Summary

GAO reviewed the Food and Drug Administration's (FDA) new rule declaring dietary supplements containing ephedrine alkaloids adulterated because they present an unreasonable risk. GAO found that (1) the rule would declare dietary supplements containing ephedrine alkaloids adulterated under the Federal Food, Drug, and Cosmetic Act because they present an unreasonable risk of illness or injury under the conditions of use recommended or suggested in labeling, or if no conditions of use are suggested or recommended in labeling, under ordinary conditions of use; and (2) FDA complied with applicable requirements in promulgating the rule.