FDA proposes regulation for safe, effective sunscreen

Safer beauty products are something various brands are trying to incorporate into their product portfolio, and it’s something the Food and Drug Administration wants to do with sunscreens currently available for purchase.

The organization issued a proposed rule that would update regulatory requirements for most sunscreen products currently on the market in the United States. This action is aimed towards bringing nonprescriptive, over-the-counter sunscreens that are marketed without FDA-approved applications up to date with the latest science, the organization said.

“Broad spectrum sunscreens with SPF values of at least 15 are critical to the arsenal of tools for preventing skin cancer and protecting the skin from damage caused by the sun’s rays, yet some of the essential requirements for these preventive tools haven’t been updated in decades. Since the initial evaluation of these products, we know much more about the effects of the sun and about sunscreen’s absorption through the skin. Sunscreen usage has changed, with more people using these products more frequently and in larger amounts. At the same time, sunscreen formulations have evolved as companies innovated. Today’s action is an important step in the FDA’s ongoing efforts to take into account modern science to ensure the safety and effectiveness of sunscreens,” FDA Commissioner Scott Gottlieb, said. “The proposal we’ve put forward would improve quality, safety and efficacy of the sunscreens Americans use every day. We will continue to work with industry, consumers and public health stakeholders to ensure that we’re striking the right balance. To further advance these goals, we’re also working toward comprehensive OTC reform, which will help foster OTC product innovation as well as facilitate changes necessary for the FDA to keep pace with evolving science and new safety data.”

Part of the provisions within the proposal address active ingredient safety, dosage forms, sun protector, broad spectrum requirements and updates on how these products are labeled in order to help consumers identify key product information.

“It is important that, as this rulemaking effort moves forward and the FDA gathers additional scientific information, given the recognized public health benefits of sunscreen use, consumers continue to use sunscreen in conjunction with other sun-protection measures,” Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research said. “To help make sure this effort is successful, the FDA is looking to industry to gather the data needed to help ensure that products marketed to offer protection from the sun’s effects are safe and deliver on these promises.”

The Consumer Healthcare Products Association issused a statemenr, which reads: “FDA is clear that sunscreens contribute substantial public health benefits and that Americans should continue to use currently-marketed sunscreens confidently while this important rulemaking effort moves forward.”

“Sunscreen manufacturers and FDA are aligned on the goal of protecting the public from the harmful effects of the sun. Sunscreens save lives, that’s why millions of Americans use sunscreen products on a daily basis, relying on them to protect their health and the health of their families. We look forward to submitting comments and continuing the dialogue with FDA to reinforce the safety and efficacy of sunscreens.”