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Is a US food law loophole affecting safety?

The US Food and Drug Administration (FDA) allows companies to self-regulate the safety of their ingredients and additives by declaring them to be “generally recognised as safe” (GRAS), which poses huge public safety concerns, say researchers.

The researchers from New York University state that there are gaps in the FDA's review process, which may disrupt its ability to determine which substances are “generally recognised as safe” (GRAS). 

The FDA is responsible for ensuring the safety of the US food supply, establishing rules for nutritional labelling, collaborating with companies on food recalls, and addressing foodborne illness outbreaks. According to the research article, published in the American Journal of Public Health, the FDA has adopted a more passive stance regarding overseeing additives in our food and specific ingredients’ safety.

While it evaluates premarket safety for those ingredients regulated as food additives, the FDA allows the food industry to self-regulate and determine which items to classify as GRAS. Companies can then decide whether to disclose the safety data of these ingredients and their use to the FDA. Many new substances have been introduced into the food supply without government oversight, leading to potential risks.

The New York University professors say this legal loophole allows unsafe ingredien ts to enter US foods and the wider supply chain, and that increasingly prevalent health concerns in today’s food system, including diet-related diseases, are partly due to this loophole in federal law.

“The biggest takeaway for consumers is that people should stop eating ultra-processed foods as much as possible,” Jennifer Pomeranz, associate professor of public health policy and management at NYU School of Global Public Health and the study’s first author, told Ingredients Network.

“Both the FDA and the public are unaware of how many of these ingredients – which are most commonly found in ultra-processed foods – are in our food supply.”

Inadequate safety reviews

In addition, the researchers state that the FDA does not have a formal approach to reviewing food additives and GRAS substances already found in the food supply. After an ingredient enters the market, the FDA can review new data indicating its potential harm and risks. Where needed, the FDA will take further action to instruct the manufacturer to modify their formulation to lower or remove the ingredient entirely.

The FDA stated in March 2024 that it would review 21 chemicals found in foods to ascertain whether they should stay on our shelves or require further action. One of these food additives the FDA is reviewing is potassium bromate, a chemical added to baked goods and drinks, which is banned in numerous global markets, including Europe, Canada, China and Japan. In the US, California passed a law in October 2023 to ban its use in food with three other chemicals. New York, Illinois, and Pennsylvania have also passed similar bills.

“This is a stark example of the FDA’s regulatory gap,” said Pomeranz. “We’re seeing states starting to act to fill the regulatory void left by the FDA’s inaction over substances increasingly associated with harm.”

The researchers also state that the FDA’s lack of GRAS ingredient examination is limited as it rarely rescinds the classification once given. During their research, an FDA inventory showed that only 15 substances were categorised as GRAS and then declassified. Furthermore, the FDA does not regularly review foods with GRAS ingredients that can be safe at low levels but not in larger amounts, such as sugar, salt or caffeine.

Closing the legal loophole

The professors propose several recommendations to improve the FDA and US Congress’s ability to evaluate and govern GRAS substance and food additive safety.

Among these, the researchers suggest including a new requirement for companies to publicly notify the FDA when they use GRAS ingredients and share their safety data before using them in foods. The New York University researchers also suggest creating a stringent review process to reassess the safety of GRAS ingredients and food additives once they are on the market, AND clarifying the difference between GRAS ingredients and food additives.

To bolster the FDA’s ability to oversee the food supply, researchers suggest Congress could assign additional resources to the organisation or create a user fee program whereby food companies pay for the FDA to review ingredients’ safety before manufacturers add them into their formulations.

“Both the FDA and Congress can do more to enable the FDA to meet its mission of ensuring a safe food supply,” said Pomeranz.