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

Ephedra “Black Box” Warning Considered By FDA

This article was originally published in The Tan Sheet

Executive Summary

FDA is suggesting that a "black box" warning appear on the principal display panel of all ephedrine alkaloid-containing dietary supplements, FDA Commissioner Mark McClellan, MD/PhD, said during a Feb. 28 briefing held in Washington, D.C

You may also be interested in...



Ephedra Rule Cites Lack Of Safety Data In Vulnerable Subjects

Research weighed by FDA in evaluating the safety of ephedrine alkaloid-containing dietary supplements was lacking in subjects that were adequately representative of the broader population, the agency maintains in the 1final rule banning the botanical

FDA Regulatory Framework For Ephedra Ban Expected To Get Court Review

FDA's regulatory framework for removing dangerous dietary supplements from the market under the Dietary Supplement Health & Education Act's "unreasonable risk" standard will be issued shortly by the agency

FDA Focusing On Ephedra Solution Within DSHEA Parameters, McClellan Says

FDA is committed to operating within the confines of the Dietary Supplement Health & Education Act rather than seeking changes in the law as it prepares for action on ephedra-containing dietary supplements, according to FDA Commissioner Mark McClellan, MD/PhD

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS129556

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