Pink Sheet 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

Amarin Decision Could Spur Pressure Against FDA On Supplement Claim Policy

This article was originally published in The Tan Sheet

Executive Summary

First Amendment advocate Jonathan Emord says the industry bows to FDA “intimidation” in not making truthful claims for their products. But the federal district court ruling for Amarin is the latest decision to strike against FDA’s policy on regulating supplement label claims, he says.

You may also be interested in...



Omega-3 Ingredients Fair Trade Complaint? Not FDA's Bailiwick, Amarin Says

The drug maker says it's not asking ITC to interpret the FD&C Act, but to investigate whether some omega-3 ingredient suppliers and marketers are failing to fulfill "certain marketplace expectations about the nature" of their products. ITC on Oct. 27 will vote on whether to investigate the complaint targeting a large part of the omega-3 market.

Omega-3 Drug Firm’s Trade Complaint Questions US Dietary Ingredient Standards

Amarin targets purified EPA dietary supplements or formulations containing primarily EPA in ethyl ester or re-esterified form and raises general questions about using synthetic dietary ingredients in supplements and about the extent to which a substance’s previous identification as an IND candidate precludes its subsequent use as a dietary ingredient.

Omega-3 Petition Seeks Unqualified Blood Pressure, CHD Claims

The trade group Global Organization for EPA and DHA Omega-3 petitions FDA for an unqualified health claim related to reduced blood pressure as a surrogate marker for coronary heart disease risk.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS107846

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