Hundreds of ingredients in U.S. foods are potentially unsafe

The Food and Drug Administration (FDA) is responsible for ensuring the safety of the U.S. food supply, but a new study reveals that the agency has taken a hands-off approach when it comes to the safety of many additives already in our food.

Self-regulation of food additives 

Under current regulations, the FDA allows the food industry to self-regulate thousands of added ingredients. Companies decide on their own which ingredients are classified as “generally recognized as safe” (GRAS) and whether to disclose their use and safety data to the FDA. 

This self-regulation has led to many new substances entering the food supply without government oversight.

“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,” said Jennifer Pomeranz, associate professor at NYU School of Global Public Health and the study’s lead author.

A legal loophole

Since 1958, the FDA has been responsible for evaluating the safety of new chemicals and substances added to foods. However, food safety laws distinguish between “food additives,” which require FDA review, and GRAS ingredients, which are exempt. 

Initially, GRAS status was intended for well-known substances like vinegar, but since 1997, the FDA has allowed companies to determine whether new substances qualify as GRAS, often without notifying the FDA or sharing safety data.

Study senior author Dariush Mozaffarian, director of the Food is Medicine Institute at Tufts University, said that as a result of the FDA’s policy, the food industry has been free to “self-GRAS” new substances they wish to add to foods without notifying FDA or the public. 

“There are now hundreds, if not thousands, of substances added to our foods for which the true safety data are unknown to independent scientists, the government, and the public.”

More resources needed to review food additives 

The study highlights that the FDA lacks the resources and formal strategies needed to review existing food additives and GRAS substances. Even when new research suggests potential harm, FDA actions are rare. 

In March, the FDA announced it would review 21 chemicals, including potassium bromate, a substance added to baked goods and drinks that has been linked to cancer. Potassium bromate is banned in several countries, and states like California have also moved to ban it.

“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.”

Minimal oversight of food additives

The study also points out that the FDA’s oversight of GRAS ingredients is minimal. The agency rarely revokes GRAS status, and it doesn’t consistently review the safety of ingredients that may be safe in small quantities but harmful in larger amounts, such as caffeine. 

“In 1977, the FDA approved caffeine as a GRAS substance for use in sodas at a low level: 0.02 percent,” said Pomeranz. “But today, caffeine is added to energy drinks at levels far exceeding this, which is causing caffeine-related hospitalizations and even deaths.”

Emily Broad Leib is a co-author of the study and director of Harvard Law School’s Center for Health Law and Policy Innovation.

Ensuring a safe food supply

Leib argued that the sheer number of GRAS substances and food additives on the market – combined with the lack of knowledge about the existence of self-GRAS ingredients, insufficient resources, and documented time delays even for well-supported action – renders reliance on post-market authority flawed and unreliable to ensure a safe food supply.

The researchers recommend that the FDA and Congress take several actions to improve oversight, such as requiring companies to notify the FDA of GRAS ingredient use and share safety data before these ingredients are added to foods. They also suggest establishing a process to reevaluate the safety of existing GRAS ingredients and food additives.

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

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