From our perspective: Ensuring the safety and effectiveness of sunscreens
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 for sunscreen active ingredients that are not already included in the OTC sunscreen monograph.
Changing use of sunscreens
Sunscreens are a preventive treatment for sunburn. 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 occasionally at the beach and often as tanning aids. Now, many different groups, 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 CDC recommend that consumers use broad-spectrum sunscreens with a sun protection factor (SPF) of 15 or more 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 sunscreens.
Sunscreen regulation in the United States and abroad
Because sunscreens are indicated for use to help prevent sunburn, and some are also indicated for use to decrease the risks of skin cancer and early skin aging caused by the sun, they are regulated as drugs in the United States. In recent years, there has been a growing interest in new 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. 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 determine the type and extent of safety testing for sunscreen active ingredients to be marketed under the OTC sunscreen monograph. 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 require for these nonprescription sunscreen active ingredients. The advisory committee unanimously agreed that our proposed framework was a good starting point for sunscreen 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 advisory committee meeting, Congress passed the Sunscreen Innovation Act (SIA), creating a new process for the review of safety and effectiveness of nonprescription sunscreen active ingredients. 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, 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 must meet. We still must adhere to the scientific standards for evaluating the safety and effectiveness of sunscreen products. FDA must rely on industry to provide adequate data to enable us to make positive safety and effectiveness determinations.
New guidance to address safety data gaps
As required by the SIA, today FDA is publishing four draft guidances pertaining to nonprescription sunscreen active ingredients. The most noteworthy 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. The proposed studies are not novel and are consistent with our standard data requirements for approved topical drug products for chronic use.
As outlined in the draft guidance, we are recommending skin safety studies to determine if products containing a certain active ingredient 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, we will also review available adverse event data. 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, then we will ask for additional animal data including whether the active ingredient causes cancer, reproductive harm, or endocrine effects 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 or an NDA. For example, final formulation testing is required to confirm that each final product provides the promised SPF level. As described in more detail in the draft guidance, we anticipate that additional safety-related final formulation testing will be necessary to ensure that the safety of a sunscreen product is not compromised by a particular combination of active and inactive ingredients. While we welcome comment on all of the draft guidances, we particularly encourage the public to comment on the approach to final formulation safety testing.
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. These products should be used 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.
We encourage industry and the public to provide us with comments on our draft guidances, particularly the guidance on safety and effectiveness. As manufacturers review this guidance, we ask that they work on studies to address any 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 as the SIA is implemented to 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 providing American consumers with additional options for safe and effective sunscreen ingredients.
