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. The recall affected more than 400 stores.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. In February, Family Dollar stores in six states closed after the FDA discovered a rodent infestation of over 2,000 rodents at a distribution center in Arkansas, prompting a recall of potentially contaminated and unsafe products. Any adverse reactions linked to the purchase of any affected product should first be brought to a primary health care provider, and then reported to the FDA using the MedWatch Adverse Event Reporting program either online or by calling 1-80 to request a mail-in reporting form. Alaska, Delaware, and Hawaii are exempt from the recall, as Family Dollar doesn’t have store locations in those states.Ĭustomers who may have purchased any affected product, the statement reads, may return it to the Family Dollar store where they were purchased without a receipt.įor any questions, the FDA recommends contacting Family Dollar Customer Service at 84 between 9 a.m. The products affected are isolated to those sold in certain retail stores, those of which the FDA has notified and advised to check their stock immediately and quarantine and discontinue the sale of anything on the above list. A full, extensive list of products and their serial numbers, released by the FDA, can be found here.Īt the time the statement was released, the FDA had received no reports of adverse reactions, illness, or consumer complaints. Their name brands include Tylenol, DayQuil, Banana Boat, Dove, and Old Spice, among others. The items affected include over-the-counter pain medication, sunscreen, deodorant, toothpaste, diaper rash cream, cough syrup, and more. According to the statement, they were stored outside of labeled temperature requirements and inadvertently shipped to certain stores on or around May 1 through June 10. On July 21, the Food and Drug Administration (FDA) announced that Family Dollar initiated a voluntary recall of over 400 personal care products. Name brand medicine, sunscreen, deodorant, and toothpaste were among the products affected.The items were stored outside of labeled temperature requirements, according to the FDA’s statement. ![]()
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