IPA chief on manufacturing standards, the ODI list, global regs, and more

By Stephen Daniells contact

- Last updated on GMT

As growth in probiotics continues to accelerate, the International Probiotics Association is ramping up its regulatory outreach efforts and working on ultimately producing a comprehensive quality guidebook for the probiotic industry, says IPA’s executive director.

Speaking with NutraIngredients-USA at the recent SupplySide West show in Las Vegas, IPA’s George Paraskevakos noted that he’s seeing some interesting growth rate numbers with 17% and 19% growth rates predicted for the US probiotic dietary supplements market. “There are a lot of new players diving into the market and a lot of older players expanding their probiotic product line,”​ he said.

Paraskevakos also discussed the organization’s work on various standards and guidelines. Earlier this year, working in collaboration with the Council for Responsible Nutrition, IPA released best practice guidelines for the labeling, storing, and stability testing of probiotics.​ The association is now working to tie these in with manufacturing standards.

“We have the GMPs and other guidelines that manufacturing companies are following, but because probiotics are a very unique category and ingredient there’s a different set of guidelines that we have to consider when handling everything from bulk materials to finished products,” ​said Paraskevakos.

“We’re also looking to do some testing standards, validated standards, and what are the things these manufacturers should be testing for. At the end of the day, all of these guidelines will tie into one comprehensive quality guidebook for the probiotic industry.”

Attendees at the IPA’s second probiotic workshop in DC later this month will get a first look at the draft of the manufacturing standards, said Paraskevakos.

NDIs and ODIs

When asked about the ongoing discussion about new dietary ingredients (NDIs) and old dietary ingredients (ODIs), Paraskevakos explained that IPA submitted a 15-page document to the FDA last year during the public comment period about the re-issued new dietary ingredient draft guidance. “Within those comment we also proposed a list of strains that could make a safety list, with of course certain parameters that need to be covered.”

Paraskevakos also discussed the global regulatory landscape, noting that some governments remain hesitant about how to regulate the beneficial bacteria.

“[Brazil’s] ANVISA just released some guidelines, which make sense. We’ve submitted our comments and now we’re pushing to have a meeting with the director there in Brazil. It will be a follow-up of the workshop we did [with ANVISA] about a year and a half ago.

“These are initiatives that we like to do with different governmental agencies, to create these one-day probiotic workshops and we’ve reached out to agencies in other parts of the world, like China in APAC, and of course the on-going work in Europe.”

For more information about the October 26th Probiotic Workshop in DC​ (Bethesda, MD), hosted by the by International Probiotics Association and the U.S. Pharmacopeia, please click HERE​. 

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