FDA Warns Companies Illegally Marketing Dietary Supplements as Sunscreen



On May 22, 2018, FDA sent warning letters to companies illegally marketing dietary supplements that make unproven drug claims about sun protection without meeting FDA’s standards for safety and effectiveness. FDA said the 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.” FDA instructed the companies to correct all violations associated with their products and were advised to review product labeling and websites to ensure that the claims do not violate federal law. Examples of claims include “Enhances photoprotection,” “It’s basically an oral sunscreen,” and “Every second you spend in the sun damages your skin. But Sunsafe Rx is always working: it protects your whole body,” according to the FDA’s letters.

In a statement released by FDA Commissioner Scott Gottlieb, M.D., it was made clear that there is no pill or capsule that can replace sunscreen. Commissioner Gottlieb stated that legitimate sunscreens are made in a wide range of sun protection factor values, also known as SPF values, and are over-the-counter drugs that come in many forms. These 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.

FDA is not authorized to review dietary supplement products for safety and effectiveness before they are marketed. However, FDA can take dietary supplements off the market if they are found to be unsafe or if the claims on the products are false and misleading.

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