FDA Takes Action to Improve Safety, Efficacy, and Quality of Sunscreens
According to an FDA News Release posted September 24, 2021, the U.S. Food and Drug Administration announced that they would be implementing new steps to improve sunscreens’ safety, quality, and efficacy as part of its implementation of new authorities for certain over-the-counter (OTC) drugs. The FDA also stated that it also is implementing new authorities for some over-the-counter drugs.
The FDA proposed updates and revisions to requirements related to active ingredients, maximum sun protection factor (SPF) values, product labeling, and broad-spectrum requirements.
According to acting FDA Commissioner Janet Woodcock, M.D., sun safety is very important for everybody, regardless of skin tone. Americans may also reduce risks associated with sun exposure by using sun protection products that contain broad-spectrum sunscreen with SPF values of at least 15. Dr. Woodcock also stated that the FDA’s latest activities are an important milestone in the FDA’s implementation of transformative new authorities associated with Over-the-counter drugs and will allow the FDA to continue assuring that sunscreen products are effective and safe for frequent, life-long use. She also said that the FDA is committed to using their new authorities to “advance innovative, safe, and effective options for consumers and secure a robust OTC marketplace.”
The recall report states that the 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act modernized the way sunscreen products are marketed without approved applications as typically regulated in the U.S. The Act established a final order for sunscreen products and established the requirements for marketing OTC sunscreen products. The CARES Act will not change the scientific standards required for deciding whether sunscreen products could be marketed without filing an approval application. The OTC orders establish the conditions in which the FDA may permit certain OTC drugs to be marketed without filing a new drug application since they are recognized as safe and effective.
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