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 order for sunscreens and has also issued a proposed order. What are the main components of these two orders, and what do they mean for the sunscreen market?
The requirements of the sunscreen deemed final order essentially keep the status quo.
The deemed final order for sunscreens includes certain requirements about active ingredients from the 1999 final monograph regulation for OTC sunscreen products, which never took effect, and the labeling and effectiveness requirements from a final 2011 labeling and effectiveness testing rule.
In addition to incorporating requirements already in effect under the final 2011 regulation, the deemed final order largely corresponds to the approach of an FDA sunscreen enforcement policy guidance, which had been in place before the CARES Act because the sunscreen monograph was not in effect.
Meanwhile, the proposed order proposes changes to these requirements to bring them up to date with the current science. When finalized, the proposed order will fully replace the deemed final order with new requirements for sunscreens.
FDA first articulated its proposed changes to the sunscreen OTC monograph in the 2019 proposed rule. We are now using this proposed order to efficiently transition our ongoing consideration of the appropriate requirements for OTC sunscreens from the previous rulemaking process to the new order process that the CARES Act created.
The CARES Act did not change the scientific standard for making a GRASE determination. For that reason, the proposed requirements in the proposed order are substantively the same as those in the 2019 proposed rule.
There are notable differences between the sunscreen deemed final order and the proposed order. Below are a few key examples and short explanations. For more information, please visit this webpage.
Maximum SPF:The deemed final order does not impose an upper limit on SPF values. The proposed order, in contrast, proposes a maximum labeled SPF of 60+ and also proposes a maximum on the formulated SPF value of a sunscreen.
Active ingredients:The deemed final order makes sunscreens containing 16 specified sunscreen active ingredients GRASE by incorporating the ingredients from the (not in effect) 1999 sunscreen monograph. However, the proposed order proposes GRASE status for sunscreens containing zinc oxide and titanium dioxide; not GRASE status for sunscreens containing aminobenzoic acid and trolamine salicylate because of data showing safety issues; and not GRASE status for sunscreens containing cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone because of inadequate data to support a safety finding.
Broad spectrum requirements:Consistent with the requirements in the labeling and effectiveness rule for sunscreens issued in 2011, the deemed final order does not require broad spectrum testing, but it creates an optional broad spectrum labeling claim and broad spectrum testing that is required to include this claim on labeling. To address the growing evidence of significant harms associated with UVA exposure, the proposed order proposes a requirement that all sunscreens with SPF values of 15 and above satisfy broad spectrum requirements.
Why doesn’t the proposed order address comments the agency received in response to the 2019 proposed rule? Will FDA address those comments?
FDA will consider the on-time comments we received on the 2019 proposed rule as comments submitted on this proposed order. For this reason, FDA is asking people not to resubmit the same comments, or rewrites of the same comments, to the proposed order if they submitted those comments during the comment period for the 2019 proposed rule. This will make things easier for both the commenters and for FDA and will help keep the process moving quickly. In addition, this proposed order gives the public an opportunity to submit new information that has become available since the comment period closed on the 2019 proposed rule.
In response to the 2019 proposed rule, manufacturers requested that FDA defer action on eight sunscreen active ingredients while data were being gathered to fill the identified safety gaps. What if data collection is still underway at the close of the comment period for the proposed order?
If at any time, sufficient evidence becomes available to answer the outstanding questions about whether a sunscreen containing any of these eight ingredients is GRASE, FDA plans to proceed to a final order reflecting our conclusion about that ingredient’s status. However, if there is not sufficient data to resolve the questions about each of these ingredients at the end of the proposed order comment period, FDA could consider deferring further action on the GRASE status of sunscreens containing the particular ingredient(s) to allow additional time for data to be developed and submitted. This would be the case if the agency has received adequate indication that the party seeking the deferral had made timely and diligent progress in trying to obtain that safety information.
In addition, if FDA initially defers further action regarding sunscreens containing a specific active ingredient, FDA plans to re-evaluate the progress of studies periodically. If FDA later decides that the studies are not progressing or otherwise are not productive, we expect we would move forward with a final order on sunscreens containing this ingredient. Moving forward, to make decisions on the GRASE status for OTC sunscreen products with certain active ingredients, the agency will use the administrative order process as established by the CARES Act. The statute gives FDA the authority to use the order process to add, remove or change conditions for an OTC monograph drug.
This is a complex area of medicine and policy right now, to say the least. As a trained health care provider and the director of CDER’s Office of Nonprescription Drugs, what do you want the public to know about sunscreen?
One thing — please protect yourself from the sun! Incidence rates for both melanoma and non-melanoma skin cancers have been rising for the past quarter century. The relationship between skin cancers and overexposure to the sun is well-documented.
Sun safety is important for everyone, including people of all skin tones. Consumers should continue to use sun protection measures, including using broad spectrum sunscreen of SPF 15 or higher, as we gather more safety data on sunscreen ingredients.
However, sunscreen is only one part of the solution. People should engage in sun protective behaviors, such as wearing protective clothing; wearing sunglasses and a hat that provides adequate shade; and finding shade whenever possible during periods of peak sunlight. Also, consumers should use adequate protection and appropriate precaution with sunlamps and tanning beds/booths. Both are sources of UV radiation that have been linked to skin cancer, skin burns, premature skin aging, and both short-term and long-term eye damage. More about sun protection and sunscreens is available on the FDA website. Check out these resources and stay safe in the sun.