GRASE

FDA Regulation of OTC Sunscreen Products

FDA Congress, FDA, GRASE, OTC, Sunscreen, TEA

Have you ever wondered who ensures the safety of your sunscreen? With many people, including pregnant women and children, choosing to wear sunscreen on a daily basis throughout the summer months, it is imperative that the sunscreen on the market is safe and effective. With that in mind, on November 26, 2014, Congress enacted the Sunscreen Innovation Act to provide an alternative process for review of safety and effectiveness of nonprescription sunscreen with the U.S. Food & Drug Administration (“FDA”). The Sunscreen Innovation Act does not relax the FDA’s scientific standards for evaluating safety and effectiveness of sunscreen ingredients. It…

FDA Seeks to Review Safety and Effectiveness of Antibacterial Soaps

FDA Cosmetics, Drugs, FDA, GRASE, Proposed Rule, Rulemaking

On December 16, 2013, the U.S. Food & Drug Administration (FDA) issued a proposed rule, “Safety and Effectiveness of Consumer Antiseptics,” that would require manufacturers of over-the-counter (OTC) antibacterial soaps and body washes to provide the FDA with data demonstrating that the products are safe for long-term use and effective in preventing illness and infection. You can read the FDA’s announcement here. The proposed rule is part of the FDA’s ongoing review of the safety and effectiveness of the active ingredients in antibacterial soaps and related products, which are not found in non-antibacterial, or plain, soap. Further, as noted above,…