It’s a U.S. Food and Drug Administration rule that most Americans know little about, yet gives corporations the license to add potentially harmful ingredients to foods without regulatory oversight or public notice.

For decades, the FDA’s “generally recognized as safe,” or GRAS, designation has allowed food makers to decide for themselves whether certain novel ingredients are safe or not — even without providing evidence to agency scientists.

Consumer advocates claim the system has allowed companies to add harmful chemicals, including suspected carcinogens, to such products as cereals, baked goods, ice cream, potato chips and chewing gum.

Now, President-elect Donald Trump’s nomination of Robert F. Kennedy Jr. to lead the Department of Health and Human Service promises to elevate the issue. Although Kennedy’s penchant for amplifying medical conspiracies and his anti-vaccination activism have alarmed many public health experts, his vow to crack down on chemical additives in food has resonated with consumer health advocates.

The problem, critics say, is that a GRAS determination is supposed to follow a scientific assessment, ideally one conducted by independent experts.

Under the law, however, it is entirely optional for companies to share their assessments with FDA reviewers. That means the FDA and American consumers are in the dark about hundreds of compounds in processed foods.

“FDA cannot ensure the safety of our food supply if it does not know what is in our food,” said Thomas Galligan, principal scientist for food additives and supplements at the Center for Science in the Public Interest.

When the agency does learn about a new compound, it evaluates the company’s safety report to see whether it agrees. If FDA scientists see problems and request additional information, the company doesn’t have to provide it. It can simply withdraw its GRAS notice and use the ingredient anyway.

Natalie Mihalek, a former prosecutor and current state legislator in Pennsylvania, said she doesn’t understand why the FDA treats food additives like criminal defendants — “innocent until proven guilty, safe until proven otherwise.”

“Right now we’re relying on the companies that are going to profit off selling these substances to do the research for us,” said Mihalek, a Republican who has introduced a bill to ban six food dyes in her state. “It just blows my mind.”

FDA officials acknowledge the limits of the GRAS system but say they don’t have the authority to change it.

“Congress sets GRAS as part of the law,” said Kristi Muldoon Jacobs, director of the FDA’s Office of Food Additive Safety. “It is our responsibility to administer the law. We do not in fact have the authority to make the laws.”

Concern about the safety and purity of food prompted Congress to pass the Food and Drugs Act in 1906, just months after Upton Sinclair brought the meatpacking industry’s unsanitary practices to light in his book “The Jungle.” The new law forbade the manufacture and sale of foods that were “adulterated or misbranded or poisonous.”

The FDA’s regulatory powers expanded in 1938 with the passage of the Food, Drug and Cosmetic Act, and a 1958 amendment divided food ingredients into two categories: additives that must be assessed for safety, and substances that could go straight into foods because they are “generally recognized as safe.”

Unfortunately, the legal distinction between the two kinds of ingredients is “very vague,” said Jennifer Pomeranz, a public health lawyer at New York University’s School of Global Public Health.

The types of ingredients that were considered GRAS in 1958 included items that were already in wide use, such as salt, vanilla extract, baking powder and vinegar.

The FDA established a list of GRAS substances and added new items if they passed a safety review. Individuals from outside the agency also could ask to have a particular substance studied for inclusion on the official GRAS list.

But the process was time-consuming, and petitions from industry could take six years or more to evaluate. As part of the Clinton-era initiative to streamline government operations, the FDA embraced a newer, faster system designed to make it more enticing for companies to keep the agency in the loop about their GRAS decisions. Now the FDA pledges to respond to GRAS notices within 180 days.

The notification process is also low-risk for food companies.

If everything looks good, the FDA says it has “no questions” about the compound, effectively endorsing the GRAS assessment. This happens about 80% of the time, according to researchers Thomas Neltner and Maricel Maffini, who analyzed notices filed with the agency.

If things aren’t so clear, the agency may say it needs more information before it can weigh in. And if a company decides not to provide that information, it can back out of the process and the FDA will say it ended its evaluation at the filer’s request.

Such was the case with an ingredient in Sleepy Chocolate.

Not just another gourmet candy bar, the dark chocolate with lavender and blueberry flavors is infused with the hormone melatonin, the amino acid L-tryptophan, a blend of soothing botanicals and something called PharmaGABA, an artificial version of a neurotransmitter that calms the brain.

PharmaGABA is made by Pharma Foods International Co. of Kyoto, Japan. The company touts its product as having “US-FDA’s self-affirmed GRAS approval” even though the FDA twice raised serious concerns about its safety and has never indicated to the public that its misgivings were addressed.

Nothing about this violates the law.

Neltner, a chemical engineer and attorney, and Maffini, a biochemist and consultant, dug into the FDA’s files on PharmaGABA to see why regulators were concerned about it.

In its initial notice filed in 2008, Pharma Foods said it hired a Canadian consulting firm to determine whether PharmaGABA should qualify for GRAS status when used in candy, chewing gum, beverages and other products.

The consulting firm produced a report about the product and tapped three university professors with expertise in pharmacology, toxicology and food science to weigh in. The trio’s determination that the product was “safe and suitable and would be GRAS” was unanimous, according to the filing.

Yet after reviewing all 155 pages of the PharmaGABA notice, FDA scientists raised concerns about the product’s purity, its risk for causing low blood pressure and electrolyte imbalances, and the lack of data on how PharmaGABA is metabolized, among other problems.

Pharma Foods withdrew its notice, and the FDA ended its evaluation.

The company tried again in 2015 with a GRAS notice for using PharmaGABA in yogurts and cheese, cereals and snack bars, candy and gum, and an array of beverages including sports drinks and flavored milks. The same consulting firm assembled a scientific panel that said consuming PharmaGABA in expected quantities was “reasonably expected to be safe.”

As before, FDA reviewers had concerns. They said the new filing didn’t back the company’s claims that the product would be absorbed into the bloodstream at low levels and that it wouldn’t cross the blood-brain barrier. The reviewers were particularly concerned with the compound’s potential to harm pregnant women and children, as well as its effect on the pituitary gland.

Pharma Foods withdrew its notice so it could “conduct further studies,” and the FDA ceased its second evaluation of the product.

Maffini said it wasn’t unusual for agency scientists to find fault with GRAS decisions that passed muster with hired consultants. Giving their clients favorable reviews increases their chances of being hired again, she said.

Nine years later, Pharma Foods has yet to share additional results with the FDA. But PharmaGABA legally remains in Sleepy Chocolate based on Pharma Foods’ determination that the compound should be generally recognized as safe.

Pharma Foods International and Functional Chocolate Co., which makes Sleepy Chocolate, did not respond to requests to discuss PharmaGABA’s safety.

Maffini said she was frustrated that the FDA scientists who examined PharmaGABA couldn’t post a memo to warn the public about their concerns. (She and Neltner obtained the GRAS documents by filing a Freedom of Information Act request.)

“They ask questions,” Maffini said of the agency scientists, “but then there’s really nothing they can do.”

For every ingredient like PharmaGABA that is disclosed to the FDA, another probably makes its way to the market without any regulatory review.

By definition, there’s no way to know for sure how many new additives are granted GRAS status in secret. To make an estimate, researchers scoured websites and trade journals to find every corporate announcement of a new GRAS product during an eight-week period. Ten of those products weren’t on the FDA’s GRAS notice list.

If those eight weeks were typical, at least 65 new substances are being introduced into the food supply every year without any vetting by the agency. That’s on a par with the 60 to 70 GRAS notices that Muldoon Jacobs said the FDA evaluates each year.

The situation is something of a catch-22, Pomeranz said: Since GRAS products are presumed to be safe, they aren’t subject to regulatory review. But since they’re not regulated, how can the public be assured that they’re safe?

And that’s only part of the problem, she said. When companies use novel ingredients, they can list them on food labels using generic terms like “flavors” or “colors.” That makes it all but impossible for consumers to know that something new has been added to their food, she said.

This helps explain how an ingredient called tara flour was able to sicken hundreds of people who consumed French Lentil + Leek Crumbles, a meat replacement product sold by Daily Harvest in 2022. Customers suffered severe abdominal pain, fever, chills and acute liver failure, and more than 100 were hospitalized, according to the FDA. The company issued a voluntary recall and blamed a compound in tara flour for the illnesses.

Tara flour is a high-protein substance made from the seeds of an evergreen tree found in South America. There is no GRAS notice for the ingredient in the FDA’s database. Tests conducted after the outbreak found that an amino acid in the flour caused liver damage in mice.

In May, nearly two years after the recall, the FDA concluded that tara flour doesn’t meet the scientific standard to qualify for GRAS status. That makes it an unapproved food additive and is considered unsafe.

The agency added that it’s not aware of any products made in the U.S. that contain tara flour, nor has it identified any imported products that contain the ingredient.

The case shows why the FDA’s regulatory approach needs to change, said Jensen N. Jose, regulatory counsel for food chemical safety at the Center for Science in the Public Interest.

“Self-declaring that your chemical is safe should not be the law of the land,” Jose said. “I highly doubt that’s what Congress meant” when it created the GRAS designation in 1958, he said.

Bills introduced in the U.S. House and Senate would put an end to the practice of allowing companies to make GRAS determinations in secret. The legislation would require companies to share their scientific reviews and give the FDA and the public at least 90 days to review — and potentially challenge — them before they take effect, among other provisions.

But both bills have a ways to go in order to pass before the congressional term ends in January.

Jose has another idea for reducing the secrecy surrounding novel food ingredients: Require companies using self-declared GRAS ingredients to submit the safety data to the New York Department of Agriculture and Markets in Albany as a condition for selling their products in the Empire State.

Jose laid out the plan in a bill that is under consideration in the New York state Legislature. If it passes, state regulators would not be required to review the safety data, but at least it would become publicly available, he said.

“The goal is that you’d have a database so if something like tara flour happens, the FDA can look there and be able to respond more quickly,” Jose said.

Companies could avoid the notification requirement by keeping their products out of New York stores, but that would be a tip-off to watchdog groups like his, Jose said.

“If we find them selling everywhere except New York, we’ll know there might be something wrong with this chemical,” he said.

Jim Jones, the FDA’s deputy commissioner for human foods, has acknowledged the “growing public demand for the FDA to do more to ensure the safety of chemicals currently in the U.S. food supply.”

California and other states have sought to fill the void by regulating or banning select food additives within their borders. But “a strong national food-safety system is not built state-by-state,” Jones said. “The FDA must lead the way.”

WASHINGTON —  The Supreme Court on Monday did not sound ready to sharply limit the power of the Food and Drug Administration to prohibit the sale of new candy-colored vaping products aimed at teenagers.

Instead, the justices, both conservative and liberal, said Congress in 2009 gave the agency the power to stop the sale of new tobacco products, and it has used this authority in recent years to reject new vaping flavors with names like “Rainbow Road” and “Peachy Strawberry.”

This is exactly the kind of regulatory question that companies hope to get before the conservative Supreme Court, but it was not clear they will win this time.

Justice Brett M. Kavanaugh questioned the vaping industry’s claim of FDA overregulation, saying its objection rests with the law itself.

“You disagree with the statute giving this authority to FDA,” he told an attorney for two companies whose products were denied approval.

Justice Elena Kagan agreed. “Everyone knows these flavors are particularly dangerous in terms of kids starting the use of smoking product,” she said. “The FDA has been upfront about this. There is not a lot of mystery here.”

The Biden administration defended the FDA’s stance.

The agency admitted it had two related goals. One was to persuade adults to quit smoking by switching to e-cigarettes with appealing flavors, but without encouraging millions of teenagers to start using a product with nicotine.

Eric Heyer, an attorney for two vaping companies, argued the FDA had switched directions and surprised his clients by demanding new studies to prove their products would persuade more adult smokers to switch to e-cigarettes.

His clients won before the conservative 5th Circuit Court in New Orleans, which called the FDA’s decisions “arbitrary” and illegal.
But most of the justices on Monday sounded as though they leaned in favor of the FDA’s view.

Chief Justice John G. Roberts Jr. and Justice Amy Coney Barrett said they were not convinced the FDA had misled the companies.

Other conservative justices voiced support for the industry.

Justice Clarence Thomas said the FDA’s regulations set a “moving target,” and Justices Samuel A. Alito Jr. and Neil M. Gorsuch voiced a similar skepticism.

It’s unclear if the court’s ruling in the months ahead will settle the controversy.

Twice, the attorney for the vaping companies pointed to an impeding change at the FDA with the election of President-elect Trump.

“We have a new administration coming in,” he said, and new agency officials may change the policy.

Kavanaugh said the companies are free to try again.
“You can reapply,” he said.

It’s also not clear the FDA disapproval has much impact. Large numbers of e-cigarette flavors are widely available even if they were not approved by the FDA.

He had written more than 20 books, drew healthy audiences speaking across America and attracted coverage from the country’s top newspapers and magazines. Still, by the height of the pandemic, Robert F. Kennedy Jr. said he felt muzzled.

Facebook and Instagram had banned posts by Children’s Health Defense, the Kennedy-founded organization that questions the value of vaccines. The social media sites noted that Kennedy’s group trafficked in medical misinformation, and a science research team labeled him a “superspreader” of bogus claims about COVID-19 vaccines.

But as 2024 loomed, the scion of America’s most famous Democratic family saw a way back into the public eye.

“I started thinking, ‘Well, the one place that they couldn’t censor me was if I was running for president,’ ” Kennedy told the New Yorker. As he prepared to announce his candidacy in 2023, he proclaimed, “The censors are permitting me to talk to Americans again!”

Indeed, a 16-month run for the White House and subsequent two months as a supporter of Republican nominee Donald Trump succeeded in keeping RFK Jr. close to the center of the public’s consciousness. It’s a prominent perch he’s likely to maintain if he succeeds in being confirmed as secretary of the Department of Health and Human Services.

Loyola Marymount University political scientist Michael A. Genovese said Trump’s designation of Kennedy for the Cabinet post demonstrates “the power of mutual opportunism.”

“RFK revives his failing career. Trump is linked to the glamour of the Kennedy name,” said Genovese, ticking off factors that may have informed Trump’s decision. “RFK gains some measure of respectability. Trump puts Kennedy in a Cabinet position he cares little about. RFK finds a way to stay in the glow of the spotlight. Trump gets an anti-science colleague to complement Trump’s anti-science sentiments.”

Kennedy’s halting ramble from Democratic Party fringe player to fervent MAGA ally did not shock anyone who has watched him closely in recent years. They recall how Kennedy visited Trump Tower shortly before Inauguration Day in 2017 and proclaimed that Trump would make him chair of a commission on vaccine safety and scientific integrity. The Trump administration position never materialized.

Campaigning for the White House this year, Kennedy criticized both major parties, though he saved his most spirited beat-downs for the Democrats. Part of the reason surely was that Democratic nominee Kamala Harris had spurned his overtures. It eventually became clear that Trump — as he had so many times before — was more than willing to strike a strategic alliance with a former adversary.

Kennedy, 70, came with a checkered personal history. Controversial — even bizarre — revelations dotted his presidential run. But several Trump appointees came with unsettling personal histories.

Kennedy, who declined to be interviewed for this article, has persevered over the course of a life frequently turned upside down by tragedy. He was 14 when his father and namesake was assassinated in 1968 at the Ambassador Hotel in Los Angeles. Not long after, he became addicted to heroin, a habit he did not kick until he was 29. Despite that, he graduated from Harvard and the University of Virginia law school.

His two strongest calling cards as a candidate appeared to be his family name and his career as an attorney who fought to clean up the environment. But both became overshadowed by his later preoccupations.

Kennedy spread the myths — refuted by science — that vaccines commonly injure children and cause autism. He outraged many in 2022 by comparing vaccine mandates to the totalitarianism of Nazi Germany.

When he announced last fall that he would continue his presidential run as an independent rather than as a Democrat, many in his family did not hesitate to heap on their disdain.

“Bobby might share the same name as our father, but he does not share the same values, vision or judgment,” three of the candidate’s sisters and one brother said in a joint statement. “We denounce his candidacy and believe it to be perilous for our country.”

This spring, nearly 50 of his former colleagues and leaders of the Natural Resources Defense Council Action Fund pilloried Kennedy.

“In nothing more than a vanity candidacy, RFK Jr. has chosen to play the role of election spoiler to the benefit of Donald Trump — the single worst environmental president our country has ever had,” the environmental leaders wrote in a broadside published in several newspapers.

Not unlike the man who would later offer him a Cabinet position, the candidate seemed impervious to criticism, positioning himself as someone who was delivering inconvenient truths to an unyielding establishment.

The candidate liked to quote his famous relatives, suggesting he was living by his father’s words: “Moral courage is a rarer commodity than bravery in battle or great intelligence. Yet it is the one essential, vital quality for those who seek to change a world that yields most painfully to change.”

Not long after the NRDC disowned him, Kennedy suffered another embarrassment. The New York Times reported on a 2012 deposition in which he described his concerns that he might have a brain tumor. A doctor, Kennedy said, had told him that his abnormal brain scans were likely “caused by a worm that got into my brain and ate a portion of it and then died.”

The revelation made him the butt of a slew of jokes on late-night TV, just as he was trying to assure voters of the seriousness of his candidacy.

Kennedy also took incoming fire from the right. “Kennedy is a Radical Left Democrat, and always will be!!!” Trump posted in April on his Truth Social platform. “It’s great for MAGA, but the Communists will make it very hard for him to get on the Ballot.”

Kennedy accused Trump of “a barely coherent barrage of wild and inaccurate claims.”

Into the summer, Kennedy continued to insist that the American people would eventually turn to him and away from the major party candidates. But while he wanted to talk about the evil of corporate and government elites, his past kept resurfacing in the media.

In July, Vanity Fair reported that a woman accused Kennedy of groping her decades earlier when she was the 23-year-old nanny of his children. Kennedy was married at the time.

After the story broke, the candidate texted an apology to the woman, while contending that he remembered nothing of the episode.

Not long after that, a video surfaced that raised questions about Kennedy’s long-term commitment to the race. In the recording, posted by his son on social media, the candidate is speaking by phone with Trump, who hints that he wants Kennedy to jump to his side.

“I would love you to do something,” Trump said, without offering further context. “And I think it’ll be so good for you and so big for you. And we’re going to win.” Kennedy’s response: “Yeah.”

Yet in public Kennedy insisted he offered a third way, unattached to the two major parties.

Then in August came a series of events that set the stage for Kennedy’s later emergence as a Cabinet pick. He weathered yet more embarrassing revelations, but also threw his backing behind Trump.

A story in the New Yorker recounted an odd prank that Kennedy had pulled several years prior.

After finding a dead bear cub on a mountain roadside, according to his account, he loaded the carcass into his car and drove into New York City. Kennedy then deposited the body in Central Park, alongside a bicycle. The New Yorker reported: “A person with knowledge of the event said that Kennedy thought it would be funny to make it look as if the animal had been killed by an errant cyclist.”

Most of the attention from the story surrounded the dead bear, but it also revealed text messages in which Kennedy called Trump a “terrible human being” and “probably a sociopath.” But Kennedy judged that President Biden was “more dangerous to the Republic and the planet.”

Despite Kennedy’s assurances he was running to win, his campaign manager hinted in the profile that he might be willing to take a lesser role. She called the possibility of Kennedy as Trump’s secretary of Health and Human Services “incredibly interesting.”

Kennedy had reached out to Harris, too, CNN reported, expressing interest in a role in her administration. He was rebuffed.

“No one has any intention of negotiating with a MAGA-funded fringe candidate who has sought out a job with Donald Trump in exchange for an endorsement,” Democratic National Committee spokesperson Matt Corridoni told the cable network on Aug. 14.

It became apparent change was afoot six days later when Trump began to publicly flatter Kennedy, while the Democratic National Convention was in full swing and buoyed by Harris’ energetic candidacy.

“I like him a lot, I respect him a lot,” Trump told CNN. At a campaign event in Arizona, Trump called Kennedy “very smart.”

On Aug. 23, the day after the Democratic convention ended, the Kennedy heir endorsed the Republican, saying that, together, they were going to “Make America Healthy Again.” Trump’s handlers later rhapsodized at how a MAGA crowd in Glendale, Ariz., greeted Kennedy “like a rock star.”

The campaign knew it had a problem with some young female voters, particularly because Trump’s Supreme Court picks had eliminated federal protection of abortion access by overturning of Roe vs. Wade. But some of those same women were won over by Kennedy’s calls for improving healthcare and removing food additives that could harm children, said a senior campaign official who declined to be named. “A lot of that group of young moms loved what Bobby was saying,” said the advisor. “He moved that group for us.”

It’s impossible to know how many voters were moved by such feelings. Or how many were turned off by the continuing drumbeat of Kennedy oddities.

Just three days after Trump and Kennedy took the stage together for the first time, Kennedy faced another embarrassing headline. An old magazine article surfaced in which one of Kennedy’s daughters remembered her father’s strange encounter with a dead whale on Cape Cod.

Town & Country magazine reported that, many years earlier, Kennedy “ran down to the beach with a chainsaw, cut off the whale’s head, and then bungee-corded it to the roof of the family minivan for the five-hour haul back to Mount Kisco, New York.”

Again, late-night comics had fodder for Kennedy jokes. But, again, Kennedy weathered the storm and went on to campaign vigorously for his new ally.

Kennedy’s path to confirmation is uncertain. Although the incoming GOP majority in the Senate should clear the way, even some Republicans have said the former Democrat will have to answer questions about his vaccine stances and his desire to change how processed foods are made.

Kennedy proclaimed on X his readiness “to free the agencies from the smothering cloud of corporate capture so they can pursue their mission to make Americans once again the healthiest people on Earth.”

Though well short of the spot in the Oval Office once held by his uncle and coveted by his father, the Cabinet post would put Kennedy the closest he has ever been to the heart of a federal government that he previously pilloried only from the outside.