Health Law Daily FDA issues proposed rule for final monograph on sunscreen products
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Tuesday, February 26, 2019

FDA issues proposed rule for final monograph on sunscreen products

By Jeffrey H. Brochin, J.D.

The proposed rule describes the conditions under which the FDA proposes over-the-counter (OTC) sunscreen products are generally recognized as safe and effective (GRASE) and not misbranded. It is being published to comply with the federal Food, Drug and Cosmetic Act (FDC Act), as amended by the Sunscreen Innovation Act (SIA).

The FDA has issued a proposed rule to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products. In the nearly 20 years since publication of the final rule ‘‘Sunscreen Drug Products for Over the Counter Human Use’’ (64 FR 27666, May 21, 1999) (stayed) changed conditions have prompted the FDA to believe additional safety data are now needed in order to establish that certain of the active ingredients listed in the Stayed 1999 Final Monograph are generally recognized as safe and effective (GRASE) for use in sunscreen products. The proposed rule does not represent a conclusion by the FDA that the sunscreen active ingredients included in the Stayed 1999 Final Monograph—ingredients cited in the current proposed rule as Category III—are unsafe for use in sunscreens. Rather, the FDA is requesting additional information on those ingredients so as to evaluate their GRASE status in light of substantially increased sunscreen usage and exposure and evolving information about the potential risks associated with the products since they were originally evaluated (Notice, 84 FR 62014, February 26, 2019).

OTC monographs. An OTC monograph establishes conditions under which certain OTC drugs may be marketed without approved new drug applications because they are generally recognized as GRASE and not misbranded. The proposed rule classifies active ingredients and other conditions as Category I (proposed to be GRASE and not misbranded), Category II (proposed to be not GRASE or to be misbranded), or Category III (additional data needed).

The OTC Drug Review is the process established by the FDA to evaluate the safety and effectiveness of OTC drug products marketed in the United States before May 11, 1972. The OTC Drug Review is generally conducted via a multiphase public rulemaking process (each phase requiring a Federal Register publication), resulting in the establishment of a monograph for an OTC therapeutic drug category.

Stayed 1999 final monograph. The Stayed 1999 Final Monograph established a minimum SPF value of 2, and an SPF of 30+ as the maximum labeled SPF value. The Stayed 1999 Final Monograph has never been in effect, and in 2011, the FDA published a draft guidance for industry entitled ‘‘Enforcement Policy—OTC Sunscreen Drug Products Marketed Without an Approved Application,’’ addressing the circumstances under which the FDA intended to exercise its enforcement discretion with respect to certain marketed OTC sunscreen products in the period until a final OTC sunscreen monograph becomes effective. The guidance was finalized in May 2018 (see FDA shines light on enforcement discretion and trails for sunscreen products, May 23, 2018).

Emerging safety concerns. In recent years, a growing body of data has suggested that the transdermal absorption of some sunscreen active ingredients is greater than previously thought, and thus may raise previously unevaluated safety concerns, including the potential for reproductive, developmental, or carcinogenic effects. Newly available information suggests, for example, that there is the potential for toxicity associated with the transdermal absorption and systemic availability of oxybenzone. This new information about absorption and potential safety risks is inadequate, by itself, to support an affirmative conclusion that products containing the active ingredients at issue are not safe. Coupled with the lack of clinical pharmacology and nonclinical safety data for certain sunscreen active ingredients, however, the FDA is led to conclude that, for some sunscreen active ingredients, the current record does not include adequate evidence of safety to satisfy the applicable legal standards for general recognition of safety and effectiveness as set forth in § 330.10.

Electronic or written comments on the proposed rule must be submitted on or before May 28, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of May 28, 2019.

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