FDA Revision Of NDI Draft Guidance Starts With Grandfathered List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Trade groups say FDA committed to revisiting issues in the NDI draft guidance including how firms prove ingredients’ grandfathered status, notifications required for ingredients or finished products and data necessary to demonstrate NDI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FDA’s NDI notification draft guidance should be rewritten and its Nutrition Facts and Supplement Facts Final Rule delayed, the Natural Products Association says in comments submitted to the agency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.