The FDA has proposed new changes to the regulations regarding over-the-counter sunscreen products. Perhaps the most impactful change to manufacturers, the FDA seeks to significantly decrease the ingredients that are generally recognized as safe and effective (GRASE) with their proposed order published on September 24, 2021.
The proposed order, titled “Amending Over-the-Counter (OTC) Monograph M020: Sunscreen Drug Products for OTC Human Use”, will replace the Deemed Final Order entirely if it is approved after a 45-day comment period.
FDA issues a proposed rule, “Sunscreen Drug Products for Over-the-Counter Human Use”, in February 2019. This proposal included amendments to the regulations regarding sunscreen active ingredients, maximum SPF levels, labeling requirements and more. If approved, it would have amended the sunscreen monograph regulation issued in 1999. However, the FDA decided this 2019 proposed rule would require significant safety data that would take considerable time to compile and deferred further rulemaking on the GRASE status of the following ingredients: avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone, ensulizole, and meradimate.
The CARES Act then changed the process for amending OTC sunscreen monograph in 2020. This created the Deemed Final Order for sunscreens stating that the 1999 requirements should be followed, with some exceptions of effectiveness and labeling according to 21 CRF 201.327. The CARES Act also required the FDA to amend and revise the Deemed Final Rule with the proposed order being issued by September 27, 2021. The FDA has fulfilled this requirement with the current proposed order “Amending Over-the-Counter (OTC) Monograph M020: Sunscreen Drug Products for OTC Human Use”.
The proposed order is largely the same as the 2019 Proposed Rule with the same scientific basis. It claims the Deemed Final Order does not ensure sunscreens are GRASE under Section 201(p)(1) of the FD&C Act. The FDA has made sure to note this proposed order does not conclude the ingredients in question are unsafe but rather require more data. Factors including new information about potential risks and increased sunscreen usage since 1999 have created a need for reevaluation.
Sunscreen and insect repellent combination products would not be considered GRASE under this proposed order.
Additional changes include a lower and upper limit to SPF labeling claims. No sunscreen should claim an SPF lower than 2 or higher than 60+, though they may be formulated with a higher SPF. The label must also contain dosage form, an alphabetical list of active ingredients and an indication if the product has not been proven to help prevent skin cancer or early skin aging.
The FDA has noted the data collected at this point in time is not sufficient to determine GRASE for the eight ingredients in question: avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone, ensulizole, and meradimate. As such, FDA is open to deferring a final decision for a particular ingredient for up to 1 year if there is proven indication of timely and diligent research.
Sunscreens that are not considered GRASE can still be submitted to FDA for review and potential approval as a new drug.
The FDA will consider all comments submitted in the comment period for the 2019 Proposed Rule in this comment period and ask they not be resubmitted.
For additional information about what this proposed rule means for your company, contact us at [email protected] or +(1) 215-557-3010.
For information about other Over-the-Counter requirements, view our recent webinar series.
Deemed Final Order