Manufacturing standards and Codex to be discussed at IPA’s DC Workshop
The workshop will cover a range of key issues, including next generation analytical tools, USP probiotic standards, INDs and probiotics, how regulations affect science and how science affects regulations, updates from a number of IPA committees, market sizing and consumer perspectives, and initiatives at Codex.
“An excellent opportunity in opening dialogue”
The second IPA DC workshop in collaboration with the US Pharmacopeia will take place on October 26 in Bethesda, MD, and brings together key industry stakeholders and federal regulators.
“Probiotics are unique in every way, from the manufacturing processes, storage and stability needs and the analytical requirements to touch but on a few areas,” explained George Paraskevakos, IPA’s executive director. “Careful consideration must be taken when it comes to looking at how regulators view their inclusion into guidance’s and guidelines.
“Probiotics cannot be blanketed into all the other food and dietary supplement categories when creating definitions on how industry should conduct themselves. Hence the workshop presents an excellent opportunity in opening dialogue and possible collaborations in looking at how these friendly organisms can be considered within these regulations.”
To watch our interview with IPA’s Paraskevakos discussing the new manufacturing guidelines at SupplySide West 2017, please click HERE.
Codex
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.
The event will also feature a presentation about the opportunity to develop a guidance or standard by Codex Alimentarius. This update will be provided by Amy Smith from DuPont Nutrition & Health and the IPA Codex Task Force Chair.
“Despite the widely recognized FAO/WHO definition (2001), revised by Hill et al. (2014), as “Live microorganisms that, when administered in adequate amounts, confer a health benefit on the host”, there is global occurrence of products sold as “probiotics” that do not meet this definition,” writes Dr Smith in her abstract for the meeting. “As such, the probiotics industry recognizes the need and opportunity for development of a Codex Alimentarius guidance or standard to more clearly define the required characteristics of probiotics, and to ensure quality probiotics are manufactured to be safe and efficacious as live microorganisms.”
Dr Cara Welch, Senior Advisor, FDA’s Office of Dietary Supplement Programs will also provide an update on the Agency’s activities.
For more information and to register, please click HERE.
Click on the following link to read our coverage of the 2016 workshop: 13 things we learned from the IPA’s DC Workshop
