HBW Insight 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

US FDA Allows Supplement Firms More Time To Submit NDI Notifications, And For It To Respond

Executive Summary

More time for notifications than current deadline of at least 75 days before NDI-containing product is offered for sale in US doesn’t solve problems with FDA’s management of NDI regulation, say trade groups.

You may also be interested in...



US FDA Narrows Guidance For New Dietary Ingredient Notifications To Magnify Compliance

Draft guidances in 2011 and 2016 were met with widespread questions and opposition from supplement industry, joined by then-senators who had were chief authors of DSHEA. FDA in 2023 said it would provide separate guidance documents on “discrete sections” of the requirement.

Tianeptine Rings Latest Unapproved Drug Alarm, Followed By Echo About Lack Of FDA Regulation

Tianeptine isn’t approved as drug in US nor allowed for use as dietary ingredient or food additive. FDA has warned multiple firms selling tianeptine-containing products and federal prosecutors recently announced guilty plea from man who sold the drug to consumers.

The Dietary Supplement Market US FDA Is Regulating Isn’t Your 1994 DSHEA Version

“In the last 30 years, we've seen this sort of explosion, and it's not just more products and more sales. We're talking about more complex products,” says Cara Welch, FDA Office of Dietary Supplement Programs director. “Today's products are not the products from 1994.”

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS152538

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