Science
How the FDA allows companies to add secret ingredients to our food
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.”
Science
Just one mutation can make H5N1 bird flu a threat to humans, California researchers say
California researchers say the world may be just one genetic tweak away from human-to-human transmission of the H5N1 bird flu virus — a worrisome mutation that could open the door to widespread human infections and possibly even a pandemic, according to some experts.
In a study published Thursday in the journal Science, Scripps Research Institute biologists determined that a single mutation of the hemagglutinin protein — the “H” in H5N1 — could transform a virus that has so far sickened or killed mostly birds and cows into a pathogen that targets cells in human beings.
The finding comes amid a growing number of H5N1 outbreaks among California dairy cows, as well as a state-ordered recall of raw milk products. Since the virus began infecting the nation’s dairy stock in March, infectious disease experts have warned that unprotected contact between dairy workers and infected cows could enable the virus to evolve in a manner that threatens humans.
Now, Scripps researchers suggest the path for such a genetic change may be much shorter than state and national health officers anticipated.
“This really surprised us,” said study coauthor James Paulson, a biochemist and molecular biologist. This one mutation “satisfies a requirement for transmission,” he said.
Richard Webby, director of the World Health Organization’s Collaborating Center for Studies on the Ecology of Influenza in Animals and Birds, said the study’s finding countered prevailing thought on the virus — specifically, that it would take multiple mutations for the virus to pose a threat to humans.
“This will likely cause a stir,” said Webby, who is also a researcher in the department of infectious diseases at St. Jude Children’s Research Hospital in Memphis, Tenn., and was not involved in the Scripps research.
“I think most of us thought it would probably need more than one change,” Webby said.
Yoshihiro Kawaoka, a virologist at the University of Wisconsin-Madison and the University of Tokyo, called the Scripps teams’ finding a “significant discovery” and said it was “critical because, given the mutation rate of influenza viruses, one in every 10,000 particles of the bovine H5N1 virus could carry this mutation.”
That means the potential emergence of an H5N1 virus “that can recognize human receptors is closer than we may have thought,” he said.
Several months ago, Paulson and coauthor Ian Wilson, a Scripps structural biologist, decided they’d investigate the current H5N1 strain, and see what it would take for it to cause a human pandemic.
Paulson is an expert in researching where and how different influenza viruses bind to cells when they enter a host. Wilson studies the structure of influenza virus proteins.
The scientists began their research by accessing a global influenza database and locating the genetic sequence for A/Texas/37/2024 — the strain of H5N1 bird flu found in a Texas dairy worker.
They then examined the hemagglutinin proteins, or spikes, on the outer surface of the virus, since those enable it to latch onto the cell membrane of its host. Animals such as birds and humans have different docking stations on their cells — known as sialic acid receptors. In order for a flu virus to open a door into a cell and begin replicating, it needs just the right spike, or key.
Although more than 50 humans have been infected by H5N1, many of these cases involve dairy workers who were likely sprayed in the eyes and nose with milk from infected cows. Researchers postulate that repeated exposure of this sort allowed the virus to push into the cells — a brute force entry more than a lock-picking.
Ordinarily, person-to-person transmission of a flu virus “is mainly through the air from droplets from a sneeze or cough, which contains very little virus,” Paulson said. “In this context, the virus needs to be able to recognize human-type receptors to bind to cells in the human airway in amounts sufficient to cause infection.”
In order to figure out what it would take for the virus to gain the right docking equipment to unleash a human pandemic, Paulson, Wilson and their team looked at previous flu outbreaks that had jumped the bird-human divide, including the influenza outbreaks of 1918, 1957, 1968 and 2009 — as well as some earlier research.
They “selected a number of positions” on the hemagglutinin protein “to mutate, one at a time” with amino acids they knew had been implicated in previous pandemics.
Then they attempted to bind these altered “H” proteins with human and bird receptor analogues.
Lo and behold, when they switched a glutamine to a leucine at position 226, it no longer bound to the bird receptors, but instead exclusively to those of humans.
Paulson said it was especially interesting because this mutation had occurred before in earlier strains of H5N1, including one from around 2010 — but “at that time, that single mutation was not sufficient to change receptor specificity. So, the unexpected thing is that virus has changed in subtle ways — evolved, if you will — so that now that single mutation does change the receptor specificity.”
Although the researchers demonstrated that it was possible for the virus to become a threat to humans with just one genetic change, that does not mean nature will follow that specific path. A multitude of factors can influence the evolution of an organism, and they are not easily predicted. This may be why the virus has not yet gained the ability to widely infect humans, some say.
“Despite more than 50 human infections with bovine H5N1, we have not seen evidence of this virus adapting to humans on a larger scale,” Kawaoka said. “This suggests that … additional mutations are likely required for the virus to become fully transmissible between humans.”
Paulson acknowledged that the “context of the total biological picture is extremely important.”
He said the research focused on just “one property that is important for the virus to be successful when adapting to a new host,” but there are others that may also be important.
For instance, H5N1 in the past was known to cause severe respiratory disease. But recently, it’s mostly been associated with conjunctivitis and only occasionally with mild, upper respiratory disease in people.
“Why is that? I don’t think anybody knows,” Paulson said.
What is known is that the virus is moving swiftly through a variety of species around the globe — with ample opportunity to mutate and adapt.
As of Thursday, the Centers for Disease Control and Prevention had confirmed H5N1 infections in 58 people: 35 as a result of working with infected dairy cows, 21 from infected poultry, and in two cases, the source is unknown.
In addition, 707 dairy herds across 15 states have also been infected. And in just the last 30 days, 23 commercial poultry farms in California have come down with the virus — affecting more than 5.6 million birds.
Science
All raw milk from Fresno dairy farm will be cleared from store shelves; cows have bird flu
After two limited recalls, all raw milk and cream from a Fresno-based dairy farm must be removed from store shelves. The cows at Raw Farm are infected with H5N1 bird flu, state officials say.
The recall, which is voluntary, encompasses all milk and cream products not included in the recalls announced last month, officials said in a statement Tuesday night.
State officials quarantined the Raw Farm dairy herds — which are in Fresno and outside Hanford — Thursday and suspended future sales.
This new recall is meant to remove all products remaining on store shelves.
Public health officials identified the H5N1 virus in retail raw milk samples on Nov. 21 and Nov. 27. Further testing of Raw Farm’s bulk milk storage and bottling facility showed more of the virus.
The recall applies only to raw whole milk and cream. However, the state is urging consumers to avoid other raw milk products, including cheese and kefir, as well as raw milk pet food products, including “raw milk pet food topper” and “pet food kefir.”
The state’s Department of Food and Agriculture has placed the farm under quarantine and has suspended distribution of any raw milk product produced on or after Nov. 27.
No human bird flu cases have yet been associated with raw milk products from Raw Farm.
State health officials warn that drinking or accidentally inhaling raw milk infected with H5N1 could lead to illness.
“In addition, touching your eyes, nose, or mouth with unwashed hands after touching raw milk with bird flu virus may also lead to infection,” state officials said in a statement.
Symptoms of bird flu infection include eye redness or discharge, cough, sore throat, runny or stuffy nose, diarrhea, vomiting, muscle or body aches, headaches, fatigue, trouble breathing and fever.
“Anyone who has consumed these specific products and is experiencing these symptoms, should immediately contact their health care provider or local health department,” the statement said.
Science
Supreme Court weighs FDA's power to prohibit new vaping products for teens
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.
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