To hear Robert F. Kennedy Jr. tell it, making America healthy again means making American food healthy again.
The nation’s top health official says hundreds of additives should be removed from the U.S. food supply out of concern that they’re contributing to a rash of chronic health problems.
Plenty of Americans share his wariness. In a Gallup poll conducted in the summer, 28% of respondents said they had “not much” confidence in the federal government’s ability to ensure the food supply was safe, while 14% had “none at all.”
“Our food system as currently constituted is not designed to maximize health,” said Dr. James Krieger, executive director of Healthy Food America.
Kennedy insists it doesn’t have to be that way. And as the newly installed leader of the Department of Health and Human Services, he is in a prime position to change that.
But subjecting food additives to more scientific scrutiny won’t be cheap, experts warn. The added costs would present a hurdle at any time, but especially now as President Trump aims to reduce the price of eggs and other groceries.
“Food safety is in everyone’s best interest, including the manufacturers,” said Michael T. Roberts, executive director of the Resnick Center for Food Law and Policy at UCLA Law. “There’s only one thing that cuts against a full investment in food safety, and that is the cost.”
One of Kennedy’s biggest priorities could be the most expensive: closing a loophole that allows companies to vouch for the safety of new food additives by declaring them “generally recognized as safe,” or GRAS. The designation was initially intended for familiar items such as salt, vinegar and baking powder but now applies to more than 1,000 compounds, experts estimate.
Food makers that take advantage of the GRAS loophole are supposed to conduct a scientific assessment to make sure their new ingredients will not increase risks for developmental disorders, disrupt the endocrine system, trigger allergies or lead to other health problems. But companies are not required to share those assessments with the Food and Drug Administration, nor to notify the agency when they introduce a novel additive to the food supply.
“Nowadays somebody finds a new product — a new seed or a new plant somewhere else in the world — and they start using it,” said Neal Fortin, director of the Institute for Food Laws and Regulations at Michigan State University.
That’s how a substance called tara flour became an ingredient in a meat-replacement product sold by Daily Harvest and sickened hundreds of customers in 2022. More than 100 were hospitalized with severe problems including acute liver failure, and the product was recalled.
Tara flour “was never submitted to the FDA, and it didn’t have to be submitted to the FDA,” Fortin said. The manufacturer “self-declared it as being safe and it harmed a lot of people.”
If it were up to him, Fortin said, he’d require companies to share their safety studies with the FDA so that regulators could check them for red flags.
“All they have to do is look for problems,” he said. “If they see one they can slow it down or stop it, or ask for more information” before the ingredient goes on the market.
Researchers have estimated that implementing this type of plan would roughly double the number of additives evaluated by agency scientists each year.
Food-safety advocates also have called on the FDA to step up its oversight of additives that are already on store shelves.
“Things that may have been in the food supply for 50 years do occasionally need to be reevaluated,” Fortin said. “Dietary patterns change. Formulations change. Before, maybe we were only getting red dye in maraschino cherries. Now it’s in a ton of different things.”
The agency has been revamping its system for reassessing GRAS ingredients, preservatives, food dyes and the like, giving priority to those suspected of posing a risk to public health. Under the FDA’s proposal, a comprehensive assessment of a food additive could take a year or more, the agency said.
In a statement Monday to the Times, an FDA official said that those and other efforts “to safeguard the food supply and ensure that food is a vehicle for wellness” are still on track. “We remain committed to moving forward with our priorities to develop a new post-market safety assessment framework and to improve processes for pre-market review of additives,” the official said.
A Food and Drug Administration scientist tests for undisclosed and potentially dangerous ingredients in products marketed as dietary supplements.
(Michael J. Ermarth / U.S. Food and Drug Administration)
Analyzing additives — either before or after they are on the market — takes manpower, and more work will require more money. Yet the $1.2-billion budget for the FDA’s food program in fiscal year 2024 was dwarfed by the $3.7 billion devoted to drugs, biologics and medical devices for people.
Experts both inside and outside the agency — including its recently departed commissioner, Dr. Robert Califf — have called on Congress to appropriate more funds for food regulation, but they’re not holding their breath.
“More money from Congress is not in the cards,” said Dr. Peter Lurie, president of the Center for Science in the Public Interest, a nonprofit focused on public health issues. “Realistically, it’s not happening.”
So some would like to adopt a practice used elsewhere in the FDA — charging companies a fee to have their new products vetted by the agency. Such user fees accounted for $3.3 billion of the FDA’s $7.2-billion budget in 2024.
Though they’ve funded important work, user fees have also introduced the appearance of a conflict of interest. Kennedy has criticized them for giving deep-pocketed companies an advantage over startups, and for giving the pharmaceutical industry leverage over regulators.
Lurie is sympathetic to those critiques.
“My overall opinion on user fees is that they’re not a good idea,” he said. “But the problem is that they’re better than the alternative.”
Jennifer Pomeranz, a public health lawyer at New York University’s School of Global Public Health, sees user fees as sensible way to pay for more food safety. Such fees don’t change the work FDA scientists do, she said. They just make it possible to get the work done faster.
Although the companies would pay for the reviews, that wouldn’t guarantee that their applications pass muster. Plenty of drug and medical device candidates are rejected by regulators, Pomeranz said. User fees fund the process, not the outcome, she said.
Getting rid of the GRAS loophole and implementing user fees to pay for independent regulatory reviews would actually reduce the FDA’s dependence on food companies, said Sean Cash, a food economist and chair of the Division of Food, Agriculture and the Environment at Tufts University.
“In the current regime, we’re already relying heavily on inputs and attestations from industry,” he said. Curtailing that will increase trust in the food system, he believes.
These changes, of course, would cost the companies money. Several experts agreed that companies might respond by raising prices, though it’s unclear how much they could get away with before damaging their businesses.
Shoppers are more sensitive to price increases for food than for drugs, which could minimize the toll on consumers, Cash said. Besides, any inflationary effect of user fees is likely to be swamped by the effects of other policy changes, such as reducing the number of immigrants in the workforce and imposing tariffs on imported goods.
The costs of reviewing additives already in use could be minimized if the FDA took advantage of work already done by regulators in the European Union and elsewhere, Pomeranz said. “When other countries ban ingredients, why do we wait 20 years to do the same thing?”
Even if stricter scrutiny of additives results in higher food prices, that may be preferable to maintaining the status quo, Cash said.
“If they’re really not safe for us, is that a trade-off we want to make?” he said. If we don’t take a closer look at these ingredients, “are we going to pay for it in other ways later?”