Theresa M. Michele, M.D., Director of FDA’s Center for Drug Evaluation and Research’s Division of Nonprescription Drug Products, discusses the changing pattern of sunscreen use and the need for additional safety data to support sunscreen active ingredients seeking to be included in the (currently stayed) over-the-counter (OTC) sunscreen monograph.

Changing use of sunscreens

Sunscreens are extensively used by American consumers to help prevent sunburn, and certain sunscreens also help reduce the risk of skin cancer and premature skin aging caused by the sun when used as directed with other sun protection measures. When sunscreens first came on the market, they were used only occasionally at the beach and often as tanning aids. Now, many authorities including dermatology societies, the Surgeon General and FDA, encourage people of all ages, ethnicities, and complexions to use sunscreens liberally and reapply frequently whenever they are out in the sun. In fact, FDA and the Centers for Disease Control and Prevention(CDC) recommend that consumers use broad-spectrum sunscreens with a sun protection factor (SPF) of 15 or more as directed and in conjunction with other sun-protective measures like seeking shade at peak hours and wearing protective clothing, hats, and sunglasses.

Evolving scientific knowledge

A number of scientific advances were responsible for the dramatic changes in sunscreen recommendations. Of course, the major discovery is that the sun actually causes radiation-induced damage to the skin. No less important is the knowledge that certain sunscreens—those that provide broad spectrum protection and an SPF value of 15 or more—can be an important tool for skin cancer prevention, when used as directed with other sun protection measures. In addition, there have been a number of technological advances in the formulation of sunscreens, allowing SPFs greater than 15 and greater broad-spectrum protection against ultraviolet rays (UV-A and UV-B rays). We've also learned, however, that sunscreen active ingredients may be absorbed through the skin, a significant discovery that needs to be considered when regulators evaluate the safety of long-term, regular sunscreen use.

Sunscreen regulation in the United States and abroad

Because sunscreens are intended for use to help prevent sunburn, and some are also labeled for use to decrease the risks of skin cancer and early skin aging caused by the sun when used as directed with other sun protection measures, they are regulated as drugs in the United States. In recent years, there has been a growing interest in sunscreen active ingredients that have been used in products marketed in European countries but that cannot be legally included in sunscreens marketed in the United States without an approved new drug application (NDA). In Europe, sunscreens are regulated as cosmetics, not as drugs, and there are different requirements for marketing in these countries.

FDA’s work to modernize sunscreen regulation

The changing pattern of sunscreen use and evolving scientific knowledge all prompted FDA to solicit input from external experts regarding our safety evaluation of sunscreen active ingredients not currently listed in the stayed final sunscreen monograph. In September 2014, we held a meeting of the Nonprescription Drug Advisory Committee to bring together medical and scientific experts from all parts of the field to help us determine the type and extent of safety testing we expect to be necessary for additional sunscreen active ingredients to be marketed under the OTC monograph system. At the meeting, FDA representatives explained that sunscreens should be viewed like any other nonprescription drug chronically administered to the skin, and laid out a proposed framework to describe the safety data we expect will be needed for these nonprescription sunscreen active ingredients to be marketed under the OTC monograph system. The advisory committee unanimously agreed that our proposed framework was a good starting point for sunscreen active ingredients. In fact, some committee members wanted us to go even further in terms of requesting additional data.

The Sunscreen Innovation Act

Shortly after the 2014 advisory committee meeting, Congress passed the SIA, creating a new process for the review of safety and effectiveness of nonprescription sunscreen active ingredients. FDA is currently using the SIA process to determine whether, and under what conditions of use, sunscreen products marketed in the United States may contain one or more of eight sunscreen active ingredients that are currently available more broadly in other countries but that can only be marketed in the United States with approved NDAs. To do so, FDA must review available scientific data for each active ingredient and conclude that the ingredient is generally recognized as safe and effective for nonprescription sunscreen use under a specified set of conditions. A misperception of the SIA is that it dictates exactly when and how fast sunscreens using these additional active ingredients will be available on the market without an NDA. The SIA gives FDA very specific timeframes for review of safety and effectiveness data once it is made available to the Agency, but these timelines are not triggered until a sponsor submits the necessary data. The SIA also does not change the safety and effectiveness standard that nonprescription sunscreen products marketed without approved NDAs must meet. We still must adhere to the scientific standards for evaluating the general recognition of safety and effectiveness of sunscreen products. FDA must rely on industry to provide adequate data to enable us to make positive general recognition of safety and effectiveness determinations.

During 2014 and 2015, FDA issued proposed sunscreen orders under the SIA for each of the active ingredients currently under consideration. In each case, FDA preliminarily determined that additional data are needed to support each active ingredient, and identified remaining data gaps for each active ingredient. To date, however, none of the recommended data has been submitted by active ingredient sponsors.

New guidance to address safety data gaps and other matters

As required by the SIA, today FDA is publishing two final guidances for industry pertaining to safety and effectiveness reviews for nonprescription sunscreen active ingredients evaluated under the SIA process. The first guidance describes FDA’s current thinking on the scientific testing needed to determine whether a sunscreen active ingredient is generally recognized as safe and effective for use in nonprescription sunscreens. The recommended studies are not novel and are consistent with our standard data requirements for NDA-approved topical drug products for chronic use. The second guidance is a procedural guidance describing the recommended content and format of the data submissions. Earlier this year FDA published two other SIA-required final guidances on other procedural aspects of the SIA process. All four final guidances reflect FDA’s consideration of public comments submitted on draft versions published in 2015.

As outlined in the final guidance on safety and effectiveness data, we are recommending skin safety studies to determine if products containing the active ingredient under review could cause irritation or rashes, or reactions when exposed to the sun. Because a sunscreen active ingredient must have a history of marketing—usually in other countries—to be considered under the SIA, there may be adverse event data available for the active ingredient, which we will also review. In addition, we are recommending studies to obtain pharmacology data in humans and animals to assess how much, if any, of the active ingredient is absorbed into the body when applied to skin. If the active ingredient is not absorbed above a specified amount, we ask for minimal data in terms of additional studies, such as looking at its effects on the skin of animals. If a sunscreen active ingredient is found to be absorbed past this minimal amount, then we will ask for additional animal data, including data concerning whether the active ingredient causes cancer, reproductive harm, or endocrine affects once it gets into the body.

For some time now, manufacturers have had to test the final formulation of each OTC sunscreen product for effectiveness, whether marketed under the monograph system or an NDA. For example, final formulation testing is required for sunscreens marketed under the OTC monograph system to establish the SPF provided by each final product. As described in more detail in the final guidance, we anticipate that additional safety-related final formulation testing may be necessary to establish that a sunscreen product, including its particular combination of active and inactive ingredients, is generally recognized as safe and effective . For this reason, the guidance describes the Agency’s current thinking about final formulation safety testing that we anticipate requiring in the future.

Next steps – going forward to ensure safety and effectiveness of sunscreens

FDA strongly recommends that consumers use broad-spectrum sunscreens with an SPF value of 15 or more in conjunction with other sun-protective measures, including staying out of the sun at peak times, seeking shade, and wearing protective clothing, hats, and sunglasses.

FDA encourages industry to take the final safety and effectiveness guidance into consideration as they work on studies to address the safety data gaps for each of their sunscreen active ingredients being evaluated under the SIA. We also encourage sponsors to come in and talk to us so that we can address any questions they may have regarding these studies or the guidances.

We recognize that sunscreens are used very broadly by the whole population, even on children as young as 6 months of age. FDA will continue to work with industry and public health stakeholders to help ensure that the sunscreens consumers use on themselves and their families are safe and effective for daily use over a lifetime in all different populations. Recognizing the public health benefits of sunscreen use, we are committed to doing our part to provide American consumers with additional options for safe and effective sunscreen ingredients.



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Dr. Michele joined FDA in 2007 as a medical officer in CDER’s Division of Pulmonary, Allergy, and Rheumatology Products. She currently serves as Director of CDER’s Division of Nonprescription Drug Products. Dr. Michele received her medical degree at Northeastern Ohio Universities College of Medicine and completed her residency at the Osler Medical Service at the Johns Hopkins University Hospital, as well as a fellowship in pulmonary and critical care medicine at Johns Hopkins. Before coming to FDA, she worked in the pharmaceutical industry as a leader in clinical aspects of drug development planning and implementation, covering pulmonary medicine and several other therapeutic areas.

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