The Food and Drug Administration (FDA) has announced new rules and proposals to help consumers make more informed decisions about sunscreens. Intended to help reduce skin cancer and early skin-aging risks, the changes include a final rule, rulemaking proposals and draft industry guidance.
To strengthen labeling standards, the final rule prohibits sunscreen manufacturers from labeling their products with “broad spectrum” claims unless the products protect against both ultraviolet A (UVA) and ultraviolet B (UVB) sunlight. Effective June 18, 2012, the rule will allow manufacturers to market “broad spectrum” sunscreens with SPF values of 15 or higher as products that “if used regularly, as directed, and in combination with other sun protection measures will help prevent sunburn, reduce the risk of skin cancer, and reduce the risk of early skin aging.”
“Any product that is not broad spectrum, or that is broad spectrum but has an SPF between 2 and 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,” and can be labeled to help prevent sunburn only, according to FDA. Manufacturers with annual sales less than $25,000 will have two years to comply with the new regulations, which also prohibit claims that sunscreens are waterproof. Water-resistance label claims must describe how long the product will be effective while swimming or sweating.
FDA’s proposed rule “would limit the maximum SPF value on sunscreen labels to ‘50+,’” due to insufficient data showing that products with higher values provide greater protection than products with SPF values at 50. The agency requests comments and data to support adding higher SPF values in the final rule by September 15, 2011.
FDA’s advance notice of proposed rulemaking (ANPR) will “allow the public a period of time to submit requested data addressing the effectiveness and the safety of sunscreen sprays and to comment on possible directions and warnings for sprays that FDA may pursue in the future.” Comments are requested by September 15.
The draft guidance for industry “outlines information to help sunscreen product manufacturers understand how to label and test their products in light of the new final rule and other regulatory initiatives,” according to FDA. FDA requests comments by August 16, 2011. See Federal Register, June 17, 2011.