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Warning Letters issued by FDA to the manufacturer of a hair removal system (available in HTML and PDF) and the manufacturer of a microdermabrasion device (available in PDF) illustrate an important legal distinction -- the difference between the legal definitions of cosmetics and medical devices.
Although the devices cited in these Warning Letters are intended to affect a person's appearance, the fact that a product is used to diagnose or treat a medical condition or affect the structure or function of the body makes it a medical device, not a cosmetic, under the Federal Food, Drug, & Cosmetic Act (FD&C Act).
The FD&C Act requires medical device manufacturers to obtain marketing clearance for their products before offering them for sale [FD&C Act, section 501(f)(1)]. The law does not require clearance or approval to market cosmetic products or ingredients. (An exception is color additives, which are covered separately in section 721 of the FD&C Act.) In addition, medical devices are subject to the Quality System Regulation (21 CFR part 820). Cosmetics are not subject to this regulation.
This is how the FD&C Act defines a device:
The term ''device'' (except when used in paragraph (n) of this section and in sections 301(i), 403(f), 502(c), and 602(c)) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is - (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (2) 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 (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. [FD&C Act, section 201 (h)]
This is how the FD&C Act defines a cosmetic:
The term ''cosmetic'' means (1) 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 (2) articles intended for use as a component of any such articles; except that such term shall not include soap. [FD&C Act, section 201(i)]
For related information, see Is It a Cosmetic, a Drug, or Both? (or Is It Soap?), Cosmeceuticals, Soap, Warning Letters, and Medical Devices.
Warning Letter to Rejuvenu International Ltd.(available in HTML and PDF). August 16, 2004
Warning Letter to Biorem s.r.l. (available in PDF). December 14, 2001
