Uncovering the Regulatory Gaps in Food Additives: A Call for Stricter Oversight

The U.S. Food and Drug Administration (FDA) is tasked with ensuring the safety of the nation's food supply, but a recent study has revealed a concerning lack of oversight when it comes to the proliferation of food additives. The report highlights the FDA's hands-off approach, allowing the food industry to self-regulate thousands of added ingredients without government scrutiny.

Exposing the Loopholes in Food Additive Regulation

The Rise of Self-Regulation

Under the current regulatory framework, the FDA permits the food industry to self-determine the safety of many additives, classifying them as "generally recognized as safe" (GRAS) without the need to disclose their use or provide supporting safety data to the agency. This self-regulatory approach has led to a surge in the number of new substances entering the food supply without any 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.

The GRAS Loophole

The study highlights a legal loophole that has allowed this self-regulation to thrive. 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, the GRAS designation was intended for well-established substances like vinegar, but over time, the FDA has allowed companies to determine whether new substances qualify as GRAS, often without notifying the agency or sharing safety data."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," said Dariush Mozaffarian, director of the Food is Medicine Institute at Tufts University and a senior author of the study.

Inadequate FDA Resources and Oversight

The study also reveals that the FDA lacks the necessary resources and formal strategies to effectively review existing food additives and GRAS substances. Even when new research suggests potential harm, the agency's actions are often slow and limited.For instance, 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 some states 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 GRAS Ingredients

The study also highlights the FDA's limited oversight of GRAS ingredients. 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."

Ensuring a Truly Safe Food Supply

The researchers argue that the sheer number of GRAS substances and food additives on the market, combined with the lack of knowledge about their existence, insufficient resources, and documented time delays in taking action, render the FDA's post-market authority flawed and unreliable in ensuring a safe food supply.To address these issues, the study recommends that the FDA and Congress take several actions, such as requiring companies to notify the FDA of GRAS ingredient use and share safety data before these ingredients are added to foods. The researchers 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.