Protecting families from contaminated food and water
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Protecting families from contaminated food and water
Posted in Food Safety,Our Blog on May 30, 2025
Under the Make America Healthy Again movement, we have seen changes to many aspects of our food supply. While some of this happens behind the scenes, others have been made quite publicly.
Changes to GRAS (or Generally Recognized as Safe) procedures are likely next on the chopping block. More specifically, one part of the approval process.
What does it mean to be GRAS and how will changes to GRAS impact consumers?
“GRAS” is a term used to shorten the phrase, Generally Recognized As Safe. All food additives for human consumption must meet this criteria.
Rules for GRAS are governed by sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act.
There are two ways that food or ingredient manufacturers can be granted that status for specific food additives.
The first method of approval involves scientific proof.
For the most part, in order to be labeled as GRAS, certain safety studies must be performed and turned in to the U.S. Food and Drug Administration (FDA) during a premarket review process.
These independent studies are reviewed by the FDA, and if data adequately shows that the product is safe under the conditions of intended use, or unless the use of the substance is “otherwise excepted from the definition of a food additive,” then it can be used.
But there is also another way.
GRAS also has a common use clause.
For foods additives or ingredients that have been used in food before 1958, the Food, Drug, and Cosmetics Act allows for a “common use” categorization. Under these conditions, a “substantial history of consumption for food use by a significant number of consumers” is all that is required.
If no significant reports of adverse effects have been documented over the course of the 67 plus years (based on the 1958 benchmark), no major approval is required.
That is, until new information becomes available that changes that stance.
Even with scientific proof, if information becomes available that negates prior safety status, GRAS can be revoked.
Sometimes the FDA may present a “request for information.” In these cases, they require a manufacturer to conduct safety testing or cite existing safety data to maintain GRAS status.
You would expect that a pre-market review is required for all food additives to meet the GRAS status. But due to the sheer number of products and additives that the FDA tracks and manages, there is a procedure that currently allows a “self-affirmed” GRAS standing.
In this case, a food additive manufacturer can indicate that they have performed all due diligence. Allowing them to skip the official pre-market review process with the FDA.
It is a sort of honor system.
The FDA expects that all the I’s are dotted, and the t’s are crossed. But unfortunately, that isn’t always the case.
Changes to GRAS under Health and Human Services Secretary RFK Jr will remove this loophole. A move that will require pre-market review for all new food additives. A more robust food system may be the beneficial trade off for longer wait times and approval processes.
The Federal Food, Drug, and Cosmetic Acts defines a food additive as “any substance the intended use of which results or may reasonably be expected to result – directly or indirectly – in it becoming a component or otherwise affecting the characteristic of any food.”
That’s a lot of words. But what applies to it?
Things like xanthan gum are considered a direct food additive. It is added to salad dressings, bakery fillings, puddings, chocolate milk, and other foods to manipulate texture.
Certain dyes are considered additives. As are sweeteners.
In a March Press Release Secretary Kennedy publicly directs the acting FDA commissioner to take steps toward possible revision to the GRAS Final Rule. More specifically, eliminating the self-affirmed GRAS pathway.
“For far too long, ingredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemical, often with unknown safety data, to be introduced into the U.S. food supply without notification to the FDA or the public,” said Secretary Kennedy in a statement. Eliminating this loophole will provide transparency to consumers, help get our nation’s food supply back on track by ensuring that ingredients being introduced into foods are safe, and ultimately Make America Healthy Again.”
The press release indicates that eliminating the self-affirmation process. This would require that companies seeking to introduce new ingredients into food to publicly notify the FDA of their intended use of such ingredients. As well as safety data prior to being introduced into the US food supply.
The FDA has completed and published more than 1,000 GRAS notices and averages 75 new notices each year. The removal of this loophole will likely increase this workload. But the impact on the health and safety of American food supply will benefit.
Acting FDA Commissioner Sara Brenner, M.D., M.P.H. approves this move to implement changes to GRAS review.
“The FDA is committed to further safeguarding the food supply by ensuring the appropriate review of ingredients and substances that come into contact with the food,” says Acting Commissioner Brenner. “The FDA will continue to follow our authorities and leverage our resources to protect the health of consumers to ensure that food is a vehicle for wellness.”
Do you think it’s time for a change to GRAS procedures?
Personally, I had no idea that there was a self-affirmation option for GRAS approval. So, while I do expect this could create delays in the approval process, overall it seems like it is a change for the better.
Make Food Safe will continue to follow this topic as it develops and update our Make Food Safe family as information becomes available.
If you’d like to know more about food safety topics in the news, like “Changes to GRAS May Remove Self-Affirmation Option for Food Manufacturers,” check out the Make Food Safe Blog. We regularly update trending topics, foodborne infections in the news, recalls, and more! Stay tuned for quality information to help keep your family safe, while The Lange Law Firm, PLLC strives to Make Food Safe!
By: Heather Van Tassell (contributing writer, non-lawyer)