Regulating Your Fun in the Sun

Originally published by Lori-Ann Craig.

Did you know that the Friday before Memorial Day has been designated as Don’t Fry Day? Relax. It doesn’t mean that you cannot eat or cook any fried food, such as fried chicken or French fries, but rather, it is day set aside by the National Council on Skin Cancer Prevention to encourage sun safety awareness. In the United States, Memorial Day weekend is typically the unofficial beginning of the summer season. That would mean (in a pandemic-free world), trips to the beach or the park, backyard barbecues, and swimming, all of the hallmarks of summer living. All of that time spent outdoors in the sunshine also means that it’s time to slather on the sunscreen.

According to the Centers for Disease Control and Prevention (CDC), skin cancer is the most common form of cancer found in the United States. While it recognizes that there are benefits to spending time outdoors, the CDC recommends protecting your skin from harmful UV rays “by staying in the shade, wearing protective clothing, and applying a broad spectrum sunscreen with a sun protection factor (SPF) of 15 or higher.”

All of this talk of sunscreen made us wonder about the regulations that govern the sunscreen that we are putting in our skin. (We’re law librarians. Can’t you tell?) The U.S. Food & Drug Administration (FDA) is the agency responsible for regulating the topical sunscreens that consumers find on store shelves. These regulations can be found in 21 C.F.R. §§352.1 – 352.77 (2020). Specifically, the FDA regulates the active ingredients that are in the sunscreen, the combination of those ingredients, the labeling of the products, and the testing procedures. In addition, to be “generally recognized as safe and effective” (GRASE) and not misbranded, a sunscreen product must meet the conditions set forth in 21 C.F.R. § 330.1 (2020) as well as those found in Part 352.

To comply with provisions in the Federal Food, Drug, & Cosmetic Act (FDCA), as amended by the Sunscreen Innovation Act (SIA), the FDA published a proposed rule in the Federal Register early last year requesting additional data to determine whether certain active ingredients found in sunscreens are GRASE in light of changed conditions since the publication of the previous rule in 1999. The proposed rule would update the regulatory requirements for most sunscreens. The FDA planned to implement this rule and make it part of a final Monograph, but never did. The proposed rule and monograph have been thrust once again into the light of day with the enactment of the Coronavirus Aid, Relief, and Economic Security (CARES) Act in March. Section 3854 of the CARES Act, which sunsets the SIA on September 30, 2022, permits a sponsor of a nonprescription sunscreen active ingredient to elect a review of the ingredients in accordance with the procedure set forth in section 505G of the FDCA, as added by Section 3851 of the CARES Act or pursuant the process set forth in section 586C of the FDCA (21 U.S.C. §360fff-3). The effect of these new rules concerning the safety of certain active ingredients remains to be to seen. Until then, the FDA still highly recommends that everyone use sunscreen and be smart when it comes to sun exposure. So, on this Feel Good Friday, we want you to enjoy, have fun, and be safe. And, remember, don’t fry today or any day.

Curated by Texas Bar Today. Follow us on Twitter @texasbartoday.

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