FDA Delays New Sunscreen Labeling Rules

The FDA has granted sunscreen manufacturers a 6-month extension to comply with new labeling rules in order to avoid having mislabeled sunscreens on the shelves this summer or a product shortage.

New rules announced by the FDA last summer require sunscreens with less than SPF-15 sun protection to carry warnings about the product’s shortcomings so consumers don’t think they’re getting more sun protection than they actually are.

Manufacturers can no longer refer to their products as “sunblock,” “waterproof” and “sweatproof,” or as providing “all day protection” - claims that the FDA says overstate a sunscreen’s abilities.

The rule allows makers of lotions and sprays that are at least SPF-15 to carry labels stating they protect against sunburn, early signs of aging, and skin cancer.

Sunscreens that meet the FDA’s criteria for adequate sun protection levels and for protecting against ultraviolet B rays as well ultraviolet A rays, which contribute to skin cancer, can label themselves as “broad spectrum.”

Those changes were supposed to take effect June 17, but the FDA is pushing that back to Dec. 17, 2012. And small companies that have total annual sales of less than $25,000 will get an extra year beyond that.

An extension was requested by the cosmetic and personal care and over-the-counter drug industries. The two trade groups told the FDA that complying with the agency’s new label rules requires a significant disruption in manufacturing processes.

In addition, some products must undergo testing to determine if they can legally make the claim that their product protects against both UVB and UVA rays. That additional broad-spectrum testing will take time, the companies said, according to a notice in the Federal Register.

The FDA was persuaded. Shelly Burgess, a spokeswoman for the agency, said that although some sunscreen manufacturers have already implemented the new testing and labeling requirements for some products, others would be unable to comply with the final rule by June.

The agency was concerned that sunscreen makers who couldn’t complete broad-spectrum testing in time would take those products off the shelves, or else not label them as broad-spectrum.

“FDA concluded that this could result in denying consumers valuable broad-spectrum labeling information and possibly limiting the quantities of sunscreens currently available in the marketplace, at least in the short term,” Burgess said in an email. “This was not desirable from a public health perspective.”


By Emily P. Walker, Washington Correspondent, MedPage Today

Provided by ArmMed Media