In a move that could ultimately prevent some cases of skin cancer, the FDA has issued new regulations for the testing and labeling of sunscreens to help consumers choose products that offer the best protection against skin damage caused by excessive sun exposure.
The final rule establishes a standard test for over-the-counter (OTC) sunscreen products that will determine which such products can be labeled “broad spectrum.” This designation indicates that the particular sunscreen provides protection against both ultraviolet A (UVA) and ultraviolet B (UVB) radiation, both of which can cause skin cancer as well as sunburn and premature aging of the skin. (UVC rays are also dangerous, but they are absorbed by the ozone layer before reaching the ground.) Approximately 65% to 90% of melanomas alone are caused by exposure to UV light (www.cdc.gov/cancer/skin/basic_info/index.htm).
The FDA Division of Nonprescription Regulation Development has been developing and testing labeling requirements for sunscreen products for decades, but only recently have the data become sufficient to establish an accurate and reliable test for broad-spectrum UV protection.
Sunscreen products that protect against all types of sun-induced skin damage will be labeled not only broad spectrum but also SPF 15 (or higher). In combination with the broad-spectrum properties and other sun-protection measures, an item with a Sun Protection Factor of 15 or higher can reduce the risks of skin cancer and premature skin aging (wrinkling). A sunscreen that is not designated broad spectrum or that has an SPF value of 14 or lower has only been shown to help prevent sunburn, not skin cancer or early skin aging. A warning on the packaging will warn consumers of this.
Under the final rule, manufacturers will no longer be allowed to claim that their products are waterproof or sweatproof, or are a sunblock, because these claims overstate their effectiveness, according to the FDA. Sunscreen packaging also will not be able to claim to provide sun protection for more than 2 hours without reapplication or to provide protection immediately after application without submitting data to support these claims and obtaining FDA approval.
The final rule will take effect by June 2012 for most manufacturers (those with annual sales less than $25,000 will have 2 years to comply), but the agency expects that some sunscreen labels will change sooner.
The FDA also released three additional regulatory documents along with the final rule:
• A proposed rule that limits the maximum SPF value on sunscreen labels to 50+ because no sufficient data show that products with higher SPF values provide greater protection for users than products with SPF values of 50
• An advanced notice of proposed rulemaking for dosage forms that allocates a period of time for the public to submit requested data addressing the effectiveness and the safety of sunscreen sprays and to comment on possible directions and warnings for sprays
• A draft enforcement guidance for industry that outlines information to help sunscreen product manufacturers understand how to label and test their products in light of the new final rule and other regulatory initiatives. ONA