Strivectin Operating Company 2/12/15
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||College Park, MD 20740 |
FEB 12, 2015
RETURN RECEIPT REQUESTED
Melisse Shaban, CEO
StriVectin Corporate Headquarters
601 West 26th Street
New York, NY 10001
Re: CMS #442184
Dear Ms. Shaban:
This letter is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.strivectin.com in December 2014. Based on this review, you take orders there for your products, “Potent Wrinkle Reducing Treatment” and “TL Advanced Tightening
Neck Cream,” which appear 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 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. You may find the Act and its implementing regulations through links in FDA’s home page at www.fda.gov
Examples of some of the claims on the website www.strivectin.com include:
Potent Wrinkle Reducing Treatment:
- “Clinically proven to change the anatomy of a wrinkle”
- “This superb age-fighting serum is super charged with …potent elastin stimulating peptides….”
- “Potent elastin-stimulating peptides help enhance skin structure ….”
TL Advanced Tightening Neck Cream:
- “#1 Selling Neck Cream. Now even more tightening, lifting…”
- “[F]eatures breakthrough Gravitite-CF Lifting Complex to restore the elastin fiber architecture, providing noticeable lift and improving resistance to gravity.”
- “Breakthrough Gravitite-CF Lifting Complex [an ingredient in your product] contains a powerful blend of active ingredients that stimulate elastin synthesis…”
Your “Potent Wrinkle Reducing Treatment” and “TL Advanced Tightening Neck Cream” 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 the violations associated with your products, including the violations identified in this letter. Failure 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 submit your response to Ms. Dehlia Young, Compliance Officer, Labeling and Dietary Supplement Compliance Branch (HFS-608), Division of Enforcement, Office of Compliance, 5100 Paint Branch Pkwy, College Park, MD 20740. If you have any questions, please contact Ms. Young at firstname.lastname@example.org.
Office of Compliance
Center for Food Safety
and Applied Nutrition