Warning Letters Address Drug Claims Made for Products Marketed as Cosmetics
The Warning Letters appearing below illustrate an important legal distinction, the difference between a cosmetic and a drug under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Under the FD&C Act, a product intended to diagnose, mitigate, treat, or prevent disease, or to affect the structure or function of the body is classified as a drug (FD&C Act, Section 201(g)). If such a product is not generally recognized by qualified experts as safe and effective when used as labeled, it is a “new drug” (FD&C Act, Section 201(p)) and requires an approved New Drug Application to be marketed legally in the United States (FD&C Act, Section 505(a)). FDA issued Warning Letters to the following firms, citing drug claims associated with topical skin care, hair care, and eyelash/eyebrow preparations, noted on both product labeling and Web sites. Some examples of the drug claims cited are acne treatment, cellulite reduction, stretch mark reduction, wrinkle removal, dandruff treatment, hair restoration, and eyelash growth.
Warning Letter Addressing Eyelash and Eyebrow Treatments
- Lifetech Resources, LLC, April 18, 2011
Warning Letters Addressing Topical Skin Care Preparations
- Pharmagel International, May 22, 2015
- Skin Authority LLC, March 25, 2015
- Moy-Fincher Medical Group--DNA EGF Renewal, February 12, 2015
- StriVectin Operating Company February 12, 2015
- L’Oréal USA February 12, 2015
- Chaga Mountain, Inc., January 20, 2015
- Cell Vitals, November 24, 2014
- USA Far Ocean Group Inc., October 24, 2012
- Skin Biology, Inc., October 11, 2012
- Avon Products, Inc., October 5, 2012
- Bioque Technologies, October 5, 2012
- Andes Natural Skin Care LLC, September 21, 2012
- Janson-Beckett, Inc., September 21, 2012
- Lancôme USA, September 7, 2012 -- See also Federal Trade Commission Action on L'Oréal Anti-aging Claims for Génifique and Youth Code
- Greek Island Labs, September 7, 2012
- Set-N-Me-Free Aloe Vera Co., June 12, 2012
- JabaLabs, LLC, March 1, 2011
- Fusion Brands International SRL, April 24, 2007
- Freedom Plus Corporation, March 29, 2007
- BioForm Medical, Inc., February 15, 2007
- Hydroderm Beverly Hills, September 26, 2005
- Basic Research, LLC, January 20, 2005
Warning Letters Addressing Hair Care Preparations
- Skin Biology, Inc., October 11, 2012
- Greek Island Labs, September 7, 2012
- Freedom Plus Corporation, March 29, 2007
Related Resources
.png)
No hay comentarios:
Publicar un comentario