Foods Generally Recognized as Safe (GRAS) Aren’t Always

The GRAS isn’t always greener. 

Chemicals enter your food without any oversight. Companies pay scientists to say their chemicals are Generally Recognized as Safe (GRAS) and don’t even have to notify the FDA they’ve created and are using a newly created synthetic food additive. 

 

Over 10,000 chemicals are used as food additives in the US. So, how do all these ingredients enter our food? Who’s testing them? How do we know they are safe? The answer is shocking and infuriating. In short, we don’t know who’s testing them, and we don’t know if they are safe.

According to Michael Taylor, a former FDA Deputy Commissioner, “FDA simply does not have the information to vouch for the safety of many of the chemicals added to food. Although informing the FDA is voluntary, the law was meant to increase public scrutiny of additive safety by encouraging companies to publish their science in academic journals. The assessments need to be based on publicly available information where there is agreement among independent scientists. It’s got to be more than three employees in a room looking at information that is only available to them.”

 

What is GRAS?

Food chemical manufacturers are self-regulated in terms of product safety. Under the current system, food manufacturers can invent a new chemical additive, hire their own scientists to declare the chemical safe, begin using the new chemical in food products or sell it to other food companies for use, and never notify the FDA that the new additive even exists.

Even if a food or chemical company chooses to alert the FDA, if the FDA starts asking questions about its methodology and data, the company can just withdraw the notification, essentially ending the inquiry. The company continues selling its food chemicals, while the FDA has to wait for an overwhelming response to start a “Post-Market” review of the ingredient, which rarely happens. 

 

A Game of Whack-a-Mole

Allowing additives to enter the market without prior review means we don’t have a complete understanding of what we are ingesting and what the potential health consequences are. 

Food additives that enter our food via GRAS are often found to be harmful to human health. For example, Brominated Vegetable Oil (BVO) has been used predominantly in orange soda for years. It entered the market via GRAS in 1958, but research suggesting it was unsafe has been mounting for decades. It took the FDA until 2024 to finally ban BVO in the US. 

 

How Did We Get Here?

In 1958, the Congress passed the Food Additives Amendment to the Food Drug and Cosmetics Act. The Food Additives Amendment is mostly sound law. It sets up a system for food additives to be reviewed before entering the market; however, it allows for products already in the market that scientists “generally recognized as safe” to avoid this pre-market review process. This provision was intended for food additives like baking soda or vinegar, but the provision has been hijacked by food companies who have no reason to fear FDA scrutiny, and now nearly every food additive enters the market through the GRAS loophole without FDA review. 

 

Conflict of Interest in the GRAS System

Within the GRAS system lies an inherent conflict of interest. If food chemicals that are generally recognized as safe are allowed to enter the market, it begs the question, “Who are the people recognizing and judging these products as safe?” The loophole implies that the scientific community at large recognizes these items as safe, but that is not the case. The reality is that the food companies hire their own scientists to certify new additives as safe. 

So, who are these scientists for hire? Well, between 2015 and 2020 just seven individual scientists accounted for nearly 50% of all GRAS determinations (source). These individuals often served together on the same panels, reviewing multiple products. The possibility of bias and conflict of interest abound. How could that possibly be interpreted as the scientific community defined in the statute? 

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