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PCPC Defends FDA on Sun Care Regulation

Posted: August 29, 2008

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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.”