Identity of probiotics a key factor in determining safety, efficacy of popular ingredient

US PharmacopeiaMar 28 2012

Regulators, manufacturers and academic researchers from around the world will convene for a two-day workshop on the scientific and regulatory challenges posed by the use of probiotic ingredients in food products. Discussions will focus on how public standards can assist in supporting transparency, consistency and competitiveness of ethical industry players as health claims surrounding probiotic products undergo increased scrutiny. Co-sponsored by the U.S. Pharmacopeial Convention (USP) and the Institute of Food Technologists (IFT), the workshop will be held May 9-10, 2012, at USP's headquarters in Rockville, Md.

"Probiotics are being utilized in a growing variety of food products as consumers incorporate foods into their diets they believe to have a positive, or 'functional,' effect on their health," said Praveen Tyle, Ph.D., executive vice president and chief science officer for USP. "These ingredients pose a host of scientific challenges, many of which can impact the validity of health claims. This could have regulatory and other implications. At this workshop, we will seek to define the needs of various stakeholders-and how public specifications for the identity, quality and purity of probiotic ingredients can address differing needs."

Central to safety and health claims of probiotic ingredients is proper identification of the particular strain that is incorporated into a food product. Given the large number of strains being researched and optimized for use in foods, manufacturers must verify that the strain they are using is the one studied in the safety/clinical trial upon which their health claims and safety determinations were based. This is difficult because of the level of specificity needed to differentiate strains, and is further complicated by factors arising from the fact that probiotics are live microorganisms-and are subject to wide variability and sensitivity to different environments.

Tests for identification as well as enumeration (microbe dose) are areas where public standards can provide benefit. Through the Food Chemicals Codex (FCC)-an international compendium of food ingredients-USP is beginning to develop these standards. The workshop will help drive future probiotics standards work.

Workshop sessions will include:

• Overview of Global Regulations

• Significance of Detectable Differences to Identity, Safety and Efficacy of Probiotic Organisms

• Developing Standard Methods for Functional Assays

• Regulatory Perspective: When Will Process Changes Affect Safety, Identity and Efficacy of Probiotic Organisms?

• Scientific Perspective: What Process Changes Impact Safety, Identity and Efficacy of Probiotic Organisms?

• The Role of Standards-Setting Organizations for Stakeholders or Regulators

Speakers from regulatory agencies including the U.S. Food and Drug Administration, Health Canada and the European Food Safety Authority; associations including the International Food Additive Council and International Scientific Association for Probiotics and Prebiotics; various manufacturers and more will present at the workshop.