Why Food Additives May Not Be FDA Reviewed

Nearly 70 years ago, Congress amended the Federal Food, Drug, and Cosmetic Act to prohibit companies from using food additives before they have been rigorously vetted for safety. This change in the law, however, did not play out as the legislators intended.

The Food Additives Amendment, passed in 1958, created two pathways. One was for food additives, which would undergo a safety review conducted by the Food and Drug Administration. The other pathway was created to enable common ingredients already in the food supply — think vinegar, or baking soda — to bypass the review because those ingredients were “generally recognized as safe,” or GRAS.

And yet today, the vast majority of new ingredients, most of them industrially produced, make it to market via the GRAS pathway, said Jennifer Pomeranz, an associate professor of public health policy and management at the NYU School of Global Public Health. Researchers like Pomeranz, along with some physicians, nonprofits, and the Government Accountability Office, have argued that these ingredients are not, in fact, generally recognized as safe. Instead, they say, food companies have learned to exploit what’s become known as the “GRAS loophole.”

This loophole hinges on a few things. For one, the 1958 amendment does not clearly state whatmakes a product GRAS. And further, food companies are allowed to make the determination themselves after conducting their own safety research, which can be based on unpublished studies. Companies can then put their ingredients on the market without notifying the FDA or making their data available to the public. Taken together, these factors allow new food additives to bypass FDA review — and public awareness.

The food industry has framed the regulatory landscape a bit differently. The Consumer Brands Association, a trade group representing makers of packaged goods, hosts a website that states that food and beverage manufacturers “follow strict regulations and rigorous safety protocols” for the making and labeling of ingredients. The aim, according to the website, is “to ensure transparency and empower consumers to make informed choices.”

The Trump administration recently got involved in the issue. In March, Health Secretary Robert F. Kennedy Jr. directed the FDA commissioner to explore whether the agency might develop new rules to require companies to notify the FDA and share their safety data before introducing a new ingredient into the food supply.

Undark sat down with Pomeranz to discuss all of this by Zoom. The interview has been edited for length and clarity.

Undark: Is it true that there are many new ingredients in the food supply that the FDA is not even aware of?

Jennifer Pomeranz: Yes, unfortunately, it’s probably thousands because there’s no requirement that the companies tell the FDA that they’re adding these ingredients to the food supply.

The other part that is concerning is the labeling requirements. We think that all our ingredients are shown on the labels, but the label does not tell you the specific chemicals or compounds that are being added. They use general words like “corn oil” or “flavorings.” So no one knows what these new ingredients are.

UD: Are most of the substances that take the GRAS pathway these days chemicals that contribute to a food being ultra-processed?

JP: The hallmark of an ultra-processed food is the industrial ingredients. Both these — what should be food additives, and then also these GRAS compounds — they’re not what we used to use a hundred years ago in the food supply. It’s not salt, sugar, vegetable oil, and paprika. It’s complex chemicals that are added to ultra-processed foods. So that’s exactly what we’re talking about here.

UD: It almost feels like the GRAS acronym is a bit misleading because it sounds like something out in nature — it’s “grass.”

JP: And even “generally recognized as safe” is not accurate.

Also, just so it’s even more clear how that’s such a misnomer: Studies have shown that when the food industry does do a safety analysis, they use something called a GRAS panel. It’s supposed to be a panel of experts. This is what it says in the regulations. It should be scientific consensus. One hundred percent of those experts are industry-paid or have conflicts of interest with industry.

It’s the whole fox guarding the hen house scenario.

UD: Once a substance is on the market, it can take several decades to get it off the market if it does turn out to be harmful. I was wondering if you could talk about the example of trans fats.

JP: Partially hydrogenated vegetable oil is industrially produced trans fat. Just so you know. There’s also trans fat naturally occurring.

The long and short is it took more than 30 years to have the FDA act, after the science showed that partially hydrogenated vegetable oil was dangerous. Even in the 1950s, there was literature saying that industrially produced trans fat was associated with health harm. And then there were some very seminal pieces in the ’90s basically proving that trans fat had negative effects. And even in 2005, the Institute of Medicine, which is now the National Academy of Medicine, issued a report on the health harms. There were citizens petitions in 2004, 2009.

The FDA didn’t even revoke its status until — first they proposed revoking its status in 2013, and then they finalized it. But actually it didn’t fully go into effect until 2023.

UD: Wow.

JP: The FDA has been so historically slow, and they haven’t historically taken action even after Europe or Canada or other countries have ruled that the ingredient is not safe. That doesn’t trigger FDA review, or trigger FDA to do an expedited review, or anything like that.

UD: Robert F. Kennedy, Jr., the secretary of the Department of Health and Human Services, directed the FDA commissioner to explore ways to eliminate the GRAS loophole. In your view, would this be a positive development? Do you think it will happen?

JP: It would definitely be a positive development. They would remove the ability of the companies to just put ingredients into the food supply without notification to the FDA. Definitely a huge development. Completely applaud that if it happens. There is a regulation before the [Office of Management and Budget]. No one’s seen it, so I don’t know what it says. But it would be a huge accomplishment, something that is decades overdue.

But one concern that the summary of what they’re planning to do doesn’t talk about: What about the ingredients already in the food supply that went through the GRAS loophole?

Whether this is going to happen: I do think the administration is behind the MAHA movement, but it conflicts with MAGA and cutting regulatory authority. I don’t know how they’re going to fund the FDA to actually do the work that needs to be done to review the safety data.

I don’t know how that’s going to happen unless they pass a user fee or increase appropriations. But it has to be increased appropriations not just for a year; it has to be for a while. That’s why my colleagues and I have suggested a user fee because it would ostensibly remain and also be able to fund this new pathway.

UD: There’s a precedent for this. Pharmaceutical companies currently pay user fees to the FDA. Is this right?

JP: Yes, and actually, even some entities have requested user fees because they’ve seen the benefits. It does speed up the process and guarantee a review period time that the FDA will meet; whereas, right now, when it comes to food, FDA does not meet its review time periods for anything. Of course, there’s an occasion, but it’s usually not meeting its review timelines.

I just really want people to understand one thing. There’s this misconception that a user fee is almost like a bribe, and you’re going to be bribing the FDA to affirm the GRAS status.

It’s not a bribe that you’re getting the FDA to be on your side. It simply funds the process. It doesn’t fund an outcome, but it funds the process of review.

UD: Is there anything else that you’d like to add?

JP: Even people who are not happy about this administration. I want people to just have an open mind that there are some things that are going in the right direction, and in the food space, this is one of them, if they close the GRAS loophole.

But again, the ingredients that are already in the food supply, that is an open question. We need support for the FDA to be able to review those ingredients as well.