New FDA Requirements for Sunscreen Manufacturers
New rules to require protection against UVA rays associated with skin cancer
Help is on the way to consumers confused by the jumble of sun protection numbers and other claims on sunscreens.
Currently, standards of protection apply only to one part of the sun’s spectrum, ultraviolet B rays, which cause sunburn. Under new rules published Tuesday, they will also have to protect against the more penetrating ultraviolet A rays associated with skin cancer.
Sunscreens that don’t protect against both ultraviolet A and B rays and have a sun protection factor, SPF, of at least 15 will have to carry warning label: “This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.”
Currently, the FDA only requires testing for ultraviolet B rays that cause sunburn. That’s what the familiar SPF measure is based on.
But the new regulations require testing for the more dangerous ultraviolet A rays, which can penetrate glass and are most commonly linked to wrinkles and skin cancer.
The new regulations require testing for the more dangerous ultraviolet A rays, which can penetrate glass and pose the greatest risk of skin cancer and premature aging. Now, the FDA only requires testing for ultraviolet B rays that cause sunburn. That’s what the familiar SPF measure is based on.
“For the first time, the FDA has clearly defined the testing required to make a broad-spectrum protection claim in a sunscreen and indicate which type of sunscreen can reduce skin cancer risk,” said Dr. Ronald L. Moy, president of The American Academy of Dermatology Association.
Under the new rules:
- The FDA will prohibit sunscreen marketing claims like “waterproof” and “sweatproof,” which the agency said “are exaggerations of performance.”
- The FDA also proposes capping the highest SPF value at 50, unless companies can provide results of further testing that support a higher number.
- FDA says manufacturers must phase out a four-star system currently used by some companies to rate UVA protection.
In reviewing more than 3,000 comments submitted to the agency, the FDA decided the star system was too confusing. Instead, protection against UVA should be proportional to protection against UVB, which is already measured using SPF.
The SPF figure indicates the amount of sun exposure needed to cause sunburn on sunscreen-protected skin compared with unprotected skin. For example, an SPF rating of 30 means it would take the person 30 times longer to burn wearing sunscreen than with exposed skin.
The rules were decades in the making.
FDA announced its intent to draft sunscreen rules in 1978 and published them in 1999. The agency then put the plan on indefinite hold until it could address issues concerning both UVA and UVB protection.
Continue reading on msnbc.com
