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A Warning Letter issued to University Medical Products USA, Inc. illustrates an important legal distinction, the difference between a cosmetic and a drug under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Warning Letter cited numerous drug claims associated with the company's topical skincare preparations, noted on both product labeling and the firm's Web site. Among these claims were increased collagen production; strengthening collagen and elastin fibers; cellulite reduction through cellular stimulation to release stored fat; weight reduction through appetite suppression, increased metabolism, and fat burning; and reduced water retention. These claims establish the products' intended use, namely, to affect the structure or function of the body, thus causing them to be drugs under Section 201(g) of the FD&C Act. Because these drugs are not generally recognized by qualified experts as safe and effective when used as labeled, they are new drugs under the section 201(p) of the FD&C Act and require an approved New Drug Application for legal marketing. The Warning Letter charges these products as unapproved new drugs in violation of Section 505(a) of the FD&C Act.
For related information, see Is It a Cosmetic, a Drug, or Both? (or Is It Soap?), "Cosmeceuticals", and Warning Letters and Responses.
