12.16.15
The US Food and Drug Administration issued Warning Letters to two cosmetics companies, Dr. Brandt Skin Care and Episciences, Inc., earlier this month for making unapproved drug claims under the Federal Food, Drug and Cosmetic Act. FDA took exception to claims on Dr. Brandt's website that included:
• "(B)oosts collagen production..." for the Glow product line (Overnight Resurfacing Serum, Ruby Crystal Retinol Hydracrème, Revitalizing Retinol Eye Cream, Glow by Dr. Trandt travel kit);
• “(H)elps breakdown fat deposits…” for Cellusculpt;
• "[R]epairs damaged skin” for Do Not Age with Dr. Brandt;
• “[A]ntibacterial” for Pores No More Poresolution; “[A]ntibacterial action” for Pores No More Pore Refiner Primer;
• “Helps fade dark circles by stimulating microcirculation,” “Reduces puffiness by draining excess fluids” and “Helps reduce under eye bags by breaking down abnormal fatty deposits” for Dr. Brandt Dark Circles Away;
• “[A]n emergency solution for post laser, peeling or injections” for Save Our Skin.
The Warning Letter sent to Episcience took exception to product claims made for several products including Lytic Gel Cleanser, Milky Lotion Cleanser, Lite Lytic TX, Lytic Plus Tx, Lytic Sport Tx, Lytic Tx, Extreme Barrier Cream and Medical Barrier Cream. In its warning, FDA noted that the company's web page titled “How Epionce Helps” contains a list of links for skin diseases or other conditions, such as acne, dermatitis/eczema, diabetes related conditions, hyperpigmentation, keratosis pilaris, psoriasis, radiation dermatitis, rosacea, and skin aging. These links connect to other web pages Epionce products are recommended e used as part of a “regimen” for a particular skin disease or other condition. These recommendations are accompanied by links to the recommended Epionce products. For example:
• On Episcience's page for the “Regimen for Patients with Diabetes," the company recommends “Epionce cleaner for skin type,” “Lytic Gel Cleanser,” a “Lytic product suitable for skin type and/or condition,” and an “Extreme Barrier Cream or Medical Barrier Cream.” The page also states that “Epionce is the perfect solution to help improve the visible skin conditions associated with diabetes” and “Regular use of a topical anti-inflammatory… like Epionce strengthens the skin’s natural ability to repair and protect itself. A healthy skin barrier will help reduce the severity of skin conditions that are common with diabetes….”
• "(B)oosts collagen production..." for the Glow product line (Overnight Resurfacing Serum, Ruby Crystal Retinol Hydracrème, Revitalizing Retinol Eye Cream, Glow by Dr. Trandt travel kit);
• “(H)elps breakdown fat deposits…” for Cellusculpt;
• "[R]epairs damaged skin” for Do Not Age with Dr. Brandt;
• “[A]ntibacterial” for Pores No More Poresolution; “[A]ntibacterial action” for Pores No More Pore Refiner Primer;
• “Helps fade dark circles by stimulating microcirculation,” “Reduces puffiness by draining excess fluids” and “Helps reduce under eye bags by breaking down abnormal fatty deposits” for Dr. Brandt Dark Circles Away;
• “[A]n emergency solution for post laser, peeling or injections” for Save Our Skin.
• On Episcience's page for the “Regimen for Patients with Diabetes," the company recommends “Epionce cleaner for skin type,” “Lytic Gel Cleanser,” a “Lytic product suitable for skin type and/or condition,” and an “Extreme Barrier Cream or Medical Barrier Cream.” The page also states that “Epionce is the perfect solution to help improve the visible skin conditions associated with diabetes” and “Regular use of a topical anti-inflammatory… like Epionce strengthens the skin’s natural ability to repair and protect itself. A healthy skin barrier will help reduce the severity of skin conditions that are common with diabetes….”