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U.S. Department of Health and Human Services

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Enforcement Actions

Lancome 9/7/12

  

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

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

 

WARNING LETTER
SEP 7 2012 
 
VIA CERTIFIED MAIL
 
Mr. Serge Jureidini
President
Lancôme USA
575 Fifth Avenue
New York, NY 10017
 
Re: 273596
 
Dear Mr. Jureidini:
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.lancome-usa.com in August 2012. Based on this review, your products Génifique Youth Activating Concentrate, Genefique Eye Youth Activating Eye Concentrate, Genefique Cream Serum Youth Activating Cream Serum, Génifique Repair Youth Activating Night Cream, Absolue Precious Cells Advanced Regenerating and Reconstructing Cream SPF 15 Sunscreen, Absolue Eye Precious Cells Advanced Regenerating and Reconstructing Eye Cream, Absolue Night Precious Cells Advanced Regenerating and Reconstructing Night Cream, and Rénergie Microlift Eye R.A.R.E.™ Intense Repositioning Eye Lifter appear to be promoted 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 these claims evidencing these intended uses violates the Act.
 
Examples of some of the claims observed on your web site include:
 
Génifique Youth Activating Concentrate, Génifique Eye Youth Activating Eye Concentrate, and Génifique Cream Serum Youth Activating Cream Serum
  • “[B]oosts the activity of genes and stimulates the production of youth proteins.”
 
Génifique Repair Youth Activating Night Cream
  • “[B]oosts the activity of genes.”
 
Absolue Precious Cells Advanced Regenerating and Reconstructing Cream SPF 15 Sunscreen
  • “A powerful combination of unique ingredients – Reconstruction Complex and Pro-Xylane™, a patented scientific innovation-- has been shown to improve the condition around the stem cells and stimulate cell regeneration to reconstruct skin to a denser quality.”
  • “See significant deep wrinkle reduction in UV damaged skin, clinically proven.”
 
Absolue Eye Precious Cells Advanced Regenerating and Reconstructing Eye Cream and Absolue Night Precious Cells Advanced Regenerating and Reconstructing Night Cream
  • “A powerful combination of unique ingredients – Reconstruction Complex and Pro-Xylane™, a patented scientific innovation-- has been shown to improve the condition around the stem cells and stimulate cell regeneration to reconstruct skin to a denser quality.”
 
Rénergie Microlift Eye R.A.R.E.™ Intense Repositioning Eye Lifter
  • “Immediate lifting, lasting repositioning. Inspired by eye-lifting surgical techniques . . . helps recreate a younger, lifted look in the delicate eye area.”
  • “[U]nique R.A.R.E. oligopeptide helps to re-bundle collagen.”
 
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/HowDrugsareDeveloped
andApproved/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 fifteen (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 fifteen 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 Rob Genzel, Jr., 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