FDA Announces New Rules for Sunscreen

FDA sunscreen labeling regualtionsAfter 33 years of consideration, the FDA has issued new guidelines for sunscreen labeling which have been designed to give consumers more information to help reduce the risk of skin cancer and early aging. The regulations will aim to prevent companies from making false promises about the levels of protection they provide.

The new rules laid out by the FDA require that sunscreens must protect equally against both UVB and UVA sun radiation in order to earn the newly coveted designation of offering “broad spectrum” protection. Both types of radiation contribute to sunburn, skin cancer, and premature skin aging; however, sunburn is primarily caused by UVB radiation.

No More “Waterproof” Sunscreens

The new rules, which go into effect in a year, prevent manufacturers from using “waterproof”, “sweatproof” and “sunblock” on labels and in marketing material. Such claims are false, states the FDA.  Manufactures will only be allowed to claim in minutes the amount of time in which the product is water resistant, depending on standardized FDA tests.

Under the new labeling, only sunscreens that are classified as “Broad Spectrum” and have a sun protection factor, or SPF, of 15 or higher will be allowed to maintain that they help prevent sunburn and reduce the risks of skin cancer and early skin aging. However, sunscreens that have SPF between 2 to 14 can be labeled as Broad Spectrum, if they pass the required test.

“FDA has evaluated the data and developed testing and labeling requirements for sunscreen products, so that manufacturers can modernize their product information and consumers can be well-informed on which products offer the greatest benefit,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “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.”

Warning! Does Not Help Prevent Skin Cancer

Any sunscreen that fails to offer Broad Spectrum, or that is Broad Spectrum but has an SPF between 2 to 14 must include a warning stating that the product has not been shown to help prevent skin cancer or early aging.

The FDA also released a proposed rule that would limit the maximum SPF value on sunscreen labels to “50+”, because there is not sufficient data to show that products with SPF values higher than 50 provide greater protection. However, it remains only a proposal for which the agency will seek further comment.

Even though the FDA did not rule on the use of SPF values greater than 50, dermatologists and industry advocates are still thrilled. But not all.

Advocates Speak Out

The Environmental Working Group, a non-profit organization who has been the main voice in fighting for stricter FDA sunscreen guidelines, feels the new rules did not go far enough to fully protect the consumer.

“The agency’s weak standard for UVA protection will not allow consumers to differentiate between superior and mediocre products,” said David Andrews, Ph.D, a senior scientist with Environmental Working Group. “FDA’s rule will allow most products on the U.S. market to use the label ‘broad spectrum sunscreen,’ even though some will not offer enough protection to assure Americans they can stay in the sun without suffering skin damage from invisible UVA radiation. For that reason, about 20 percent of products that meet the new FDA standards could not be sold in Europe, where UVA standards are strict.”

The FDA continues to allow oxybenzone, retinyl palmitate and several other ingredients in sunscreens despite EWG scientists’ concerns about their toxicity. The FDA is currently re-examining that safety information available for approximately 17 active sunscreen ingredients approved for use in the US. Although, the FDA claims that there is no information to suggest that they are not safe.

The new regulations will become effective for most manufacturers in one year.  Manufacturers with annual sales less than $25,000 have two years to comply.

Click here for an image and description of the new FDA sunscreen labeling requirements.

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Posted by on Jun 14th, 2011 and filed under NEWS. You can follow any responses to this entry through the RSS 2.0. You can skip to the end and leave a response. Pinging is currently not allowed.

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