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Comment & Response
February 2019

Probiotic Safety—Reasonable Certainty of No Harm

Author Affiliations
  • 1University of California, San Francisco, San Francisco
  • 2University of Turku, Turku, Finland
  • 3International Scientific Association for Probiotics and Prebiotics, Centennial, Colorado
JAMA Intern Med. 2019;179(2):276. doi:10.1001/jamainternmed.2018.7498

To the Editor The Viewpoint by Cohen1 that was recently published in JAMA Internal Medicine dismisses a diligent approach to probiotic safety assessment undertaken by regulatory authorities, as well as the long history of safe use of probiotics in foods.

No guarantee of safety exists. In the United States, the safety standard for food ingredients, including probiotics, is reasonable certainty of no harm. Several probiotic strains have undergone rigorous safety assessment (Generally Recognized as Safe) followed by notification of the US Food and Drug Administration for comment. These assessments typically include total genomic sequencing, which confirms the absence of transferable antibiotic resistance genes. Furthermore, such assessments consider if the species of microbe is on the European Food Safety Authority’s qualified presumption of safety list of microbes that are safe for food use. This list is based on a history of safe use as well as an assessment of existing relevant data; it is reviewed twice yearly against emerging data.

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