Scientists Alert: Unsafe Ingredients Could Sneak into US Foods Through FDA Loophole

Think your pantry is filled with safe food? Think again.

Recent findings published by the American Journal of Public Health reveal serious gaps in the oversight by the U.S. Food and Drug Administration (FDA) that may allow harmful substances to enter the food supply unchecked.

The study points to loopholes in how the FDA allows food companies to classify certain ingredients as Generally Recognized as Safe (GRAS) without proper accountability.

This distinction is vital, as some food additives need FDA approval, while GRAS substances do not. Alarmingly, this includes harmful chemicals such as potassium bromate, a known carcinogen that is banned in many countries but still permitted in the U.S.

Countries like Canada, China, and all European nations have prohibited its use, and recently, California passed a law to ban it alongside other harmful substances. Similar legislation is being considered in states like Illinois, New York, and Pennsylvania.

Jennifer Pomeranz, the study’s lead author and a public health policy professor at NYU, stated, “Neither the FDA nor the public has a full understanding of how many of these ingredients—often found in ultra-processed foods—are in our food supply.”

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Since 1958, the FDA has been responsible for assessing the safety of new food chemicals. Although they play a crucial role in food safety, the agency’s approach to regulating GRAS substances poses significant challenges.

Originally, GRAS status was meant for commonly used ingredients like vinegar and spices, but since 1997, companies have been allowed to self-define which substances qualify, without notifying the FDA or providing safety data. This has resulted in thousands of new ingredients being introduced without government scrutiny.

The implications of this self-regulation are troubling, as many GRAS ingredients, particularly those found in processed foods, lack independent safety assessments.

A 2021 court ruling upheld the FDA’s authority over GRAS regulations but did not affirm the safety of current practices. Pomeranz mentioned, “The court only ruled that the FDA’s practice was not unlawful, not that it ensures our food is safe.”

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In 2010, the U.S. Government Accountability Office (GAO) advised the FDA to enhance its oversight of GRAS substances with better transparency and reduced conflicts of interest. However, these recommendations haven’t been fully integrated into FDA practices.

The researchers suggest key policy changes: requiring companies to notify the FDA about their GRAS designations, submit safety data for review, and secure additional funding to improve FDA operations.

A thorough review process could ensure that substances, including everyday ingredients like caffeine, sugar, and salt, are safe in both low and high quantities common in processed foods.

Pomeranz concluded, “The FDA and Congress can take further steps to help the FDA fulfill its mission of ensuring our food supply is safe.”

References

Pomeranz, J. L., Leib, E. M. B., & Mozaffarian, D. (2024). Regulation of Added Substances in the Food Supply by the Food and Drug Administration Human Foods Program. American Journal of Public Health, e1–e10. https://doi.org/10.2105/ajph.2024.307755

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