Nutritional Outlook

Nutritional Outlook, June 2018

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NEWS ■ NUTRITIONAL OUTLOOK 12 JUNE 2018 In late May, FDA announced it sent warning letters to four makers of ingestible nutricos- metic supplements whose products make illegal "sun protection" drug-level claims of preventing sunburn, reducing early skin ag- ing resulting from sun exposure, or protecting consumers from the risk of skin cancer. Only certain topical sunscreen ingredients are ap- proved as legitimate sunscreens, the agency says. FDA classif es topical sunscreens as over-the-counter drugs and reviews sun- screen ingredients before they can be sold. On May 18, FDA sent warning letters to the following companies: GliSODin Skin Nu- trients (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 May 22 statement pub- lished on FDA's website by FDA Commis- sioner Scott Gottlieb, MD, "T ese compa- nies…are putting people's health at risk by giving consumers a false sense of security that a dietary supplement could prevent sun- burn, 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 re- ducing UV ray–induced oxidative stress. In the warning letter to GliSODin, FDA said the brand's Advanced Skin Brightening Formula marketing states: "T e good news is there is a simple and natural way to strength- en your skin's defenses against ultraviolet ra- diation in the form of a daily supplement de- signed to improve skin health." FDA said the company also claimed that the product can "reduce oxidative stress (one of the harmful ef ects of UV light)" and that it "enhances photoprotection," which FDA said it classi- f es 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 specif c ingredients [which] can promote your skin's natural de- fenses against UV rays. T ese powerful anti- oxidants help your body quench free radicals created by ultraviolet radiation before they can do extensive damage." In addition, ac- cording to FDA, the company made a claim that "lutein and zeaxanthin protect your eyes from the oxidative stress of UV rays and may help f ght the causes of age-related mac- ular degeneration." T e other two companies also made drug-type claims. Pharmacy Direct's Solari- care product, for instance, claimed to con- tain 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 ex- posed to excess sunlight" and featured product reviews mentioning skin cancer and "repairing sun damage." FDA regulates topical sunscreens as over- the-counter drugs. T e agency reviews the active ingredients in sunscreens to deter- mine whether those ingredients are general- ly recognized as safe and ef ective (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. T e products FDA regulates as sunscreens include lotions, creams, sticks, and sprays. "All of these formulations are applied top- ically 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, Commissioner Gottlieb said, "T ere's no pill or capsule that can replace your sunscreen." FDA's warning letters to the aforemen- tioned nutricosmetic f rms are part of what Gottlieb described as the agency's current ef orts "to advance the FDA's framework for sun-protection products," he said. In ad- dition to the warning-letter news, Gottlieb announced a new FDA draft guidance re- lated 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 enforce- ment approach to OTC sunscreens being "marketed without approved applications during the period before a f nal OTC sun- screen monograph becomes ef ective." Gottlieb also said FDA continues to en- courage the sunscreen industry to perform more research on sunscreen active ingredi- ents in order to study their safety and to de- termine whether and how active sunscreen ingredients are absorbed by the skin. T is vetting is crucial, Gottlieb said, as consumers are more often advised to apply sunscreen frequently or even daily. FDA Warns Nutricosmetic Brands Making "Sun Protection" Health Claims Stay informed! See the latest news at NutritionalOutlook.com ISTOCKPHOTO.COM/AGRIGORJEVA

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