In a bold move aimed at enhancing food safety and consumer transparency, US Health and Human Services Secretary Robert F. Kennedy has initiated the process of dismantling the FDA's GRAS (Generally Recognized as Safe) program. This program, established in 1958, has long been criticized for allowing the food industry to introduce new chemicals into the food supply without adequate oversight or safety data. Kennedy's announcement marks a significant step toward addressing a loophole that has been exploited by the industry for decades, potentially exposing consumers to harmful additives.

According to a 2022 analysis by the Environmental Working Group (EWG), nearly 99% of new chemicals used in food or food packaging since 2000 were approved not by the FDA, but by the food and chemical industry itself. During this period, food manufacturers sought FDA permission to introduce a new substance only 10 times. This startling revelation underscores the extent to which the GRAS loophole has been abused, allowing potentially unsafe additives to enter the food supply without proper scrutiny.

Kennedy's statement on Monday highlighted the urgency of the situation: "For far too long, ingredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the US food supply without notification to the FDA or the public." By eliminating this loophole, Kennedy aims to provide transparency to consumers and ensure that ingredients introduced into foods are genuinely safe.

Experts have welcomed the move, describing it as long overdue. Marion Nestle, the Paulette Goddard Professor Emerita of nutrition, food studies, and public health at New York University, expressed her support, saying, "I’m all for dealing with the GRAS loophole. It’s way past time for the FDA to close it." However, Nestle also raised concerns about the feasibility of implementing such reforms, given the current state of the FDA. "It’s hard for me to believe that this administration will give the FDA the resources it needs—and this means well-paid experts in food toxicology—to take on additive assessments, especially while agency personnel are being fired right and left," she added.

Former FDA Commissioner Dr. Robert Califf echoed these concerns, noting that any reform would have to overcome significant resistance from the powerful food industry lobby. "If it were to happen, it would be a real reversal of years of lobbying and politicians who mostly were blocking the efforts to make this happen," Califf said. "The industry has resisted it; the Republican Congress has blocked it. Now, if they’re in favor, let’s take advantage of it and get this done. I’d be all for it."

Kennedy has already taken steps to engage with major food industry players. On Monday, he met with the CEOs of Kraft Heinz, General Mills, Tyson Foods, Kellogg’s, Smuckers, and Pepsi to discuss potential solutions. "You should be able to exercise informed choice. You should know what that product is, what’s in your food, and what the health impacts are, and that’s all we’re going to do," Kennedy told Fox News host Sean Hannity in an interview. "We’re going to incentivize companies to be transparent and inform Americans about what’s making them sick."

Melissa Hockstad, president and CEO of the Consumer Brands Association, which represents the food industry, described the meeting as "constructive." "We look forward to continued engagement with the secretary and the qualified experts within HHS to support public health, build consumer trust, and promote consumer choice," Hockstad said.

The GRAS program was initially intended to apply narrowly to safe, commonly used ingredients such as garlic, oil, vinegar, and baking soda. However, in 1997, an overwhelmed and underfunded FDA made the program voluntary, allowing industry to declare a substance GRAS without first providing safety data to the agency. Since then, critics argue that food manufacturers have introduced numerous untested additives into the food supply, many of which have later been identified as harmful.

One notable example is brominated vegetable oil (BVO), a vegetable oil used in citrus sodas and sports drinks. Although BVO was declared no longer GRAS in 1970, the FDA did not officially ban the additive from the US food supply until July 2024. "The FDA knew for decades that brominated vegetable oil, or BVO, would be harmful, but it was allowed to remain in use at the request of food manufacturers," Illinois Secretary of State Alexi Giannoulias said at a September news briefing.

Tired of waiting for the FDA, several states have taken matters into their own hands. In October 2023, California banned four substances—BVO, potassium bromate, propylparaben, and red dye No. 3—due to links with serious health concerns such as cancer, endocrine and reproductive issues, and heart and liver problems. The FDA eventually banned red dye No. 3 in January, more than 30 years after scientists discovered its links to cancer in animals.

Eliminating the GRAS loophole would require companies to publicly notify the FDA of their intended use of new ingredients, along with underlying safety data, before introducing them into the food supply. However, representatives for food companies argue that the GRAS process plays an important role in enabling companies to innovate and meet consumer demand. "As the administration looks to revise GRAS, we stand ready to work with agency experts on continued analysis of safe ingredients and increase consumer transparency," said Sarah Gallo, senior vice president of product policy and federal affairs for the Consumer Brands Association.

Not everyone agrees that the GRAS program should be entirely dismantled. Jensen Jose, regulatory officer for the Center for Science in the Public Interest, a nonprofit food safety organization, cautioned that eliminating GRAS is not as simple as removing regulations. "There are many secret GRAS chemicals that are already in our food supply," he said. "Making these chemicals immediately illegal until obtaining FDA approval may cause disruptions in the food supply. Ensuring that existing GRAS chemicals are safe to remain in our foods should be a systematic process."

Jennifer Pomeranz, an associate professor of public health policy and management at New York University’s School of Global and Public Health, suggested a more nuanced approach. "They should grandfather ingredients that were GRAS in 1958 when Congress created the food amendment, like garlic, salt, and pepper, that we have eaten for decades without harm," she said. "Past that, have everything go through a food additive petition to assure its safety."

Another concern is the potential economic impact of reforming the GRAS process. Former FDA Commissioner Califf noted that conducting rigorous safety research costs money, and food companies might pass these costs on to consumers in the form of higher prices. "To do this research costs money. That’s a lot different than just declaring our stuff is safe, versus actually doing the work rigorously and having an independent government evaluation," he said.

Identifying the long-term health impacts of food additives is also a complex and time-consuming process. Califf explained, "These are not issues of people developing cancer in one week. It’s increased risk of cancer 20 years later. It takes large-scale epidemiology, a lot of expertise, and teams of people, including those who know about chemistry, biology, epidemiology, and human disease. It’s not easy."

Despite these challenges, the push to close the GRAS loophole has gained momentum. Strengthening the FDA's budget and resources could be a crucial step in ensuring the safety of the US food supply. "Beefing up the FDA budget, this would be a good deal for the American people," Califf said.

The effort to eliminate the GRAS loophole represents a critical battle for food safety and consumer transparency. While the move is long overdue and widely supported by experts, it faces significant challenges, including resistance from the food industry, resource constraints within the FDA, and the complexity of assessing long-term health impacts. As the debate continues, it is essential to strike a balance between innovation and safety, ensuring that the food we consume is free from harmful additives. The future of the US food supply depends on it.