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IPA Excited To Learn The FDA Has Decided To Issue A New, Revised NDI Draft Guidance
International Probiotics Association looking forward to working with FDA to develop proper guidance necessary to deliver safe and effective supplements to consumers
“This is a huge move forward for the supplement industry, yet there’s still a lot of work to be done,” said Ioannis Misopoulos, director general of the IPA.
The NDI guidance was intended to assist the dietary supplement industry in deciding when a premarket safety notification for a dietary supplement containing a new dietary ingredient (NDI) was necessary. But, the guidance went so far as to impose significant burdens on manufacturers and especially on manufacturers of probiotic supplements. The initially proposed guidance document went far beyond its intent as it imposed burdens all the way through the probiotic supply chain running from the original manufacturer to the company marketing the finished product.
“We look forward to continuing our work with the FDA to further develop the proper guidance necessary to deliver safe and effective supplements to consumers. And in the meantime, we applaud the successful efforts of industry leaders, in particular Jarrow Formulas for their diligent work and guidance,” continued Misopoulos.
The International Probiotics Association (IPA) is an international organization with members equally divided between industry and academia and its goal is to provide a unique forum for the exchange of research and the latest breakthroughs in probiotic technology and new product development. IPA holds NGO status before Codex Alimentarius and is the global voice of probiotics as the majority of the world’s industrial producers are members. Additionally, IPA will work with government bodies and industry to assist in establishing scientific standards for probiotic supplements, probiotic pharmaceutical products and functional foods. IPA will educate consumers on the proven health benefits of probiotics for humans and animals by attending trade shows, health tours/walks and other media functions. IPA promises to always put forth timely, unbiased information to every interested party, and share the documented benefits of probiotics to its international forum of members.