The United States Food and Drug Administration (FDA) recently reviewed your websites (listed in the table located at the bottom of this letter and in the attachment) and has determined that your websites offer products for sale in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). More specifically, the websites listed below offer unapproved and misbranded new drugs for sale in violation of sections 301(a), 301(d), 502(f), 503(b)(1), and 505(a) of the FD&C Act [21 U.S.C. §§ 331(a), 331(d), 352(f), 353(b)(1), 355(a)]. We request that you immediately cease marketing violative drug products to United States consumers.
Unapproved New Drugs
As labeled, certain products you offer for sale through your websites are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These products, as marketed through your websites, are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. Based upon our information, no approved applications pursuant to section 505 of the FD&C Act [21 U.S.C. § 355] are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 505(a) and 301(d) of the FD&C Act [21 U.S.C. §§ 355(a) and 331(d)].
As two examples, your firm offers for sale through your websites “Levitra Super Force” and “Viagra Super Force,” which contain the brand names of FDA-approved drugs ( “Levitra” and “Viagra”). Your websites claim that Levitra Super Force and Viagra Super Force are “for the treatment of male impotence and premature ejaculation” and “for the treatment of male sexual problems,” respectively, both of which are intended uses to treat disease and, as such, are subject to section 505 of the FD&C Act [21 U.S.C. § 355]. In addition, Levitra Super Force and Viagra Super Force include dapoxetine, an active ingredient that is not the subject of an FDA-approved application. These two drugs your firm offers for sale without approved applications are in violation of section 505 of the FD&C Act [21 U.S.C. § 355]. Accordingly, their introduction or delivery for introduction into interstate commerce violates section 301(d) of the FD&C Act [21 U.S.C. § 331(d)].