CARES Act amends OTC monograph, updating sun care regulations

07-Apr-2020 - Last updated on 07-Apr-2020 at 19:04 GMT

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Related tags Sun care legislation coronavirus

The Coronavirus Aid, Relief, and Economic Security Act, passed late last month, includes some five sections on OTC Drug Review.

Five sections of the new CARES Act address over-the-counter drug regulations (3851, 3852, 3853, 3854, and 3855). And several of those change the FDCA or other sun-care-specific legislation.

Section 3851 adds to section 505 of the Federal Food, Drug, and Cosmetics Act

The CARES Act adds a section G to the existing FDCA section 505. And the new section makes several updates, including that minor dosage changes can be made by a manufacturer without administrative orders if the manufacturer runs set studies.

Though as the Personal Care Products Council (PCPC) notes in that organization’s official comment on the CARES Act, much of the OTC monograph is unchanged by the new legislation: “In the U.S., FDA regulates OTCs under a monograph system, which establishes various requirements for approval, including the safety and effectiveness of active ingredients in sunscreens. The legislation retains the regulations in the final monograph issued in 1999, which, among other things, confirms that active ingredients currently used in sunscreens on the market today are generally recognized as safe and effective (GRASE).”

Section 3954 will bring the Sunscreen Innovation Act to an end

President Barack Obama signed the SIA into law in late 2014. The law allows for an accelerated review and approval process for sunscreen actives. Or, as the FDA site describes it “to provide an alternative process for the review of safety and effectiveness of nonprescription sunscreen active ingredients.” The CARES Act will bring the SIA to an end on September 30, 2022.

Also, according to a Covington writeup on the sun care implications of the CARES Act, “The section would also make changes to harmonize the procedures under the SIA with those under OTC Drug Review. A final sunscreen order will no longer be incorporated into the final sunscreen monograph. Instead, a final sunscreen order will automatically be deemed to be a final administrative order.”

And other new legislation is mandated in the CARES Act. According to the Covington writeup, the “FDA must issue a proposed administrative order concerning nonprescription sunscreens no later than 18 months after the date of enactment of the Act. The final administrative order must be issued at least one year prior to the effective date of the order.”

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Deanna Utroske is a leading voice in the cosmetics and personal care industry as well as in the indie beauty movement. As Editor of CosmeticsDesign.com, she writes daily news about the business of beauty in the Americas region and regularly produces video interviews with cosmetics, fragrance, personal care, and packaging experts as well as with indie brand founders. Find out how else the Coronavirus crisis has changed the beauty industry in this recent #duviews video.