FDA Considers New Sunscreen Labeling Rules

29 Jun

Advertising Specialty Institute (ASI) sent this note out this afternoon. We are reprinting with links for our readers. We are also awaiting comment from Tom Whaley, CEO of Aloe Up Sun & Skin Care Products, one of the leaders in our industry for eco-friendly sun products.

FDA Considers New Sunscreen Labeling Rules

The U.S. Food and Drug Administration (FDA) is considering implementing new guidelines for retail and promotional sunscreen later this year, potentially updating standards that have been in place since 1978. As part of its proposals, the FDA is looking at stricter rules to prevent misleading labeling, while also developing a rating system to measure a sunscreen’s effectiveness against ultraviolet A rays. “The FDA has been talking about new labeling for sunscreen for a dozen years,” says Bijan Hosseini, president of HandsFree Sunscreen (asi/59523). “I do think a rating system would be effective because of the technology that exists today.”

If the current proposals become regulations, companies would be banned from using terms like “sunblock” and “all-day protection” on labels. The maximum sun protection factor (SPF) that a product could claim would be capped at 50+ and a multi-star ranking system would be established, with a one-star rated sunscreen offering the least protection and a four-star rated sunscreen offering the most. “I think you’ll see a move to improve formulas,” says Larry Wilhelm, CEO of Custom HBC (asi/47934). “Sunscreens will be updated to provide broader spectrum coverage. We’ve done that with our sunscreen over the last year in anticipation of these rules.”

Since 2007, when the latest proposals were first discussed, the FDA has received thousands of comments from companies, including large retailers that are lobbying for testing standards that would benefit their individual product lines. Within the promotional market, the real concern about the proposals relates to the scope of the enforcement. “The FDA is vigilant and very thorough,” says Mel Ellis, president of HumphreyLine (asi/62050). “The system for domestically sourced product is sophisticated. The problem is there’s no apparatus for international sourcing.”

Besides updating sunscreen guidelines, the FDA is also considering approving the use of Tinosorb M, a popular ingredient in sunscreens found in Europe. Tinosorb M and similar ingredients appear to be effective against ultraviolet A rays, which cause wrinkles and cancer. Compliant and improved sunscreen products could be on the American market by 2012, according to an FDA spokesman.

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