Peptide Partners LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Based on a review of your website, “GLP-1 S (Semaglutide),” “GLP-2 T (Tirzepatide),” “GLP-3 Reta (Retatrutide),” “SS-31 (Elamipretide),” “Tesa Peptide (Tesamorelin),” “PT-141 (Bremelanotide),” and “Reconstitution Solution (BAC)” are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.

Passage 2

“GLP-1 S (Semaglutide),” “GLP-2 T (Tirzepatide),” “GLP-3 Reta (Retatrutide),” ”SS-31 (Elamipretide),” “Tesa Peptide (Tesamorelin),” “PT-141 (Bremelanotide),” and “Reconstitution Solution (BAC)” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling.