FDA today announced it sent warning letters to four makers of ingestible nutricosmetic supplements whose products make illegal “sun protection” drug-level claims of preventing sunburn, reducing early skin aging resulting from sun exposure, or protecting consumers from the risk of skin cancer. Only certain topical sunscreen ingredients are approved as legitimate sunscreens, the agency says. FDA classifies topical sunscreens as over-the-counter drugs and reviews sunscreen ingredients before they can be sold.
On May 18, FDA sent warning letters to the following companies: GliSODin Skin Nutrients (maker of Advanced Skin Brightening Formula), Napa Valley Bioscience (maker of Sunsafe Rx), Pharmacy Direct Inc. (maker of Solaricare), and Sunergized LLC (maker of Sunergetic). All brands sell ingestible pills advertised as dietary supplements.
According to a statement published today on FDA’s website by FDA Commissioner Scott Gottlieb, MD, “These companies…are putting people’s health at risk by giving consumers a false sense of security that a dietary supplement could prevent sunburn, reduce early skin aging caused by the sun, or protect from the risks of skin cancer.”
In the warning letters to these companies, FDA censures the companies for making unapproved drug claims that their products can cure, mitigate, treat, or prevent disease. Many of the claims FDA highlights are claims that products provide sun protection by reducing UV ray–induced oxidative stress.
In the warning letter to GliSODin, FDA said the brand’s Advanced Skin Brightening Formula marketing states: “The good news is there is a simple and natural way to strengthen your skin’s defenses against ultraviolet radiation in the form of a daily supplement designed to improve skin health.” FDA said the company also claimed that the product can “reduce oxidative stress (one of the harmful effects of UV light)” and that it “enhances photoprotection,” which FDA said it classifies as a drug claim.
Napa Valley Bioscience was targeted for claims such as “protect you from both UVA and UVB rays” and “just one capsule per day provides natural, healthy…protection from UV rays.” FDA also took issue with the claim that “Sunsafe Rx uses specific ingredients [which] can promote your skin’s natural defenses against UV rays. These powerful antioxidants help your body quench free radicals created by ultraviolet radiation before they can do extensive damage.” In addition, according to FDA, the company made a claim that “lutein and zeaxanthin protect your eyes from the oxidative stress of UV rays and may help fight the causes of age-related macular degeneration.”
The other two companies also made drug-type claims. Pharmacy Direct’s Solaricare product, for instance, claimed to contain an ingredient (Polypodium leucotomos extract) used “for treating skin disorders such as psoriasis, eczema, polymorphic light eruption, and sunburn.” Sunergized’s Sunergetic product provided directions such as “take an additional capsule if exposed to excess sunlight” and featured product reviews mentioning skin cancer and “repairing sun damage.”
FDA regulates topical sunscreens as over-the-counter drugs. The agency reviews the active ingredients in sunscreens to determine whether those ingredients are generally recognized as safe and effective (GRASE). So far, the agency has approved a limited list of sunscreen ingredients it considers GRASE; in 2014, the Sunscreen Innovation Act (SIA) was enacted to further outline the timeline for these FDA ingredient reviews.
The products FDA regulates as sunscreens include lotions, creams, sticks, and sprays. “All of these formulations are applied topically over the skin and must pass certain tests before they’re sold,” Gottlieb said in his FDA website announcement. Sunscreens are required to be tested to measure the level of UV radiation exposure, with and without the sunscreen, that will cause sunburn.
In his statement published on FDA’s website today, Commissioner Gottlieb said, “There’s no pill or capsule that can replace your sunscreen.”
FDA’s warning letters to the aforementioned nutricosmetic firms are part of what Gottlieb described as the agency’s current efforts “to advance the FDA’s framework for sun-protection products,” he said. In addition to the warning-letter news, Gottlieb announced a new FDA draft guidance related to Maximal Usage Trials (how much sunscreen usage and absorption is safe) for those sunscreen ingredients being evaluated for inclusion an OTC sunscreen monograph, as well as a guidance outlining FDA’s enforcement approach to OTC sunscreens being “marketed without approved applications during the period before a final OTC sunscreen monograph becomes effective.”
He also said FDA continues to encourage the sunscreen industry to perform more research on sunscreen active ingredients in order to study their safety and to determine whether and how active sunscreen ingredients are absorbed by the skin. This vetting is crucial, Gottlieb said, as consumers are more often advised to apply sunscreen frequently or even daily.