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CARES Act includes OTC drug reform.
March 28, 2020
By: Happi Staff
The newly-signed Coronavirus Aid, Relief, and Economic Security Act (CARES Act) includes over-the-counter (OTC) drug reform, which impacts how sunscreens are regulated by the U.S. Food and Drug Administration (FDA), observed the Personal Care Products Council (PCPC). In a statement, PCPC noted that 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). “Because of their well-established role in protecting public health, the significant benefits sunscreens provide should be appropriately weighed against any potential risks. We support FDA’s commitment to ensuring that sunscreens are safe and effective for their intended use,” said PCPC. “We are confident that currently marketed sunscreens are safe and effective based on the long history of safe use of these products in the United States and around the world, the breadth of existing safety data, and the established benefits sunscreens provide.” PCPC noted that the dangers of sun exposure are clear and universally recognized by dermatologists and other public health professionals. The Centers for Disease Control and Prevention (CDC), the American Academy of Dermatology (AAD), the Skin Cancer Foundation and health care professionals worldwide emphasize the important role of sunscreen use as part of a safe sun regimen. “Skin cancer is a significant, and largely preventable, public health concern,” said PCPC. “Our industry’s goal continues to be to help consumers make informed decisions and use sunscreen as an important part of an overall safe sun program. We are proud that our industry offers innovative sunscreen products that help protect consumers from the harmful effects of the sun’s ultraviolet (UV) rays. “Ultimately, having an array of safe and effective sunscreen active ingredients allows sunscreen manufacturers to formulate products that meet the differing needs of individuals and their families. Ensuring that consumers have access to these products containing a broad variety of sunscreen active ingredients is critical and an important contribution to FDA’s public health mission.”
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