FDA Fundamentals: A Brief History of GRAS

by | Aug 17, 2023 | FDA, Food, Regulatory

Earlier this month the FDA issued its direct final rule to finalize the determination that partially hydrogenated oils (PHOs) are no longer considered Generally Recognized as Safe (GRAS) in food. PHOs were established as not GRAS back in 2015, however the final rule was just published this month.[1] This rule affects foods like peanut butter, canned tuna, and certain types of oils. While determining PHOs are not GRAS will not come as a surprise to people who are familiar with their side effects, how exactly did they end up with a GRAS status in the first place? What exactly is GRAS when it comes to food?

GRAS is a common term across industries, including pharmaceuticals. GRAS first came to the food sector with the enactment of the 1958 Food Additives Amendment, which was followed by the first published list of GRAS substances in December of that year.[2] The landmark GRAS list from 1958 was based on certain substances long-standing history in food and the information generally available to scientists at that time (which is probably why PHOs ended up on there). Today, the GRAS list can be found in Parts 182, 184, and 186 of the Code of Federal Regulations, and even includes substances that are considered GRAS for food packaging materials.

The Federal Food, Drug, and Cosmetic Act governs GRAS under sections 201(s) and 409. The FD&C Act describes the legal way to differentiate between when something is GRAS, and when it is subject to premarket review and approval by the FDA.[3]

Throughout the years it became clear to the FDA’s Bureau of Foods (now known as the Center for Food Safety and Applied Nutrition, or CFSAN) that an ongoing evaluation of GRAS substances was critical. Thus, in 1972, the Select Committee on GRAS Substances (SCOGS) was born. In its 10 years, SCOGS produced 151 detailed reports covering over 400 substances. The public can access the SCOGS database to review opinions and conclusions on all GRAS substances on FDA’s website.

If you need support with ensuring that your food product complies with FDA regulations, let the experts at EMMA help! Give us a call at 248-987-4497 or email us at info@emmainternational.com to learn more.

[1] FDA (August 2023) Revocation of Uses of Partially Hydrogenated Oils in Foods 88 FR 53764 Pages 53764-53774 retrieved on 08/17/2023.

[2] FDA (January 2018) History of the GRAS List and SCOGS Reviews retrieved from: https://www.fda.gov/food/gras-substances-scogs-database/history-gras-list-and-scogs-reviews#:~:text=The%20FDA%20first%20published%20a,of%20Federal%20Regulations%20(CFR). on 08/17/2023

[3] FDA (July 2023) Generally Recognized as Safe (GRAS) retrieved from: https://www.fda.gov/food/food-ingredients-packaging/generally-recognized-safe-gras on 08/17/2023

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