Probiotic Safety—Reasonable Certainty of No Harm—Reply

In Reply I appreciate Cabana and colleagues’ interest in my recent Viewpoint.¹ However, they incorrectly characterize the safety standard for probiotics sold in the United States. Probiotics may be sold in a variety of products, including as a constituent of food, a food additive, or a dietary supplement. Each of these categories has different safety standards. Probiotics sold as dietary supplements, for example, are not required to have a reasonable certainty of no harm, as Cabana and colleagues suggest.² Rather, the standard for supplements requires only that a supplement ingredient cannot present “a significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling.”³