FDA Responds To AG’s Sunscreen Complaint

HARTFORD — Attorney General Richard Blumenthal announced recently that  the Food and Drug Administration (FDA) — however belatedly — has responded to his petition and issued new proposed rules to stop misleading claims by sunscreen manufacturers.

The new rules were issued after Mr Blumenthal’s May petition urging FDA action. Before officially implementing its new rules, the FDA must accept public input by November 26. Once the administration officially adopts the rules sometime after that, manufacturers will have nearly two years to comply with the stricter labeling requirements.

The new rules, as drafted, will prohibit blanket sun protection promises. The rules will also require specific rating systems for UVB and UVA protection. For UVB, the rules will require a specific SPF (sun protection factor) number and category rating of low, medium, high, and highest. For UVA, the rules require a four-star rating system in which four is the greatest protection, and, in addition, a category of low, medium, high, and highest.

In light of new scientific evidence, SPF designations cannot exceed “50+.” Waterproof claims are barred, and rules require additional instructions to consumers to reapply sunscreen. Mr Blumenthal, however, said he remains concerned that sunscreen manufacturers can continue to claim products are “water resistant” or “sweat resistant,” which consumers may be unable to differentiate from the soon-to-be banned “waterproof” claims.

“These rule changes — unacceptably late — are a significant milestone in cancer protection,” Mr Blumenthal said. “The FDA should adopt them by next summer, not later, because they are vitally important in fighting melanoma and other deadly cancers.

“The FDA, acting on my petition, has finally agreed to upgrade and implement rules to screen out pervasive deception on sunscreen labels about protection levels,” he said. “Rather than enable sunscreen manufactures to falsely promise blanket UVB and UVA protection, the FDA will soon require specific ratings — low, medium, high, and highest for UVB and UVA protection; as well as an additional four-star system for UVA.

“No longer will sunscreen makers be permitted to falsely claim that products are waterproof or all-day protection,” the attorney general added. “Blatantly deceptive claims may be blocked, but consumers must still be vigilant about protecting themselves and their families from the sun.”

Mr Blumenthal said the new system is critical for consumers to make informed decisions about sun exposure — but should be implemented no later than next summer.

“Allowing nearly two years for compliance enables damaging deception for too long. My office is preparing comments to the FDA to demand even stricter and clearer rules and shorter time for compliance,” he said.

Mr Blumenthal petitioned the FDA to act in May after the agency failed to make sunscreen standards mandatory as he urged in a letter nearly a year ago. The FDA in 1999 updated — but stayed — its sunscreen labeling rules, which would prohibit sunscreen makers from making misleading claims about their protection levels.