FDA regulates sunscreens, which are nonprescription drugs, to help make sure that consumers have access to safe and effective sun protection products. There have been several developments involving sunscreen regulation in the past few years. Today, there are two more: FDA is posting the deemed final order for over-the-counter (OTC) sunscreens and is issuing a proposed order for sunscreens.
In this CDER Conversation, Theresa Michele, M.D., director of the Office of Nonprescription Drugs, explains today’s activities and what the orders mean for consumers, health care providers, industry, and other stakeholders.
What are the big changes in sunscreen regulation over the past few years that have brought us to today’s activities?
Sunscreens have been regulated by FDA since the 1970s, but they have garnered a lot of attention recently. In 2019, FDA issued a proposed rule on sunscreens, which proposed to revise the requirements for sunscreen active ingredients; maximum sun protection factor (SPF) levels; broad spectrum requirements (protection against both ultraviolet A and B rays); and dosage forms (for example, cream, lotion, or spray), among other things. The proposed rule also included updates on how sunscreens are labeled to make it easier for consumers to identify key information.
The 2019 proposal aimed to bring sunscreens up to date with the latest science, including new information showing that certain sunscreen ingredients can be absorbed through the skin into the body. For more information on this issue, I co-authored two FDA Voices articles, one in 2019 and an update in 2020, explaining sunscreen absorption studies.
Then came the 2020 Coronavirus Aid, Relief, and Economic Security Act, also known as the CARES Act, which Congress enacted in March 2020 in response to COVID-19. Most of its provisions focus on economic relief to individuals, families, businesses, and other groups. However, the CARES Act also reformed and modernized the way FDA regulates certain OTC monograph drugs, including sunscreen. As background, an OTC monograph is a “rule book” for each therapeutic category that establishes conditions, such as active ingredients, uses (indications), doses, labeling, and testing, under which an OTC drug is “generally recognized as safe and effective” (“GRASE” for short) and can be marketed without a new drug application and FDA pre-market approval.
The CARES Act replaced the rulemaking process for OTC monograph drugs with an administrative order process for issuing, revising, and amending the OTC monographs. The administrative order process gives FDA new tools to help revise the OTC monographs as science changes, innovation progresses, new data become available, or emerging safety signals arise.
In addition, the CARES Act established deemed final orders for certain OTC monograph therapeutic categories, which became effective in March 2020. The deemed final orders establish a baseline of current GRASE conditions for the therapeutic categories. To learn more about OTC monograph reform, please see this FDA Voices article I wrote in 2020 on the topic.
For sunscreens specifically, in addition to establishing a deemed final order, the CARES Act requires FDA to issue a proposed order to amend and revise the deemed final order for sunscreens.
It is important to remember that the proposed order is a proposal, and any new sunscreen requirements will not take effect until after the agency issues a final order. A 45-day public comment period began when FDA issued the proposed order. After reviewing and considering the comments, FDA will issue a final order with an effective date, which, by law, will not be earlier than one year after the agency issues the final order.
FDA has now posted the deemed final o...
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