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Comment & Response
February 2019

Probiotic Safety—Reasonable Certainty of No Harm—Reply

Author Affiliations
  • 1Somerville Hospital Primary Care, Cambridge Health Alliance, Somerville, Massachusetts
JAMA Intern Med. 2019;179(2):276-277. doi:10.1001/jamainternmed.2018.7492

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

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