‘Several points in the NDI draft guidance should not apply to probiotics’: Expert

By Stephen Daniells contact

- Last updated on GMT

The NDI draft guidance contains several points that are potentially issues for probiotics, and there appears to be a disconnect with the GRAS (generally recognized as safe) process, says a leading industry expert.

“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

Probiotics ©  Jezperklauzen
"Probiotics as an ingredient are so unique and different from a number of dietary supplement ingredients" - Amy Smith, DuPont. Image © iStock / Jezperklauzen

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The new NDI draft guidance also discusses the production of a grandfathered list of ingredient (old dietary ingredients that we on the market prior to the passage of DSHEA in 1994).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​. 

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1 comment

One Small Slice

Posted by Jm Lassiter,

The notations made in this article are but a small slice of the challenges presented by the most recent Draft Guidance. Each of theses slices involves one of two things -- misunderstanding of the Law as written or misapplication of science. In this instance, the point made is a recognition (in GRAS determinations) of how science should be applied while in the NDI guidance there is a contrary view. This reflects on the misunderstanding of the Law in that 1 - dietary ingredients are not subject to food additive regulations with the reasoning being that these ingredients are safe and 2 - the unfortunate approach of providing a literal approval process for dietary ingredients ignores the definition of the word "notify". The probiotic segment of the market is one from which foundational commentary can be developed as specific examples of what is incorrectly done in the draft guidance. There are solutions and these solutions lie, in part, with individual segments of the industry that need to be coalesced. Ideally with a neutral facilitator for presentation and discussion.

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