CFSAN/Office of Cosmetics and Colors: 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 and hair care 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, and hair restoration.
Warning Letters Addressing Topical Skin Care Preparations
- Fusion Brands International SRL April 24, 2007 (also available in PDF*, 184kB)
- Freedom Plus Corporation March 29, 2007 (also available in PDF*, 349kB)
- BioForm Medical, Inc. February 15, 2007 (also available in PDF*, 300kB)
- Athletes.com, Inc. / Higher Power, Inc., dba bodybuilding.com July 7, 2006 (also available in PDF*, 760kB)
- Hydroderm Beverly Hills September 26, 2005 (also available in PDF*, 385kB)
- Basic Research, LLC January 20, 2005 (also available in PDF*, 283kB)
- University Medical Products USA, Inc. January 22, 2004 (also available in PDF*, 209kB)
Warning Letters Addressing Hair Care Preparations
- Freedom Plus Corporation, March 29, 2007 (also available in PDF*, 349kB)
- Global Vision Products, Inc., April 3, 2003 (also available in PDF*, 254kB)
- Pride and Power, Inc., March 3, 2003 (also available in PDF*, 348kB)
- Farouk Systems, Inc., July 24, 2002 (also available in PDF*, 297kB)
(Comment : No date listed, but may have come out with or after the FDA release of October 8, 2008 on Warning Letters Highlight Differences Between Cosmetics and Medical Devices October 8, 2008)
Tags: Cosmetics, Drugs, Warning Letter
