Peaks Curative, LLC dba Peaks Warning Letter Details

Summary

Peaks Curative was cited for misbranding compounded semaglutide products through false or misleading claims on its website, including labeling that falsely identified "Peak Now" as the compounder when it was not. The company violated FDA regulations by claiming its compounded semaglutide products were "FDA-approved" and making efficacy claims (such as promoting "safe, effective weight loss" and reducing up to 20% body weight) when compounded drugs cannot be FDA-approved. The FDA determined these representations on the website and product labeling violated sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act, resulting in misbranded products being introduced into interstate commerce.