FDA Guidance Document Details Enforcement Policy for OTC Suncreens
The Food and Drug Administration on May 22 issued a guidance document detailing its policy of enforcement discretion for over-the-counter sunscreen products marketed without approved new drug applications or abbreviated new drug applications. FDA will continue not pursuing enforcement action…
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on such products in the absence of a long-awaited monograph for sunscreens, as long as the unapproved OTC sunscreen products meet certain labeling and testing requirements, including those outlined in a 2011 final rule, it said.