HBW Insight 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

Herbal Sleep Aid With Rx 'Reformulation' Gives FDA A Nightmare

This article was originally published in The Rose Sheet

Executive Summary

FDA inspects Belmora's website and product labeling in March and issues a warning letter that firm’s Elavil OTC Sleep Aid is an unapproved new drug with inadequate directions for its intended use.

You may also be interested in...



Amarin's Omega-3 Fair Trade Complaint Questions US Dietary Ingredient Standards

Amarin's recent fair trade complaint targetting purified EPA dietary supplements and formulations also raises broader questions about using synthetic dietary ingredients in consumer supplements and the extent to which a substance’s identification in an IND precludes subsequent use as a dietary ingredient.

Amarin's Omega-3 Fair Trade Complaint Questions US Dietary Ingredient Standards

Amarin's recent fair trade complaint targetting purified EPA dietary supplements and formulations also raises broader questions about using synthetic dietary ingredients in consumer supplements and the extent to which a substance’s identification in an IND precludes subsequent use as a dietary ingredient.

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.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

RS109311

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