FDA warns five online peptide vendors over 'research use only' sales
CDER letters cite tesamorelin, SS-31, PT-141 and incretins, saying website context outweighs RUO disclaimers in establishing human intended use.
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By Daniel Okafor · Regulatory Correspondent
Sep 18 01:00 ETSource: ArentFox Schiff
The wire
- 01On August 24 FDA's CDER issued warning letters to Peak Performance Peptides, Royal Peptides, NuScience Peptides, Peptide Partners and TXP Innovations (Tex Peptides), alleging unapproved new drug sales; each has 15 business days to respond.
- 02Products named go well beyond weight loss, covering semaglutide, tirzepatide, retatrutide, tesamorelin, SS-31/elamipretide, PT-141/bremelanotide, survodutide, mazdutide and bacteriostatic water bundled with injectables.
- 03FDA said it looks past labeling to the net impression of a site, citing dosing guidance, reconstitution calculators and bundled bacteriostatic water; law firm analysis notes this follows March and June letters to telehealth marketers.
From the source
Read at afslaw.comRUO-ined: Five Peptide Vendors Learn That ‘Research Use Only’ Is Not a Legal Strategy
The US Food and Drug Administration’s ( FDA ) enforcement machine does not take summer Fridays. On August 24, the agency’s Center for Drug Evaluation and Research ( CDER ) issued five Warning Letters to online peptide vendors.