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


FDA Dismisses List Of “Grandfathered” Ingredients In Pyridoxamine Decision

This article was originally published in The Tan Sheet

Executive Summary

Companies determining whether a substance is a new dietary ingredient cannot rely on industry-developed lists of "grandfathered" ingredients believed to be marketed prior to the Dietary Supplement Health and Education Act, FDA says in response to a citizen petition

You may also be interested in...

Pyridoxamine Petition Paints Better Option As Dietary Ingredient Than IND

ViGuard Health says in a petition that with two IND programs for studies of pyridoxamine's potential therapeutic use formally withdrawn, FDA should rescind its 2009 decision that it did not qualify as a dietary ingredient.

Amarin's Omega-3 Fair Trade Complaint Reaches Regulatory Dead End

International Trade Commission won't investigate Amarin's complaint that some dietary supplements containing omega-3 formulations similar to icosapent ethyl in its Vascepa are actually drugs and should be blocked from import into US, likely discouraging others from this novel approach.

Pyridoxamine Debate Continues; CRN Points To Ingredient’s Presence In Food

Pyridoxamine's presence in many common foods makes it exempt from 75-day premarket notification, the Council for Responsible Nutrition maintains in comments supporting the ingredient's status as a dietary supplement

Related Content





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