Tech and Tofu

Introduction

The FDA allows companies to self-certify chemicals as “Generally Recognized as Safe” (GRAS). Even so that they are responsible for the safety of the U.S. food supply. A recent article in the American Journal of public health published that the current FDA process opens a loophole. Companies can add substances to food without notifying the FDA or providing safety data.

The GRAS Loophole

The GRAS (Generally Recognized as Safe) system was originally created for widely accepted, safe ingredients. However, companies now self-certify chemicals without FDA notification or review, bypassing oversight. This has allowed thousands of untested additives into the food supply. Compounds of “Food additives” must be reviews and approved while ingredients considered as GRAS are exempted.

In 2021 a federal court case upholds the non-handling attitude of the FDA.

“Notably, the court did not find that the FDA’s practices on GRAS ingredients support the safety of our food supply,” said Pomeranz. “The court only ruled that the FDA’s practice was not unlawful.”

“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.”

Study senior author Dariush Mozaffarian, director of the Food is Medicine Institute and distinguished professor at the Friedman School of Nutrition Science and Policy at Tufts University

FDA’s Limited Power and Resources

The FDA lacks the resources to monitor new substances or reassess existing ones. Even harmful chemicals like potassium bromate, banned in many countries like Europe, Canada, China, and Japan, remain in U.S. food products due to delays and weak post-market review processes.

“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.”

Caffeine, salt and sugar are save, when added in low levels but not in large quantities.

“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. Given that the FDA regulates the use of GRAS substances, the agency could set limits on the amount of caffeine in energy drinks.”

The Impact on Public Health

Many additives linked to serious health risks, such as cancer and hormone disruption, remain unregulated. Consumers are largely unaware due to limited transparency around safety data.

Calls for Reform

The authors of this study provided the FDA and the congress with several potential actions, better asses to increase the safety of GRAS and food additives. They also suggest that the FDA allocate additional resources or a program in which the food companies pay the FDA to review their products for safety of the used ingredients and give the public access to this data.

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

States like California are stepping in to ban risky chemicals where federal regulation lags. Other states introduced similar bills to ban chemicals.

Reference: “Regulation of Added Substances in the Food Supply by the Food and Drug Administration Human Foods Program” by Jennifer L. Pomeranz, Emily M. Broad Leib and Dariush Mozaffarian, 9 June 2024, American Journal of Public Health.
DOI: 10.2105/AJPH.2024.307755
The research was supported by the National Institutes of Health (2R01HL115189-06A1).