FDA Institutes New Sunscreen Rules

The U.S. Food and Drug Administration (FDA) just announced that sunscreen products meeting modern efficacy standards may be labeled with new information to help consumers find products that, when used with other sun protection measures, reduce <"http://www.yourlawyer.com/practice_areas/diseases">skin cancer risks and early skin aging, and help prevent sunburn.

The final regulation allows sunscreen products that pass the agency’s test for protection against ultraviolet A (UVA) and ultraviolet B (UVB) rays to be labeled “Broad Spectrum.” Both UVB and UVA radiation contribute to sunburn, skin cancer, and premature skin aging; sunburn is primarily caused by UVB radiation.

The new labeling will allow sunscreens labeled as both Broad Spectrum and SPF 15 (or higher) to state that when used regularly, as directed, and in combination with other sun protection measures, they will help prevent sunburn, reduce the risk of skin cancer, and reduce the risk of early skin aging, said the FDA. In other words, products with SPF values between 2 and 14 may be labeled as Broad Spectrum if they pass the required test, but only products that are labeled both as Broad Spectrum with SPF values of 15 or higher may state that they reduce the risk of skin cancer and early skin aging, when used as directed.

Any product that is not Broad Spectrum, or that is Broad Spectrum but has an SPF between 2 to 14, will be required to have a warning stating that the product has not been shown to help prevent skin cancer or early skin aging.

New regulations will become effective for most manufacturers in one year; manufacturers with annual sales under $25,000 have two years to comply.

“FDA has evaluated the data and developed testing and labeling requirements for sunscreen products, so that manufacturers can modernize their product information and consumers can be well-informed on which products offer the greatest benefit,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “These changes to sunscreen labels are an important part of helping consumers have the information they need so they can choose the right sun protection for themselves and their families. Most skin cancers are caused by sun exposure. FDA encourages consumers to protect themselves,” Woodcock said. “Not only should consumers regularly apply and reapply sunscreens with Broad Spectrum and SPF of 15 or higher, they should also limit sun exposure,” she added.

The FDA, which said it is reexamining the safety information available for active ingredients included in current sunscreen products, also released three additional regulatory documents: A Proposed Rule, an Advance Notice of Proposed Rulemaking (ANPR) for Dosage Forms, and a Draft Enforcement Guidance for Industry.

• Proposed Rule: The maximum SPF value on sunscreen labels will be “50+” because sufficient data does not prove that products with higher values provide greater protection. The proposal allows for data submission to support higher SPF values in the final rule.

• ANPR: Includes a time frame for data submission that addresses sunscreen spray efficacy and safety and to comment for potential directions and warnings for sprays that the FDA may pursue in the future, among other issues on dosage forms for sunscreens.

• Draft Enforcement Guidance for Industry: Outlines information to help sunscreen makers understand how to label and test products under the new final rule and other regulatory initiatives.

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