Stop Being Shady: How Current Sunscreen Regulatory Processes and Standards Burn Consumer Protection

In the United States, the Food and Drug Administration (FDA) regulates sunscreen as an over-the-counter (OTC) drug and not a cosmetic, subjecting it to the agency’s OTC drug review process. In 1999, the FDA published a final set of standards for marketing sunscreens in the United States, called a monograph. Since its publication, the FDA has tried to amend the monograph with little success. Congress has also acted to ease the procedural burdens and hurdles the FDA faces in updating the monograph, but these attempts brought about little change in sunscreen regulations. The United States’ efforts to properly update the standards for sunscreen pale in comparison to other countries, such as those in the European Union and parts of Asia. There, sunscreens are regulated as cosmetics, and new sunscreen ingredients face a different review process, leading to approval of newer and more effective ingredients on an expedited basis. Meanwhile, the FDA has taken a risk-averse approach to sunscreens, and in particular, approvals of new sunscreen active ingredients, as they have consistently denied approvals for new ingredients due to insufficient safety data. This approach has impeded meaningful progress for sunscreens—the last time the FDA approved a new sunscreen active ingredient to be broadly used in sunscreens was in 1999. Some groups support the FDA’s risk-aversion, but others question whether such stringency actually benefits public health long-term. This Note argues that the FDA’s risk-averse approach improperly balances sunscreen safety with public health. To better serve the FDA’s mission of consumer protection, Congress should step in to fund public research or provide enticing incentives for industry stakeholders to encourage them to take up the costs associated with the rigorous, yet crucial, safety testing.