more information and provide information about registering for the event in September. Find the report here.
Tennessee requests SNAP waiver. Tennessee Governor Bill Lee has asked the USDA to approve a Supplemental Nutrition Assistance Program (SNAP) waiver that would exclude sugary foods and drinks from SNAP benefits, and enable SNAP recipients to purchase certain prepared foods (such as rotisserie chicken and other non-fried non-breaded items such as grilled chicken tenders). Under the waiver, SNAP recipients would not be allowed to use their benefits to purchase items listing sugar, corn syrup, high-fructose corn syrup, or a similar caloric alternative as the first ingredient; also excluded would be carbonated sweetened beverages in which carbonated water and sugar, high-fructose corn syrup, or a similar caloric alternative are the first two ingredients. To date this year, the USDA has approved waiver requests from 12 states – Arkansas, Colorado, Florida, Idaho, Indiana, Iowa, Louisiana, Nebraska, Oklahoma, Texas, Utah, and West Virginia – that allow those states to prohibit certain foods and beverages from being purchased with SNAP benefits. Those waivers go into effect in 2026. Each state has targeted somewhat different products: Colorado, for instance, restricts the purchase of soft drinks, while Florida restricts the purchase of sodas, energy drinks, candy, and prepared desserts. According to media reports, South Carolina, Mississippi, and Pennsylvania may be the next states requesting a SNAP waiver. See some of our earlier coverage of such waiver requests here.
US agencies taking actions to combat spread of New World screwworm. Both USDA and FDA are taking action to protect the US food supply from of Cochliomyia hominivorax, commonly called New World Screwworm (NWS), a devastating parasite endemic in parts of South America and the Caribbean that in July was detected less than 400 miles south of the US–Mexico border. While no NWS has been reported or detected in animals in the US, Agriculture Secretary Brooke Rollins announced several new initiatives, stating that the screwworm “endangers our livestock industry and it threatens the stability of beef prices for consumers across America.” In response, USDA is taking a broad swath of action. A key long-term part of the plan is to produce and introduce 300 million sterile screwworm flies a week to prevent the parasite’s spread. Other USDA initiatives include expanding detection and mitigation work for livestock along the US–Mexico border for fever and also investing USD100 million to develop viable new technologies, veterinary drugs, and sterile fly production methods. HHS issued a declaration that allows FDA to issue Emergency Use Authorizations (EUSs) for animal drugs to treat or prevent infestations caused by NWS. Currently, there are no FDA-approved drugs for NWS in the US.
US spirit exports to Canada have tumbled. Exports of US-made distilled spirits to Canada in the first six months of 2025 have fallen by about 62 percent compared to the same period last year, the Distilled Spirits Council states, and exports of US wines similarly fell about 67 percent in that time frame. In 2024, Canada bought about 35 percent of all US wine exports, making it the world’s largest market for those products, according to the Wine Institute, a trade group for California-based vintners; this year, Canada’s turn away from US wines, the Wine Institute stated, has translated to more than USD173 million of lost export value so far this year. The reality is more nuanced, the Wall Street Journal noted. For instance, in 2024 the Liquor Control Board of Ontario sold worth more than USD700 million of American-made alcoholic beverages; this year, that number has fallen to nearly zero. The province of Alberta, which like Ontario stopped buying US-made alcohols early this year, resumed such purchases in June in hopes of improving the tone of trade talks. Since then, US wine and bourbon sales in the province have jumped. The owner of a Calgary liquor store told the Wall Street Journal that Canadians from other provinces are flocking to Alberta to stock up on their favorite modest US-grown wines.
Canadian company working with University of Guelph to explore possibility of growing food on the moon. The project, backed by both the Canadian and German space agencies, is part of an effort to build a lunar greenhouse capable of delivering light, nutrients, and monitoring systems to cultivate fresh produce on the moon within the next few years. The moon’s temperature swings from -130°C to 120°C, and the dark, desert-like conditions make cultivation extraordinarily difficult. The team completed experiments in late 2024 and early 2025, growing barley and oat plants in simulated lunar conditions. Canadian Space Agency astronaut David Saint-Jacques highlighted that the fresh produce would not only provide psychological benefits for astronauts, but also further contribute to life support systems and purifying air quality.
Canada: CSA Group and PR3 publish reusable packaging system design standard. Recognized by both the Standards Council of Canada (SCC) and the American National Standards Institute (ANSI), the new binational standard – RES-002:25/CSA R303:25 – sets consistent requirements to ensure reusable food and beverage containers are safely sanitized and prepared for reuse at scale. It addresses gaps in existing food safety programs by providing clear expectations for washing facilities, supporting interoperability across reuse systems in settings such as cafes, stadiums, and packing facilities. Developed with input from more than 100 stakeholders across 20-plus countries, the new standard is the first in a series of 6 to be finalized by 2026. By establishing common benchmarks, it aims to reduce costs, improve efficiency, and enable the safe transition from pilot projects to scalable, harmonized reuse systems. Leaders at CSA Group and PR3 highlighted the initiative as a key step toward addressing plastic waste and building public confidence in reuse as a sustainable alternative to single-use packaging.
China announces provisional 75.8-percent anti-dumping tariff on Canadian canola imports. As the world’s largest importer of canola – sourcing nearly all of it from Canada – China’s levy effectively shuts out Canadian canola from its market (worth nearly CAD5 billion in annual Canadian canola exports). The recent announcement has resulted in canola futures plunging by about 6.5 percent, signaling a notable fallout in trading markets. At the same time, Chinese authorities opened a one-year anti-dumping investigation into Canadian pea starch, citing concerns that imports in 2024 were increasingly undercutting domestic producers. This dual action contrasts with the conciliatory tone in June, when Chinese Premier Li Qiang told Canadian Prime Minister Mark Carney during a phone call that the two countries had no fundamental conflicts of interest. Agriculture analyst Even Rogers Pay has highlighted that the move significantly increases the pressure on Canada to resolve its ongoing trade disputes with China.
FAO launches tool to help countries monitor veterinary drug residues in human foods. The UN’s Food and Agricultural Organization (FAO) has launched its Residues of Veterinary Drugs in Foods Tool, created to helped low- and middle-income countries “strengthen their national food safety systems through improved monitoring of veterinary drug residues” that increase the risk of antimicrobial resistance. The tool is based on the modular design of the FAO’s Assessment Tool for Laboratories and AMR Surveillance Systems, allows countries to identify and address gaps in capacity, even when they may lack a centralized monitoring infrastructure. In describing the tool, FAO notes, “Often, the situation is more positive than countries think.” See FAO’s fact sheet about the tool here.
USDA announces grants to mitigate spread of an invasive fish. The USDA has announced a new grant program for seafood processors to help mitigate the spread of blue catfish, an invasive species, in the Chesapeake Bay. Under the program, grant recipients would be able to modernize their equipment, expand their operations, and better market wild-caught blue catfish. A total of USD6 million in grant funding is now available through USDA Rural Development’s Meat and Poultry Processing Expansion Program; eligible projects, USDA stated, may receive grants from USD250,000 up to USD1 million. The USDA also announced a related one-year pilot program in partnership with Maryland’s Department of Agriculture to purchase up to USD2 million of the fish which, USDA stated, would “provide nutritious protein to families in need through food banks and other food distributors.”
Avian flu update.
- In a unanimous decision, on August 21 Canada’s Federal Court of Appeal upheld an order issued by the Canadian Food Inspection Agency (CFIA) in January requiring the culling of the remaining 400 ostriches at Universal Ostrich Farms in British Columbia. The court concluded that in ordering the cull in January, CFIA had acted lawfully and reasonably, and that its “stamping out” H5N1 cull policy is within its purview and is based on scientific evidence. The court also stated that the farm is entitled to compensation for the loss of the ostriches, up to USD3,000 per bird. At this writing, the farms owners have indicated they will continue their advocacy for their flock, including seeking a stay order in the coming days. They called on their supporters – some of whom have been camping on the farm for months – to “stand against destruction and shine a light of love.” See some of our earlier coverage of this story here and here.
- The USDA reports that in the 30-day period before August 18, an outbreak of H5N1 was confirmed in only one small backyard flock in Los Angeles County. The most recent confirmed outbreak in a commercial US poultry operation was in July, at a pheasant farm in Pennsylvania. Among dairy herds, three new outbreaks were confirmed in that period, all in California.
- New research from Cornell University demonstrates that the impact of H5N1 infection in dairy herds may be more serious, and last longer, than previously understood. The study, which examined a single dairy herd on an Ohio farm, found lower milk production over a longer term than expected as well as higher mortality in infected cows, estimating the cost of such viral infections in a herd at USD950 per clinically affected cow “for a total cost of ~$737,500 for the herd during the observation period.” Lower dairy production, the researchers found, may extend for months beyond the clinical outbreak period, and, they learned, “the risk of clinical influenza diagnosis increased as lactation progressed,” a finding suggesting “an association between cumulative exposure to the milking process and the risk of clinical disease” and supporting the hypothesis “that transmission of HPAI H5N1 could be occurring during the milking process.” The study is “The impact of highly pathogenic avian influenza H5N1 virus infection on dairy cows.”
- Meanwhile, concerns are rising across Europe about the potential spread of H5N1 to farms. CIDRAP (the University of Minnesota’s Center for Infectious Disease Research & Policy Research and Innovation) reported on August 11 that the UK in particular is experiencing “an unusual rise in H5N1 avian flu outbreaks in commercial poultry, with 10 reported over the past 2 weeks.”
- As the fall migration begins, the European Food Safety Authority (EFSA) has been ramping up its H5N1 vigilance; EFSA has expressed particular concern that the viral subtype that has infected may US dairy herds and that “has not been reported so far in any country other than the USA” could find its way to the EU. EFSA has expressed concerns about “the potential for the virus to be introduced into Europe through trade,” offering the example of viral transmission through imported raw milk. By the end of the year, the agency stated, it will release its recommendations for ways to mitigate any potential spread of H5N1 to European dairy herds.
- Among other countries reporting recent outbreaks in commercial poultry operations are Cambodia, Canada, and Taiwan.