U.S. Food and Drug Administration
Provide specific guidance for how to substantiate structure/function claims and health claims for probiotic foods, dietary supplements, and medical foods Provide realistic guidance specific to IND applications for human studies investigating probiotic products Provide investigator-initiated IND exemptions if regulation allows these Consider extending health claim status (i.e., reduction of risk of disease) to acute diseases and health conditions, not just chronic, diet-related diseases
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National Institutes of Health
Provide a service to investigators to stimulate study rigor Continue supporting patient-oriented clinical trials of probiotics, even if they need to be preceded by Phase 1 studies
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Probiotic food and supplement manufacturers
Understand FDA labeling regulations Ensure that structure/function claims are accurately substantiated and are worded so as not to be understood as an unauthorized health or drug claim Develop sufficient evidence to meet requirements to petition FDA for health claims
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Researchers
Consult with FDA early when contemplating clinical research to determine whether IND regulations apply to their particular study Request a pre-IND application meeting when an IND application is required to facilitate compliance with regulations and identify regulatory challenges before investing time and resources to submit an IND application Follow FDA guidelines for IND content Engage individuals experienced with IND application processes to help them with IND applications for probiotic studies Maintain a good working relationship with the manufacturer or master file holder in order to adequately address the CMC section of the IND application Know the characteristics, potency, purity, and stability, as well as safety, of their probiotic test agents Follow the CONSORT guidelines in reporting study results
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