FDA advances new proposed regulation to make sure that sunscreens are safe and effective

SILVER SPRING, Md., Feb. 21, 2019 /PRNewswire/ -- The U.S. Food and Drug Administration today issued a proposed rule that would update regulatory requirements for most sunscreen products in the United States.

This significant 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, and sun protection factor (SPF) and broad-spectrum requirements. It also proposes updates to how products are labeled to make it easier for consumers to identify key product information.

"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," said FDA Commissioner Scott Gottlieb, M.D. "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 final 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 last twenty 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.

In the proposed rule, the FDA makes the following proposals for sunscreens marketed without FDA-approved applications:

    --  Proposes that, of the 16 currently marketed active ingredients, two
        ingredients - zinc oxide and titanium dioxide - are GRASE for use in
        sunscreens; two ingredients - PABA and trolamine salicylate - are not
        GRASE for use in sunscreens due to safety issues. There are 12
        ingredients for which there are insufficient safety data to make a
        positive GRASE determination at this time. To address these 12
        ingredients, the FDA is asking industry and other interested parties for
        additional data. The FDA is working closely with industry and has
        published several guidances to make sure companies understand what data
        the agency believes is necessary for the FDA to evaluate safety and
        effectiveness for sunscreen active ingredients, including the 12
        ingredients for which the FDA is seeking more data.
    --  Proposes that dosage forms that are GRASE for use as sunscreens include
        sprays, oils, lotions, creams, gels, butters, pastes, ointments and
        sticks. Powders are proposed to be eligible for inclusion in the
        monograph, but additional data are requested before powders can be
        included in the monograph. Wipes, towelettes, body washes, shampoos and
        other dosage forms are proposed to be categorized as new drugs because
        the FDA has not received data showing they are eligible for inclusion in
        the monograph.
    --  Proposes to raise the maximum proposed SPF value on sunscreen labels
        from SPF 50+ to SPF 60+.
    --  Proposes to require sunscreens with an SPF value of 15 or higher to also
        provide broad spectrum protection and that, for broad-spectrum products,
        as SPF increases, the magnitude of protection against UVA radiation also
        increases. These proposals are designed to ensure that these products
        provide consumers with the protections that they expect.
    --  Proposes new sunscreen product label requirements to assist consumers in
        more easily identifying key information, including the addition of the
        active ingredients on the front of the package to bring sunscreen in
        line with other OTC drugs; a notification on the front label for
        consumers to read the skin cancer/skin aging alert for sunscreens that
        have not been shown to help prevent skin cancer; and revised formats for
        SPF, broad spectrum and water resistance statements.
    --  Proposes to clarify FDA's expectations for testing and record keeping by
        entities that conduct sunscreen testing to ensure that the FDA can
        assess industry compliance with regulations.
    --  Proposes that products that combine sunscreens with insect repellents
        are not 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," said 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. Sunscreens are only one element of a skin cancer prevention strategy. Other sun protective behaviors include: wearing protective clothing that adequately covers the arms, torso and legs; wearing sunglasses and a hat that provides adequate shade to the whole head; and seeking shade whenever possible during periods of peak sunlight.

The FDA is seeking public comment on the proposed rule and will consider comments provided as the agency works towards developing a final rule.

For more information:

    --  Proposed Rule: Sunscreen Drug Products for Over-The-Counter-Human Use
    --  Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA actions
        to keep consumers safe from the harmful effects of sun exposure, and
        ensure the long-term safety and benefits of sunscreens
    --  FDA: Sunscreen: How to Help Protect Your Skin from the Sun
    --  From our perspective: Helping to ensure the safety and effectiveness of
        sunscreens

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

View original content to download multimedia:http://www.prnewswire.com/news-releases/fda-advances-new-proposed-regulation-to-make-sure-that-sunscreens-are-safe-and-effective-300799690.html

SOURCE U.S. Food and Drug Administration