FDA Issues Warning Letter to Skin Authority

Skin Authority, LLC, Carlsbad, is the latest company to be issued a warning letter from the US Food and Drug Administration following a review of the firm’s website. In its review, undertaken last month, FDA contends Skin Authority’s  “Wrinkle Reversing Serum,” “Moisturizing Lift Cream,” “VitaD Fortified Topical Elixir,” “Reviving Eye Brightener,” “Coffee Almond Scrub,” and “Bamboo Ginseng Scrub,” 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)]. 
 
Examples of some of the claims on the website 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)…”
•   “Interleukins (IL3, IL6-8) …improve anti-inflammatory response.”
 
Moisturizing Lift Cream
•  “Skin Growth Factors / Human Fibroblast Conditioned Media- Four essential skin proteins stimulate collagen, inhibit cellular breakdown, increase cell growth, and enable cells to locate nutrients fostering faster skin growth, stronger blood vessel formation, reduce infection, calm inflammation…”
•  “Glycolic Acid – Helps open follicles and reduce oil production.”
•  “Green Tea Extract – Potent anti-inflammatory agent helps reduce inflammation and prevents collagen breakdown by inhibiting the collagenase enzyme.”
 
VitaD Fortified Topical Elixir
•  “Vitamin D3 (cholecalciferol) – Helps reduce inflammation, calm irritation…”
•  “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.”
•  “Coffea Arabatica (Coffee) Seed Powder – Micronized coffee effectively stimulates circulation…”
•  “Caffeine – Stimulates lipolysis in the cellulite cells…”
•  “Zea Mays (Corn) Cob Powder – …improves microcirculation…”
•  “Olea Europaea (Olive) Seed Powder – …vasodilatation properties to increase circulation and promote detoxification.”
 
Bamboo Ginseng Scrub
•  “[S]timulate circulation…”
•  “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…”