The CARES Act gave the FDA until September 27, 2021, to propose revisions to the 2020 Final Administrative Order. The CARES act provided the agency with new authorities for some over-the-counter (OTC) drugs, like sunscreen. The final administrative order was first put in place in March 2020, as part of the 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act. According to the FDA, a growing body of scientific evidence has linked UVA exposure to skin cancer and other health problems. One of the new requirements will only allow sunscreen products with an SPF value of 15 or higher to declare that use can help protect against skin cancer, while those with lower SPF values will only be able to advertise themselves as helping to prevent sunburn.Īnother focus of the new provisions is to acknowledge the importance of ultraviolet A rays (UVA) and to make sure consumers have access to sunscreens with adequate UVA protection. “Today’s activities represent a key milestone in our implementation of transformative new authorities related to OTC drugs that will allow us to continue ensuring that sunscreens are safe and effective for frequent, life-long use and provide consumers with the protection they expect from these products.” Americans can reduce risks from sun exposure with continued use of sun protection measures including broad spectrum sunscreen with SPF values of at least 15,” Acting FDA Commissioner Janet Woodcock, said in the press release. “Sun safety is important for everyone, regardless of your skin tone. Some of the requirements are from a 1999 final monograph regulation for OTC sunscreen products, which never took effect, as well as labeling and effectiveness requirements from a 2011 labeling and effectiveness testing rule. Sunscreen products will have to meet these new requirements in order to be deemed by the FDA as “generally recognized as safe and effective (GRASE)”. The agency issued a proposed order in the Federal Register, which would make key changes to a Final Administrative Order (PDF) issued in 2020, to add new requirements affecting the maximum sunscreen protection values (SPF), the active ingredients, labeling, testing requirements and numerous other requirements. Food and Drug Administration issued a press release announcing plans to improve the quality, safety and effectiveness of over-the-counter sunscreen products. If you or a loved one regularly used benzene-containing sunscreens and have been diagnosed with a blood or bone cancer like AML, MDS, non-Hodgkin’s Lymphoma (NHL), or multiple myeloma (MM), please call 1-800-BENZENE and speak to a lawyer today.Following recent massive sunscreen recalls issued after it was confirmed that certain spray products contained high levels of the carcinogen benzene, federal regulators are now looking for ways implement more stringent standards for products sold in the U.S. Numerous other manufacturers have issued recalls as well, including Johnson & Johnson, the manufacturer of Neutrogena and Aveeno sunscreens. While the Valisure study did not indicate that Coppertone sunscreens contained benzene, Coppertone subsequently did its own testing and issued a recall of the following products:
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