FDA issues warning letters to marketers of sunscreen pills
WASHINGTON — The U.S. Food and Drug Administration announced on Tuesday that it has sent warning letters to companies illegally marketing pills and capsules labeled as dietary supplements that make unproven drug claims about protecting consumers from the dangers of sun exposure without meeting the FDA’s standards for safety and effectiveness.
The companies are GliSODin Skin Nutrients, which markets Advanced Skin Brightening Formula; Napa Valley Bioscience, which markets Sunsafe Rx; Pharmacy Direct, which markets Solaricare; and Sunergized, which markets Sunergetic.
The FDA instructed these companies to correct all violations associated with their products and were advised to review product web sites and product labeling to ensure that the claims they are making don’t violate federal law.
“Consumers should be watchful for unscrupulous companies making unproven claims. When the FDA sees companies taking advantage of people’s desire to protect themselves from the harmful effects of the sun — we’ll step in. There’s no pill or capsule that can replace your sunscreen,” the FDA stated.
The FDA is also encouraging new research and regulations to further promote the safety and effectiveness of traditional sun protection products like sunscreen lotions, creams, sticks and sprays that are applied topically.
“When sunscreens first came on the U.S. market, sunscreen active ingredients were not thought to penetrate the skin. We now have evidence that it’s possible for some sunscreen active ingredients to be absorbed through the skin. This combination of a large increase in the amount and frequency of sunscreen usage, together with advances in scientific understanding and safety evaluation methods, has given rise to new questions about what information is necessary and available to support general recognition of safety and effectiveness (GRASE) of active ingredients for use in OTC sunscreens,” the FDA stated.
The companies are GliSODin Skin Nutrients, which markets Advanced Skin Brightening Formula; Napa Valley Bioscience, which markets Sunsafe Rx; Pharmacy Direct, which markets Solaricare; and Sunergized, which markets Sunergetic.
The FDA instructed these companies to correct all violations associated with their products and were advised to review product web sites and product labeling to ensure that the claims they are making don’t violate federal law.
“Consumers should be watchful for unscrupulous companies making unproven claims. When the FDA sees companies taking advantage of people’s desire to protect themselves from the harmful effects of the sun — we’ll step in. There’s no pill or capsule that can replace your sunscreen,” the FDA stated.
The FDA is also encouraging new research and regulations to further promote the safety and effectiveness of traditional sun protection products like sunscreen lotions, creams, sticks and sprays that are applied topically.
“When sunscreens first came on the U.S. market, sunscreen active ingredients were not thought to penetrate the skin. We now have evidence that it’s possible for some sunscreen active ingredients to be absorbed through the skin. This combination of a large increase in the amount and frequency of sunscreen usage, together with advances in scientific understanding and safety evaluation methods, has given rise to new questions about what information is necessary and available to support general recognition of safety and effectiveness (GRASE) of active ingredients for use in OTC sunscreens,” the FDA stated.