What additives are in your food? The FDA doesn’t always know, but seeks to change that

For nearly 70 years, food and beverage companies have been able to decide on their own that a new ingredient is safe and put it on the market without informing the Food and Drug Administration. But a new proposal could require that companies notify the agency when they add a new substance to human or animal food.

Right now, companies can self-certify ingredients as “generally recognized as safe” (GRAS). The proposed rule seeks to close an information gap that food safety experts have criticized for years, but stops short of requiring companies to wait for the FDA to determine that an ingredient is safe before selling it.

The proposal is part of Health Secretary Robert F. Kennedy Jr.’s broader “Make America Healthy Again” (MAHA) agenda, an effort to reshape federal oversight of the nation’s food supply.

WATCH: MAHA has a plan to clean up the American diet. Will it work?

The change would be “something of a step forward, but it is not nearly as significant a step forward as they make it out to be,” said Peter Lurie, president of the Center for Science in the Public Interest and a former FDA official.

Here’s what to know about the proposed changes.

Why was this exemption created in the first place?

Congress created the GRAS exemption in 1958 for widely accepted substances – such as salt and vinegar – where a formal FDA review was considered unnecessary.

Over time, however, the exemption has been used for far more types of ingredients than what Congress initially envisioned. An estimated 99% of food chemicals introduced since 1958 have entered the market through the GRAS pathway rather than the FDA’s formal food additive approval process, according to a 2025 analysis by the Environmental Working Group.

Not knowing when food ingredients are in use has complicated some food safety scenarios. Take tara flour. A 2022 foodborne illness outbreak tied to Daily Harvest plant-based crumbles, which hospitalized 133 consumers, was eventually linked to products containing the ingredient. The FDA later determined that tara flour in human food doesn’t meet GRAS standards, officially reclassifying it as an unapproved additive.

“What you would have hoped is that they would have submitted something to FDA, FDA would have looked at it, and perhaps there would have been some kind of signal in the submitted data that might have made FDA say no,” Lurie said.

Companies have long been able to submit voluntary notifications of their GRAS ingredients, which usually involves hiring their own experts to review new ingredients and detail why they deem it safe. The FDA’s Human Foods Program has logged more than 1,300 GRAS notices since it first began accepting them in 1997. But those notices have never been required to start selling food with a new GRAS ingredient.

While some critics of the GRAS exemption refer to it as a “loophole,” Patricia Zettler, a law professor at Ohio State University and former FDA associate chief counsel, cautioned that doing so can obscure the fact that the exemption was created by Congress itself.

“Maybe the ‘generally recognized as safe’ pathway is bigger than Congress initially envisioned in 1958,” Zettler said, “but it is how Congress designed the statute.”

What would the proposed rule change?

The proposal would make the FDA’s voluntary GRAS notification program mandatory.

Companies introducing a new substance under the GRAS provision would have to notify the FDA of their basis for concluding that the substance is safe for its intended use. Companies that skip this step wouldn’t be automatically barred from selling the substance, but the FDA says it would factor the lack of notification into which substances it prioritizes for post-market safety review.

READ MORE: The FDA banned Red 3 food coloring. A scientist explains the dye’s history and health risks

That would give the agency information it does not consistently receive under the current system, but falls short of a full safety review, according to agricultural economist Charles Benbrook, which requires gathering scientific data, seeking public comment and publishing an assessment.

Instead, the notification would consist of “the company’s opinion, based on what the company knows about the product,” he said. “And that’s very different from the food additive approval process … where before a new food additive is approved to put in your food, my food, my grandkids’ food, it has to go through at least a minimal and open scientific evaluation.”

The proposal also addresses ingredients that companies are already selling based on their own past “self-affirmed” GRAS determinations. If the new rule takes effect, companies would have one year to make a streamlined submission identifying the substance and its use, with no underlying safety data required.

“The FDA requires no data, no evidence, no explanation of the basis for their determination and confidence that such a food additive poses no risk,” Benbrook said.

It remains unclear whether the FDA has the resources or authority to independently evaluate all the notices, said Marion Nestle, professor emerita of nutrition, food studies and public health at New York University.

“Who’s at the FDA who can review these when 20% of the staff has been fired or left?” she said.

It’s hard to know whether the proposed rule will make any difference, Nestle added, “because the FDA is still not independently reviewing the science and making sure that these things are scientifically safe.”

What would stay the same?

Companies would not have to wait for the FDA to review their GRAS notice before marketing a substance. A company could submit a notification and sell food containing the ingredient while the FDA considers the submission.

“A company could notify FDA if they chose to,” Lurie said, “but they could also at that very same moment begin to market the product.”

That is the core difference between the proposed GRAS rule and the FDA’s formal food additive process. While the formal track requires the agency to evaluate scientific evidence before an ingredient goes to market, the proposed GRAS rule falls short of this mandate because the agency lacks the unilateral statutory authority to impose a formal approval process on the industry.

“FDA, like any administrative agency, can only do what Congress has authorized it to do by statute,” Zettler said.

Lurie questioned whether the word “mandatory” accurately describes the proposal.

“The government is depicting this as mandatory, but it really isn’t,” he said. “There is no real enforcement mechanism to assure that the companies will report, and not a lot of reason to think that they would suddenly want to do this, when the old system of not reporting had worked very well for them for decades.”

The FDA did not respond to questions from PBS News about what consequences a company would face for failing to comply, or whether prioritizing a substance for post-market review is the agency’s only enforcement tool against companies that never notify it.

How would the proposed change affect food safety?

The GRAS proposal is part of the Trump administration’s MAHA initiative, which has focused heavily on the role of food additives and chemicals in the American diet. The Department of Health and Human Services said the proposal is intended to “strengthen nutrition science, improve transparency and modernize oversight of the food supply.”

The FDA has more often been in headlines this summer for a different food safety issue: multistate cyclospora and salmonella outbreaks that sickened thousands.

WATCH: Cyclospora and salmonella outbreaks raise concerns about U.S. food safety

But these represent two different problems, Nestle said. “The GRAS rule has nothing to do with microbial food safety. It’s not going to do anything about cyclospora or salmonella. It’s about food additives. It is not about microbes.”

That distinction is part of a broader debate over what aspects of the country’s food system the government is scrutinizing. Lurie said the administration’s focus on food additives could draw attention away from other dietary factors that have stronger evidence linking to health problems.

“Sometimes they’re right that a given additive is dangerous, sometimes they aren’t, but they have a general suspicion when it comes to additives,” Lurie said, “and that’s where their focus has been, not on things that probably are more likely to kill you, like sodium, added sugar, saturated fat.”

When would the new GRAS rules take effect?

The proposal is open for public comment through early December.

“Nothing’s gonna change tomorrow,” Zettler said. “Even if a final rule came out in 2027, that would be pretty fast for one of these rulemakings.”

Under the Administrative Procedure Act, the FDA is legally required to consider the comments it receives and respond to them if it ultimately issues a final rule. That process could lead to changes in the proposal before any final rule is adopted, and Zettler said public comments can meaningfully influence agency policy.

Lurie expects the GRAS proposal to face opposition from both industry stakeholders and people who are against increased federal regulation.

Among the issues likely to draw comments are how the FDA would enforce the notification requirement, whether the agency has enough staff to review the submissions and whether notification alone does enough to address the safety concerns underlying the rule.

For Lurie, a more meaningful overhaul would involve two changes beyond what’s in the proposal: a public database of companies’ GRAS determinations, and independent FDA review of the evidence supporting those determinations.

Still, the proposal could give the FDA something it has lacked for decades: a clearer picture of which ingredients companies are putting into the food supply under the GRAS exemption.

“We will know better what’s in the food,” Lurie said. “We will know better whether or not there’s a sustainable claim for safety … instead of leaving it all to a self-interested industry to make those kinds of determinations.”