The company’s comments on probiotics, which run to 32 pages, come on top of a similarly weighty set of comments submitted on the draft guidance in general, which, like the most recent comments, were penned by the company’s two regulatory attorneys, Susan Brienza and Scott Polisky.
Reluctance to use term ‘probiotic’
“JFI has concerns that the Guidance seeks to limit what qualifies as a probiotic, by restricting the variety of probiotics. Jarrow’s latest Comment supplements the firm’s extensive December 12, 2016 Comment on the Revised Guidance in general, emphasizing that it is at odds with DSHEA, with applicable regulations, and with prior FDA policies and statements, in essence imposing a new and unauthorized pre-approval scheme for dietary supplements,” the company said in a statement about the comments submission.
A curious aspect of the NDI guidances has been FDA’s apparently reluctance to use the term ‘probiotic’ at all, the company noted in its comments. JFI’s document elucidates the word ‘probiotic’ showing up in many official FDA communications in the past, but the NDI guidances (the first iteration was released in 2011, the most recent in 2016) eschew the term altogether, substituting ‘live cultures’ instead
“The fact that the FDA has not defined probiotics is not a reason to limit their development. They are indeed part of human ‘usual food and drink.’ The Agency’s problematic avoidance of the science in attempting to redefine the category of probiotics would eviscerate the Act of its quintessential term ‘Supplement’ and the kaleidoscopic subtleties of the term ‘dietary,’”said JFI’s founder and president Jarrow L. Rogovin.
Fermentation medium disagreement
The JFI comments also take the agency to task on its position on fermentation media, and how a change in this production parameters could create a different ingredient, thus creating the need for the filing of an additional New Dietary Ingredient Notification. This provision seems to fall in line with FDA’s broad interpretation in the draft guidance of the meaning of ‘chemical alternation,’ i.e. those manufacturing changes to an existing ingredient that change the resulting ingredient in such a way that existing safety information on that ingredient can no longer be said to apply. As matters stand, almost all manufacturing changes, including solvent changes such as using CO2 extraction, would create NDIs. FDA’s stance on fermentation media has raised consternation by by JFI and by the International Probiotics Association, which submitted its own comments to FDA on the draft guidance. The fermentation medium is the food of the organism, and changing the fodder is not akin to switching feedstocks in a chemical process. If a mouse changes its diet, it won’t then become an elephant.
“Jarrow asserts at this point that this argument leads to the conclusion that one’s diet should constitute a 'chemical alteration’ or ‘shift’ of one’s own resident bacteria genetics – which is nonsensical. Diet does have a dramatic impact on which flora proliferate and which are suppressed, but there is zero evidence that diet will cause a resident species to shift from beneficial to harmful. There is no science to support such a notion, and no reason to believe that fermenting acidophilus in milk instead of peptones will a pathogen make,” JFI’s comments state.
In conclusion, JFI urges FDA to go back to teh drawing board and come up with another draft of the guidance.
“The Guidance contains many provisions that flout regulatory law, contemporary science, and common sense. Clearly, the Guidance, if final, would dramatically and negatively impact how new and existing probiotics are regulated, developed, and manufactured in the future, contradicting the long history of safe use of various probiotics in foods,” the company said.