FDA's Puzzle: Measuring How DSHEA Fits For Supplement Industry Oversight
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.
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Commissioner Scott Gottlieb announces FDA's plan for policy changes to implement "one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years." Plan includes steps to ensure its regulatory framework is flexible enough to adequately evaluate product safety while also promoting innovation, particularly finalizing NDI notifications guidance and fostering submissions of the notifications.
FDA has little priority, and limited resources available for finalizing its 2016 draft guidance on NDI notifications and for establishing a process that certifies dietary ingredients as being available before October 1994, says regulatory attorney Miriam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."
More than four years after beginning to revise its widely criticized initial draft guidance on NDI notifications, FDA on Aug. 11 released a second draft. "I think it is reflective of a new effort by the agency to have a dialogue with the industry," says Steve Mister, president and CEO of the Council for Responsible Nutrition.