Pink Sheet is part of the Business Intelligence Division 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


FDA Revision Of NDI Draft Guidance Starts With Grandfathered List

This article was originally published in The Tan Sheet

Executive Summary

Trade groups say FDA committed to revisiting issues in the NDI draft guidance including how firms prove ingredients’ grandfathered status, notifications required for ingredients or finished products and data necessary to demonstrate NDI safety. The agency’s decision followed a meeting between industry allies Sens. Hatch and Harkin and FDA Commissioner Hamburg.


Related Content

NPA Submits Wish List For Reducing FDA Regulatory Burdens Per Trump Order
Ingredients Missing From Potential Pre-DSHEA List Could Be Class Action Bullseyes
‘Old’ Ingredient List On FDA Table Could Spur New Supplement Launches
Industry Eyes NDI Notification Common Ground With Gottlieb-Led FDA
DMAA Warnings Shed Light On FDA NDI Enforcement
Reps Threaten Legislation To Align NDI Guidance With DSHEA
Hatch, Harkin Call For Withdrawal of NDI Draft Guidance
FDA Should Accept Industry’s Grandfathered Ingredient Lists – NPA
NDI Guidance Sparks Questions Even From Firms Ready To Comply
Synthetics Stance In NDI Guidance Raises Red Flag For Industry





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