Summit Research Peptides

Selected passages from the FDA letter

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

Passage 1

your “Semaglutide” (or “Sema”), “Retatrutide” (or “Reta”), “Cagrilintide,” “Tirzepatide” (or “Tirz”), and “Mazdutide” products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d).

Passage 2

Despite statements on your product labeling marketing your products as “RESEARCH USE ONLY” and “INTENDED AS A RESEARCH CHEMICAL ONLY,” evidence obtained from your websites establish that your products are intended to be drugs for human use.

Passage 3

Your “Semaglutide” (or “Sema”), “Retatrutide” (or “Reta”), “Cagrilintide,” “Tirzepatide” (or “Tirz”), and “Mazdutide” products are not generally recognized as safe and effective for the above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).