A recent FDA proposed rule would transform over-the-counter sunscreen regulation.
The U.S. National Park Service records the highest number of visitors in the months of June through August. But as millions of Americans experience the natural wonders of their country, they must protect themselves.
Each year over 5 million people are treated for skin cancer in the United States. According to the U.S. Centers for Disease Control and Prevention, most skin cancers can be prevented by avoiding prolonged exposure to ultra violet rays from the sun or an indoor tanning bed. Sunscreen, if used effectively, can protect skin from ultra violet rays and help prevent skin cancer.
Earlier this year, the U.S. Food and Drug Administration (FDA) proposed changes to update the regulation of over-the-counter sunscreen in an effort the agency says is needed “to make sure that sunscreens are safe and effective.”
Over-the-counter sunscreens are classified as drug products under FDA regulation. New over-the-counter active ingredients must be “generally recognized as safe and effective” before they can be marketed to the public. This designation requires that the active ingredient in a sunscreen be subjected to clinical investigation. Those investigations must then be published in scientific literature, and experts must generally agree on the findings that the ingredient is safe and effective for the marketed use.
The approval of new sunscreen ingredients in the U.S., however, is slow when compared to other countries. FDA did not approve a single new active sunscreen ingredient between 1999 and 2013. In response, Congress passed the Sunscreen Innovation Act in 2014. The Act requires FDA to provide a streamlined approach to approving new over-the-counter sunscreen ingredients, including evaluating applications that an ingredient is safe and effective on an expedited timeline.
The new FDA proposal was published, in part, to comply with the Act’s requirements to update sunscreen regulations.
Currently, FDA recognizes 16 active ingredients as safe and effective for use in over-the-counter sunscreens. But under the proposed rule, only two of those 16 ingredients would remain designated as safe and effective. Two other ingredients would be classified as not safe and therefore prohibited from use. But FDA officials have requested additional data from interested parties to decide whether the other 12 ingredients will remain designated as safe and effective in light of new evidence.
Furthermore, sunscreens that are combined with insect repellants would be reclassified as not safe and effective.
FDA says that these reclassifications are needed because the scientific community now knows “much more about the effects of the sun and about sunscreen’s absorption through the skin.”
This new scientific knowledge not only affects the ingredients of over-the-counter sunscreen, it also affects the ways consumers can apply sunscreen.
Currently, forms of sunscreen that are generally recognized as safe include sprays, oils, lotions, creams, gels, butters, pastes, ointments, and sticks. Under the proposed rule, sunscreen powders would also become available to purchase over-the-counter. But FDA indicates that it lacks sufficient data to determine whether other forms of sunscreen, such as wipes, towelettes, body washes, and shampoos should be approved.
The proposed rule would also change FDA’s guidelines about sun protection factor, more commonly known as SPF. The maximum SPF level would be raised from 50+ to 60+, and any SPF value of 15 or more would be required to include broad spectrum protection. To provide broad spectrum protection, a sunscreen must protect against both UVA and UVB radiation.
FDA indicates that, under current law, a potential exists for higher SPF sunscreens to provide less protection because a 50 SPF sunscreen without broad spectrum protection could potentially provide less protection than a 15 SPF sunscreen with broad spectrum protection. According to FDA, this proposed change should cure this potential inconsistency.
According to the Environmental Working Group, FDA’s proposed changes would be a major win for public health. The group argues that rising melanoma rates are partly due to a lack of federal standards in the sunscreen industry. The Group contends that these new standards would help consumers “navigate the sunscreen aisle and choose better and more effective products for themselves and their families.”
But less than 15 percent of adult men and 30 percent of adult women regularly use sunscreen in the United States. Furthermore, only about 10 percent of U.S. high school students apply sunscreen on a regular basis. As FDA updates sunscreen regulations, organizations, like the Skin Cancer Foundation, support the modernization effort but argue for more holistic approaches to sun protection, such as seeking shade and covering up with clothing.
FDA will accept public comments on its proposed rule until May 28, 2019.