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 Letters Addressing Topical Skin Care Preparations
- PhytoCeuticals, Inc. October 18, 2016
- Bioque Technology, Inc & Vouray, Inc. October 7, 2016
- Osea Internacional September 27, 2016
- Face Naturals September 20, 2016
- Harrington House, Inc. September 2, 2016
- Enessa Inc. September 1, 2016
- ZO Skin Health Group, LLC August 29, 2016
- Sarkli/Repechage, Ltd. August 18, 2016
- Tata’s Natural Alchemy, LLC August 2, 2016
- Ageless Aesthetics, Inc. July 18, 2016
- Menscience Androceuticals July 18, 2016
- La Bella Figura, LLC July 21, 2016
- Healing-Scents July 29, 2016
- Michael Todd True Organics LLC July 18, 2016
- MiN New York July 28, 2016
- Lavian Ltd. July 22, 2016
- Peter Thomas Roth Labs, LLC July 22, 2016
- TPR Holdings LLC July 22, 2016
- Finally Pure, LLC July 20, 2016
- Sevani Botanica July 19, 2016
- Sircuit® Cosmeceuticals July 19, 2016
- Aloe Farms, Inc. July 15, 2016
- Annemarie Gianni Skin Care July 15, 2016
- Be Green Bath and Body July 15, 2016
- Reviva Labs, Inc. May 10, 2016
- Crescent Health Center, Inc. April 20, 2016
- Hollywood Skincare International, Inc. April 14, 2016
- Black Onyx World LLC dba Alikay Naturals March 16, 2016 -- See also FDA Warns Consumers About Health Risks with Alikay Naturals – Bentonite Me Baby – Bentonite Clay, on lead contamination
- Beauty & Health International, Inc. February 5, 2016
- Cosmetic Dermatology Inc./Drbrandtskincare.com December 3, 2015
- Episciences Inc. December 2, 2015
- Golden Caviar Skin Care, July 13, 2015
- 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
- Fioravanti Custom Products DBA Essential Wholesale & Labs November 21, 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
Warning Letters Addressing Hair Care Preparations
- Healing-Scents July 29, 2016
- Beauty & Health International, Inc. February 5, 2016
- Skin Biology, Inc., October 11, 2012
- Greek Island Labs, September 7, 2012
- Freedom Plus Corporation, March 29, 2007
Warning Letters Addressing Eyelash and Eyebrow Treatments
- Allure Laboratories, Inc. May 24, 2011
- Lifetech Resources, LLC, April 18, 2011
Related Resources
- It a Cosmetic, a Drug, or Both? (or Is It Soap?)
- Wrinkle Creams and Other Anti-aging Products
- "Cosmeceutical"
- FDA's main Warning Letters page