Ageless Cure, LLC – FDA Warning Letter

The FDA issued a Warning Letter to Ageless Cures LLC and Atman Homes LLC after reviewing their website, www.agelesscures.com. The FDA determined that the products "Curcumin C3 Complex," "Super Curcumin C3 Complex? w/ Bioprerine," and "Super Curcumin C3 Complex? Eco Pack" are promoted for conditions that classify them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)].

The therapeutic claims on the website, such as "cancer curing properties," "prevent and treat cancer," and "interferes with melanoma cells," establish the products as drugs intended for the cure, mitigation, treatment, or prevention of disease. The website also cites numerous scientific articles concerning the use of curcumin for treating or preventing cancer and other diseases, which the FDA considers evidence of intended use under 21 CFR 101.93 (g)(2)(iv)(C).

Because these products are not generally recognized as safe and effective for these uses, they are considered "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs cannot be legally marketed in the U.S. without prior FDA approval. Additionally, the products