Pink Sheet is part 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

UsernamePublicRestriction
UsernamePublicRestriction

Small entity compliance guides

This article was originally published in The Tan Sheet

Executive Summary

FDA proposes small entity compliance guides for separate final rules concerning ephedra and nutrition claims in order to help small businesses understand the regulations. In a July 17 Federal Register notice, FDA solicits comments on a 1guide for a 2004 final rule declaring dietary supplements containing ephedrine alkaloids adulterated for presenting an unreasonable risk of illness or injury under conditions of use recommended in labeling (2"The Tan Sheet" Feb. 16, 2004, p. 10). A July 18 notice says FDA is accepting comments on an 3SECG on a 1997 final rule amending regulations defining the terms "high potency" and "antioxidant" for use in supplement nutrient content claims (4"The Tan Sheet" Sept. 29, 1997, p. 1)...

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

Dietary supplement new label features established in three final rules.

DIETARY SUPPLEMENT NEW LABELING REQUIREMENTS EFFECTIVE MARCH 23, 1999 under three final rules published in the Sept. 23 Federal Register. The rules implement some major provisions of the Dietary Supplement Health & Education Act of 1994 regarding the format and terms to be used in labeling. Proposed versions of the rules were published Dec. 28, 1995 ("The Tan Sheet" Jan. 1, 1996, pp. 16-20).

‘Wrong Move’: Gottlieb Blasts Azar’s Perceived Regulatory Power Play Over FDA; HHS On Defense

The US HHS played defense on 20 September, pushing back on suggestions that secretary Alex Azar’s recent move to exert control over regulations by signing off on them was a power play aimed at the FDA. Meanwhile, former agency head Scott Gottlieb says it’s “the wrong move at the wrong time.”

Topics

UsernamePublicRestriction

Register

MT125529

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

Cancel