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PCPC Defends FDA on Sun Care Regulation

The Personal Care Products Council (PCPC) has defended the U.S. Food and Drug Administration (FDA) against criticisms that the body is failing to regulate sun care products properly.

Critics have accused the FDA of stalling new regulation that was proposed in August 2007, including Samuel Epstein from the Cancer Prevention Coalition who earlier this month accused the FDA of ignorance and indifference. In addition, he quoted two senators, Jack Reed and Christopher Dodd, who are also calling on the FDA to speed up their actions in the area.

However, John Bailey from the PCPC believes much of the delay is due to technical difficulties behind UVA testing. In addition, he adds that consumers should have confidence in a regulatory system that ensures products work and work in the way they are expected to work.

UVA protection

Much of the controversy surrounds the ability of sun care products to protect the consumer against UVA rays, and how to communicate the level of protection to the consumer.

According to Epstein, organic sunscreens do not protect against the longer wavelength UVA rays—a claim that Bailey refutes. “A number of ingredients can provide UVA protection, including avobenzone and the recently approved combination avobenzone, ecamsule and octocrylene. To say there is no protection against UVA is misleading the consumer,” he said. In addition, he noted that a number of ingredients were awaiting approval by the FDA.

Sunscreens are regulated as over-the-counter medicines in the United States, and obtaining approval can be a costly process both in time and money. Indeed, Chris Flower from the Cosmetic Toiletry and Perfumery Association, the U.K. cosmetics trade association, suggested that the significant investment needed to gain approval for ingredients in the United States may deter some manufacturers from attempting to develop new ingredients.

Bailey however did not agree, stating that in his opinion the portfolio of ingredients available to sun care product formulators was very similar for the two regions. “Bringing a new active ingredient to market is a very intensive process in Europe and the United States,” he said.

Technical difficulties surround UVA testing

When questioned on the delay to the proposed FDA regulations, Bailey said much of it was due to technical difficulties and uncertainty within the scientific community regarding UVA protection. Analyzing the protection given by a product against UVA rays is much more complicated than for UVB, he said. “UVA penetrates much deeper, and doesn’t produce the same visible sunburn effects,” he explained. “If you are going to measure how well you are being protected you have to decide on a marker or indicator of damage. The methods are still evolving and this is one of the reasons why the FDA has deferred.”

Regarding a timeframe for the FDA decision, Bailey said he expected a decision to be made within a year and a half, adding, however, that it is always difficult to predict the pace with which regulatory authorities work., August 26, 2008



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