838. Are manufacturers using a regulatory loophole to sneak untested chemicals into our food? In this episode, we break down what GRAS really means, why it exists, and how the process works.
838. Are manufacturers using a regulatory loophole to sneak untested chemicals into our food? In this episode, we break down what GRAS really means, why it exists, and how the process works.
Resources:
Database of substances added to foods
Find a full transcript here.
Hello! Welcome to the Nutrition Diva podcast, a show where we take a closer look at the latest nutrition headlines and memes and sort fact from fiction. I’m your host, Monica Reinagel and today we’re tackling a rather obscure regulatory term that lately has become quite a buzzword.
GRAS is a regulatory term for certain ingredients used in food manufacturing. It stands for Generally Recognized As Safe. But there are some influencers out there suggesting that many of the ingredients that fit under this regulatory umbrella are anything but safe (or, for that matter, generally recognized!).
In this episode, I want to explain how the GRAS process really works, clear up some of the most common misconceptions (including about whether the E.U. allows fewer additives than the U.S.) , and hopefully leave you with a little more peace of mind about what’s in your food. I want to thank the International Food Information Council, who recently hosted an in-depth informational session for food and nutrition professionals, featuring government and legal experts who were able to dispel a lot of misinformation on this topic. I’m happy to have an opportunity to pass some of that clarity along to you.
Before we get into some of the most common myths or misunderstandings about GRAS status, let’s clarify some categories. Because not every substance in food requires FDA approval.
Everyday foods and staples — things like apples, flour, sugar, salt, and oils — don’t need to go through any formal FDA approval process. They’ve always been recognized as safe to eat. Anything that’s added to these ingredients during the manufacturing process, whether that’s things like vitamins, protein isolates, or added fiber, or things like preservatives, emulsifiers or thickeners, is considered to be a food additive.
Normally, a food additive would require premarket approval from the FDA, meaning that the FDA would need to explicitly say that it is safe to use before you can include it in foods.
However, certain ingredients are exempt from this requirement. The GRAS exemption says that if a substance is generally recognized as safe, it can be used in food without going through that formal petition process. But it’s not just a matter of a manufacturer saying, “I think it’s safe,” and everyone taking their word for it. Not by a long shot.
To achieve GRAS status for a new ingredient, a company assembles a scientific dossier that describes the ingredient, how it’s made, how much people are likely to consume, and the results of toxicology and metabolism studies. (That’s right: there have to be toxicology and metabolism studies!) Next, qualified experts must agree, based on publicly available science, that this ingredient is safe for its intended use.
At this point, a company has a choice. They can simply hold onto that dossier in case anyone asks for it. Or, they have the option of submitting their dossier to the FDA for review. If the FDA has any concerns or questions, the company can amend and submit it. Alternatively, the FDA may issue a formal response indicating that they have “no questions” about the dossier.
So there are two things about this process that are a little odd.
The “no questions” response indicates the FDA has reviewed the dossier and has no objection to the company’s conclusion that the ingredient is generally recognized as safe. However, the agency does not technically “approve” the applications or these ingredients. So, when people say that these ingredients have not been approved, they’re correct in the literal sense. But I think this is really just a semantic distinction.
The other thing that’s a bit surprising is that companies don’t have to submit their dossier to the FDA. It’s optional. This is known as “self-affirmed GRAS status.” However, this is not just a matter of declining to participate in the process. The companies who choose to self-affirm have exactly the same burden of evidence as those who submit their dossiers for review. They can be asked to produce that dossier at any time, and if they can’t, or it does not sufficiently establish an expert consensus, they will face serious legal and financial consequences.
In truth, the vast majority of food manufacturers do submit those dossiers. They want that “no questions” response on the books because it acts as a stamp of approval. If there are concerns about their dossier, they want an opportunity to address them. And, quite frankly, it’s not just a matter of integrity and public trust. It’s also about avoiding legal, financial, and perhaps moral liability.
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Now that you have a basic understanding of how the GRAS process works, let me tackle a few of the most common myths and misunderstandings:
First, let me just clarify that food colorings are never eligible for GRAS status. They must always go through the full pre-market approval process and get explicit sign-off from the FDA that they are safe to use before they can be used in any products.
There’s also a lot less wiggle room than you might think. Let’s say an ingredient already has GRAS status. But a company wants to use it in a different way, or in a different amount, or for a different purpose than described in the original dossier. Maybe they want to use a different processing method to make it. In any of those cases, it’s back to the drawing board. A brand new dossier must be created to demonstrate that the new process or use is also safe. In other words, contrary to popular notions, a substance isn’t just declared GRAS once and for all. It’s GRAS only for a specific intended use and only at certain levels.
I also see people claiming that this whole process takes place out of public view, in some secret back rooms. Although the process may be poorly understood, it’s actually pretty transparent. The studies used to justify safety must be public and peer-reviewed. Although you can include unpublished studies as supporting material, GRAS status cannot be granted exclusively on that basis. And the FDA also maintains public databases where you can look up any food additive and see its complete history and current status. (I’ll include links in the show notes.)
And finally, let me address the assertion that the U.S. allows ingredients that are banned in Europe. First, it’s important to understand that the two systems use different approaches. The U.S. uses a risk-based approach, which weighs both the ways in which a substance could potentially cause harm as well as the likelihood of harm occurring, based on the way it is being used. The European Union, on the other hand, often applies the precautionary principle, which can restrict or ban a substance simply because it could pose a hazard, even if only at levels people would never realistically consume. Both systems are built on rigorous scientific evaluation — they just have slightly different philosophies of risk.
And because the two systems sort and categorize food additives differently, it sometimes looks as if the U.S. has approved a lot more additives. But appearances can be misleading. One of the biggest categories of food additives, for example, are flavoring agents. Here in the U.S., these are included in the GRAS category; in Europe, they are broken out into their own category. When you add up all the different categories, the number of approved additives in Europe and the U.S. is actually quite similar. And here’s a fun fact: Europe has approved 15 synthetic coloring agents; here in the U.S., we only have 9!
The big picture here is that the GRAS process is not a loophole for sneaking untested chemicals into the food supply. It’s a regulatory pathway that Congress created to recognize ingredients that experts agree are safe — either because they’ve been safely used for generations or because the science clearly shows a “reasonable certainty of no harm.” And these ingredients and additives are in our food for a reason. Some are definitely there to make our food more appealing and palatable. But a lot of those additives are there to keep our food safe, stable, affordable, and sometimes even more nutritious.
And while I think there’s always room for improvement in regulatory processes like these, food manufacturers are actually highly incentivized to play by the rules and to make sure their food products are safe. Recalls are a legal, financial, and public relations nightmare for manufacturers. Honestly, they may go to far greater lengths to ensure food safety than most of us do in our own kitchens!
If you’ve been concerned about some of the things you’ve heard or read about food additives and the GRAS process, I hope that this episode has cleared up some confusion and put things into perspective.
If you have a question or topic you’d like me to tackle on the podcast, you can email me at nutrition@quickanddirtytips.com. And if you’d like to find out about having me speak at your next in person or virtual event, you can learn more at wellnessworkshere.com
Nutrition Diva is a Quick and Dirty Tips podcast. Holly Hutchings is our Director of Podcasts. Steve Riekeberg is our audio engineer, Morgan Christianson heads up Podcast Operations & Advertising, Rebekah Sebastian is our Manager of Marketing and Publicity and Nat Hoopes is our Marketing Assistant. Thanks to all of them and thanks to you for listening!