Little Health Law Blog
Our healthcare and business law firm advises many medical practices, telehealth companies, and providers on compliantly offering weight management services, including GLP-1 medications. On February 20, 2026, the Food and Drug Administration (“FDA”) issued warning letters to numerous companies offering compounded GLP-1 medications—specifically compounded semaglutide and tirzepatide. This post summarizes the FDA’s warning letter actions and outlines the top concerns the FDA has identified regarding how companies are marketing and labeling compounded GLP-1 products. If you would like to discuss GLP-1 compliance matters or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.
(1) Background: FDA Warning Letters on Compounded GLP-1s
GLP-1 medications such as semaglutide (the active ingredient in Ozempic® and Wegovy®) and tirzepatide (the active ingredient in Mounjaro® and Zepbound®) have become among the most prescribed drugs in the United States. Given high demand and prior drug shortages, a large market for compounded versions of these drugs developed. As the FDA resolved shortage designations for these drugs, it began more actively scrutinizing how compounders and telehealth platforms were marketing their compounded GLP-1 products.
On February 20, 2026, the FDA’s Center for Drug Evaluation and Research (CDER) issued a wave of warning letters to companies offering compounded semaglutide and tirzepatide products. Three of those letters—sent to Lean Rx, Inc. dba SkinnyRx, Strut Health, LLC dba Strut, and Newman Clinic, PLLC—are representative examples of the FDA’s enforcement focus. Each letter was issued by the Acting Director of the Office of Compounding Quality and Compliance and identifies violations of the Federal Food, Drug, and Cosmetic Act (“FDCA”). The letters demand written responses within fifteen (15) working days and warn that failure to comply may result in legal action, including seizure and injunction.
(2) The FDA’s Top Concerns
Reviewing these warning letters, the FDA’s enforcement concerns fall into two principal categories.
A. Misbranding Through False or Misleading Labeling—Incorrectly Identifying the Compounder
Under section 502(a) of the FDCA [21 U.S.C. § 352(a)], a drug is misbranded if its labeling is false or misleading in any particular. Under section 502(bb) of the FDCA [21 U.S.C. § 352(bb)], a compounded drug is misbranded if its advertising or promotion is false or misleading in any particular.
In many of the warning letters, including the three linked above, the FDA found that the company’s website depicted product labels bearing the company’s own name—“SkinnyRx,” “Strut,” or “Newman Clinic”—when in fact that company was not the actual compounder of the drug. Under 21 CFR § 201.1(h)(2), placing a name on a drug label without qualification represents that the named entity is the sole manufacturer. When that is not the case, the label is false or misleading, and the product is misbranded. Companies that are marketing or reselling compounded GLP-1 products without being the licensed compounder must be mindful of how their name appears on product labels and advertising.
B. Misbranding Through Claims That Imply FDA Approval
The second major concern in each letter involves website marketing language that implies a compounded product has been FDA-approved or is equivalent to an FDA-approved drug. Compounded drug products are not FDA-approved. The FDA identified the following types of claims as false or misleading:
- “From the same family as GLP-1 treatments like Mounjaro® and Zepbound®” (SkinnyRx)
- “Get access to the same active ingredient as name-brand GLP-1 medications” (SkinnyRx)
- “Generic Zepbound, Mounjaro” (Strut)
- “Same Ingredient as Ozempic® and Wegovy®” (Newman Clinic)
The FDA’s position is that these types of claims mislead consumers into believing the compounded product has undergone the same approval process as the brand-name drug. Referring to a compounded product as a “generic” is particularly problematic, as FDA-approved generic drugs are not the same as compounded drugs. With an FDA-approved generic drugs, the manufacturer must demonstrate to the FDA that the generic is bioequivalent to the brand-name drug. Compounded drugs are patient-specific drugs that are not specifically FDA approved.
If you offer compounded GLP-1s, it is important to review your marketing materials to ensure compliance, particularly following the FDA’s recent wave of warning letters. If you would like to discuss GLP-1 compliance matters, compounding regulations, or telehealth practice issues, or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.