| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||College Park, MD 20740 |
FEB 12, 2015
VIA OVERNIGHT DELIVERY
Brigitte Liberman, President Active Cosmetics Division
575 Fifth Avenue
New York, NY 10017
Re: CMS # 440851
Dear Ms. Brigitte Liberman:
This letter is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.laroche-posay.us in December 2014. Based on this review, you take orders there for your products “Rosalic AR Intense” and “Mela-D Pigment Control,” which appear to be promoted for uses that cause the 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 website indicate that the products are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or any function of the human body, rendering them drugs under the Act. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
Examples of some of the claims on the website www.laroche-posay.us, that provide evidence that your products are intended for use as drugs include:
Rosaliac AR Intense:
- “Localized Redness Intensive Serum”
- “RECOMMENDED FOR: Redness-prone skin, experiencing overall redness, flushing and sensations of discomfort”
- “Reduces visible redness and sensations of discomfort”
- “[F]ormula combining 3 effective ingredients to help reduce redness with a long lasting efficacy”
- “I have rosaceaon my neck when I get warm or under stress. This product really works to keep it under control!!!”
- “I have broken capillaries and generalized redness on several areas of my face. I was told laser treatment was the only fix. Then…the miracle of Rosalic AR!”
- "With powerful Ambophenol [0.5%] to visibly reduce redness"
Mela-D Pigment Control:
- “Concentrated Dark Spot Correcting Serum”
- “Use to treat dark spots and discolorations”
- “Recommended For: Hyperpigmentation and Dark Spots”
- "With 2% Kojic Acid to visibly reduce the intensity of dark spots"
Your “Rosalic AR Intense” and “Mela-D Pigment Control” products are not generally recognized as safe and effective for the above-referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. 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.
Furthermore, your “Rosaliac AR Intense” product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for its intended purposes. Thus, this drug is misbranded within the meaning of section 502(f)(1) of the Act, in that its labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
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 the violations cited in this letter. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.
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.
You should direct your written reply to Dehlia Young, Compliance Officer, Division of Enforcement (HFS-608), Office of Compliance, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy, College Park, MD 20740. If you have any questions regarding this letter, you may contact Ms. Young via email at firstname.lastname@example.org.
William A. Correll
Office of Compliance
Center for Food Safety
and Applied Nutrition