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

“Unreasonable risk” bill

This article was originally published in The Tan Sheet

Executive Summary

HHS Secretary would be granted greater authority to deem a dietary supplement's risk "unreasonable" under a bill introduced June 30 by Rep. Susan Davis (D-Calif.) and cosponsored by Reps. Henry Waxman (D-Calif.) and John Dingell (D-Mich.). The "Dietary Supplement Access & Awareness Act" (H.R. 3156) provides that in certain court procedures, the Secretary may consider a supplement's risk to be unreasonable by weighing its potential benefits against possible health risks. "In the absence of a sufficient benefit, the presence of even a relatively small risk of a serious adverse health effect to a user may be considered" unreasonable, the legislation states. The provision is new to the bill, which otherwise mirrors H.R. 3377, introduced by Davis in October 2003 (1"The Tan Sheet" Nov. 3, 2003, p. 13)...

You may also be interested in...



Democrats Expected To Put Supplement, Drug Regulation Under Microscope

Increased scrutiny of issues including the safety of dietary supplements and phenylephrine efficacy is likely as senior Democrats move into leadership roles on Congressional committees following the 2006 midterm elections

CRN on Davis bill

New legislation authorizing FDA to consider a dietary supplement's "unreasonable risk" in light of the level of its benefit would reverse the basic tenets of DSHEA, according to the Council for Responsible Nutrition. HR 3156, introduced June 30 by Rep. Carolyn Davis (D-Calif.), also would "codify FDA's risk/benefit rationale for removing ephedra from the market that was invalidated by the court in Nutraceutical v. Crawford," CRN maintains. The bill contains a provision establishing that in the absence of a sufficient benefit, the presence of even a relatively small risk of serious adverse health effect to a user may be considered unreasonable (1"The Tan Sheet" July 1, 2005, In Brief)...

House Bill Prohibits Sale Of High-Risk Supplements To Minors

Consumers under age 18 would not be allowed to purchase dietary supplements that FDA deems as posing a significant risk to minors, according to a new bill authored by Rep. Susan Davis (D-Calif.)

Topics

UsernamePublicRestriction

Register

PS098414

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