Warning Letters Highlight Differences Between Cosmetics and Medical Devices
December 13, 2003; Updated August 8, 2008 and April 28, 2011
Warning Letters issued by FDA to the manufacturers and/or distributors of laser devices marketed for regrowing hair, treating acne, and promoting wound healing; a hair removal system; and a microdermabrasion device 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 they are intended to diagnose or treat a medical condition or affect the structure or function of the body makes them medical devices 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 medical device:
"...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:
"...(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)]
FDA regulates false eyelashes and artificial nails, for example, as cosmetics. The Consumer Product Safety Commission [http://www.cpsc.gov] has jurisdiction over many non-medical devices that people use to affect their appearance, such as manicure tools, hair dryers, cotton-tipped swabs, razors and electric shavers. 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 BNB Medical Co., Ltd. April 19, 2011
- Warning Letter to Refine USA, LLC April 18, 2011
- Warning Letter to Gaunitz Hair Sciences, LLC August 7, 2008
- Warning Letter to Sunetics International Corporation August 7, 2008
- Warning Letter to Rejuvenu International Ltd. August 16, 2004