FDA Issues Warning Letter to Skin Authority
The US Food and Drug Administration (FDA) recently sent a Warning Letter to Skin Authority, LLC, due to marketing claims used by the company to promote its personal care products, including its “Wrinkle Reversing Serum,” “Moisturizing Lift Cream,” “VitaD Fortified Topical Elixir,” “Reviving Eye Brightener,” “Coffee Almond Scrub,” and “Bamboo Ginseng Scrub.” The FDA states in the Warning Letter that claims used to promote these products cause them to be “drugs.” The FDA objected in part to the following claims:
- “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.”
- “Vitamin D3 (cholecalciferol) – Helps reduce inflammation, calm irritation…”
- “Interleukins (IL3, IL6-8) … improve anti-inflammatory response.”
- “Oligopeptide Complex – Inhibits tyrosinase activity which is a leading cause of spots and uneven skin tone.”
- “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.”
The FDA’s Warning Letter to Skin Authority, and similar Warning Letters sent a month earlier to DNA EGF Renewal for claims associated with the company’s “DNA Eye Renewal” product, and to L’Oreal for claims concerning its skin pigmentation creams, may be a signal the agency is once again increasing its attention on aggressive marketing claims used to promote personal care products.
The FDA has requested that Skin Authority respond to its Warning Letter within 15 working days on how it plans to correct the stated violations.
We will continue to monitor FDA enforcement related to personal care products. If you have any questions regarding FDA’s enforcement activity related to personal care products, please contact Georgia C. Ravitz, James R. Ravitz, or Brian P. Waldman.