The Food and Drug Administration (FDA) has confirmed it would be receptive to a probiotics monograph that may serve as the basis of a qualified health claim, the International Probiotics Association (IPA) has confirmed.
The IPA was active in establishing a monograph that included 16 strains and four approved generic claims published by Health Canada in February 2009, a dossier it said could form the basis of a submission to the FDA, probably in 2011.
IPA head of marketing committee, George Paraskevakos, said the revelation had come at a two-day probiotics conference held in June at the New York Academy of Sciences, where the FDA, Federal Trade Commission and others had given presentations.
“We spoke to the FDA’s Dan Levy and welcomed how open the agency appears to be to the idea of a probiotics monograph,” Paraskevakos told NutraIngredients-USA.com.
He said the IPA hoped a monograph could be presented to the agency next year, although it had to compete with the 10-year-old organization’s resources that were already stretched over three major initiatives:
- establishing standards for probiotic testing
- establishing protocols for clinical trials
- a revamped consumer-friendly probiotics information website due to launch in Q1 2011
“At least with the Health Canada monograph we have the ground work in place and that should speed and simplify any submission to the FDA.”
The IPA also sent a copy of the Health Canada monograph to the New York Academy of Sciences for perusal.
Health Canada monograph
In the meantime the IPA has submitted comments to Health Canada after the agency sent a discussion document to industry with a view of updating its own monograph.
“They have asked for more scientific data and this may include data on strains that are not yet listed in the monograph. We have posted comments but these have not been made public yet.”
Such a revision may be welcomed by some probiotic players who have been critical of the Health Canada monograph for lacking depth and data.
“It basically says you need to genotype the strain (which is good) and you can call it probiotic, and this is insufficient! You also need to state total viable count - but they don't require this at end of shelf life (which is needed),” Professor Gregor Reid from the Canadian R&D Centre for Probiotics at the Lawson Health Research Institute, and The University of Western Ontario said last year.
“This baby step Monograph is not sufficient for other countries to utilize, unless it's as a starting point for a proper monograph.”
The monograph can be read here .