421 N. Rodeo Dr. Suite T-7 Beverly Hills, CA90210 United States
Center for Food Safety and Applied Nutrition
Department of Health and Human Services
Public Health Service Food and Drug Administration
College Park, MD 20740
FEB 12, 2015
VIA OVERNIGHT MAIL
RETURN RECEIPT REQUESTED
Ronald L. Moy
DNA EGF Renewal
421 N. Rodeo Dr. Suite T-7
Beverly Hills, CA 90210
Re: CMS # 440852
Dear Mr. Ronald L. Moy:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://www.dnaegfrenewal.com in December 2014. Based on this review, you take orders there for your "DNA Eye Renewal" product, which appears to be promoted for conditions that cause the product to be drugs under section 201(g)(l)(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 product is 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 this product for introduction into interstate commerce for such uses violates the Act. You may find the Act and CFR through links in FDA's home page at www.fda.gov.
• "Beta Glucan: Helps stimulate collagen production for added strength to the dermal matrix ... " • "Willowherb ... control inflammation." • "Spanish Lavender ... inhibit muscle fibers from contracting ... " • "Matrixyl3000 ... stimulating the production of collagen, elastic, and hyaluronic acid and decreasing cell damage caused by glycation and inflammation." • "Tetrapeptide . .. mimic the activity of the youth hormone thymopoietin ... reinforcing the cutaneous immune defenses in the skin ... stimulate the growth of new cells in the epidermis."
Your "DNA Eye Renewal" product is not generally recognized as safe and effective for the above-referenced uses and, therefore, the product is a "new drug" 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 in the form of a New Drug Application (NDA), as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) ofthe Act [21 U.S.C. § 331(d)]. 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/NewDrugApplicationNDAIdefault.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.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the 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 15 working days, state the reason for the delay and the time 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 email@example.com.
/S/ William A. Correll, Jr. Director Office of Compliance Center for Food Safety and Applied Nutrition