AWG Regulatory Roundup — April 8, 2025
Subscribe here!
- Texas Senate Votes to Require Warning Labels on Manufactured Food
- Massive Layoffs at FDA following HHS “Transformation”
- Senate Votes to Confirm Marty Makary
- Baseball Season is Here, and We Have Our First Strikeout
- Environmental Impact Claims Targeted in Complaint
- Hemp Happenings™ + California Corner
Texas Senate Votes to Require Warning Labels on Manufactured Food
On March 12, 2025, the Texas Senate passed Senate Bill 25 which, if passed in the Texas House of Representatives and signed into law, will require food manufacturers to include a warning label on packaged foods if the food contains any of the 50 ingredients listed in the bill. These ingredients include numbered food dyes such as Blue No. 1 and Red No. 40, potassium bromate, and titanium dioxide. The bill will also require nutrition education for students in Texas high schools and institutions of higher learning, as well as updated nutrition training for all Texas physicians, medical residents, nurses, physician assistants, and medical students. Additionally, S.B. 25 will establish the Texas Nutrition Advisory Committee to develop nutritional guidelines with a focus on metabolic health, functional medicine, and chronic disease.
Massive Layoffs at FDA following HHS “Transformation”
On March 27, 2025, the Department of Health and Human Services (HHS) announced what it calls “a dramatic restructuring in accordance with President Trump’s Executive Order, ‘Implementing the President’s ‘Department of Government Efficiency’ Workforce Optimization Initiative,’” also known as DOGE. The restructuring includes a reduction in workforce from 82,000 to 62,000 full-time employees, consolidation of “redundant” units into divisions to include a new “Administration for a Healthy America” (AHA), and implementation of HHS’ priority focused on ending chronic illness through “safe, healthy” food and reducing environmental toxins. A fact sheet prepared by HHS provides additional information on the restructuring.
Following the announcement, several news sources (see here and here) reported that as many as 10,000 staffers across HHS, including top officials at FDA, received reduction in force (RIF) notices. In total, FDA is expected to lose about 3,500 employees.
Senate Votes to Confirm Marty Makary
On March 25, 2025, the United States Senate voted 56 to 44 to confirm Dr. Martin “Marty” Makary as the 27th FDA Commissioner. Before his confirmation, Dr. Makary was a surgeon at Johns Hopkins, where he founded the Johns Hopkins Center for Surgical Trials and Outcomes Research. He has also authored multiple books and peer-reviewed articles.
FDA Authorizes First At-Home STI Test for Women
FDA recently granted de novo authorization for the Visby Medical Women’s Sexual Health Test, which is a milestone in women’s health in that it is the first diagnostic test for chlamydia, gonorrhea, and trichomoniasis that can be purchased without a prescription and performed entirely at home. The test addresses a critical need for discreet and accessible sexual health diagnostics, while also reducing the risk of serious health complications associated with untreated sexually transmitted infections (STIs).
Baseball Season is Here, and We Have Our First Strikeout
Despite legislative limitations imposed by the Commerce Clause, FDA has been seeking to establish its jurisdiction over Laboratory Developed Tests (LDTs) since 1997, when it asserted that laboratories performing such tests were medical device manufacturers. In 2014, the agency attempted to clarify its position by issuing guidance stating that the FDA had jurisdiction and intended to end its “enforcement discretion” over these products. At that point, Congress stepped in to tell FDA to cease such efforts. Most recently, FDA tried again when it promulgated a rule in 2024 to regulate LDTs. Predictably, its efforts were challenged in court, and, on March 31, 2025, the U.S. District Court for the Eastern District of Texas ordered the final rule to be vacated and set aside in its entirety.
Hat tip to our friends at Hyman, Phelps, McNamara, P.C. for a job well done.
Environmental Impact Claims Targeted in Complaint
A complaint filed in the Western District of Washington alleges Amazon, Inc. makes deceptive claims about its commitment to environmental responsibility and sustainability in violation state consumer protection laws (and inconsistent with the FTC’s Green Guides), including through the use of the Forest Stewardship Council, Sustainability Leaf, and Climate Pledge Friendly logos on its point-of-sale website for its Amazon Basics Paper Products. Plaintiffs accuse Amazon of “greenwashing,” alleging that the company fails to disclose that the products are sourced from harvests that rely on harmful logging practices, such as clearcutting and burning of Canada’s boreal forests.
This case serves as a reminder that the use of a seal or logo, or third-party certification associated with the use of a seal or logo, does not eliminate the need for substantiation to support all claims reasonably communicated by the seal or logo.
Hemp Happenings™ + California Corner
On April 4, 2025, the California Department of Public Health (CDPH) issued a Notice of Informal Stakeholder Engagement inviting stakeholders to participate in the development of CDPH’s proposed Industrial Hemp regulations, prior to the start of the formal promulgation process. Specifically, CDPH is requesting information on the following questions related to serving size and age requirements for hemp products:
- What issues or concerns should the Department be aware of in establishing regulations for serving size? If you have any studies or data the Department should consider, please provide citations, links to studies, etc.
- What other issues or concerns should the Department be aware of in establishing regulations for an age requirement? If you have any studies or data the Department should consider, please provide citations, links to studies, etc.
Written comments must be received by April 18, 2025 and may be submitted as follows:
- By email to: [email protected]. Please include the identifier “Industrial Hemp Regulations” in the subject line of the email.
- By fax transmission to (916) 650-6650.
- By postal service to CDPH Food & Drug Branch, MS 7602, P.O. Box 997435, Sacramento, CA 95899.
