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


GRAS Self-Affirmation Fades As Sound Strategy Under FSMA

This article was originally published in The Pink Sheet Daily

Executive Summary

Experts at a FDLI conference say Food Safety Modernization Act obligations should convince companies to move beyond self-affirming food ingredients as “generally recognized as safe” without notifying FDA. While the GRAS process generally is considered effective, it lacks transparency in some areas.

You may also be interested in...

Court Suggests Critics Ask Congress To Change FDA's GRAS Rule – Same For NDI Notifications?

Federal judge suggests consumer health and environmental advocacy groups made strong arguments about potential for unsafe ingredients in foods available in the US through the self-GRAS process, but FDA adopted and exercises the rule entirely in line with congressional intent of the authorizing legislation.

NDI Or GRAS? Supplement Label But A Drug Claim? Answers Unclear For Some Regulatory Questions

“We try to interpret the language that is given to us and if Congress would make it more clear to us, we would absolutely carry that forward,” ODSP's Cara Welch says about whether FDA regulations require NID notifications or self-GRAS submissions for dietary ingredients yet to be used in supplements.

Sen. Lautenberg Plans Toxic Substances Control Update Bill

Introducing a bill to modernize the 36-year-old Toxic Substances Control Act is a priority for Senator Frank Lautenberg in the 113th Congress. Senator David Vitter might introduce his own industry-backed bill to modernize the act.

Related Content


Related Companies




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