Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

FDA Revision Of NDI Draft Guidance Starts With Grandfathered List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Trade groups say FDA committed to revisiting issues in the NDI draft guidance including how firms prove ingredients’ grandfathered status, notifications required for ingredients or finished products and data necessary to demonstrate NDI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.

You may also be interested in...



US Supplement Industry Capitol Hill Champion, Pivotal Drug Legislation Author Orrin Hatch Dies

DSHEA, legislation Congress passed in 1994 establishing framework for FDA’s oversight of supplement manufacturing and marketing, doesn’t bear Hatch’s name. But in US consumer health products industry, his name is probably more frequently linked with DSHEA than with pivotal drug legislation he co-authored.

NPA Submits Wish List For Reducing FDA Regulatory Burdens Per Trump Order

FDA’s NDI notification draft guidance should be rewritten and its Nutrition Facts and Supplement Facts Final Rule delayed, the Natural Products Association says in comments submitted to the agency in response to President Trump’s executive order aimed at cutting down on burdensome regulations.

Ingredients Missing From Potential Pre-DSHEA List Could Be Class Action Bullseyes

A potential official list of pre-DSHEA dietary ingredients must allow adding more that are substantiated later, or it could spur class action litigation targeting ingredients not on the list. FDA announces topics for Oct. 3 public meeting on processes and policy for an authorized list of "old" ingredients.

Related Content

Topics

Latest News
UsernamePublicRestriction

Register

PS105810

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