Executive Summary: Scientific and Regulatory Challenges of Development of Probiotics as Foods and Drugs

Workshop participants endorsed the Joint Food and Agriculture Organization/World Health Organization Working Group’s definition of probiotics: “Live microorganisms which, when administered in adequate amounts, confer a health benefit on the host”. This definition may need to be revisited as knowledge expands regarding the mechanisms of action of probiotics and as novel formulations and genetically engineered microorganisms become available

Freddie Ann Hoffman; James T. Heimbach; Mary Ellen Sanders; Patricia L. Hibberd

2008

Scholarcy highlights

  • Workshop participants endorsed the Joint Food and Agriculture Organization/World Health Organization Working Group’s definition of probiotics: “Live microorganisms which, when administered in adequate amounts, confer a health benefit on the host”. This definition may need to be revisited as knowledge expands regarding the mechanisms of action of probiotics and as novel formulations and genetically engineered microorganisms become available
  • It is time to require that all microorganisms used as probiotics be identified by genus, species, and strain with the use of current methods
  • Conference participants noted that some products that are claimed to be probiotics are marketed with taxonomically incorrect or fictitious microbial names
  • For those National Institutes of Health-sponsored clinical investigations of probiotics assessed to be of high priority in the peer-review process, the NIH should make appropriate resources available to address the regulatory filings with the Food and Drug Administration that are mandated by law
  • An understanding of the science relating to probiotics is an essential foundation for good regulatory decisions, and an understanding of the regulations and their impact on product development and marketing is crucial if the exciting potentials of probiotic-containing products—foods, dietary supplements, and biological drugs—are to be fully realized
  • This article was published as part of a supplement entitled “Developing Probiotics as Foods and Drugs: Scientific and Regulatory Challenges,” sponsored by the Drug Information Association, the National Institutes of Health National Center for Complementary and Alternative Medicine

Need more features? Save interactive summary cards to your Scholarcy Library.