CTFA Statement on FDA’s Proposed Amendments

The Cosmetic, Toiletry, and Fragrance Association (CTFA) issued the following statement in response to the August 23 announcement by the U.S. Food and Drug Administration (FDA) on proposed amendments of a final monograph for sunscreen drug products for over-the-counter human use:

“We are pleased that FDA has proposed these new sunscreen regulations, and we look forward to working with the agency as it develops final rules that include both UVB and UVA standards for the benefit of consumers.  It is important to note that the FDA decision to accept SPF sunscreen protection levels of up to at least 50 plus will provide a substantial public health benefit for American consumers. We have long urged the FDA to take action to ensure that consumers have access to this critical protection information on sunscreen product labels.

“While the final rulemaking is ongoing, there are currently strong FDA safety and effectiveness regulations that govern the manufacture and marketing of all sunscreen products.  The FDA requires significant safety and efficacy data on every active ingredient before it is approved for use in a sunscreen product. The FDA has broad authority to inspect manufacturers, require strict manufacturing practices, and enforce rigorous, science-based regulations to ensure that sunscreen products are safe and effective for consumers.  Consumers should have a high level of confidence that sunscreen products are safe and effective when used as directed.

“We have worked closely with the FDA to support science-based regulations that protect consumers, and ensure sunscreens are safe and effective.  Sunscreens are an important tool for consumers and health professionals to prevent skin cancer, premature skin aging and other harmful effects of the sun.   We join the Academy of Dermatology, the Skin Cancer Foundation, Centers for Disease Control, FDA and other health professionals in urging consumers to minimize their sun exposure as part of their personal safe sun strategy. This includes all of the following: limiting outdoor activities between 10:00 a.m. – 4 p.m. when exposure to UVA/UVB rays is the highest, wearing protective clothing, and using sunscreens.”