If you were a regulatory agency, and your goal was to protect the health and safety of your country’s consumers, which system would you use to regulate the chemicals added to food?
Would you use a precautionary system—in which any new food additive must be independently tested for safety before companies can add it to food, and if regulators are not convinced that it is safe, the additive will not be approved?
Or would you use a “post-cautionary” system—in which a company can use any additives they like without government oversight or approval, and only if, years later, overwhelming evidence happens to emerge that the additive was harmful all along, regulators might take action?
Most high-income countries use a precautionary system—Australia, Japan, South Korea, and the entire European Union, to name a few.
On the other hand, the U.S. sets itself apart by using an incredibly lenient, post-cautionary system of additive regulation. This system may possibly play a role in the unprecedented rise in autoimmune conditions and other chronic illnesses among Americans in recent decades. At the core of this system is a policy known as the GRAS, or “Generally Recognized As Safe,” loophole.
To understand the GRAS loophole, it’s important to understand the history of additive regulation in the United States.
The 1958 Food Additives Amendment to the Food, Drug, and Cosmetic Act required the Food and Drug Administration (FDA) to scientifically evaluate any food additives for absolute safety before allowing them to be used in food—a precautionary approach. The law defined additives as “any substances the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food.” However, this definition excluded one group of additives, stating that the term “does not include… substances which experts have classified ‘generally recognized as safe’ (GRAS).”
This exclusion actually served a very practical purpose at the time it was written. Hundreds of additives had already been in use for centuries prior to 1958 and were widely known to be safe, including vinegar, salt, and spices. The GRAS clause was intended to avoid having to put these obviously safe substances through an unnecessary and lengthy approval process.
Most importantly, the clause was only meant to apply retroactively—that is, to substances in use prior to 1958. Any new additives introduced after 1958 were meant to go through the standard precautionary approval process.
At first, the statute was applied largely as intended; the FDA had to evaluate and approve any new additives prior to use, and it maintained a tightly controlled list of GRAS substances. Eventually, the FDA began to allow new additives onto the GRAS list, but only after a federal review and approval process.
However, things began to change in the 1980s. As the number of additives being developed by the food industry started to rapidly increase, the FDA began to allow industry groups to conduct their own GRAS evaluations and determinations. Still, the government had the final say.
Then, in 1997, the modern “GRAS loophole” was born. The FDA released a rule giving industry groups the right to classify substances as GRAS without any government oversight or approval whatsoever—not even requiring them to notify the FDA. Taking advantage of the vague language of the GRAS clause, the FDA gave the food industry the ability to completely sidestep the precautionary approval process intended by the 1958 Food Additives Amendment.
As a result, a food company today can develop an entirely new, barely understood chemical, employ their own experts to privately determine that the substance is GRAS, and then add the chemical to food—without any sort of independent oversight or disclosure to the government or public. Thus, thanks to the GRAS loophole, our system is now post-cautionary.
While a post-cautionary system is convenient for industry, it is deeply problematic for consumers. The vast majority of additives are designed solely to make ultra-processed foods more appealing, addictive, or cheap to produce—not with consumer health in mind. Aside from boosting corporate profits, the social benefits of these additives are virtually nonexistent, while the social costs of risking long-term health effects for consumers are high.
Post-cautionary additive regulation is also inherently ineffective. Once an additive becomes widespread, it is nearly impossible to link it to long-term health problems, even if such a relationship exists. Additives, by definition, are always consumed in addition to other ingredients and additives, making it extremely unlikely that any one substance’s harmful effects will be detected and isolated.
This is especially true given that there is little motivation for anyone to even collect such data once an additive is already on the market. As long as additives don’t have immediate, directly traceable effects, food companies don’t have to be concerned with their long-term health impacts, since there is very little risk of facing consequences.
This system sets up a very troubling set of incentives for food companies. Additives are profitable and easy to implement, providing a strong incentive for companies to use them without restraint. At the same time, additives’ health effects are often subtle, long-term, and hard to trace, meaning there is very little incentive for companies to be responsible and cautious in their use, particularly if there is no regulatory oversight. As such, the conditions are ripe for food producers to flood the market with barely understood chemicals.
And that is exactly what has happened. A 2013 Pew Charitable Trusts report estimated that the American regulatory system allows more than 10,000 chemical additives in food, with about half being added directly to food and the rest used in food packaging and processing. Thousands of these additives have not been reviewed by the FDA. Many of these additives have even been found unsafe in other countries yet remain in our food due to the GRAS loophole.
By contrast, the European Union permits approximately 300 additives.
The consequences of the GRAS loophole are difficult to measure but troubling to consider. Over the same decades that thousands of unregulated additives have entered our diets, rates of rare health issues, chronic disease, and mental health conditions have skyrocketed. Ultra-processed foods, which contain the highest amounts of food additives, have shown exceptionally strong associations with these health effects. While direct causation is difficult to prove, there has certainly been a correlation between increasingly unrestricted additive usage and the rise of chronic conditions in America.
We can at least be certain of one thing: we do not yet understand most additives’ long-term health impacts, nor their complex interactions with other additives, foods, and our bodies. Allowing them in food without oversight or restrictions amounts to experimenting with Americans’ health.
Closing the GRAS loophole would not fix our food system, but it would be an important first step. Until then, the American approach will remain an outlier among high-income nations, one that leaves citizens unknowingly participating in a vast, uncontrolled experiment every time they sit down for a meal.
In places like the EU, the philosophy for additive regulation can best be described as, “if you can prove it’s safe, it can go in our food.”
In the United States, the philosophy is, “it can go in our food.”
“FDA’s practice on GRAS additives flouts the law and leaves the agency unaware of what chemicals are being added to our food and with no way to ensure that these additives—and the food that contains them—are safe.”
— Tom Neltner, Chemicals Policy Director at Environmental Defense Fund
References:
European Food Safety Authority. (2025, September 15). Food additives.
Food Additives Amendment of 1958, 21 U.S.C. § 321(s) (2018).
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