FDA Announces Labeling Changes and Effectiveness Testing for OTC Sunscreen Products

Jun 21, 2011   

After decades of deliberation, the U.S. Food and Drug Administration (FDA) announced changes to the requirements for over-the-counter (OTC) sunscreen products. In 1978, the FDA began developing new rules for the regulation of sunscreen products. Now, over thirty years later, the FDA issued a Final Rule as part of its “ongoing efforts to ensure that sunscreens meet modern-day standards for safety and effectiveness” for sunscreens sold without a prescription. The FDA issued four regulatory documents: a Final Rule, a Proposed Rule, an Advance Notice of Proposed Rulemaking, and a Notice of Availability of Guidance Document for Industry (ANPR). The new requirements under the Final Rule will take effect by the summer of 2012.

After reviewing current scientific data, the FDA established a standard broad spectrum test procedure for OTC sunscreens and developed new labeling requirements for marketing sunscreen products. While the current rule focuses almost exclusively on protection against only ultraviolet B (UVB) radiation from the sun, the new Final Rule addresses protection against UVB rays and early skin aging and skin cancer caused by exposure to ultraviolet A (UVA) rays. This new standard broad spectrum test essentially measures the level of UVA radiation protection in relation to the amount of UVB radiation protection. Products are required to pass this broad spectrum test in order to be labeled as “Broad Spectrum” sunscreens. This new designation is intended to help consumers make more informed decisions when selecting sunscreens.

The new rule will also affect the labeling of “Sun Protection Factor” (SPF), the value that indicates the overall amount of protection provided by sunscreen, and claims for use. When used as directed, “Broad Spectrum” sunscreens with SPF values above 15 can help to protect against sunburn, skin cancer, and early skin aging. Under the FDAs new Rule, only these products may claim to reduce the risk of skin cancer and early skin aging if used as directed with other sun protection measures. Products with SPF values below 15, however, are prohibited from using “Broad Spectrum” on their labels and can only claim to help prevent sunburn.

In addition to “Broad Spectrum,” SPF, and use claims labeling, the Final Rule also outlines requirements for water resistance claims and “waterproof,” “sweatproof,” or “sunblock” claims. The new labeling rules will require manufacturers to indicate on the front label whether the sunscreen product is effective for 40 minutes or 80 minutes while swimming or sweating, or if the product is not water resistant, to direct consumers to use a water resistant sunscreen if swimming or sweating. The Rule provides that sunscreen manufacturers cannot label products as “waterproof,” “sweatproof,” or identified as a “sunblock” because these claims “overstate their effectiveness.” As part of the new labeling requirements, manufacturers will also be required to include drug facts on their labels, which will provide consumers with easy access to the products active and inactive ingredients and detailed directions on proper usage.

The FDA is also interested in obtaining additional information and data about sunscreen in other dosage forms, such as sprays, lotions, oils, sticks, gels, butters, ointments, creams, and pastes. The FDA seeks information about the safety and effectiveness of these alternative dosage forms of sunscreen because “the record (data and information) about sunscreens in spray dosage forms is not comparable to that for sunscreens in other dosage forms.” The ANPR serves as an invitation to the public to comment on regulations the FDA may pursue in its future rulemaking.

By creating regulations that require testing and limit misleading claims, the FDA has demonstrated its increased effort to strengthen labeling regulation of sunscreen products. Despite these improvements, some continue to question whether the FDA could have done more. Advocacy groups, like Environmental Working Group (EWG), continue to pressure the FDA to further tighten safety standards for sunscreen products sold in the United States. “The Agencys weak standard for UVA protection will not allow consumers to differentiate between superior and mediocre products,” a representative of EWG said. EWG claims that the FDAs rule is not stringent enough and that “about 20 percent of products that meet the new FDA standards could not be sold in Europe, where UVA standards are strict.” According to the FDA, however, “the ingredients in sunscreens marketed today have been used for many years and the FDA does not have any reason to believe these products are not safe for consumer use.” The FDA is currently reexamining the safety information available for active ingredients included in sunscreens marketed today.

The FDAs decision to make changes to the labeling and testing of sunscreen products comes less than one year after it released a Consumer Health Information publication warning about the dangers of exposure to devices such as sunlamps and tanning beds. As we reported here, the FDA announced its concern about the use of both UVA and UVB radiation in tanning salons because of the known risks associated with exposure, such as skin damage, early skin aging, and skin cancer. These concerns are the very same ones that prompted the FDA to make labeling changes to sunscreen products this year. While the FDA has yet to release new regulations governing sunlamps and tanning beds, the new changes to sunscreen product labeling may serve as an indication of the FDAs shift towards stricter oversight and regulation of products and devices associated with UVA and UVB exposure.

Fuerst Ittleman will continue to monitor the FDAs rules for labeling and effectiveness testing of sunscreen products and other products or devices related to UVA or UVB exposure. For more information, please contact us at contact@fidjlaw.com.