FDA Could Stick With Current Advice On NDI Notifications, Old Ingredient Evidence
This article was originally published in The Rose Sheet
FDA has little priority, and limited resources available for finalizing its 2016 draft guidance on NDI notifications and for establishing a process that certifies dietary ingredients as being available before October 1994, says regulatory attorney Miriam Guggenheim.For both of those developments, she says, "I'm not holding my breath."
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"It is just common sense that there's going to be fraud where you have the combination of high growth, developing science, imported products or ingredients and limited oversight," says David Morrell, deputy assistant US attorney in DoJ'd Consumer Protection Branch. CPB
"I look forward to beginning a productive dialogue about reshaping our oversight of these products," acting FDA Commissioner Norman Sharpless said recently about agency's public meeting on May 16. Access to meeting at CFSAN headquarters opens at 8 a.m. and irst of four sessions on questions center stated in meeting notice begins at 9 a.m. Each discussion followed by question and answer sessions and public comments scheduled for 3 p.m.
FDA says it has "only received about 1,200 NDI notifications" in 25 years under DSHEA as US VMS market has grown from around $4b and 4,000 products to more than $40bn with 80,000 or more products. In interviews on potential changes agency may attempt to bring to its regulatory oversight, attorneys noted NDI notifications are among problems for both industry and FDA.