This page outlines laboratory testing considerations for testing probiotic Dietary Supplements/Natural Health Products. Our GMP and ISO 17025 accredited laboratory assists clients in the USA, Canada and internationally with their quality control testing for both input cultures and finished goods.
What are probiotic supplements?
Probiotic supplements are dietary supplements that contain live beneficial bacteria and/or yeasts that are intended to provide health benefits when consumed. These supplements are designed to increase the population of beneficial bacteria in the gut, which is believed to support digestive and immune health, and may also have other benefits such as reducing inflammation and improving mental health. Probiotic supplements are available in various forms, including capsules, powders, and liquids, and typically contain a specific strain or combination of strains of bacteria that have been shown to have beneficial effects.
What are the regulatory guidelines for testing of probiotic dietary supplements in USA?
The US Food and Drug Administration (FDA) mandates that dietary supplements, including probiotics, are manufactured and labeled in compliance with the regulations established in the Dietary Supplement Health and Education Act (DSHEA) of 1994, as outlined in 21 CFR Part 111. These regulations include requirements for good manufacturing practices (GMPs) and labeling, as set out in 21 CFR Part 101. Under the GMPs, manufacturers of dietary supplements, including probiotics, are required to ensure that their products meet certain quality standards, such as testing the identity, purity, strength, and composition of their products, in accordance with 21 CFR 111.70, 111.75, 111.80, and 111.90. While the FDA does not mandate specific testing methods, manufacturers are responsible for ensuring that their testing methods are scientifically valid and reliable, in accordance with 21 CFR 111.75 and 111.320. In addition, the labeling of probiotic supplements must be truthful and not misleading, as required by 21 CFR Part 101, and manufacturers must ensure that their products do not contain harmful levels of contaminants, such as heavy metals or harmful microorganisms, in compliance with 21 CFR 111.15, 111.110, and 111.113. Overall, while the FDA does not have specific testing requirements for probiotic supplements, manufacturers must follow the regulations in 21 CFR Parts 101 and 111 to ensure the safety and accuracy of their products.
What are the regulatory guidelines for testing of probiotic Natural Health Products (NHPs) in Canada?
The Canadian guidance for testing of probiotic products is more explicitly articulated when compared to US regulations. The guidance can be found in Health Canada’s Quality of Natural Health Products page. Appendix 4 “General finished product specifications for products containing live microorganisms” contains the most granular guidance for probiotic NHPs. It outlines testing strategies to be employed both on the input culture and the finished good. This includes stability, identity testing of the input culture, assay of the cfu/g or cfu/mL label claim in the finished product, contaminant testing, antibiotic/antifungal resistance, virulence factors and toxigenic activity.
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