Law360 recently published Spencer Fane attorneys Beth Siemer and Kaleb Rasmussen’s article, What to Expect After FDA Warnings to GLP-1 Compounders.
The piece originated as a post on the firm’s Health Care Solutions blog and discusses recent U.S. Food and Drug Administration (FDA) activity that serves as part of a large crackdown on prescription drug advertising. Beth and Kaleb detailed warning letters the FDA sent to numerous online sellers of compounded versions of GLP-1 medications for type 2 diabetes and weight loss, analyzing what these actions mean for direct-to-consumer marketing for pharmaceuticals.
“With so little guidance from the FDA on what will be considered misleading in the context of compounded products, the enforcement outlook for advertising remains unclear,” the team said. “In any case, anyone continuing to sell compounded GLP-1 products should review their websites in light of the FDA’s enforcement position on advertising, and the content that was flagged in the letters that are now publicly available.”
At Spencer Fane, Beth and Kaleb advise individuals and organizations navigating complex state and federal laws that govern transactions, compliance, and reimbursement. Beth brings a unique combination of in-house and private practice experience to her business-centric and solution-oriented work. Kaleb is a part of the firm’s 2025 Fall Associate Class and brings a data-driven approach to both employee benefits and health care clients so they can make confident decisions amid risk.
Read the team’s full article here. Please note, a subscription may be required.