OMB Extends Review of FDA Final and Proposed Rules on OTC Sunscreen Products
The Office of Management and Budget states that it has extended its review of a FDA final rule and proposed rule on over-the-counter sunscreen products. In its July 30, 2010 final rule submission to OMB, the Food and Drug Administration…
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states that the OTC drug review establishes conditions under which such drugs are generally recognized as safe (GRAS) and effective and not misbranded. After a final rule is issued, only OTC drugs meeting the conditions of the rule, or having an approved new drug application, may be legally marketed. The first action addresses active ingredients reviewed under Time and Extent Applications. The second action addresses other effectiveness issues for OTC sunscreen drug products. The third action finalizes sunscreen formulation, labeling, and testing requirements for both ultraviolet B and ultraviolet A radiation protection. The last action addresses combination products containing sunscreen and insect repellent ingredients. Also on July 30, 2010, the FDA has submitted a proposed rule to OMB titled: "Revised Safety and Effectiveness Determination; Sunscreen Drug Products for Over-the-Counter Human Use.'"