FDA to Telehealth Companies: What to Know When Promoting Compounded Drugs

FDA warns telehealth companies

FDA is concerned about telehealth companies promoting compounded drugs, including glucagon-like peptide-1 receptor agonists (GLP-1s) and other drugs, with false or misleading claims. This puts patients at risk as they cannot make an informed decision about their health based on false or misleading claims. It also violates federal law.

FDA has issued warning letters to telehealth companies regarding concerns on false or misleading claims. Use the search term “telehealth” in the warning letter database to find these warning letters.

FDA reminders for telehealth companies

The agency reminds telehealth companies not to market compounded GLP-1 drugs to consumers with false or misleading claims, including:

• using branding on their website that falsely or misleadingly implies the telehealth company is the compounder.
• describing a compounded drug as a generic version of an FDA-approved drug or the same as a drug approved by FDA. Generic drugs are approved by FDA prior to marketing, while a compounded drug is not approved by FDA.
• claiming a compounded drug has been FDA-approved or has otherwise been evaluated for safety and effectiveness when they are not. Compounded drugs are not reviewed by the agency for safety, effectiveness or quality prior to marketing.
• describing a compounded drug as clinically proven to produce the same result as the FDA-approved drug.
• claiming a compounded drug is sourced from an FDA-approved or FDA-licensed pharmacy or outsourcing facility. FDA does not approve or license any facility.

The agency remains vigilant in its oversight of promotional materials and will continue to take actions to help protect patients from false or misleading claims by telehealth companies.