After reviewing and considering the comments, FDA will issue a final order that will include an effective date. A 45-day public comment period began when FDA issued the proposed order. The proposed order is a proposal and does not “take effect” until it is finalized. When will the proposed order be in effect?Ī. The proposed order sets out FDA’s proposed revisions to this deemed final order and therefore reflects FDA’s proposed requirements for OTC sunscreen products for the future. FDA believes that most sunscreens on the market are in compliance with this order. As established by the CARES Act, the deemed final order consists of the requirements in the 1999 stayed (not in effect) final monograph for OTC sunscreen products, except for labeling and testing requirements, which are described in a final labeling and effectiveness testing rule for sunscreens published in 2011. The deemed final order, which came into existence by operation of law on Mathrough the enactment of the CARES Act, establishes the current monograph for OTC sunscreen products. What is the difference between the deemed final order for OTC sunscreen products and the proposed order?Ī. Because of this, the proposed order’s proposals are substantively the same as those that FDA issued in the 2019 proposed rule. The CARES Act did not change the scientific standards for making a GRASE determination. FDA is using the proposed order as a vehicle to efficiently transition its ongoing consideration of the appropriate requirements for OTC sunscreens marketed without approved applications from the previous rulemaking process to the order process created by new section 505G of the FD&C Act. Is the proposed order the same as the 2019 proposed rule?Ī. The CARES Act also directs FDA to amend and revise this deemed final order for OTC sunscreens products, and requires that the proposed version of this revised sunscreen order be issued no later than 18 months after the enactment of the CARES Act (i.e., by September 27, 2021). The CARES Act specifies that sunscreens that conform to these requirements (and to the other requirements specified by section 505G of the FD&C Act, including the general requirements for nonprescription drugs) are deemed to be GRASE and not new drugs. Section 505G of the FD&C Act, which was enacted by the CARES Act, created a “final administrative order” for sunscreens (the deemed final order) consisting of the requirements specified in the 1999 stayed (not in effect) final monograph for OTC sunscreen products, except for requirements governing labeling and effectiveness, which are described in a final labeling and effectiveness testing rule for sunscreens published in 2011. Specifically, the CARES Act amended the Federal Food, Drug, and Cosmetic (FD&C Act) to replace the monograph rulemaking process with an administrative order process for issuing, revising, and amending OTC monographs. On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law. The CARES Act includes statutory provisions to reform and modernize the way over-the-counter (OTC) monograph drugs are regulated in the United States. Why did the FDA issue a deemed final order for over-the-counter (OTC) sunscreen products and then issue a proposed order shortly after?Ī. The following questions and answers provide more information on the deemed final order and proposed order. The proposed order reflects FDA’s proposed requirements for OTC sunscreen products for the future. FDA also posted the proposed order for sunscreens to amend and revise this deemed final order for OTC sunscreens products. FDA posted the deemed final order for sunscreens which sets the current requirements for marketing OTC sunscreen products. On September 24, 2021, FDA took steps aimed at improving the quality, safety, and efficacy of sunscreens as part of its implementation of new authorities for certain over-the-counter (OTC) drugs.
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