HBW Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA's Puzzle: Measuring How DSHEA Fits For Supplement Industry Oversight

Executive Summary

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.

You may also be interested in...



Modernizing FDA's Supplement Industry Regulation Mapped Out In Five-Point Plan

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 Could Stick With Current Advice On NDI Notifications, Old Ingredient Evidence

FDA has little priority, and limited resources available for finalizing its 2016 draft guidance on NDI notifications and for establishing a process that certifies dietary ingredients as being available before October 1994, says regulatory attorney Miriam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."

Revised NDI Notification Draft Guidance Shrinks Divide Between FDA And Industry

More than four years after beginning to revise its widely criticized initial draft guidance on NDI notifications, FDA on Aug. 11 released a second draft.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.

Topics

UsernamePublicRestriction

Register

RS148715

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel