Federal regulators warned natural sunscreen companies Tuesday that they’re illegally marketing pills and capsules that claim to protect against the sun.
The Food and Drug Administration Commissioner Scott Gottlieb said the companies are “misleading consumers, and putting people at risk.”
“There’s no pill or capsule that can replace your sunscreen,” said Gottlieb.
If an ingestible product was making the claim that it could protect against the sun, FDA says it would be considered a drug and the agency hasn’t approved a drug with that claim.
The companies that are receiving warning letters sell products called Advanced Skin Brightening Formula, Sunsafe Rx, Solaricare and Sunergetic, which Gottlieb says “are 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 warned the companies to correct all violations associated with their products and to review product websites and labeling to make sure claims don’t violate federal law.
Skin cancer is the most common cancer in the U.S., with one in five Americans at risk of developing it in their lifetime. Natural and artificial ultraviolet (UV) light increases the risk of developing skin cancer.
The health care community and federal regulators have been working to improve UV protection, but also have been fighting false claims. In 2015, actress Jessica Alba’s Honest Company was sued and widely pilloried for claims about a number of products, including sunscreen consumers claimed didn’t work.
Consumers should be wary of what might be “unscrupulous companies making unproven claims,” Gottlieb says.
None of the companies warned by FDA are members of the Personal Care Products Council (PCPC), which represents several companies that make sunscreen. PCPC general counsel Tom Myers says the group knows well that the FDA requires all claims to be substantiated before products can be sold to consumers.
Chris Flower, director general of the Cosmetic Toiletry & Perfumery Association in the United Kingdom, says he’s leary about a lot of the claims made by “natural” products.
“There are plenty of sites making unsubstantiated claims and these include lifestyle, food supplements and diets as a whole,” says Flower. “In the absence of robust scientific trials, I remain thoroughly skeptical, and doubly so when the words ‘real food’ are included in the text.”
