FDA WARNING_LETTER - Summit Research Peptides - December 10, 2024

On December 10, 2024, the FDA issued a Warning Letter to Summit Research Peptides after reviewing their website (https://summitpeptides.shop) in October 2024 and their social media (https://www.facebook.com/summitpeptides/). The FDA observed that Summit Research Peptides offers "Semaglutide," "Retatrutide," "Cagrilintide," "Tirzepatide," and "Mazdutide" for sale in the U.S.

Despite labeling these products as "RESEARCH USE ONLY," the FDA determined, based on website claims, that they are intended for human use as drugs. Examples of claims include "Sema is a GLP-1 analog with therapeutic applications in type 2 diabetes and obesity," "Reta presents a promising approach for obesity and diabetes treatment," and "Cagrilintide and Semaglutide...designed to help you achieve your health goals...Enhanced Weight Loss."

These products are considered "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 for their intended uses. Their introduction into interstate commerce without FDA-approved applications violates sections 301(d) and 505(a) of the FD&C Act, 21 U.