“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, told us. “Regulators have realized that probiotics are a unique category.”
The workshop will cover a range of key issues, including the NDI draft guidance, the GRAS final rule, analytical methods and potential new technology, probiotics labelling and best practices guideline, market sizing, claims substantiation, and discussing the role of the media.
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
FTC’s position in regards to activities and marketing supplements with an emphasis towards probiotics - Richard L. Cleland, FTC
NDI draft 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 will be limited to 150 places, and there is a two-tier registration system with pre-registration open to current IPA member companies, and then non-member companies will be eligible to register.
FDA: “Live microbials present some unusual regulatory considerations”
The 2016 retail value of probiotic dietary supplements is $2 billion in the US, according to data from Euromonitor, and expected to grow to almost $3 billion by 2020.
Dr Cara Welch, Senior Advisor for the Office of Dietary Supplements at the FDA, told us: “The Office of Dietary Supplement Programs appreciates opportunities like this to engage with stakeholders, where we can provide updates and hear about industry's current practices and interests. Dietary supplements containing live microbials are growing in popularity with consumers and present some unusual regulatory considerations.
“ODSP is looking forward to hearing about new scientific and technical advancements, recent and upcoming research, and other practices that stakeholders are implementing in the formulation, manufacturing, and marketing of live microbial dietary supplements.”
For more information and to register, please click HERE.