FDA’s Sunscreen Guidance outlines safety and effectiveness data recommended for additional active ingredients

Posted on November 22, 2016 by FDA Voice

By: Theresa M. Michele, M.D.

American consumers rely extensively on over-the-counter (OTC) sunscreens to help prevent sunburn. Certain sunscreens are also used, along with other protective measures, to reduce the risks of skin cancer and early skin aging caused by the sun.

The vast majority of sunscreens marketed in the United States are marketed under a regulatory framework called the OTC Monograph System. But they cannot contain active ingredients that FDA has not determined to be generally recognized as safe and effective (GRASE) for OTC sunscreen use, unless the sunscreen product has an approved FDA marketing application in place.

The Sunscreen Innovation Act (SIA) of 2014 established an alternative process for the review of safety and effectiveness of additional active ingredients for use in sunscreens, and set deadlines for reviewing the ingredients and taking certain other actions. But it did not eliminate the need for a GRASE determination before reaching the market without an approved marketing application, and it did not relax the scientific standards for these products. Further, the FDA’s review deadlines are only triggered after the data has been submitted to the agency.

Since the SIA was passed, FDA has met all of the deadlines for implementing this complex legislation. That includes inviting public comment on our actions, holding requested meetings with industry, issuing draft and final guidances, issuing proposed and final rulemaking required to date, and issuing a report to Congress on our progress.

When the SIA was enacted, eight sunscreen active ingredients were already under evaluation. The FDA has issued proposed sunscreen orders identifying data we believe is necessary for the agency to make a positive GRASE determination on those within the SIA-required time frame, but has yet to receive the additional data we requested.

Today, as required by the SIA, we released a final guidance document that details the Agency’s current thinking on the specific information we believe we need from sunscreen manufacturers or other interested parties before we can determine that a sunscreen active ingredient is GRASE for use in OTC sunscreens. This guidance will also help clarify FDA’s outstanding requests for additional safety and effectiveness data on the eight active ingredients, including the importance of skin absorption data.

Sunscreens are intended to be used on a regular basis in liberal amounts and over large portions of the body surface whenever consumers are exposed to the sun. And yet some sunscreen active ingredients may be absorbed through the skin into the body, making it important to complete studies in humans to determine whether, and to what extent, consumers’ use of sunscreen products as directed may result in unintended, chronic, systemic exposure to these ingredients.

The guidance recommends that industry provide data from a Maximal Usage Trial or MUsT, to help determine if the ingredient is absorbed into the blood and at what level. This type of study is designed to capture the effect of maximal use on absorption into the blood. It is the same standard used by FDA for all topically applied drugs, and especially for drugs that are used routinely over the course of one’s life.

Sunscreens are a valuable tool for sun safety and public health, but of course, are not the only tool. Seeking shade at peak sunlight hours and wearing protective clothing, hats, and sunglasses are key to every sun protection plan. The sunscreen page on FDA’s website provides useful information for sun safety.

FDA is committed to helping to ensure that sunscreens are safe and effective for U.S. consumers, but we need data to move forward.

We hope the final guidance encourages industry to provide the FDA with the data we need, so that together we can help bring a wider assortment of safe and effective sunscreen products to the American public.

Theresa M. Michele, M.D., is the Director of the Division of Nonprescription Drug Products, Office of New Drugs, at FDA’s Center for Drug Evaluation and Research