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Is my product really a cosmetic under the law?
Persons requesting a cosmetic certificate have the responsibility to ensure that their products are cosmetics as defined under U.S. law. Make sure your product meets the legal definition of a cosmetic before you request a cosmetic certificate. Do not request a cosmetic certificate for a product regulated as a drug or medical device in the U.S. See "What if my product is a drug or medical device?" below concerning drug or device certificates. The terms "drug," "device," and "cosmetic" are defined in the Federal Food, Drug, and Cosmetic Act (FD&C Act) (Sections 201 (g), (h) and (i)): The term "drug" includes articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals and articles (other than foods and dietary supplements) intended to affect the structure or any function of the body.
The term "device" includes an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body, and which does not achieve its primary intended purposes through chemical action within or on the body and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term "cosmetic" means articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and articles intended for use as a component of any such articles; except that such term shall not include soap (soap is defined in the Code of Federal Regulations at 21 CFR 701.20. Generally speaking, the intended use of a product is determined by claims made on the product label, in collateral labeling, and in other promotional materials such as advertising. Information on the company's Internet site is also considered when evaluating intended use. Specific and implied drug or device claims are not appropriate for products marketed solely as cosmetics. Some examples of intended use that may cause a product to be regulated as a drug are claims for sun protection, including use of a sun protection factor (SPF) rating; prevention and treatment of dandruff or acne; hair restoration; skin bleaching; immune and circulatory system improvement; and skin lesion healing. For more information on determining whether your product is a cosmetic or a drug, refer to our Web page article, Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?). Sometimes you may need to request certificates from different FDA Centers for different items of the same kit you wish to export. An example of this would be a dental kit that includes an anticaries toothpaste (drug), a mouthwash for cleansing and fresh breath (cosmetic), and a toothbrush and dental floss (devices).
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
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