AWG Regulatory Roundup — April 7, 2026
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- A New Free Webinar
- Recording Available for FDA’s March 27 Dietary Supplements Meeting
- FDA Extends Comment Period on Gluten RFI
- FDA Releases Draft Guidance on Alternatives to Animal Testing in Drug Development
- FDA to Hold a Public Meeting on Increasing Access to OTC Drugs
- Industry Groups Challenge California Recyclability Law
- Texas Finalizes Food Warning Rule
- California Legislator Aims to Create Seal for Non-Ultraprocessed Foods
- Bill Filed to Exclude Dietary Supplements from California’s Date Labeling Law
- Class Action Trends: Cosmetics
A New Free Webinar
Register Today to Attend FROM CONCEPT TO CLINIC: The Realities of Planning and Running Medical Device Clinical Studies In the U.S.
This hour-long, no-cost program on April 28, 2026 will address key considerations for planning and running a medical device clinical study in the U.S. Neil O’Flaherty, Partner, Amin Wasserman Gurnani, and Robin McIntosh, Founder, McIntosh Clinical Consulting, will walk attendees through the most important clinical, regulatory, and operational considerations, explain common misconceptions, and highlight decisions that are difficult—or impossible—to fix later. While the focus is on medical devices, many of the concepts apply to clinical studies of dietary supplements, cosmetics, and other product categories.
Learn more and register here.
Recording Available for FDA’s March 27 Dietary Supplements Meeting
If you missed FDA’s Public Meeting on Dietary Supplement Innovation and the Scope of Dietary Ingredients (or want to watch it again), the recording of the March 27, 2026 meeting is now available. You can also hear comments and remarks from AWG’s Bob Durkin and Ivan Wasserman. Those wishing to provide additional input may also submit comments through the official public docket, and please reach out if you’d like AWG to assist with comments.
FDA Extends Comment Period on Gluten RFI
FDA published a notice extending the comment period for its Request for Information on Labeling and Preventing Cross-Contact of Gluten for Packaged Foods. The original comment deadline of March 23, 2026 has been extended to April 22, 2026.
FDA Releases Draft Guidance on Alternatives to Animal Testing in Drug Development
On March 18, 2026, FDA issued a draft guidance titled “General Considerations for the Use of New Approach Methodologies (NAMs) in Drug Development,” which describes the Center for Drug Evaluation and Research’s (CDER’s) general approach to assessing the reliability and “fit-for-purpose” validation of new, non-animal testing methods to support the safety of over-the-counter drugs and other drug applications. While the guidance is specific to drugs, it is a key part of FDA’s roadmap to reducing animal testing and may serve as a model for cosmetics and dietary supplements. Under MoCRA, FDA is required to identify and promote alternatives to animal testing, and the agency is increasingly pointing to non-animal testing methods to assess the toxicology of new dietary ingredients (NDIs). Comments on the guidance will be accepted through May 18, 2026.
FDA to Hold a Public Meeting on Increasing Access to OTC Drugs
On April 23, 2026, FDA will hold a public meeting and comment period on “Increasing Access to Nonprescription Drugs.” The meeting will convene experts to discuss perspectives and practical considerations on expanding access to nonprescription (OTC) drugs, including drug developers, healthcare professionals, and consumers. Meeting topics will include:
- Specific diseases or conditions that have not been treated with nonprescription drugs for which nonprescription drugs could be safely and effectively used;
- Challenges industry may face in developing such nonprescription drugs;
- Opportunities to improve access; and
- Opportunities for stakeholder collaboration to increase cost-effective access to safe and effective nonprescription drugs.
Industry Groups Challenge California Recyclability Law
In the Southern District of California, a group of industry organizations, including the California League of Food Producers, the California Growers Association, and Californians for Affordable Packaging, filed a complaint challenging Senate Bill 343 and seeking a preliminary injunction. Effective October 4, 2026, this law restricts the use of “recyclable” and similar terms, as well as the “chasing arrows” symbol on packaging, if the packaging does not meet certain recyclable criteria. The plaintiffs argue that the law is unconstitutionally vague and violates the First Amendment because it restricts truthful, non-misleading commercial speech.
Texas Finalizes Food Warning Rule
The Texas Department of State Health Services published a final rule implementing Senate Bill 25, which requires a warning statement on food labels containing any of 44 listed ingredients, as well as on online listings of foods within its purview. The rule includes broad exemptions, including for food labeled, prepared, served, or sold at a restaurant; food labeled, prepared, or served in a retail food establishment; products regulated by FSIS/USDA; and dietary supplements.
As previously reported, the law and the newly finalized rule are currently unenforceable against four trade associations and their members, who filed a lawsuit challenging the constitutionality of the law, resulting in a preliminary injunction blocking enforcement of the warning requirement.
California Legislator Aims to Create Seal for Non-Ultraprocessed Foods
California Assembly Bill 2244, introduced by Assemblymember Jesse Gabriel, would create a voluntary “Certified California” program for foods that are not “ultraprocessed food,” “ultraprocessed food of concern”, or a “restricted school food,” as defined under Assembly Bill 1264, which was enacted in October 2025. “Ultraprocessed food” includes a food that contains one of many listed ingredients (e.g., certain stabilizers, thickeners, color additives, emulsifiers, flavors, and nonnutritive sweeteners) or that contains high amounts of saturated fat, sodium, or added sugar. Foods that qualify would be allowed to bear a “Certified California” seal, and the bill would also require the creation of a website that lists all currently certified products.
Bill Filed to Exclude Dietary Supplements from California’s Date Labeling Law
Earlier this month, the California Assembly Agriculture Committee introduced Assembly Bill 2779 to amend Section 82001 of the Food and Agricultural Code, which, beginning July 1, 2026, requires food manufacturers to include a “Best if Used By” or “Use By” date on products. The proposed amendment clarifies that the law does not apply to dietary supplements.
Class Action Trends: Cosmetics
- Cosmetic companies are facing a flood of lawsuits and demand letters alleging that “hypoallergenic” and “sensitive skin” claims are false or misleading because their products list “fragrance” as an ingredient – regardless of the specific type or amount of “fragrance” used in a particular product.
- The plaintiffs’ bar still has its sights set on advertising that goes beyond claims of improvements in appearance and “look,” asserting that products making such claims change the structure or function of the human body and are therefore “unapproved new drugs.”
- Disputes over “natural” or “naturally derived” marketing claims are ongoing, even when back label statements have attempted to define these terms.
Where We’ll Be
Please say hello or reach out to schedule a meeting!
Rend Al-Mondhiry and Ivan Wasserman, SupplySide Connect, April 14-15, 2026
Rebecca Lee, Food Protein Summit, April 15-16, 2026
Evan Phelps, Medical Device Manufacturers Association Annual Meeting, April 29-May 1, 2026
Ryan Kaiser and Ashley Rovner-Watson, International Trademark Association Annual Meeting, May 2-6, 2026
