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California probiotic bill inconsistent with FDA standards.jpg

California probiotic bill clashes with FDA policy

In 2019, the California State Assembly presented legislation that was inconsistent with FDA’s current probiotic policy and regulation, causing confusion for industry and consumers.

Earlier this year, the California State Assembly presented legislation concerning the labeling of dietary supplement products containing live microorganisms, including probiotics. The introduced Assembly Bill AB 1178 required probiotic dietary supplements to label ingredients by genus, species and strain, and to identify quantity at end of shelf life by CFU. The bill’s requirements are inconsistent with FDA’s current policy and regulation, putting industry in a difficult position and potentially causing confusion among consumers.

CRN worked to have the CFU requirements removed from the Senate version of the bill, leaving only the genus, species and strain requirement. While the requirement created a state-imposed labeling obligation in addition to federal requirements, it was not conflicting with current federal regulation.

The bill did not progress out of committee before the legislative session ended in mid-September, giving the responsible industry the opportunity to continue working with the bill’s author—California Assemblyman Bill Quirk (D-Hayward)—to find compromise language should the bill be reintroduced in next year’s legislative session, since he had not agreed to the Senate revision.

Americans rely on probiotics as part of their health and wellness regimens. To foster innovation in this sector and to maintain a responsible market, it’s important that the industry continues working to ensure proper labeling, regulation and research of this category.

To read this and other related articles in full, download INSIDER's Next Steps for Probiotics digital magazine.

Andrea Wong, Ph.D., is the senior vice president, scientific and regulatory affairs of the Council for Responsible Nutrition (CRN), a trade association for the dietary supplement and functional food industry.

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