AWG Regulatory Roundup — July 29, 2025
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- HHS, FDA, and USDA Seek to Define “Ultra-Processed Food”
- FDA Proposes to Eliminate 52 Standards of Identity for Foods
- FDA Accelerates Phase-Out of Petroleum-Based Synthetic Dyes
- FDA Commissioner Issues 100-Day Statement
- Click-to-Cancel is Canceled, For Now At Least
- Federal Legislation Introduced Requiring Reassessment of Food Chemicals and GRAS Reform
- Senate Proposes OMUFA Reauthorization
- Food & Supplement Litigation Trends: Plaintiffs Continue to Target Protein, “Artificial” Ingredients, and “Health Halos”
- The takeaways?
HHS, FDA, and USDA Seek to Define “Ultra-Processed Food”
As expected, HHS, FDA, and USDA are moving forward with efforts to define “ultra-processed food.” The agencies issued a joint Request for Information (RFI) on July 23, 2025, to gather data to help develop a national definition for ultra-processed foods. FDA’s news release notes that “a uniform federal definition will serve as a key deliverable on the heels of the recently published Make Our Children Healthy Again Assessment.” The agency estimates that approximately 70% of packaged foods in the U.S. may be considered “ultra-processed,” with children consuming the majority of their calories from such foods. The RFI seeks information on the factors and criteria that should be included in the definition. In tandem with these efforts, through the recently announced Nutrition Regulatory Science Program, FDA and the National Institutes of Health are investing in research to address questions about the health impacts of ultra-processed foods.
FDA Proposes to Eliminate 52 Standards of Identity for Foods
On July 16, 2025, FDA announced a Direct Final Rule and two Proposed Rules that will collectively eliminate 52 standards of identity for foods that the agency states are “obsolete and unnecessary.” Citing Executive Order 14192, Unleashing Prosperity Through Deregulation, the Direct Final Rule revokes 11 standards of identity for canned fruits and vegetables that FDA states are no longer sold in the U.S. One proposed rule aims to revoke the standards of identity for 18 processed dairy products such as sour cream, multiple cheeses, and goat’s milk ice cream, and the other would revoke the standards of identity for 23 products including bakery products, noodle products, canned fruit juices, shellfish, and vanilla flavorings. FDA notes that these standards may impede innovation and pose obstacles to providing consumers with “healthier choices.”
FDA Accelerates Phase-Out of Petroleum-Based Synthetic Dyes
On July 14, 2025, FDA granted a petition from the Gardenia Blue Interest Group allowing the use of gardenia (genipin) blue – a naturally sourced color – in certain foods, including sports drinks, flavored or enhanced non-carbonated water, fruit drinks and ades, ready-to-drink teas, hard candy, and soft candy. On the same day, FDA issued a statement encouraging companies to expedite their phase out of FD&C Red No. 3. Although the agency’s January 2025 final order revoking the authorization for Red No. 3 gives companies until January 15, 2027 to remove the ingredient from foods and dietary supplements, FDA is now encouraging companies to remove it “as soon as is practicably possible.”
FDA Commissioner Issues 100-Day Statement
FDA Commissioner Makary marked his hundredth day at the agency on July 10, 2025 by releasing a statement entitled “100 Days of Embracing Gold-Standard Science, Transparency and Common Sense.” Among other initiatives, the statement highlights FDA’s action to phase out petroleum-based synthetic food dyes from the U.S. food supply, improve infant formula, initiate a process to review food chemicals, GRAS reform, reduce animal testing for investigational new drug applications, expand the use of unannounced foreign inspections, and address the potential health risks associated with talc used in food, drugs and cosmetics.
Click-to-Cancel is Canceled, For Now At Least
On July 8, 2025, the Eighth Circuit Court of Appeals vacated the FTC’s “Click-to-Cancel” rule, which was set to go into effect on July 14, 2025. The rule applies to “negative option” programs, or recurring payment arrangements such as subscriptions and auto-renewals. It would have required companies to provide disclosures explaining the payment amount and frequency, obtain informed consent from consumers regarding recurring payments, and provide consumers with a simple and accessible way to cancel their recurring payments.
Although the FTC rule is vacated, as a reminder, companies must still be diligent with recurrent payment programs, as many states have requirements similar to those found in the now-vacated rule. FTC may also appeal the Eighth Circuit’s decision or reissue a modified proposal in the future.
Federal Legislation Introduced Requiring Reassessment of Food Chemicals and GRAS Reform
Two bills recently introduced in the House of Representatives and Senate seek to significantly overhaul FDA’s review of food and dietary supplement ingredients. First, Representatives Jan Schakowsky (D-IL) and Rosa DeLauro (D-CT) introduced the “Food Chemical Reassessment Act of 2025” (House Bill 4306), which would direct FDA’s Office of Food, Chemical Safety, Dietary Supplements, and Innovation to reassess the safety of at least 10 food substances (or food substance classes) once every three years beginning in 2026. If a substance is found to be unsafe, the agency would be required to make the assessment public and amend or revoke its approval of the substance. The bill also provides a suggested list of chemicals for initial assessment that includes titanium dioxide, petroleum-based food dyes, butylated hydroxyanisole, butylated hydroxytoluene, sodium benzoate, and sodium nitrite, among others.
Next, the “Ensuring Safe and Toxic-Free Foods Act,” introduced by Senators Ed Markey (D-MA) and Cory Booker (D-NJ), would overhaul FDA’s GRAS framework by requiring companies to submit GRAS notifications for all their currently self‑affirmed ingredients within two years. The bill also would amend the FD&C Act to automatically disqualify substances that are carcinogenic or that pose risk of reproductive or developmental toxicity, as defined in the bill. In addition, the bill includes provisions that prohibit those with conflicts of interest from serving as experts in reviewing GRAS designations, and similar to the H.B. 4306, would also require FDA to reassess the safety of at least 10 food substances or substance classes every three years, while also mandating that the agency review at least 50 GRAS notices per year until a full backlog is addressed.
Senate Proposes OMUFA Reauthorization
On July 15, 2025, Senators Jim Banks (R-IN) and Tim Kane (D-VA) introduced Senate Bill 2292, which would revise and extend FDA’s user fee program for OTC monograph drugs, thereby allowing the agency to continue collecting user fees from industry to support monograph system reforms, including safety reviews, administrative updates, and modernization efforts.
Food & Supplement Litigation Trends: Plaintiffs Continue to Target Protein, “Artificial” Ingredients, and “Health Halos”
It’s more of the same on the class action litigation front, with plaintiffs increasingly targeting foods and dietary supplements that allegedly overstate the amount of protein. Many of the threatened suits that we have seen cite the omission of a percent daily value (%DV) for protein in the nutrition labeling, or argue that the %DV is miscalculated based on the Protein Digestibility-Corrected Amino Acid Score (PDCAAS).
In a trend that just won’t go away, food companies continue to get hit over “no artificial flavors or preservatives” claims for products that contain citric acid, DL-malic acid, or similar substances that plaintiffs allege are artificial – regardless of the substance’s function in the product.
Another frequent (and long-standing) target is “health halos,” whereby plaintiffs argue that despite claims suggesting a product is “healthy,” “wholesome,” or “nutritious,” the presence of too much added sugar or other “unhealthy” attributes renders the claims misleading and deceptive. Highlighting a sought-after or premium ingredient that is present in only de minimis amounts also continues to get the attention of plaintiffs, who argue that such call-outs suggest to consumers the product contains more of the ingredient than it does – and in some cases, they are prepared with consumer testing to back it up.
The takeaways? Evaluate labeling carefully for all reasonably implied claims, not just those you intend to make, and don’t rely solely on FDA compliance when signing off on a product’s label or marketing.
