Public Health Service Food and Drug Administration
Los Angeles District Pacific Region 19701 Fairchild Irvine, CA 92612-2506 Telephone: 949-608-2900 FAX: 949-608-4415
UNITED PARCEL SERVICE
July 19, 2016
WL # 36-16
Michael Wolfgeher, President
323 Mira Loma Avenue
Glendale, CA 91204
Dear Mr. Wolfgeher,
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://sircuitskin.com/ in May 2016 and has determined that you take orders there for the products REVELATION intensive anti-wrinkle eye serum, EYE TECH anti-wrinkle eye emulsion, ORAIA anti-aging intensive regeneration complex, and SUGGAH + anti-aging lip plump treatment. 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:
REVELATION intensive anti-wrinkle eye serum
“Argirilene (Acetyl Hexapeptide-8) - resembles the effects of Botox®; when applied to the skin, it relaxes facial tension leading to the reduction of facial lines and wrinkles; even more effective when combined with Leuphasyl® (Pentapeptide-18).”
“Leuphasyl® (Pentapeptide-18) - a neuropeptide that gives Botox®- like results, it works synergistically with Argirilene and increases the benefits…caused by the muscle contractions of facial expressions.”
“Leontopodium Alpinum Meristem Cell Culture -…inhibition of collagenase and hyaluronidase…”
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.
Refer to the identification CMS# 495638 when replying. We remind you that only written communication is considered official. If you have any questions about the content of this letter please contact Dr. William Vitale, Compliance Officer at 949-608-2919.