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
• Freedom Plus Corporation March 29, 2007
• BioForm Medical, Inc. February 15, 2007
• Athletes.com, Inc. / Higher Power, Inc., dba bodybuilding.com July 7, 2006
• Hydroderm Beverly Hills September 26, 2005
• Basic Research, LLC January 20, 2005
• University Medical Products USA, Inc. January 22, 2004
  

Warning Letters Addressing Hair Care Preparations

• Freedom Plus Corporation, March 29, 2007
• Global Vision Products, Inc., April 3, 2003
• Pride and Power, Inc., March 3, 2003
• Farouk Systems, Inc., July 24, 2002

For related information, see Is It a Cosmetic, a Drug, or Both? (or Is It Soap?), "Cosmeceutical" and Warning Letters.