“Probiotics as an ingredient are so unique and different from a number of dietary supplement ingredients, and so as an industry there are several points that we recognize that are in the guidance document that should not and hopefully will not apply to probiotics,” Amy Smith, senior manager of scientific and regulatory affairs at DuPont told us at the recent SupplySide West show in Las Vegas.
“We plan to provide thorough comments to FDA, and we’ve met with FDA to talk through several of our points, to hopefully move forward in providing specific evidence and data for them to consider specifically for probiotics,” she added.
“For example, there are a number of listings in the document that would indicate that every new strain of probiotics would be a new dietary ingredient worthy of notification. And what this would mean, according to the examples in the document, is that a culture traditionally used in the dairy industry or as an article used for food with a safe history of use would be considered an old dietary ingredient. However, if you change any aspect of the new fermentation media then that would make it a new dietary ingredient. DuPont has issue with this because we have historical data that shows that the historical way of fermenting and preparing cultures for use in dairy products, and in food in general, provides a strain that is identical to a strain that is produced using new or novel fermentation ingredients that do not contain things like allergens.”
NDI vs GRAS
On the GRAS side, however, the conclusion would be the safety status of the strain not based on the exact fermentation method used to produce that strain, explained Smith.
“It’s almost unfair to assume that for a dietary supplement ingredient we would have to go through these additional steps for notification whereas if we went the GRAS route that would not be necessary.”
The new NDI draft guidance also discusses the production of a grandfathered list of ingredient (old dietary ingredients that we on the market prior to the passage of DSHEA in 1994).
“We would like to propose to FDA, and we have proposed to FDA, that they allow us to put forward a grandfathered list based on genus and species, and not strain indication because we would do our due diligence anyway in proving the safety of each individual strain,” said Smith. “It’s been shown that safety of a strain can correlate back at the species level, and so species level safety can absolutely be used to indicate the safety of a specific strain if you do the additional mining within the genome.”
IPA’s DC Workshop
The NDI draft guidance and the GRAS final rule are among some of the topics that will be explored at a workshop next month hosted by the International Probiotics Association.
The workshop will also cover analytical methods and potential new technology, probiotics labelling and best practices guideline, market sizing, claims substantiation, and discussing the role of the media.
For more information and to register, please click HERE.