On December 17, the U.S. Food and Drug Administration (FDA) issued Warning Letters to five companies offering various GLP-1 products, including Semaglutide, Tirzepatide, Retatrutide, Cagrilintide, Mazdutide, Survodutide, and Sermorelin. Based on FDA’s review of therapeutic claims made on websites and social media platforms, the FDA determined that these products are unapproved new drugs. The FDA stated in their Warning Letters that these products have been introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d).
The FDA noted that although labeling indicates the products are “for research use only and not for human consumption or clinical use,” information and testimonials presented on websites and in social media establishes that the products are intended to be drugs for human use. The FDA also stated in another Warning Letter that the products were misbranded as there were claims that the products were FDA-approved, when in fact, they were not.
What comes next? As with any Warning Letter, the FDA notifies the company of its concerns and provides the company an opportunity to address them. The FDA also notes that failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction. Companies have 15 business days from the receipt of a Warning Letter to respond in writing to the FDA, detailing the specific steps taken to correct any violations and to prevent their recurrence. Companies can also submit their reasoning and supporting information if they believe that the products do not violate the FD&C Act.
How is this action significant? This is the first time we have seen FDA Warning Letters for GLP-1s labeled “for research use only and not for human consumption or clinical use.” However, it appears that the therapeutic claims made on the websites and social media for these products were most likely the reason that the FDA issued Warning Letters to the five companies. Companies may wish to pay special attention to any claims made in social media.
We have been blogging about the compounding of GLP-1s, FDA’s removal of Tirzepatide from the drug shortage list, the October 8, 2024 lawsuit against FDA by the Outsourcing Facilities Association (OFA) – a trade association representing FDA-registered 503B outsourcing facilities relating to the agency’s removal of tirzepatide, from the FDA’s drug shortage list. We expect a report on the status of this lawsuit on December 19 and will provide another update. Foley will continue to monitor developments on the compounding of GLP-1s.
Want To Learn More? See our prior blogs.
- GLP-1 Drugs: FDA Removes Lilly’s Zepbound® and Mounjaro® (tirzepatide injection) from its Drug Shortage List
- GLP-1 Drugs: FDA Sued Over Removing Tirzepatide from the Drug Shortage List
- GLP-1 Drugs: Brand Companies Push FDA to Limit Compounding
Foley is here to help you address the short and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your Foley relationship partner, or to our Health Care Practice Group and Health Care & Life Sciences Sector with any questions.
