FDA issues warning letters to five unapproved GLP-1 websites
The home page for Peak Performance Peptides, one of the companies to receive an FDA letter.
The US FDA issued similar warning letters to five different online peptide vendors on 24th August, giving the companies 15 days to respond to accusations of selling unapproved new drugs.
Letters were sent by email to the proprietors of Peak Performance Peptides, Royal Peptides LLC, NuScience Peptides LLC, Peptide Partners LLC, and TXP Innovations LLC, doing business as Tex Peptides.
"This warning letter advises you of significant violations observed during a US Food and Drug Administration (FDA) review of your website," each letter began. "Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure, and injunction."
The websites in question offer some combination of semaglutide, tirzepatide, and retatrutide, along with other peptides that promise a variety of other therapeutic benefits. They include language that the drugs are "for research purposes only" or "not for human consumption", but the FDA explicitly said in a footnote of each letter that it's not buying it.
"Despite statements on your product labelling marketing your products 'for research use only' and 'not for human or veterinary use,' evidence obtained from your website establishes that your products are intended to be drugs for human use," the agency wrote.
The FDA's previous crackdown on GLP-1 compounders was aimed at telehealth companies that were selling compounded versions of the drug. The agency sent 30 letters to a slew of companies in March.
This latest move signals the agency is still serious about cracking down on counterfeit and unapproved GLP-1s and similar products. The publication of the letters also corresponded to an update to FDA's consumer fact sheet on the topic - the agency added a section about concerns with vials containing multiple doses.
The five companies have 15 days to respond as of 24th August, which means they could face regulatory or legal action as soon as Tuesday 8th September.
pharmaphorum has reached out to all five websites for comment and will update this story if they respond.
