Safety and Efficacy Review for Additional Ingredients in Over-the-Counter Drug Products for Human Use; Request for Environmental Impact Data and Information

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We (Food and Drug Administration (FDA)) are requesting data and information regarding the potential environmental impact of amending over-the-counter (OTC) drug monographs to include certain active ingredients not previously marketed in the United States or marketed in the United States under approved applications after the OTC drug review began in 1972. Thirteen active ingredients have been found eligible for potential inclusion in OTC drug monographs based on time and extent applications (TEAs). We are currently evaluating the safety and effectiveness of these ingredients.