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

In US, Market Exclusivity For NDI Notifications ‘Just Not There’ In DSHEA Regulation

Executive Summary

Unfounded expectation some firms have for FDA to protect their investments in preparing successful NDI notifications is part of industry’s overall interest in increased regulation of the market, says Steven Tave, Office of Dietary Supplement Programs director.

You may also be interested in...



US FDA’s NDI Notification Costs Estimate Doesn’t Add Up For Supplement Industry

FDA estimate “simply perpetuates the agency’s previous misunderstanding of the burden that NDI notifications impose,” says CRN CEO Steve Mister. FDA says its estimate is for costs of submitting information, not for studies to generate the information.

Legislating Hemp As Dietary Ingredient: Wrapping US Market In A Bow, Or Tying DSHEA In Knots?

House legislation to exempt hemp-derived cannabinoids from FDA rule that an “article” previously studied or approved for use as drugs is not allowed for use in dietary supplements either resolves a conundrum or raises additional questions for the agency and the industry.

Next US FDA Commissioner Will Have Opening To Fill In Dietary Supplement Programs Office

Steven Tave on 15 March will move from ODSP director to lead ORA’s Office of Strategic Planning and Operational Policy. Agency’s next commissioner, who Capitol Hill lobbyists say could be named next week, will appoint a replacement.

Related Content

Topics

UsernamePublicRestriction

Register

RS150505

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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