The US Food and Drug Administration has been putting a wrinkle in recent skin care claims that border drug promises. In an effort to keep companies honest, the FDA periodically sends warning letters. So far this year, several major firms have received a letter. The FDA challenged one manufacturer’s claim to be “clinically proven to change the anatomy of a wrinkle.” Claims that suggest the product retards or controls the aging process or molecule penetration or to physiologically alters a wrinkle or dark spot are suspicious. The FDA wants to limit claims to cleansing, beautifying, promoting attractiveness, or altering the appearance. Consumers expect more.
Most OTC customers are seeking flawless, ageless and spotless skin. Consumers suffer from a range of aging skin, hyperpigmentation, acne and dryness. While a company can never claim to cure an acne condition, revive cells, alter cellulite, or reverse the aging process, these are the claims consumer expect. Several major skin care manufacturers have been warned to craft their claims in such a way that they avoid legal complications. Many products are classified as both a cosmetic and a drug. Such medicated skin products must be approved by the FDA before distribution. Continued FDA concern regarding hydroquinone resulted in blocking melanin-blocking ingredients such as kojic acid, licorice root, and arbutin. A wide array of body butters, known to moisturize and soften, are attempting to claim anti-aging properties. Manufacturers must continue to offer reparative or restorative claims. Their language must be tightened up to suggest ingredients will “help” to repair or restore.