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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Avon Products, Inc. (U.S. Headquarters) 10/5/12

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 College Park, MD 20740 

 

October 5, 2012
 
WARNING LETTER
 
 
VIA CERTIFIED MAIL
 
Ms. Andrea Jung
Chairman and Chief Executive Officer
Avon Products, Inc.
Global Headquarters
1345 Avenue of the Americas
New York, NY 10105
 
Re: 262337
 
Dear Ms. Jung:
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your web site at the Internet address http://www.avon.com in August 2012. Based on this review, your products Anew Clinical Advanced Wrinkle Corrector, Anew Reversalist Night Renewal Cream, Anew Reversalist Renewal Serum, Anew Clinical Thermafirm Face Lifting Cream, and Solutions Liquid Bra Toning Gel appear to be intended for uses that cause these products to be drugs under section 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(C)]. The claims on your web site indicate that these products are intended to affect the structure or any function of the human body, rendering them drugs under the Act. The marketing of these products with claims evidencing these intended uses violates the Act. 
 
Examples of some of the claims observed on your web site include:
 
Anew Clinical Advanced Wrinkle Corrector:
  • “The at-home answer to wrinkle-filling injections. Start rebuilding collagen in just 48 hours.”
  • 4D WRINKLE-REVERSE TECHNOLOGY IS DESIGNED TO:
Rebuild collagen to help plump out lines and wrinkles.
Stimulate elastin to help improve elasticity and resilience.
Regenerate hydroproteins to help visibly minimize creasing.”
  • Formulated to boost shock-absorbing proteins to help strengthen skin's support layers.”
  • “Improve fine & deep wrinkles up to 50%. Immediately plumps out wrinkles and fine lines. Within 48 hours begins boosting collagen production.”
Anew Reversalist Night Renewal Cream & Anew Reversalist Renewal Serum
  • “[W]rinkles are a result of micro-injuries to the skin, so AVON studied how skin heals. As part of the repair process, the body produces Activin . . . . [E]xhaustive research, testing & review have resulted in an unprecedented discovery by AVON scientists: how to activate this key repair molecule. . . . Designed to boost Activin, ANEW’s Activinol Technology helps reactivate skin’s repair process to recreate fresh skin & help dramatically reverse visible wrinkles.”
Anew Clinical Thermafirm Face Lifting Cream
  • “Our effective lifting treatment is formulated to fortify damaged tissue with new collagen. In just 3 days, see tighter, firmer, more lifted skin.”
  • “[H]elp tighten the connections between skin's layers.”
Solutions Liquid Bra Toning Gel
  • “Formulated with pomegranate and fennel extracts to help boost production of collagen and elastin.”
Your products are not generally recognized among qualified experts as safe and effective for the above referenced uses and, therefore, the products are new drugs as defined in section 201(p) of the Act [21 U.S.C. § 321(p)]. Under section 505(a) of the Act [21 U.S.C. § 355(a)],  a new drug may not be legally marketed in the U.S. without prior approval from FDA in the form of an approved New Drug Application (NDA). A description of the new drug approval process can be found on FDA's internet website at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993.
 
This letter is not an all-inclusive statement of violations associated with your products or their labeling, and we have not attempted to list here all of the products that are promoted on your website for intended uses that cause them to be drugs.  It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.  We advise you to review your website, product labels, and other labeling for your products to ensure that the claims you make for your products do not reflect intended uses that cause the distribution of the products to violate the Act.
 
We request that you take prompt action to correct all violations associated with your products, including the violations identified in this letter. Failure to do so may result in enforcement action without further notice. The Act authorizes injunctions against manufacturers and distributors of illegal products and seizure of such products.
 
Please notify this office in writing within 15 working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be implemented.
 
Please direct your written reply to Kathleen Lewis, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Compliance, Division of Enforcement (HFS-608), 5100 Paint Branch Parkway, College Park, Maryland 20740-3835.
 
                                                                                   
Sincerely,
/S/
Michael W. Roosevelt
Acting Director
Office of Compliance
Center for Food Safety
   and Applied Nutrition