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                Warning Letters Related to Cosmetics

Warning Letters Related to Cosmetics Home
          Cosmetics
          Cosmetics Compliance & Enforcement
          Warning Letters Related to Cosmetics
          Warning Letters Address Drug Claims Made for Products Marketed as CosmeticsWarning Letters Related to Cosmetics Warning Letters Address Drug Claims Made for Products Marketed as Cosmetics
  
  	
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    PrintThe 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

Earthworks Health June 7, 2019
	Green Water, LLC  January 31, 2019
	Silver Armor Inc. May 17, 2018
	Long Life Unlimited January 31, 2018
	Moon Valley Natural Products, LLC August 11, 2017
	Skin 2 Spirit, LLC August 10, 2017
	Be Natural Organics July 19, 2017
	Vedame Oils LLC dba UMA Oils July 18, 2017
	Irie Star, LLC July 6, 2017
	Soapwalla Inc. June 15, 2017
	Perfectly Posh, LLC June 2, 2017
	Star Health & Beauty, LLC May 26, 2017
	Cape Fear Naturals March 2, 2017
	Aegeia Skin Care, LLC February 17, 2017
	Healthy Habits, LLC December 16, 2016
	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 Holding, 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
	Vitalife Inc. June 20, 2016
	Reviva Labs, Inc. May 10, 2016
	Macular Health April 28, 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, 2007Warning 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, 2007Warning Letters Addressing Eyelash and Eyebrow Treatments

Allure Laboratories, Inc., May 24, 2011
	Lifetech Resources, LLC, April 18, 2011Related 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

                                                                                  Content current as of:
      04/01/2022
              
              
Regulated Product(s)
		 CosmeticsWarning Letters Related to Cosmetics
 
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