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Unsafe ingredients could enter US foods via FDA ‘loopholes’, researchers warn

Unsafe ingredients could enter US foods via FDA ‘loopholes’, researchers warn

The food in your pantry may not be as safe as you think.

New research published Thursday by the American Journal of Public Health has revealed potential loopholes in the US Food and Drug Administration’s regulatory framework (FDA), which allows potentially harmful substances into the US food supply without the required oversight.

Researchers argue that the regulator’s approach provides a “loophole” for food companies to self-determine the status of certain substances as generally recognized as safe (GRAS), without being held accountable.

There is a significant difference between food additives that require FDA approval and GRAS substances that do not.

This potentially includes harmful chemicals such as potassium bromate, which is linked to cancer and banned in several countries but is still used legally in the United States

Potassium bromate is banned in Europe, Canada, China and Japan.

California recently passed a law to ban its use, along with three other chemicals, and similar bills have been introduced in Illinois, New York and Pennsylvania.

“Both the FDA and the public are unaware of how many of these ingredients — most often found in ultra-processed foods — are in our food supply,” Jennifer Pomeranz, lead author and associate professor of public health policy and management at New York University, said in a statement.

An image of a hand holding a can of energy drink. Many substances in the US food and beverage supply are self-certified, leading to potentially harmful health problems, a new study reports.

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Since 1958, the FDA has been tasked with reviewing the safety of new chemicals and substances added to foods.

While the FDA plays a critical role in food recalls, nutrition labeling, and response to foodborne illness outbreaks, protecting the use of chemicals is problematic. Initially, GRAS status was intended for ingredients commonly found in foods, such as vinegar and spices.

However, since 1997, the FDA has allowed the food industry to independently determine which substances can be considered GRAS, even for new and unknown compounds.

Companies are not required to notify the FDA or disclose safety data for these substances, resulting in thousands of new ingredients entering the market without government review.

The consequences of this self-regulation are far-reaching.

The study shows that neither the FDA nor the public know the full extent of GRAS ingredients in the nation’s food supply, many of which are often found in ultra-processed foods.

Potentially hundreds, if not thousands, of substances in commercially produced ingredients have not been independently reviewed for safety.

The court case in 2021 Center for Food Safety v. Becerra upheld the FDA’s GRAS rule and affirmed the agency’s authority to allow industry to self-regulate.

“In particular, the court did not find that FDA’s practices for GRAS ingredients support the safety of our food supply,” Pomeranz said. “The court merely ruled that the FDA’s practice was not illegal.”

A stock photo of a scientist inspecting pudding samples for quality control in a laboratory. A recent study found that neither the FDA nor the public know the full extent of GRAS ingredients in…


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In 2010, the US Government Accountability Office (GAO) recommended that the regulator strengthen its oversight of GRAS substances, particularly by requiring companies to submit basic information about these substances and minimize conflicts of interest in their decisions.

Although promising, these recommendations were not fully implemented in the FDA’s final GRAS rule.

The study’s authors suggest several policy recommendations: requiring companies to notify the FDA of GRAS determinations, sharing their safety data before adding substances to foods, and increased funding from the congress to allow the FDA to increase its scope.

The researchers say that a robust review process for both GRAS ingredients and food additives could address substances already on the market, ensuring that substances such as caffeine, sugar and salt are safe not only in small amounts but also at the higher levels that found in many processed foods.

“Both FDA and Congress can do more to enable FDA to fulfill its mission to ensure a safe food supply,” Pomeranz said.

Newsweek has contacted the FDA for comment.

References

Pomeranz, JL, Leib, EMB, & Mozaffarian, D. (2024). Regulation of additives in the food supply by the Food and Drug Administration Human Foods Program. American Journal of Public Healthe1–e10. https://doi.org/10.2105/ajph.2024.307755

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