June, 26 2012
Last week, FDA bosses said that industry concerns would lead to a revision of the initial NDI draft guidance.
The news was communicated following a meeting yesterday between the offices of Senators Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa) and FDA commissioner Margaret Hamburg, deputy commissioner Michael Taylor and assistant commissioner Jeanne Ireland.
In a note sent to trade associations after the meeting, FDA supplements division chief Dr Dan Fabricant said: “We are planning on promulgating a revised draft NDI guidance to address points that may need further clarity to avoid misinterpretation, and possibly being taken out of statutory context.
“Please assure your members that the comments received in December are still being administratively reviewed and vetted accordingly.”
In a statement, IPA said it was “delighted” that FDA is taking a second look at the controversial document, with the association’s director general, Ioannis Misopoulos, saying: “This is a huge move forward for the supplement industry, yet there’s still a lot of work to be done.”
The association said that the first version of the draft guidance “went far beyond its intent as it imposed burdens all the way through the probiotic supply chain running from the original manufacturer to the company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”.
IPA said it is looking forward to continuing its work with the FDA to further develop the proper guidance necessary to deliver safe and effective supplements to consumers.
Misopoulos also hailed the “successful efforts of industry leaders, in particular Jarrow Formulas for their diligent work and guidance.”
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