When the Food and Drug Administration’s (FDA’s) draft guidance on NDIs first came out in July, several commentators warned it spelled bad news for the probiotics sector.
However, with the appropriate clarifications and reference to the European Food Safety Authority’s (EFSA’s) Qualified Presumption of Safety (QPS) list, it can be salvaged, says the IPA.
“I do not see this as a death sentence to the probiotics industry,” a spokesman told NutraIngredients-USA.
“We argue that there should not be a need that each supplement manufacturer has to file a NDIN if the probiotic species is already known to be safe.
“If we manage to convince FDA about this, then a lot of doubt will be removed from customers making the final supplements, as this has not been made quite clear.”
EFSA’s QPS list
According to EFSA, safety should be established for the taxonomic group (genus or group of related species) rather than strains within it, says the IPA.
“Thereafter, any strain of microorganism the identity of which could be unambiguously established and assigned to a QPS group, would be freed from the need for further safety assessment other than satisfying any qualifications specified.”
All presently known and marketed probiotics in the US are on the QPS list, which is updated annually, it says.
Thus probiotics already on the QPS list should not have to go through an NDI notification process, added the spokesman.
“To be placed on the European QPS list mean that the species is safe in all applications and thereby also all fermentation media. As DSHEA is to guarantee safety the safety is guaranteed by being on the QPS list.”
New probiotics derived from genetic engineering
In formal comments filed with the FDA about the guidance, IPA director general Ioannis Misopoulos said: “The probiotics industry agrees that NDI notifications do not need to be filed on microbial ingredients like traditional dairy cultures used as probiotics in dietary supplements.
“For these ingredients, safety determinations are based on safety data and a safe history of use at the Genus/species level, with the requirement that no strain possess antibiotic resistance that is known to be transferable.
“We feel that the only probiotics ingredients that would be subject to an NDI notification would be new probiotics derived from GM engineering which would have little to no history of safe use.”
Needlessly burdensome to industry
As to whether a change to fermentation media should trigger a fresh NDI notification, he said: “Such changes would not constitute a change in the safety profile of the culture and therefore requirement of a notification would be needlessly burdensome to industry and swamp the agency with pointless work.”
He added: “To document the safe change of media to fermentation of probiotics, we refer to EFSA’s QPS concept.
“This provides a generic assessment system for use within EFSA that in principle can be applied to all requests received for the safety assessments of microorganisms deliberately introduced into the food chain.”
Dismissing industry grandfathered ODI lists is ‘inconceivable’
Along with several other commentators, the IPA also takes issue with the FDA’s insistence on multiple NDI filings for supplements containing NDIs, its refusal to acknowledge industry lists of grandfathered ingredients and its view that changes to manufacturing processes resulting in ‘chemical alteration’ should trigger a fresh NDI filing.
“It is necessary to limit the stipulations to only those stipulations that affect the safety of the product.”
Dismissing industry ‘grandfathered’ lists was “inconceivable” added Misopoulos.
“Without these lists, the grandfathered status of many dietary ingredients marketed prior to October 15, 1994 would be eliminated through unachievable documentation requirements to prove prior marketing.
“The agency needs to review and approve these substantiated lists.”
Misopoulos concluded: “Easing the stipulations suggested in this guidance document to true new dietary ingredients with little or no history of safe use would limit notifications to those ingredients that need to show a reasonable expectation of safety and ease the time and financial burden on both industry and the agency and avoid the risk of creating an unnecessary backlog in processing.”