Market Updates

FDA Warns Against Products Claiming to Replace Sunscreen

The agency issued Warning Letters to several companies making illegal marketing claims.

As the weather warms up, the U.S. Food and Drug Administration (FDA) has issued a stern warning against dietary supplements claiming to be a replacement for sunscreen. In a press release from the agency FDA Commissioner Scott Gottlieb, MD, spoke out against “companies illegally marketing pills and capsules labeled as dietary supplements that make unproven drug claims about protecting consumers from the harms that come from sun exposure without meeting the FDA’s standards for safety and effectiveness.” 
 
FDA sent Warning Letters to several companies, which said they were not delivering on advertised benefits and were putting consumers at risk. The illegal pills and capsules are making unproven drug claims by declaring they protect consumers from sun exposure without meeting FDA’s standards for safety and effectiveness.
 
The companies that received Warning Letters offer products such as Advanced Skin Brightening FormulaSunsafe RxSolaricare and Sunergetic, and were called out by FDA as putting consumers at risk by giving them “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.” These companies were instructed to correct all violations associated with their products and were advised to review product websites and product labeling to ensure that the claims they are making don’t violate federal law. 
 
FDA cautioned consumers to be aware of “unscrupulous companies making unproven claims” related to products protecting skin from damaging UV rays. The agency stressed that there is “no pill or capsule that can replace your sunscreen.”

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