The product label and your website, from which this product may be ordered, represent this product as a dietary supplement. However, the product cannot be a dietary supplement because the active ingredient used in the product,----------, is not a vitamin, mineral,amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake, nor is it a concentrate, metabolite, constituent, extract or combination of any dietary ingredient described above. Rather, it is a synthetic steroid. Consequently, ---------------- is not a "dietary ingredient" as defined in Section 201(ff) (1) of the Federal Food, Drug and Cosmetic Act (the Act) [21 USC 321(ff)(1)], and your product is not a dietary supplement because it does not contain a dietary ingredient.
Under Section 201(g)(1)(C) of the Act [21 USC 321(g)(1)(C)], products that are intended to affect the structure or function of the body are defined as drugs. The description of your product as "anabolic" on your product label and website, together with the other claims quoted above, establish that your product is intended to affect the structure or function of the body by building muscle, increasing strength, and inducing weight gain. Based on these claims, FDA considers ---------------- to be a drug.
Moreover, your product is also a new drug under Section 201(p) of the Act [21 USC 321(p)] because this product is not generally recognized as safe and effective for the uses claimed in its labeling. Under Section 505(a) of the Act [21 USC 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved new drug application (NDA) is in effect for it. Because your product is not the subject of an approved NDA, it may not be marketed in the United States and its continued distribution violates Section 505(a) of the Act. Section 301(d) of the Act [21 USC 331(d)] prohibits the introduction or delivery for introduction into interstate commerce of any article in violation of Section 505.
You should also be aware that anabolic steroids may cause serious long-term adverse health consequences in men, women, and children. These include liver toxicity, testicular atrophy and male infertility, masculinization of women, breast enlargement in males, short stature in children, adverse effects on blood lipid levels, and a potential to increase the risk of heart attack and stroke.
The violations of the Act described above are not intended to be an all-inclusive list of violations concerning your firm and its products. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.