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This Regulatory Update covers information from July 2025. Please contact <a href="mailto:pebenson@michaelbest.com">Paul Benson</a>, <a href="mailto:ttfritsch@michaelbest.com">Taylor Fritsch</a>, or <a href="http://lhziemba@michaelbest.com">Leah Ziemba</a> for additional information on regulatory issues that may affect your business. For access to articles and resources from our Premium Member law firm, Michael Best &amp; Friedrich, visit <a href="https://www.michaelbest.com/">michaelbest.com</a>.

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FDA Extends Comment Period on Chemical Ranking Method for Food Safety

July 14: The FDA announced a 30-day extension to the public comment period for its proposed method of ranking chemicals in the food supply for post-market assessments. Originally released on June 18, the method uses Multi-Criteria Decision Analysis (MCDA) to prioritize chemicals based on public health risk. This method would provide a transparent, science-based approach to determine which food chemicals the FDA would prioritize for post-market assessments. Stakeholders now have until August 18, 2025, to submit comments. More information can be found <a href="https://www.fda.gov/food/hfp-constituent-updates/fda-extends-comment-period-proposed-method-ranking-chemicals-food-post-market-assessments">here</a>.

FDA Approves Gardenia (Genipin) Blue as a Food Color Additive

July 15: The FDA issued a final rule amending its color additive regulations to permit the use of gardenia (genipin) blue in various foods, exempt from certification under 21 CFR Part 73. This action follows a petition submitted by Exponent, Inc. on behalf of the Gardenia Blue Interest Group (GBIG), proposing the additive’s use in sport drinks, flavored waters, fruit drinks, teas, and both hard and soft candies. The FDA concluded that the additive is safe when used in accordance with good manufacturing practices. The rule becomes effective August 29, 2025. More information can be found <a href="https://www.federalregister.gov/documents/2025/07/15/2025-13175/listing-of-color-additives-exempt-from-certification-gardenia-genipin-blue">here</a>.

FDA to Revoke 52 Obsolete Food Standards

July 16: The FDA announced the revocation or proposed revocation of 52 outdated Standards of Identity (SOIs) for food products. These standards, originally established to ensure consistency and consumer protection, now no longer reflect current food science or production practices. The 52 food standards are for canned fruits and vegetables, dairy products, baked goods, and other foods. More information, along with a list of the 52 standards, can be found <a href="https://www.fda.gov/news-events/press-announcements/fda-revoke-52-obsolete-standards-identity-food-products">here</a>.

FDA and USDA Seek Public Input on Defining Ultra-Processed Foods

July 25: The FDA and the U.S. Department of Agriculture (USDA) jointly issued a Request for Information seeking data and information to help develop a uniform definition of ultra-processed foods (UPFs) in the U.S. food supply. This initiative addresses growing concerns about the health impacts of UPFs, which have been linked to chronic diseases such as cardiovascular disease, obesity, and type 2 diabetes. A standardized definition would support consistent research, policy development, and public health strategies. The deadline for comments is September 23, 2025. More information can be found <a href="https://www.federalregister.gov/documents/2025/07/25/2025-14089/ultra-processed-foods-request-for-information">here</a> and <a href="https://www.fda.gov/news-events/press-announcements/hhs-fda-and-usda-address-health-risks-ultra-processed-foods">here</a>.

FDA and Reagan-Udall Foundation Release Produce Safety Roadmap

July 28: The Reagan-Udall Foundation (RUF), in partnership with the FDA, released a new Produce Safety Roadmap aimed at improving the safety of fresh fruits and vegetables. Developed with input from over 170 produce industry stakeholders, the roadmap calls for a shared responsibility approach to managing food safety risks and recommends forming a structured, stakeholder-led coalition to drive lasting change. The FDA supports these efforts and is encouraging broad collaboration across the supply chain to reduce contamination and prevent foodborne illness. More information can be found <a href="https://www.fda.gov/food/hfp-constituent-updates/ruf-releases-produce-safety-roadmap-call-action">here</a>.

FDA Files Petition to Permit 4′-PPT as a Nutrient in Medical Food

July 29: The FDA announced the filing of a food additive petition submitted by the Spoonbill Foundation, proposing to amend food additive regulations to permit the safe use of 4′-phosphopantetheine (4′-PPT) as a nutrient in medical food. More information can be found <a href="https://www.federalregister.gov/documents/2025/07/29/2025-14339/spoonbill-foundation-filing-of-food-additive-petition">here</a>.

FDA Announces 2026 User Fees for FSMA Programs

July 30: The FDA announced user fees for Fiscal Year 2026 (FY2026) for several programs operating under the Food Safety Modernization Act (FSMA). The fees cover three main areas: Third-Party Certification Program (TPP), Voluntary Qualified Importer Program (VQIP), and certain re-inspections of facilities and failures to comply with recall orders. The fees are applicable from October 1, 2025, to September 30, 2026. More information about the TPP user fee can be found <a href="https://www.federalregister.gov/documents/2025/07/30/2025-14415/food-safety-modernization-act-third-party-certification-program-user-fee-rate-for-fiscal-year-2026">here</a>. More information about the VQIP user fee can be found <a href="https://www.federalregister.gov/documents/2025/07/30/2025-14407/food-safety-modernization-act-voluntary-qualified-importer-program-user-fee-rate-for-fiscal-year">here</a>. And more information about the re-inspection fees can be found <a href="https://www.federalregister.gov/documents/2025/07/30/2025-14414/food-safety-modernization-act-domestic-and-foreign-facility-reinspection-recall-and-importer">here</a>.

FDA Launches New Tool to Help Spot Harmful Food Chemicals

July 30: The FDA introduced a new tool called the Expanded Decision Tree (EDT) to help screen the safety of chemicals in food. This tool evaluates chemicals based on their structure and potential toxicity. It builds on the older Cramer Decision Tree method but offers more detailed and accurate assessments. The EDT is part of the FDA’s broader effort to modernize food safety and reduce reliance on animal testing. It will be used to review chemicals before and after they are used in food to keep the food supply safe. More information can be found <a href="https://www.fda.gov/food/hfp-constituent-updates/fda-releases-new-tool-toxicity-screening-chemicals-food">here</a>.

FDA Warning Letters

Unapproved Kratom Products: The FDA issued a warning letters to Thang Botanicals Inc. and Shaman Botanicals LLC for illegally marketing products containing 7-hydroxymitragynine (7-OH), a kratom-derived compound. The FDA cited multiple violations of the Federal Food, Drug, and Cosmetic Act, including the sale of adulterated dietary supplements and conventional foods such as gummies and kratom shots that contain 7-OH, which are not approved as a food additive or recognized as safe.

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Unapproved New Drugs: The FDA issued a warning letter to IndulgeRx Brands Inc. for marketing nut butter products, such as Bravezil Butter, Inspiration Butter, and Wellnut Butter, with claims that classify them as unapproved drugs. The FDA found that the company’s website and product labels included statements suggesting the butters could help fight cancer and other diseases, which violates the Federal Food, Drug, and Cosmetic Act.

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A database of warning letters can be found <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters">here</a>.

Justin Ransom Takes Over at FSIS Amid Budget Overhaul

July 11: Dr. Justin Ransom officially assumed leadership of the USDA’s Food Safety and Inspection Service (FSIS), bringing over two decades of industry experience to one of the most critical food safety roles in the nation. Although Ransom began his career at the USDA’s Agricultural Marketing Service, he comes from the private sector, having worked for companies such as Tyson Foods, McDonald’s, and OSI Group. As FSIS Administrator, Ransom will oversee a $1.5 billion budget and lead 8,300 employees responsible for inspecting meat, poultry, and egg products across 7,100 establishments. His appointment comes as FSIS faces significant budget shifts, including a proposed $8.8 million funding reduction for 2026, workforce streamlining, and a pay freeze. More information can be found <a href="https://www.foodsafetynews.com/2025/07/fsis-administrator-justin-ransom-takes-over-amid-changing-budget-strategies/">here</a>.

USDA Terminates Pandemic-Era Regional Food Program

July 15: U.S. Agriculture Secretary Brooke L. Rollins announced the termination of the Regional Food Business Centers (RFBC) program, a COVID-era initiative launched under the Biden administration to support small and mid-sized farms and food businesses. Funded through temporary congressional appropriations, the program sought to strengthen local food systems disrupted by the pandemic. Rollins criticized the program’s lack of long-term financial sustainability and said it conflicted with congressional intent. While USDA will honor over 450 existing grant commitments through May 2026, centers that have not yet issued Business Builder grants, including those in the Great Lakes Midwest, Southeast, Delta, and Islands and Remote Areas, will be shut down. Remaining funds will be redirected to other agricultural priorities. More information can be found <a href="https://www.usda.gov/about-usda/news/press-releases/2025/07/15/secretary-rollins-terminates-covid-era-program">here</a>.

USDA Appoints Interim Food Safety Head

July 29: While the Senate continues to delay confirmation of Mindy Brashears as USDA Under Secretary for Food Safety, the department has named Trey Forsyth as Acting Deputy. Forsyth, who recently became Chief of Staff for the Office of Food Safety, will lead the Food Safety and Inspection Service in the interim. More information can be found <a href="https://www.foodsafetynews.com/2025/07/acting-deputy-for-food-safety-named-by-usda-while-wait-for-brashears-confirmation-continues/">here</a>.

Other Articles of Interest

Beef Prices Hit Historic High Amid Cattle Shortage

July 1: Americans are paying more than ever for ground beef, with retail prices reaching a record $6.67 per pound, according to the American Farm Bureau Federation. The surge reflects a historically low U.S. cattle inventory, driven by drought conditions, rising feed costs, and concerns over the spread of New World screwworm infestations approaching the southern border. The USDA has suspended cattle imports from Mexico, a key supplier, further tightening supply. More information can be found <a href="https://www.wsj.com/finance/commodities-futures/your-july-4th-burgers-cost-more-than-ever-as-beef-prices-hit-record-339dfa71?mod=Searchresults_pos1&amp;page=1">here</a>.

U.S. Ice Cream Makers to Phase Out Artificial Dyes by 2028

July 14: Over 40 U.S. ice cream producers, representing more than 90% of the market, have committed to phasing out artificial food dyes from their products by 2028, according to the International Dairy Foods Association. The pledge includes eliminating synthetic colors such as Red 3, Red 40, Blue 1, Yellow 5, and others from frozen dairy products. This voluntary shift aligns with broader efforts led by Health Secretary Robert F. Kennedy Jr. to reduce synthetic dyes in the American food supply. Manufacturers are responding to growing consumer demand for cleaner labels and to avoid disruptions from state-level bans. More information can be found <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/many-us-ice-cream-producers-phase-out-artificial-food-dyes-by-2028-2025-07-14/">here</a>.

FSMA 204: Time is Running Out for Traceability Compliance

July 15: Most food manufacturers are behind on meeting FSMA Section 204’s traceability requirements, despite a proposed 30-month extension to the original January 2026 compliance deadline. The rule mandates rapid end-to-end tracking of ingredients across supply chains and 24-hour response times to FDA inquiries. Traceability is more than a compliance task. It enhances recall readiness, strengthens consumer trust, and creates long-term supply chain resilience. More information can be found <a href="https://foodindustryexecutive.com/2025/07/fsma-204-the-clock-is-ticking-and-most-food-manufacturers-are-already-behind/">here</a>.

Major Food Brands Pledge to Drop Artificial Dyes by 2027

July 15: Dozens of major food companies, including General Mills, Kraft Heinz, Nestlé, PepsiCo, ConAgra, McCormick, Sam’s Club, JM Smucker, In-N-Out, Hershey, and Tyson Foods, announced plans to eliminate artificial food dyes from their products by 2027. This move follows growing consumer demand and a federal push by Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary to phase out synthetic dyes such as Red 40, Yellow 5, and Blue 1 due to health concerns. In place of synthetic dyes, food makers can use natural alternatives made from beets and pigments from purple sweet potatoes, radishes and red cabbage. More information can be found <a href="https://thehill.com/homenews/nexstar_media_wire/5402053-which-companies-have-agreed-to-drop-artificial-food-dyes/">here</a>.

Kellogg Cereals to Eliminate Synthetic Dyes from Cereals by 2027

July 18: WK Kellogg Co. announced it will eliminate synthetic dyes from its cereals, including Froot Loops, Apple Jacks, and select Rice Krispies varieties, by the end of 2027, joining a growing number of other US companies that have committed to using cleaner ingredients. The move follows growing pressure from health advocates and government officials, including HHS Secretary Robert F. Kennedy Jr., who have linked artificial dyes like Red 40 and Yellow 5 to health concerns in children. Kellogg previously committed to removing these additives from school-served cereals by the 2026–2027 school year and will no longer launch new products containing them starting in 2026.

FDA Applauds Industry Move to Eliminate Artificial Dyes

July 22: The FDA and the Department of Health and Human Services applauded the Consumer Brands Association for pledging to remove artificial dyes from food products by the end of 2027. This includes dyes like Red No. 40 and Yellow No. 5, which are commonly used in packaged foods. The pledge also focuses on removing these dyes from school foods by the 2026–2027 school year. More information can be found <a href="https://www.hhs.gov/press-room/fda-praises-consumer-brands-pledge-to-remove-artificial-dyes.html">here</a>.

FDA Head Targets Food Dyes and Ultra-Processed Ingredients

July 27: In a recent interview, FDA Commissioner Martin Makary shared that the FDA is being lobbied by the Make America Healthy Again (MAHA) movement to crack down on food dyes and ultra-processed foods, while also facing calls from industry groups to reduce regulatory oversight. While committed to bold reforms, Makary favors an incremental approach and insists he feels no pressure from industry. He also highlighted upcoming priorities in a report on childhood chronic disease and touched on broader issues including women’s health, vaping among youth, and internal agency reforms. Listen to the interview <a href="https://www.politico.com/news/2025/07/27/fda-head-marty-makary-on-food-dyes-ultra-processed-foods-and-the-maha-agenda-00478151">here</a>.

Brewers Association Urges FDA to Exempt Alcohol from Front-of-Package Labels

July 28: The Brewers Association submitted comments to the FDA urging the agency to exempt beverage alcohol products from its proposed front-of-package (FOP) nutrition labeling rule. The association argues that most alcoholic beverages are regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB), not the FDA, and that applying FOP labeling to certain products like hard seltzers and low-alcohol wines could create confusion and unnecessary burdens for small brewers. The association also requested that kegged products be excluded and that any labeling changes be coordinated with TTB timelines to avoid regulatory overlap. More information can be found <a href="https://www.brewersassociation.org/government-affairs-updates/ba-submits-comments-on-front-of-package-nutrition-labeling/">here</a>.

Western Growers and FDA Unite to Strengthen Produce Safety

July 28: Western Growers signed a Memorandum of Understanding (MOU) with the FDA to advance proactive, science-based food safety standards across the fresh produce industry. Representing growers in California, Arizona, Colorado, and New Mexico, Western Growers will collaborate with the FDA through a data-sharing pilot project utilizing its proprietary GreenLink platform to identify contamination risks and promote preventive practices in produce growing, harvesting, packing, and transportation. The MOU also establishes a broader framework for ongoing data sharing between Western Growers and the FDA. More information can be found <a href="https://www.thepacker.com/news/industry/western-growers-signs-food-safety-memorandum-fda">here</a>.

Appeals Court Upholds Dismissal of Walmart “Raw Honey” Lawsuit

July 1: A federal appeals court affirmed the dismissal of a proposed class action against Walmart Inc., finding that the plaintiff undermined his own claim that the retailer deceptively marketed its honey as “raw.” The plaintiff, John Werymer, claimed Walmart advertised honey products as raw, but the products had elevated levels of 5-hydroxymethylfurfural (HMF), indicating the products had been heated. A judge for the U.S. Court of Appeals for the Seventh Circuit said the plaintiff’s reliance on elevated levels of HMF to prove the honey had been heated was flawed, as his own complaint acknowledged that HMF levels can also rise due to prolonged storage. The court found that the plaintiff’s contradictory allegations, suggesting both heat and storage as possible causes, rendered his claim implausible. The judge noted that the honey tested had been stored for at least ten months, and that the complaint failed to establish a reliable standard for HMF levels in raw honey. Ultimately, the court concluded that plaintiff’s own evidence supported the notion that Walmart’s honey was raw, and that consumers received what they paid for.

Tree Top Faces Class Action Over “100% Apple Juice” Labeling Claims

July 2: A proposed class action was filed in the U.S. District Court for the Northern District of California alleging that Tree Top Inc. deceptively labels its apple juice products as “100% apple juice” or made from “100% USA apples,” despite the inclusion of ascorbic acid which is a synthetic preservative. The complaint claims Tree Top misleads health-conscious consumers by marketing its juices as pure apple-based beverages while quietly disclosing the presence of ascorbic acid in fine print on ingredient panels. The plaintiff argues that Tree Top’s marketing violates FDA labeling requirements and California’s consumer protection laws, including the Consumer Legal Remedies Act, Unfair Competition Law, and False Advertising Law. The suit seeks class certification, damages, and restitution.

Judge Recommends Dismissal of “Made in USA” Labeling Suit Over French’s Mustard

July 14: A federal magistrate judge recommended dismissal of a proposed class action against McCormick &amp; Company Inc. that alleges McCormick deceptively claims its French’s mustard products are made in the USA. The suit, filed in the U.S. District Court for the Eastern District of California, alleged that labeling on French’s Dijon, honey Dijon, and yellow mustard, featuring phrases like “Crafted and Bottled in Springfield, Mo.” and “American Flavor in a Bottle”, was deceptive due to foreign-sourced ingredients such as mustard seed and turmeric. However, the judge found the plaintiff, Darnell McCoy, failed to adequately allege that the products exceeded California’s legal threshold for foreign content, which allows up to 5–10% under safe harbor provisions. The judge granted the plaintiff leave to amend his complaint.

Judge Dismisses PFAS Lawsuit Against Kos Inc.

July 15: A federal judge for the U.S. District Court for the Southern District of New York dismissed a lawsuit accusing Kos Inc. of misleading consumers into believing its plant-based protein powder was organic and free of harmful chemicals. The plaintiffs claimed the product contained PFAS chemicals linked to health risks but failed to provide sufficient evidence. The judge ruled that the complaint lacked key details about the testing process, including methodology, timing, and relevance to the actual products purchased. Without specific misrepresentations on the label or proof of diminished value, the court concluded that the plaintiffs “paid for and received protein powder.” The case was dismissed without prejudice, giving the plaintiffs until the end of August to file an amended complaint.

Judge Allows “Natural Ingredients” Lawsuit Against Chobani to Proceed

July 15: Chobani LLC will continue to face part of a proposed class action lawsuit over its Zero Sugar Greek yogurt. Judge Benjamin J. Cheeks of the U.S. District Court for the Southern District of California denied Chobani’s motion to dismiss allegations that the yogurt’s “only natural ingredients” label is deceptive. The complaint argues that stevia leaf extract and monk fruit extract used in the product undergo extensive manufacturing processes that a reasonable consumer wouldn’t consider natural. The court cited detailed descriptions of the 11-step transformation of stevia leaves and similar processing of monk fruit, concluding that the claims were sufficiently tied to the product to proceed. While the judge dismissed allegations related to artificial coloring, he allowed the claims related to manufactured ingredients to proceed and rejected Chobani’s arguments that the plaintiff failed to show injury or lacked standing.

Kellogg and Walmart Face Lawsuit Over Misleading Froot Loops Cereal Labeling

July 18: WK Kellogg Co. and Walmart Inc. are facing a proposed class action lawsuit over allegedly misleading labeling on Kellogg’s Froot Loops with Marshmallows. Filed in the U.S. District Court for the Eastern District of New York, the suit claims the cereal was advertised as containing “about 12 servings” per container, when independent testing showed it only holds 10. The complaint highlights discrepancies in the nutrition facts panel, arguing that the listed serving size mass was understated, potentially deceiving consumers. The plaintiff seeks damages and injunctive relief under New York’s consumer protection laws.

Hamburger Helper Wins Dismissal in ‘Real Cheese’ Label Lawsuit

July 18: The company behind Hamburger Helper, defeated a proposed class action alleging deceptive packaging claims about being made with “real cheese.” A judge for the US District Court for the Eastern District of California dismissed the case, finding that the label’s statement “Made with Real Cheese” was not misleading, as the product does contain real cheese, albeit 2% or less. The court ruled that reasonable consumers would not be misled, especially given the detailed ingredient list on the back of the box. The dismissal was issued without leave to amend, ending the suit.

Polar Beverages Dodges Class Action Over '100% Natural' Claim for Now

July 29: Polar Beverages has temporarily avoided a proposed class action lawsuit accusing the company of falsely advertising its “100% Natural” seltzers as free from synthetic ingredients. Judge Edward M. Chen of the U.S. District Court for the Northern District of California dismissed the suit, concluding that the complaint did not identify which flavors of seltzers were tested or purchased. Although the complaint alleged the presence of synthetic compounds like ocimene quintoxide and terpineol, Chen noted that the mere identification of such ingredients, without linking them to specific products, does not meet legal pleading standards. The judge also struck class allegations due to unresolved differences in state laws and found the unjust enrichment claims lacking. However, he allowed the plaintiffs to amend their complaint by September 22, given their assertions of future harm tied to misleading labeling.

Rows of clear plastic water bottles with blue caps on a production line in a beverage manufacturing facility.

Food & Beverage Regulatory Update – July 2025

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