FDA Releases a Final Sunscreen Rule

Jun 16, 2011 | Contact Author | By: Katie Schaefer
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Title: FDA Releases a Final Sunscreen Rule
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After nearly a four-year wait for an action on sunscreens, the US Food and Drug Administration (FDA) has issued a Final Sunscreen Rule, which addresses the testing and labeling of OTC sunscreen products. In addition to the Final Rule, the FDA published a Draft Enforcement Guidance for Industry document, further explaining the Final Rule; a Proposed Rule on sunscreens with SPFs greater than 50+; and an Advance Notice of Proposed Rulemaking (ANPR), recognizing and requesting information about alternative dosage forms of sunscreen products such as sprays, powders, wipes and shampoos.

The Final Rule requires a Broad-spectrum Test, which tests a product's breadth of UVA protection and UVB protection coupled with the SPF value, before a "Broad-spectrum SPF [Value]" claim can be printed on the product's label. This test measures the product's critical wavelength (cw), where sunscreens with a cw of at least 370 are considered broad-spectrum. If sunscreens do not pass this test, manufacturers cannot print a broad-spectrum claim on their label.

In addition, products with a broad-spectrum protection of SPF 15 or higher can claim to reduce the risk of skin cancer or early aging if used as directed. Sunscreens that do not pass the broad-spectrum test (<370 cw) and broad-spectrum sunscreens with an SPF value between 2 and 14 can only claim to help prevent sunburn and must carry a warning on their label that reads "Skin Cancer/Skin Aging Alert."

Manufacturers cannot label sunscreens as "waterproof" or "sweatproof," or identify their products as "sunblocks" because these claims overstate their effectiveness. Sunscreens also cannot claim to provide sun protection for more than 2 hr without re-application, or claim to provide immediate sun protection without data supporting these claims and FDA approval. Manufacturers, however, can claim "water-resistant" by labeling the front of the product with a 40 min. or 80 min. protection limit for activities such as swimming or sweating based on standard testing. Sunscreens that are not water-resistant must instruct consumers to use a water-resistant sunscreen if swimming or sweating.

Finally, all sunscreens are required to include standard "Drug Facts" information on the back and/or side of the container.

Action on UV filters and combinations has been deferred penting Generally Recognized as Safe and Effective (GRASE) determinations.

In relation, if the FDA's Proposed Rule on sunscreens with SPFs greater than 50 is approved, the SPF value on sunscreen labels would be limited to SPF 50+. The FDA noted that there is not sufficient data to show that sunscreens with SPF values higher than SPF50+ provide greater protection for consumers. This proposed regulation is available for public comment. Those companies wishing to claim SPF values higher than 50+ must submit independent clinical test support that is validated and repeatable. They may also provide additional data to support their SPF protection claim. Without evidence that sunscreens with SPF values higher than 50+ provide additional protection to the consumer, the FDA will set a maximum of a SPF 50+.

While the Personal Care Products Council was elated that the FDA published its Final Rule, it expressed concern regarding the compliance deadline.The compliance date for all sunscreen manufacturers is June 18, 2012, with the exception of manufacturers with annual sales less of than $25,000, who must comply by June 17, 2013.

“We are evaluating FDA’s specified implementation period, but we are concerned about manufacturers’ ability to make the required testing and labeling changes in only 12 months given the thousands of products on the market, the limited number of testing facilities, and the time needed to redesign product labeling," noted Farah Ahmed, the chair for the sunscreen task force of the PCPC, in a press release by the organization. "It is unusual for FDA to require such a short implementation period for a rule making of this scope. Manufacturers typically require at least two years to design and implement broad-scale, product-wide labeling changes."

Although this Final Rule on sunscreens is a step in the right direction, the industry is still waiting on a number of steps from the FDA before a Final Monograph is produced.