The Food and Drug Administration (FDA) has issued a number of warning letters to cosmetic and dietary supplement companies over the last several months. A February 12, 2015, warning letter to L’Oreal states that Rosalic AR Intense and Mela-D Pigment Control appear to be promoted for uses that caused the products to be classified as drugs. The letter cites examples from L’Oreal’s website, including language such as “reduces visible redness and sensations of discomfort” for the Rosalic AR Intense product and “concentrated dark spot correcting serum” for Mela-D Pigment Control. The warning letter also states that the Rosalic AR Intense product is offered for conditions that are not amenable to self-diagnosis and treatment by consumers who are not medical professionals, making the directions for use unusable for laypeople.
On January 20, FDA issued a warning letter to Chaga Mountain, Inc. for its mushroom tea bags, mushroom tincture/extract, powered loose teas, skin cream and lip balm, finding that the company’s advertisements caused the products to be classified as drugs. Chaga Mountain’s website made various claims about its products, including representing that products were anti-cancer agents; antiviral, antimicrobial, antifungal, and/or anti-inflammatory; and may be used as treatment for arthritis, influenza, erectile dysfunction, Crohn’s disease, ADHD, hepatitis and several other diseases. The warning letter also notes that the tincture/ extract, tea bags and loose teas were adulterated and not prepared under conditions that meet current good manufacturing practice requirements for dietary supplements. Finally, the warning letter states that the tincture/ extract product was misbranded as a dietary supplement because it failed to bear nutritional information as required.
On January 9, FDA issued a warning letter to Derma Pen, LLC about its micro-needle skin dermabrasion device, Dermapen®, finding the device to be a Class I medical device, misbranded and adulterated because it lacked premarket approval or approval for an investigational device exemption. Dermapen® consists of needles controlled by a motor to penetrate the skin while the user moves it across the skin surface. Currently, the safe ranges of needle lengths, penetration depths and speeds of the device are unknown, creating concern that the device could damage vessels and nerves. FDA requested the company immediately cease commercial distribution of the Dermapen Auto-Microneedle Therapy System. FDA also warned about promotional materials calling products “cosmeceuticals,” as this category is not recognized by FDA.