The International Probiotics Association (IPA) is delighted that the U.S. Food and Drug Administration (FDA) is taking a second look at the New Dietary Ingredients (NDI) draft guidance, a part of the Dietary Supplement Health and Education Act of 1994 (DSHEA).
“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.