The U.S. Food and Drug Administration (FDA) has issued a proposed rule that would update regulatory requirements for most sunscreen products sold in the United States. The action is aimed at bringing nonprescription, over-the-counter (OTC) sunscreens that are marketed without FDA-approved applications up to date with the latest science to better ensure consumers have access to safe and effective preventative sun care options. Among its provisions, the proposal addresses sunscreen active ingredient safety, dosage forms, sun protection factor (SPF) and broad-spectrum requirements. It also proposes updates on how products are labeled to make it easier for consumers to identify product information.
Sunscreen is sold by multiple suppliers within the promotional products industry and sales make up part of the 2.3 percent of distributor sales reported in the health/beauty and hygiene category.
“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,” says FDA Commissioner Scott Gottlieb, M.D. “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. 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.”
The agency is issuing this proposed rule to put into effect monograph regulations for OTC sunscreen drug products as required by the Sunscreen Innovation Act. OTC monographs establish conditions under which the FDA permits certain OTC drugs to be marketed without approved new drug applications because they are generally recognized as safe and effective (GRASE) and not misbranded. Over the past 20 years, new scientific evidence has helped to shape the FDA’s perspective on the conditions, including active ingredients and dosage forms, under which sunscreens could be considered GRASE.
“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,” says Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “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.”
As this rulemaking process proceeds, OTC sunscreen products will continue to be available on the market for consumer use. The FDA is seeking public comment on the proposed rule and will consider comments provided as the agency works toward developing a final rule. For more on the FDA’s sunscreen proposals, click here.
