FDA Changes Sunscreen Labeling Standards
New standards issued by the Food and Drug Administration (FDA) Tuesday will ensure that sunscreens which claim to reduce the risk of skin cancer will have to protect against both ultraviolet A and B rays, and have a sun protection factor (SPF) of at least 15. The purpose of enacting the standards is to give consumers more information how best to protect themselves against the risk of skin cancer, and premature aging of the skin.
It is hard to imagine a time when sun exposure was not considered a bad thing. Yet only thirty years ago, sunscreen was almost unheard of, and people bought “tanning oils” to accelerate their tans. As scientists learned more and more about the damage that ultraviolet rays does to human skin, pharmaceutical companies began developing sunscreens to protect the skin and mitigate the damage wrought by ultraviolet radiation. Now sunscreens of all sizes, formulations and price points crowd the shelves of grocery stores, discount stores, and pharmacies.
It seems strange that only now has the FDA stepped forward to enact such labeling standards. Each year, 3.5 million cases of skin cancer affecting 2 million Americans are diagnosed, according to the American Academy of Dermatology (AAD). Exposure to ultraviolet radiation remains the leading cause of skin cancer. With the exception of physical barriers to skin (i.e. clothing, hats and sunglasses), the only known means to protect the skin from damage due to UV A and B rays is sunscreen. According to Janet Woodcock, M.D., the director of the FDA’s Center for Drug Evaluation and Research, “consumers should apply and reapply sunscreens with Broad Spectrum and SPF of 15 or higher”. However, both the American Academy of Dermatology and the Canadian Dermatology Association (CDA) recommend that individuals apply sunscreen with a minimum SPF of 30.
Other labeling guidelines include prohibiting the use of any SPF value over 50, as these have been found to confer no additional protection to the skin; and allowing products with an SPF between 2-14 to be labeled “broad spectrum”, but may not claim to reduce the risk of skin cancers. Products with an SPF of between 2-14 will have to contain a warning stating that the product does not reduce the risk of skin cancer and premature skin aging. These labeling regulations will take effect for most manufacturers within one year.
Image courtesy of Dave Hunter
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