Pinnacle Professional Research dba Pinnacle Peptides Warning Letter Details

Summary

Pinnacle Professional Research dba Pinnacle Peptides was cited for illegally marketing unapproved new drugs, specifically selective androgen receptor modulators (SARMs) including S4 Andarine, LGD-4033, and MK-2866, in violation of sections 301(d) and 505(a) of the FD&C Act. Despite labeling these products "FOR RESEARCH ONLY" and "NOT FOR HUMAN USE," the FDA determined that website content and marketing materials provided evidence of intended human drug use, including claims related to disease treatment and body function modification. The FDA identified significant safety concerns with SARM products, noting that life-threatening reactions including liver toxicity had occurred in people taking these products, and that they pose potential risks for heart attack and stroke.