Public Health Service Food and Drug Administration
College Park, MD 20740
MAR 25, 2015
VIA OVERNIGHT DELIVERY
Skin Authority, LLC.
5900 Sea Lion Place Suite 100 Carlsbad, CA 92010
Re: CMS #447924
Dear Skin Authority, LLC.:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://skinauthority.com in March 2015. Based on this review, you take orders there for your products “Wrinkle Reversing Serum,” “Moisturizing Lift Cream,” “VitaD Fortified Topical Elixir,” “Reviving Eye Brightener,” “Coffee Almond Scrub,” and “Bamboo Ginseng Scrub,” 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 http://skinauthority.com that provide evidence that your products are intended for use as drugs include:
Wrinkle Reversing Serum
“TGF-b(1-3) (Transforming Growth Factor Beta) to help stimulate collagen, to help inhibit cellular breakdown…”
“PDFG (Platelet Derived Growth Factor) to help activate wound healing fostering new skin growth, to help reduce scar tissue, and to help form stronger blood vessels.”
“GM-CSF (Granulocyte-Macrophage Colony- Stimulating Factor) to help restore blood cell response to the breakdown of skin structure, to help counteract infection (e.g., acne), to help even-out discolored appearance (e.g., hyperpigmentation), to help reduce inflammation (e.g., Rosacea)…”
“Oligopeptide Complex –Inhibits tyrosinase activity which is a leading cause of spots and uneven skin tone.”
“Vitamin K - Stimulates blood flow to reduce inflammation…”
“Retinol (.01%) - …collagen stimulator.”
Reviving Eye Brightener
“Vitamin K - Stimulates blood flow…”
“Arnica - Reduces swelling…”
“Green Tea Extract - Potent anti-inflammatory agent helps reduce inflammation and prevents collagen breakdown by inhibiting the collagenase enzyme.”
“Ginseng Root Extract & Bioflavoids - Strengthen capillaries to increase microcirculation blood flow. Strengthen elastin and the collagen structure for firmer texture while reducing inflammation and redness.”
“Ginko Biloba - Helps stimulate and improve circulation…”
Coffee Almond Scrub
“[D]ecrease the formation of cellulite while tightening and shrinking blood vessels to help reduce the appearance of spider veins.”
“Olea Europaea (Olive) Seed Powder - …vasodilatation properties to increase circulation and promote detoxification.”
Bamboo Ginseng Scrub
“Aloe Barbadensis (Aloe Vera) Extract - Calms inflammation with an anesthetizing response.”
“Panax Ginseng Root Extract - Strengthen capillaries to increase microcirculation blood flow. Strength elastin and the collagen structure for firmer texture while reducing inflammation and redness.”
“Further invigorate the circulatory and lymphatic system…”
Your “Wrinkle Reversing Serum,” “Moisturizing Lift Cream,” “VitaD Fortified Topical Elixir,” “Reviving Eye Brightener,” “Coffee Almond Scrub,” “Bamboo Ginseng Scrub” products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are new drugs as defined in 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 “Wrinkle Reversing Serum” product is offered for a condition that is 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 the 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 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.