Abstract:

As US regulatory framework lays the foundation of safety aspects and the efficacy of clinical effects of food products, specifically dietary supplement products, the reality of regulatory compliance is not well understood. Especially, live microorganisms as dietary supplements have many challenges in label compliance due to the unclear regulatory framework, but also due to the complexity of such living organisms. Field surveys were conducted in Southern California, USA (specifically in the Orange County and Los Angeles County regions) at local retailers or online from January 2019 to April 2021. Dietary supplements and food categories that included probiotics specifically into formula were assessed for label compliance and ingredient safety through manual annotations and curation of information. The data were observed and documented statistically. Eighty (80) unique products were collected where the number of probiotic strains ranged from 34 to 1 strain. Thirty-three (33) unique statement of identity were recorded, range of violations were maximum 9 to minimum 0. Violations were checked against the US label compliance per Chapter 21 of the Code of Federal Regulations (CFR) in food and dietary supplement label compliance regulations. Eighty-one (81) unique probiotics were observed where 33 were not confirmed of GRAS (generally recognized as safe) status, and 6 had no NDI (new dietary ingredient) status. Most labels were not in compliance with all the regulatory nuances that were found. Although most probiotics were only listed on the species level, it is still a topic worthwhile the discussion of increasing regulatory awareness to the industry. Non-compliance with labels could be mitigated by such educational outreach.

Keywords: Clinical Substantiations, Compliance, Label Compliance, Probiotics, Regulatory. 

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