According to your product label, your product contains the ingredient Arimistane (Androsta-3,5-Diene-7,17-Dione). “Arimistane” is represented as a dietary supplement on its label and other labeling; however, the product does not meet the definition of a dietary supplement in section 201(ff) of the FD&C Act [21 U.S.C. § 321(ff)]. To be a dietary supplement, a product must, among other things, “bear or contain one or more dietary ingredients' as defined in section 201(ff)(1) of the FD&C Act [21 U.S.C.§ 321(ff)(1))]. Section 201(ff)(1) defines “dietary ingredient” as a vitamin; mineral; amino acid; herb or other botanical; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract or combination of any dietary ingredient from the preceding categories.
The “Arimistane” ingredient listed on your product label, Androsta-3,5-Diene-7,17-Dione, is an aromatase inhibitor and does not constitute a dietary ingredient under section 201(ff)(1) of the FD&C Act. The product label for your “Arimistane” does not declare any other ingredients. Therefore, because “Arimistane” does not bear or contain any dietary ingredients as defined in section 201(ff)(1) of the FD&C Act, the product is not a dietary supplement under section 201(ff) of the FD&C Act.