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FDA Releases a Final Sunscreen Rule
Posted: June 16, 2011
page 2 of 2
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.