During a recent meeting at U.S. Food and Drug Administration (FDA) headquarters, the Nonprescription Drugs Advisory Committee recommended that active ingredients in over-the-counter (OT C) sunscreen products be subject to additional safety testing. FDA convened the meeting for expert scientific advice on the scope of safety testing that should be required to support an agency determination that an active sunscreen ingredient is generally recognized as safe and effective (GRASE ) for over-the-counter drug use and for advice on “a framework for evaluating the safety of sunscreen ingredients rather than on the safety of specific ingredients or sunscreens in general.”
Sixteen active ingredients are currently allowed to be used by sunscreen manufacturers based on a 2011 final monograph, but the monograph process has been challenged by the regulated industry and some members of Congress as too slow for unapproved ingredients. OT C sunscreen products may also be marketed under FDA’s new drug application process.
During the meeting, FDA reportedly proposed as new safety test requirements for sunscreen active ingredients (i) human safety testing, consisting of dermal safety studies and bioavailability; and (ii) nonclinical safety testing, consisting of carcinogenicity testing, developmental and reproductive toxicity studies, as well as toxicokinetics. According to a news source, most of the advisory committee members agreed that this type of testing should be a baseline, but called for industry studies focusing on the long-term safety of sunscreen active ingredients. Others contended that the monograph process lacks strong enough safety standards. A pharmacology professor apparently opined, “I am really shocked and surprised these products have been used so widely by so many people for so many years, without much public safety information. I think the framework that FDA proposed is fair, a minimal standard. But I would go further and say that these are drugs.” See Bloomberg BNA Product Safety & Liability Reporter™, September 5, 2014.