Unsafe Ingredients May Enter US Foods Via FDA ‘Loophole,’ Scientists Warn

By Shannon McDonagh. Originally published in Newsweek on August, 9, 2024.

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

New research published on Thursday by the American Journal of Public Health has uncovered potential gaps in the regulatory framework of the U.S. Food and Drug Administration (FDA), allowing potentially harmful substances into the U.S. food supply without the required oversight.

Researchers claim the regulator’s approach provides a “loophole” for food companies to self-determine the state of some substances as Generally Recognized as Safe (GRAS), without being held to account.

A significant distinction exists between food additives, which require FDA approval, and GRAS substances, which do not.

This includes potentially harmful chemicals like potassium bromate, which is linked to cancer and banned in several countries but still legally used in the U.S.

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—which are most commonly found in ultra-processed foods—are in our food supply,” Jennifer Pomeranz, lead study author and associate professor of public health policy and management at New York University, said in a statement.

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 responding to foodborne illness outbreaks, its safeguarding the use of chemicals is problematic. Initially, GRAS status was intended for ingredients commonly found in foods, such as vinegar and spices.

But since 1997, the FDA has permitted the food industry to independently determine which substances can be considered GRAS, even for new and unfamiliar 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 scrutiny.

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

The study highlights that neither the FDA nor the public knows the full extent of GRAS ingredients in the country’s food supply, many of which are commonly found in ultra-processed foods.

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

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

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

In 2010, the U.S. 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 minimizing conflicts of interest in their determinations.

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

The study’s authors propose 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 Congress to allow the FDA to enhance its reach.

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 like caffeine, sugar and salt are safe, not just in small amounts but also at the higher levels found in many processed foods.

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

“The FDA prioritizes its review of chemicals in food based on risk, science, safety, and the FDA’s legal authority. However, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the law governing food additives, ingredients that meet the criteria for GRAS do not require the FDA’s pre-market review and approval as a food additive,” a spokesperson told Newsweek.

“The FDA has established a GRAS Notification Program to help ensure that these ingredients are safe for the ways in which they will be used and to help industry meet its responsibility for ensuring the GRAS status of ingredients they intend to use in food.”

Furthermore, the agency say they are committing to focusing more on food chemical safety through creating a new office dedicated to reviewing chemicals already in the food supply, and requesting a budget increase of $495 million for the coming year.

“The FDA strongly encourages manufacturers to contact the agency and follow the available procedures for our oversight of GRAS conclusions by submitting a GRAS notice. This program is utilized by a broad cross section of food ingredient manufactures and the FDA receives and evaluates an average of 75 notices per year,” they added.

They plan to discuss future developments with the public on September 25, 2024.

Update 08/13/2024 13:16 pa.m. ET: This article was updated to include comment from the FDA.

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