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Group Calls on FDA to Scrutinize Sunscreens, Industry Counters

The Personal-Care Products Council, citing an FDA ruling, said the ingredients do not boost SPF values and are often used for other skin health reasons.

WASHINGTON — The Environmental Working Group has sent a letter to the head of the Food & Drug Administration calling on the agency to investigate whether ingredients such as anti-inflammatories that are used in sunscreens could boost SPF readings without providing proper protection to consumers.

The EWG is making the claim that many sunscreens containing anti-inflammatories, antioxidants and other ingredients might “mask” symptoms of skin reddening and sunburns, thereby encouraging people to stay in the sun longer and be exposed to harmful ultraviolet rays.

The FDA said in 2011 that it was “unlikely” that anti-inflammatory ingredients affect SPF values [and reduce skin redness] and declined to test them at the time. In addition, the Personal-Care Products Council, the industry’s key trade association representing more than 600 companies, has argued the use of such ingredients do not influence SPF values.

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In a seven-page letter to FDA commissioner Robert M. Califf, three EWG officials raised concerns about “sunscreen ingredients that may enable manufacturers to advertise higher SPF values for their over-the-counter sunscreen products without offering users truly enhanced protection from UVA and UVB rays.”

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The environmental health organization is asking the FDA to step up scrutiny of specific sunscreens with high SPF values. Specifically, it is asking the FDA to investigate the use of anti-inflammatories, antioxidants and other ingredients in sunscreen products, which it claimed could “increase SPF measurements without shielding the body from UV light.”

In its recent sunscreen guide, the EWG said it found anti-inflammatory ingredients in the majority of sunscreen products on the market.

The group is also challenging the FDA ruling in 2011 and calling on the agency to finalize a rule on sunscreens that would cap SPF values at 50. The group claimed that the number of products making SPF claims of 70 or greater has “increased significantly over the last decade.”

It noted  “the number of active ingredients available to U.S. manufacturers to reduce UVA exposure have remained the same.”

“Something is going on when you see such dramatic increases, whether that’s through the use of additional inactive ingredients or stretching the limits of approved testing methods,” said David Andrews, an EWG senior scientist. “It’s imperative that the FDA overhaul its sunscreen testing and marketing requirements to ensure SPF claims are accurate and consumers get the protection they expect.”

An FDA spokeswoman said, “While the FDA is aware of recent articles on sunscreen products (including Consumer Reports and EWG), we cannot speculate on why there are reported differences between SPF values in testing and those on product labels. Manufacturers of sunscreen drug products are responsible for the quality of their products and for determining the SPF reported on the labels for their products by following specific test methods set forth in FDA regulations. When performed according to current regulatory requirements, the FDA’s established SPF test method demonstrates a sunscreen’s effectiveness in helping prevent sunburn.”

The PCPC dismisses the arguments made by EWG, pointing to the FDA’s ruling in 2011 and noting that the ingredients are often used for other purposes in sunscreens.

Beth Lange, chief scientist for the PCPC said in an e-mail: “There has been a myth that sunscreens may be providing sunburn reduction via anti-inflammatory mechanisms, in addition to the UV filtering mechanism.”

She pointed to two human clinical trials that have been conducted in the past.

“Histological damage to sunscreen protected skin was found to be directly proportional to the UV exposure through the sunscreen without any “anti-inflammatory” depression of the erythema [skin redness] response,” Lange said. “In fact, the UV-induced erythema response is extremely difficult to suppress with topical applications.”

Lange added that some sunscreen products also include antioxidants such as skin health conditioning ingredients.  “These are cosmetic ingredients that do not contribute to SPF,” she said.

“Moisturizers and antioxidants are sometimes included in sunscreen products as consumers often seek skin health benefits,” Lange said. “These types of products are considered both cosmetic and drug products per the FDA and must comply with the requirements for both cosmetics and drugs.”