The U.S. Food and Drug Administration (FDA) has issued warning letters to five online companies accused of selling unapproved drugs, including popular weight-loss treatments, the agency said.
The letters, sent on 24 August, were addressed to Peak Performance Peptides, Royal Peptides LLC, NuScience Peptides LLC, Peptide Partners LLC, and TXP Innovations LLC, which operates as Tex Peptides. The companies have been given 15 days to respond or face possible legal action.
The FDA said the websites were offering substances such as semaglutide, tirzepatide, and retatrutide. These drugs are typically used or studied for diabetes and weight loss but require regulatory approval before being marketed.
According to the agency, the companies attempted to avoid regulation by labelling the products as “for research use only” or “not for human consumption”. However, the FDA said evidence from the websites showed the products were intended for use by people.
“Despite statements on your product labelling… evidence obtained from your website establishes that your products are intended to be drugs for human use,” the agency wrote in its letters.
The FDA warned that failure to correct the violations could result in enforcement action, including product seizures or court injunctions.
The move is part of a wider crackdown on unapproved GLP-1 drugs and similar products. Earlier this year, the regulator sent around 30 warning letters to companies linked to compounded versions of these medicines, often sold through telehealth platforms.
The agency has also updated its public guidance, highlighting safety concerns about multi-dose vials and the risks linked to unregulated products sold online.
GLP-1-based treatments have grown rapidly in popularity worldwide due to their effectiveness in managing blood sugar and aiding weight loss. However, officials warn that counterfeit or unapproved versions may pose serious health risks due to uncertain quality, dosing, and safety standards.
The five companies now face a deadline in early September to respond to the FDA’s concerns. Failure to do so could lead to further regulatory or legal action.