FDA Introduces New Sunscreen Regulations

New sunscreen labeling rules introduced by the Food and Drug Administration on Tuesday will help consumers sort through the heap of sunscreen lotion products to find those that best protect against the sun’s harmful rays.

Under the new regulations, sunscreen products will have to protect against both UVA and UVB rays equally to be able to carry the “broad spectrum” label and assurance that the product protects against sunburn, premature skin aging, and skin cancer. Sunburn is primarily caused by UVB rays, while UVA rays cause skin cancer and premature aging.

The new rule will also allow broad-spectrum sunscreens with sun protection factors of 15 or higher to state they help prevent sunburn and reduce the risk of skin cancer and skin aging. Sunscreens that do not meet the broad spectrum standards or are broad-spectrum but have an SPF lower than 15 must carry warnings that state the product has not been proven to protect against early skin aging and skin cancer.

“These changes to sunscreen labels are an important part of helping consumers have the information they need so they can choose the right sun protection for themselves and their families,” Janet Woodcock, director of the FDA Center for Drug Evaluation and Research, told reporters in a telephone briefing.

The agency will ban manufacturers from claiming the product is waterproof or sweatproof; instead they may state the amount of minutes the product is water resistant without exceeding 200 minutes.

Consumers can expect to see the changes in sunscreen packages by summer 2012, though Woodcock says some manufacturers may move quickly to adopt the new regulations.

In addition to the final regulation on sunscreen labeling, the FDA introduced a proposed rule that would limit the maximum SPF value on sunscreen labels to 50+. According to Woodcock, sunscreen above SPF 50 has not been proven to be any more effective in preventing sunburn, premature skin aging, or skin cancer.

“Our guidance has been that above 30 SPF, there’s not much more protection. We think the 50 SPF limit is a good step,” Consumer Union senior scientist Dr. Michael Hansen said in a statement. “Our concern is that consumers might mistake an SPF of, say, 100 to provide twice the protection of an SPF 50, when in fact the increased protection is only incremental.”

The FDA began looking into establishing a guideline for sunscreen products in 2007 following a call from Congress.

This article was found on the National Journal at http://www.nationaljournal.com/healthcare/fda-introduces-new-sunscreen-regulations-20110614.

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