Blake Koloseike

Associate Editor

Loyola University Chicago School of Law, JD 2020

In 2014, Congress passed the Sunscreen Innovation Act in the hopes of encouraging innovation for new sunscreen ingredients. Recently, the United States Food and Drug Administration (FDA) proposed new regulations regarding over-the-counter sunscreens to keep up with recent scientific and safety information. This proposal will be available for ninety days from its announcement on February 21, 2019, and addresses safety concerns of common sunscreen ingredients. Further, the proposal addresses the labeling of sunscreen, trying to make it easier for consumers to identify the product information. While this proposal seeks to alleviate safety concerns, the regulation could potentially make it more difficult for new ingredients to be approved.

FDA Seeks to Highly Regulate Ingredients Based on Scientific Information

In the United States, sunscreens are treated like over-the-counter drugs and are very carefully regulated. Currently, there are sixteen ingredients currently used as the main chemical ingredient in sunscreen products. Of those sixteen ingredients, only two are considered safe and effective based on the currently available data. Furthermore, no new ingredients have been approved since the 1990s. Based on prior law, eight ingredients accepted in Europe were submitted and rejected by the FDA.

The latest proposal seeks to improve sunscreens and make them more “safe and effective.” The updated rules cover sun protection factors or SPF, the amount people apply, and broad-spectrum requirements. The regulation would allow for some ingredients and formulations to continue to be marketed without drug approvals, but products containing certain ingredients would be considered a new drug and would have to be approved by the FDA prior to being marketed. Specifically, products containing para-aminobenzoic acid (“PABA”) and trolamine salicylate would require FDA approval prior to their marketing. Under this proposal, these two ingredients will not be permitted for use in non-prescription sunscreen products.

Additionally, the proposal requests the industry to provide additional data on twelve other ingredients included in sunscreen products. The FDA believes that these twelve ingredients are not “GRASE” or “generally recognized as safe and effective.” The agency is asking companies to submit any data and studies they have to support the safety of the twelve ingredients.

Finally, the FDA has proposed regulations regarding the labeling of sunscreen products. In this proposal, the label would be required to include the addition of the active ingredients on the front of the package to align with the requirements of other over-the-counter drugs. Additionally, a notification on the front label for consumers to read the skin cancer and skin aging alert for sunscreens that have not been shown to prevent skin cancer. The label would also be required to have broad-spectrum and water resistance statements. Moreover, any products labeled with an SPF of fifteen or greater must also offer broad-spectrum protection against both UVA and UVB rays.

These Regulations May Make Innovation Extremely Difficult

While these new regulations are merely proposals currently, enacting these regulations as proposed could make it difficult for companies to introduce new ingredients into the market. The proposed regulations would require more testing of ingredients prior to approval. According to Dr. Henry W. Lim, the former president of the American Academy of Dermatology, the testing being proposed is “onerous, expensive, and time-consuming.” This would not only prevent new ingredients from being accepted, but it may also lead to fewer options available to Americans.

While the new restrictions may be questioned by industry, environmental advocates have praised this proposal. One such organization, the Environmental Working Group (“EWG”) has tried to alert consumers to the concerns about sunscreen with oxybenzone, a very common ingredient. Specifically, oxybenzone may be an endocrine disrupter and there is evidence that this ingredient can be absorbed through the skin. However, this concern is based primarily on animal studies, and research on humans has not demonstrated the same problems with endocrine disruption from oxybenzone use. The newly proposed regulations would present a practical challenge for U.S. manufacturers to continue making UV-blocking sunscreen, because it is difficult to take oxybenzone out of sunscreen products with no comparable ingredients offering the same UV protections. With the potential implementation of these rules, it would make it difficult for manufacturers to introduce similar ingredients and so the industry may be unable to provide an equally effective and attractive alternative to a potentially harmful ingredient.

In conclusion, the FDA’s proposed regulations seek to protect consumers from harmful ingredients. However, the regulations may prove to hinder innovation regarding new ingredients and approval by the FDA. In the meantime, the FDA has emphasized that consumers should continue to use sunscreen as these regulations progress. The FDA does not seek to discourage sunscreen use, but, instead, seeks to ensure that sunscreen products marketed for consumer use are safe and deliver on the promises made.