Landmark Paper Published in Regulatory Journal Proposes Safety Assessment Parameters for Probiotics

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Jay Sirois, PhD, CHPA’s vice president of regulatory & scientific affairs, and co-author of the paper, Considerations for determining safety of probiotics: A USP perspective, recently published in the Journal of Regulatory Toxicology and Pharmacology, released the following statement regarding the publication:

“While safety assessments for many current probiotic species are backed by a solid history of safe use, the increased use of novel strains by probiotic manufacturers suggests a growing need for a global set of harmonized requirements to establish probiotic safety in foods and supplements. Our paper summarizes the current global regulatory guidelines and proposes an outline of essential parameters for comprehensive safety assessments based on perspectives from a multidisciplinary group of stakeholders with significant experience in the probiotic field.

“Specifically, this paper proposes a tiered approach to first assess the testing needs for certain genera, species, or strains based on a history of safe use, evidence from scientific and regulatory agencies, and whether the ingredient is novel. Once a safety testing tier is determined, testing recommendations range from limited to more extensive assessment, including tests for pathogenicity, antibiotic resistance, and in vivo studies when there is no existing history of safe use.

“As the dietary supplement and food industries continue to grow and innovate, safety information is needed for probiotics before they enter the marketplace. This paper provides a helpful guideline for manufacturers to accurately determine the best safety testing pathway.”

The Consumer Healthcare Products Association (CHPA), founded in 1881, is the national trade association representing the leading manufacturers and marketers of consumer healthcare products, including over-the-counter (OTC) medicines, dietary supplements, and consumer medical devices. CHPA is committed to empowering self-care by ensuring that Americans have access to products they can count on to be reliable, affordable, and convenient, while also delivering new and better ways to get and stay healthy. Visit