Workshop to explore the impact of NDI draft guidance, final GRAS rule for probiotics

By Stephen Daniells

- Last updated on GMT

©  iStock / Jezperklauzen
© iStock / Jezperklauzen

Related tags: Probiotic

A workshop hosted by the International Probiotics Association (IPA) in Washington, DC will tackle some of the key issues facing the probiotics sector, including positions from FDA and FTC on NDIs and claims substantiation.

The workshop, which will take place on November 2 at the College Park Marriott Hotel & Conference Center in Hyattsville, MD, will also explore best practices, cutting edge analytical techniques, and current market data.

“Interest in the category is continually growing, and probiotics are in the spotlight because of the science, the health benefits and the market growth,”​ said George Paraskevakos, IPA’s executive director. “Regulators have realized that probiotics are a unique category​.

Presentations by experts from the FDA and FTC include:
Genomic analysis of beneficial microbes - supporting industry and regulation with innovative science​ - Dr Chris Elkins, FDA
The Regulation of Probiotic Claims in Advertising: Don’t Let it Bug You ​- Richard L. Cleland, FTC
NDI draft guidance comments​ - Dr Cara Welch, FDA
The GRAS final rule: Overview and implications for FDA’s GRAS notification process​ - Richard Bonnette, FDA

“Monica Feldman from Euromonitor will discuss the scope and size of the sector because the government needs to know what it’s dealing with,” ​explained Paraskevakos, “and that includes the direction of the sector, from dietary supplements to functional foods and into targeted applications that would require an IND.”

“The workshop represents an excellent opportunity for industry and government to collaborate on the development of standards, best practices, and guidelines.”

The event is limited to 150 places.For more information and to register, please click HERE​.

The full program can be downloaded here: 

IPA_ProbioticWS

IPA_ProbioticWS.pdf 0.32 MB

The retail value of probiotic dietary supplements is $1.7 billion in the US, according to data from Euromonitor, and expected to grow to $3 billion by 2020.

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