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
The neuro disease rat lungworm has reached California
A disease that can cause neurological illness and meningitis in people, rat lungworm, has been found in wild opposums, rats and a zoo animal in San Diego County, indicating its establishment in California for the first time.
Researchers reported their findings in the journal Emerging Infectious Diseases, published by the U.S. Centers for Disease Control and Prevention. The authors, who include veterinarians, researchers and wildlife biologists, urged physicians and other healthcare workers in the region to consider lungworm infection when patients come in with nervous system disorders.
The discovery highlights “a notable expansion of the range of this parasite in North America,” they said.
The CDC website says the risk to the general public of getting this infection is low, but it can be deadly.
If ingested, the worms can cause severe headaches, stiff neck, the sensation of tingling or painful skin, low-grade fever, nausea, vomiting, coma and sometimes death. People who eat freshwater crab, prawns, frogs, snails and slugs are at greatest risk. However, people can also get the disease by eating un-rinsed produce that’s been slimed by a snail or slug, or eating a slug or snail that was chopped up in produce. The worms need moisture, however; if the produce is dry, the worms will die.
Domestic animals, including dogs and cats, are also at risk.
Officials with the California Department of Public Health were not ready to call the disease endemic, or established, in the state.
“Additional surveillance and testing will be necessary to determine whether the detections of rat lungworm in the animals evaluated in San Diego County represent an isolated introduction of the parasite or ongoing local transmission,” spokeswoman Elizabeth Manzo wrote in a statement to The Times.
The department said it is not aware of rat lungworm outside San Diego County, and has seen no human cases.
“However, the San Diego study affirms that the parasite can be introduced to California through movement of infected animals from endemic areas,” the statement said. “Because some species of snails and slugs present in California are capable of serving as hosts for rat lungworm, and the presence of the parasite in other parts of the state is unknown, it is advised to take certain food safety precautions. Persons should not consume any raw or undercooked wild snails or slugs, and should thoroughly wash all produce before consuming.”
The worms that cause the disease, Angiostrongylus cantonensis, are native to Southeast Asia. They’ve been found in the U.S. since the 1960s — including in isolated human and zoo animal cases in California — and are established in Hawaii as well as in much of the southeastern U.S.
It is believed they came overseas via rats on boats.
The worms favored environment is the moist, warm bed of a rat’s lung. When a rat is infected, the worms cause respiratory distress, priming the rodent to cough. Worm-filled sputum is then ejected into the rat’s mouth, and swallowed. The rat then poops the worms out, and animals such as slugs and snails eat the poop. When a rat eats an infected invertebrate, the cycle begins again.
Occasionally, another animal, such as a raccoon or dog, or a person, will accidentally eat an infected animal, or the slime of one, and contract the disease.
The discovery of the worm in San Diego County rodents and opossums was made by staff at the San Diego Zoo and a local wildlife rehabilitation center, Project Wildlife, which is run by the San Diego Humane Society.
In December 2024, a 7-year-old male parma wallaby, born and raised at the zoo, began showing concerning neurological behaviors: incessant head shaking, blindness, a lack of muscle coordination and paralysis in his hind legs. He was euthanized after 11 days in the zoo infirmary.
When zoo staff examined the body, they found six rat lungworms in the marsupial’s brain, along with a lot of damage.
Because the diagnosis was so unusual, zoo staff examined the bodies of 64 free-ranging roof rats that had either been euthanized in the course of regular pest control or found dead on the property. Two, a little more than 3%, had lungworms. Their feces had them too: “numerous live … larvae with coiled posterior ends.” The larvae, roughly 300 in each poop sample, were each about the size of a grain of sand.
Officials at the San Diego Zoo did not respond to requests for comment.
Curiously, at the same time the zoo investigation was underway, staff from Project Wildlife had been dealing with sick opossums brought to them from around the county. Tests of 10 dead animals showed seven carried the lungworms.
Many people and animals remain asymptomatic when they’re infected. Symptoms typically appear within hours or days after ingestion and can last up to eight weeks. The worms will eventually die.
Because the disease has so many varied symptoms, health officials say it can go undiagnosed and untreated. Health officials from Hawaii, where the disease is endemic, say if lungworms are suspected, it’s best to be treated as soon as possible — even before lab results come back.
The CDC too notes that treatment works best when the disease is caught early, and can consist of high doses of corticosteroids, lumbar punctures for symptomatic relief of headaches, and antiparasitic medications, such as albendazole.
Science
Owners of fire-destroyed Palisades mobile home park seek to displace residents for development deal
For months, former residents of the Pacific Palisades Bowl Mobile Estates have feared the uncommunicative owners of the property would seek to displace them in favor of a more lucrative development deal after the Palisades fire destroyed the rent-controlled, roughly 170-unit mobile home park.
A confidential memorandum listing the Bowl for sale indicates the owners intend to do exactly that.
The memorandum, quietly posted on a website associated with the global commercial real estate company CBRE, says that the Palisades fire created a “blank canvas for redevelopment” at a site “ideally positioned for a transformative residential or mixed-use project.”
“I just thought, oh my god, this is so much propaganda and false advertising,” said Lisa Ross, a 33-year resident of the Bowl and a Realtor. “How can they even get away with printing this?”
Neither the current owners of the Bowl nor the real estate companies listed on the memorandum responded to requests for comment.
The memorandum describes the current single-family residential zoning as “favorable” for developers; however, the city and mobile housing law experts have painted a different picture.
Fire debris at Pacific Palisades Bowl in January 2026.
(Myung J. Chun / Los Angeles Times)
“Multifamily and mixed-use development on this site is not allowed by existing zoning and land use regulations,” Mayor Karen Bass’s office said in a statement Wednesday, adding only low density single-family housing or reconstructing the mobile home park are currently allowed. “Mayor Bass will continue taking action and [work] with residents to restore the Palisades community.”
City Councilmember Traci Park also reiterated her focus on getting the mobile home park rebuilt and allowing residents to return, with a spokesperson noting she is not entertaining the potential for any rezoning efforts from a developer.
Zoning changes typically require a city council vote and are subject to the mayor’s approval or veto.
Beyond the zoning laws, the site is also currently governed by a state law requiring cities to preserve affordable housing along the coast and a city ordinance protecting mobile home residents against sudden displacement.
Spencer Pratt, a resident of the Palisades and an outspoken supporter of the neighborhood’s mobile home community, criticized the mayor and the owners in a statement to The Times. “It’s unfortunate that Karen Bass has not advocated for mobile home residents impacted by the fire,” he said, “and that the current owner of the Bowl is ignoring good faith offers from residents to buy the property.”
The mayor’s office disputed this, noting Bass recently led a delegation of Palisadians, including mobile home owners, to Sacramento to advocate for recovery. “Mayor Bass’ priority is getting every Palisadian home — single-family homeowners, town home owners, renters, mobile home owners.”
Los Angeles Mayor Karen Bass speaks during a private ceremony outside City Hall with faith leaders, LAPD officers and city officials to commemorate the one-year anniversary of the Eaton and Palisades fires on Jan. 7, 2026.
(Allen J. Schaben / Los Angeles Times)
Bass also advocated for the federal government to include the Bowl in its debris cleanup efforts; however, the Federal Emergency Management Agency ultimately refused to include it, unlike other mobile home parks impacted by the Palisades fire. Its reasoning: It could not trust the owners to rebuild the park as affordable housing.
Court rulings over the years found the owners routinely failed to maintain the infrastructure and worked to replace the park with an “upscale resort community.” Residents also accused the owners of attempting to circumvent rent control regulations.
After the fire, it ultimately took more than 13 months to begin cleaning up the debris.
Ross said she approached the owners with independent mobile home park developers who were interested in buying the fire-destroyed lot and letting residents rebuild within months. She also approached the owners with a proposition that the former residents band together to buy the park. She heard nothing back.
“They don’t communicate,” Ross said. “It’s a feuding family. That’s also why we had so many problems with maintenance and with upgrades in the park.”
Pratt, who is running for mayor against Bass, also called on private developers like Rick Caruso to step in and save the Bowl. (Caruso’s team noted his rebuilding nonprofit is looking into how to help residents of the Bowl.)
Ross is a fan of Pratt’s proposition. “We need those kinds of people — we need Rick Caruso. That would be great,” Ross said. To sweeten the deal: “I’ll cook for him. I would make him all his favorite dishes.”
Science
A virus without a vaccine or treatment is hitting California. What you need to know
A respiratory virus that doesn’t have a vaccine or a specific treatment regimen is spreading in some parts of California — but there’s no need to sound the alarm just yet, public health officials say.
A majority of Northern California communities have seen high concentrations of human metapneumovirus, or HMPV, detected in their wastewater, according to data from the WastewaterScan Dashboard, a public database that monitors sewage to track the presence of infectious diseases.
A Los Angeles Times data analysis found the communities of Merced in the San Joaquin Valley, and Novato and Sunnyvale in the San Francisco Bay Area have seen increases in HMPV levels in their wastewater between mid-December and the end of February.
HMPV has also been detected in L.A. County, though at levels considered low to moderate at this point, data show.
While HMPV may not necessarily ring a bell, it isn’t a new virus. Its typical pattern of seasonal spread was upended by the COVID-19 pandemic, and its resurgence could signal a return to a more typical pre-coronavirus respiratory disease landscape.
Here’s what you need to know.
What is HMPV?
HMPV was first detected in 2001, according to the U.S. Centers for Disease Control and Prevention. It’s transmitted by close contact with someone who is infected or by touching a contaminated surface, said Dr. Neha Nanda, chief of infectious diseases and hospital epidemiologist for Keck Medicine of USC.
Like other respiratory illnesses, such as influenza, HMPV spreads and is more durable in colder temperatures, infectious-disease experts say.
Human metapneumovirus cases commonly start showing up in January before peaking in March or April and then tailing off in June, said Dr. Jessica August, chief of infectious diseases at Kaiser Permanente Santa Rosa.
However, as was the case with many respiratory viruses, COVID disrupted that seasonal trend.
Why are we talking about HMPV now?
Before the pandemic hit in 2020, Americans were regularly exposed to seasonal viruses like HMPV and developed a degree of natural immunity, August said.
That protection waned during the pandemic, as people stayed home or kept their distance from others. So when people resumed normal activities, they were more vulnerable to the virus. Unlike other viruses, there isn’t a vaccine for human metapneumovirus.
“That’s why after the pandemic we saw record-breaking childhood viral illnesses because we lacked the usual immunity that we had, just from lack of exposure,” August said. “All of that also led to longer viral seasons, more severe illness. But all of these things have settled down in many respects.”
In 2024, the national test positivity for HMPV peaked at 11.7% at the end of March, according to the National Respiratory and Enteric Virus Surveillance System. The following year’s peak was 7.15% in late April.
So far this year, the highest test positivity rate documented was 6.1%, reported on Feb. 21 — the most recent date for which complete data are available.
While the seasonal spread of viruses like HMPV is nothing new, people became more aware of infectious diseases and how to prevent them during the pandemic, and they’ve remained part of the public consciousness in the years since, August and Nanda said.
What are the symptoms of HMPV?
Most people won’t go to the doctor if they have HMPV because it typically causes mild, cold-like symptoms that include cough, fever, nasal congestion and sore throat.
HMPV infection can progress to:
- An asthma attack and reactive airway disease (wheezing and difficulty breathing)
- Middle ear infections behind the ear drum
- Croup, also known as “barking” cough — an infection of the vocal cords, windpipe and sometimes the larger airways in the lungs
- Bronchitis
- Fever
Anyone can contract human metapneumovirus, but those who are immunocompromised or have other underlying medical conditions are at particular risk of developing severe disease — including pneumonia. Young children and older adults are also considered higher-risk groups, Nanda said.
What is the treatment for HMPV?
There is no specified treatment protocol or antiviral medication for HMPV. However, it’s common for an infection to clear up on its own and treatment is mostly geared toward soothing symptoms, according to the American Lung Assn.
A doctor will likely send you home and tell you to rest and drink plenty of fluids, Nanda said.
If symptoms worsen, experts say you should contact your healthcare provider.
How to avoid contracting HMPV
Infectious-disease experts said the best way to avoid contracting HMPV is similar to preventing other respiratory illnesses.
The American Lung Assn.’s recommendations include:
- Wash your hands often with soap and water. If that’s not available, clean your hands with an alcohol-based hand sanitizer.
- Clean frequently touched surfaces.
- Crack open a window to improve air flow in crowded spaces.
- Avoid being around sick people if you can.
- Avoid touching your eyes, nose and mouth.
Assistant data and graphics editor Vanessa Martínez contributed to this report.
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