Public Health Service Food and Drug Administration
New York District 158-15 Liberty Avenue Jamaica, New York 11433
July 22, 2016
WARNING LETTER NYK 2016-39
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Amos Lavian, CEO
960 South Broadway Suite 122
Hicksville, New York 11801
Dear Mr. Lavian:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://dermelect.com/ in May 2016 and again in July 2016 and has determined that you take orders there for the products Smooth Lip Volumizer, Empower MP6 Anti-Wrinkle Treatment, and Resurgent Stem Cell Firming Activator. The claims on your website establish that the products are drugs under sections 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B) and/or 21 U.S.C. § 321(g)(1)(C)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or articles intended to affect the structure or any function of the human body. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
Smooth Lip Volumizer
“An excellent alternative to medically administered treatments.”
“Vitamin A: Useful for regenerating skin and encouraging cellular renewal… used in the treatment of psoriasis.”
“Vitamin C: collagen boosting Vitamin C, also works to strengthen capillary walls for firm skin tone. Shown to help control hyperpigmentation and to enhance the skin’s immune system.”
“Vitamin E: excellent anti-inflammatory effects…”
Empower MP6 Anti-Wrinkle Treatment
“Safe and non-toxic, topical alternative to injections”
“Containing the two newest multi-peptides Argireline® and Matrixyl™ 3000… effectively stimulate the synthesis of its own collagen”
“Matrixyl™ 3000: Increases and promotes collagen synthesis”
Resurgent Stem Cell Firming Activator
“The key function for skin tissue stem cells is to continuously regenerate brand new skin…”
[R]everse skin damage through the stimulation of new skin from the stem cell reservoirs.”
“By allowing the stem cells to increase their potency and promote cell regeneration, tissue is reconstructed to a denser quality and more elastic skin.”
“Aligisium C Activates epidermal regeneration & targets damage done by free radical agents”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the 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 sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
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.
Your written response should be sent to: U.S. Food and Drug Administration, 622 Main Street, Buffalo, New York 14202, Attn: Patricia A. Clark, Compliance Officer. If you have any questions about the contents of this letter, please contact Compliance Officer Patricia A. Clark by telephone at (716) 846-6236 or e-mail at email@example.com.