FDA WARNING_LETTER - Pinnacle Professional Research dba Pinnacle Peptides - November 30, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Pinnacle Professional Research dba Pinnacle Peptides on December 12, 2025, following a website review in November 2025. The letter addresses the company"s sale of products marketed as Selective Androgen Receptor Modulators (SARMs), including "SARM’s S4 ANDARINE," "LGD-4033," and "MK-2866," in the United States.

The FDA determined these products are unapproved new drugs under the Federal Food, Drug, and Cosmetic Act. Despite labels stating "FOR RESEARCH ONLY" and "NOT FOR HUMAN USE," the agency found extensive evidence on the company’s website and product labeling indicating their intended use for human conditions such as improving fertility, treating various cancers, boosting muscle mass, addressing osteoporosis, accelerating bone healing, and improving insulin sensitivity. These claims establish the products as drugs intended to diagnose, treat, mitigate, cure, or prevent disease, or affect bodily functions.

Because these SARMs are not generally recognized as safe and effective for their promoted uses and lack required FDA approval, their introduction into interstate commerce is illegal. The FDA also highlighted significant safety concerns, including life-threatening liver toxicity and an increased risk of heart attack and stroke associated with SARMs.

Pinnacle Professional Research is required to respond within fifteen working days, outlining specific corrective actions taken to address the violations and prevent their recurrence. The company must provide supporting documentation or a justification if they believe their products comply with federal law.