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

Court Suggests Critics Ask Congress To Change FDA's GRAS Rule – Same For NDI Notifications?

Executive Summary

Federal judge suggests consumer health and environmental advocacy groups made strong arguments about potential for unsafe ingredients in foods available in the US through the self-GRAS process, but FDA adopted and exercises the rule entirely in line with congressional intent of the authorizing legislation.

You may also be interested in...



Failed NDI Notifications Suggest Futility Of Current US Position On Cannabinoids In Supplements

FDA's evaluation of NDI notifications for cannabinoids currently is pointless, say industry stakeholders asking for a rule exempting hemp-derived cannabinoids from the agency’s prohibition against using in dietary supplements any ingredient studied or approved for use as a drug.

NDI Or GRAS? Supplement Label But A Drug Claim? Answers Unclear For Some Regulatory Questions

“We try to interpret the language that is given to us and if Congress would make it more clear to us, we would absolutely carry that forward,” ODSP's Cara Welch says about whether FDA regulations require NID notifications or self-GRAS submissions for dietary ingredients yet to be used in supplements.

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.

Related Content

Topics

UsernamePublicRestriction

Register

RS151827

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