FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s

The FDA has sent warning letters to 30 telehealth companies for making false claims about compounded GLP-1 products on their websites.

The move is part of a broader enforcement effort targeting misleading pharmaceutical advertising. 

The FDA said primary violations communicated in the letters included claims suggesting equivalence with FDA-approved products and misleading branding practices.

Telehealth companies that received FDA warnings over their marketing of compounded GLP-1 products include Kin Meds, GoodGirlRx, WeightCare and PharmaZee.

Telehealth company Hims & Hers took to X to announce that it was not in the group of 30 companies that had received a letter.

FDA Commissioner Marty Makary emphasized the agency’s focus on preventing companies from bypassing the FDA’s approval process through mass marketing of compounded drugs.

“It’s a new era. We are paying close attention to misleading claims being made by telehealth and pharma companies across all media platforms, and taking swift action,” said FDA Commissioner Marty Makary, MD, MPH. “Compounded drugs can be important for overcoming shortages or meeting unique patient needs, but compounders should not try to compound drugs in a way that circumvents the FDA’s approval process.”

Related: Prescription for Change: DTC Pharma Advertising Could Face Major Crackdown

This marks the second wave of warnings since the Trump administration’s crackdown on misleading direct-to-consumer (DTC) pharmaceutical ads in September 2025.

The FDA has given the company 15 business days to respond to the letters, in which they must include the steps they will take to rectify the violations.

Given the current supply landscape for GLP-1 therapies, compounded versions of drugs such as tirzepatide and semaglutide are intended to be prepared on a patient-specific basis pursuant to a valid prescription. When the branded products are no longer in shortage, compounding pharmacies are prohibited from mass-marketing compounded alternatives.

Compounded drugs, unlike generics, are not FDA-approved, meaning their safety and effectiveness are not reviewed by the agency.

According to reporting by The Hill, in one letter, FDA Deputy Director of Compliance Matt Lash wrote:

“Compounded drug products are not FDA-approved. Your claims imply that your products have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not. As a result, these claims are false or misleading and your products are therefore misbranded.”

The FDA directed the company to submit a written response outlining how it will correct the violations and prevent them from recurring. Recommended corrective actions could include identifying the facilities compounding the GLP-1 products, providing sample product labeling and revising or removing the misleading claims cited on its platform.

Although shortages of brand-name GLP-1 therapies, such as Novo Nordisk’s semaglutide products Ozempic and Wegovy and Eli Lilly’s tirzepatide offerings Zepbound and Mounjaro, have officially been resolved, some telehealth firms, including Hims & Hers, have continued offering compounded versions. 

However, the company has said it is no longer mass-marketing the drugs but instead helping patients “access care personalized to their needs.”

Hims & Hers marketing of its compounded GLP-1 drugs has included TV advertising during high-profile events such as the Super Bowl.

In February, the FDA cited Hims & Hers in an announcement about cracking down on non-approved GLP-1 drugs, including the company’s $49 compounded weight loss pill. The agency said it intends to take steps to “restrict GLP-1 active pharmaceutical ingredients (APIs) intended for use in non-FDA-approved compounded drugs that are being mass-marketed by companies, including Hims & Hers and other compounding pharmacies, as similar alternatives to FDA-approved drugs.”

This led Hims & Hers to halt sales of certain, lower-cost, non-FDA-approved, copycat versions of drugs like Wegovy and Ozempic. The FDA and Novo Nordisk argue these, and similar, products are misbranded and violate patent law. 

The Department of Health and Human Services (HHS) flagged Hims & Hers for potential criminal violations, referring it to the Department of Justice.

In recent months, the FDA has intensified its regulatory actions. In January, the agency issued warnings to several telehealth companies for similar misleading practices. 

Additionally, the HHS and FDA announced new guidelines last year aimed at improving transparency in pharmaceutical advertising. Finalized in September 2025, the new reforms now require drug companies to include full safety warnings during their DTC ads.

The companies have been given 15 working days to respond in writing and outline steps to correct the violations.