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How the FDA allows companies to add secret ingredients to our food

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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.

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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.”

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“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.”

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.”

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L.A.'s mountain lions become more nocturnal to avoid people. Does it come at a cost?

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L.A.'s mountain lions become more nocturnal to avoid people. Does it come at a cost?

Griffith Park’s late celebrity mountain lion P-22 took the night shift to avoid hordes of hikers, bikers and dawdlers who frequented his home in the heart of Los Angeles — and it’s a pattern replicated by other pumas in the region, according to a new study.

The move to a later schedule is an encouraging example of a species doing its part to coexist in a bustling megalopolis, according to researchers from UC Davis and other institutions who conducted the study.

But the temporal gymnastics they perform may come at a cost, experts said, consuming energy and limiting the amount of time they can spend on critical tasks such as hunting. And it may compound other urban stressors, like whizzing traffic and rat poison.

The study, published last month in the journal Biological Conservation, found that Southland mountain lions became more nocturnal and less crepuscular — i.e., active at dusk or dawn — in popular recreation areas.

To examine the impact of recreation on the lions, researchers used GPS and activity data gleaned from the tracking collars of 22 mountain lions roaming the Santa Monica Mountains and surrounding region between 2011 and 2018.

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They also drew data from Strava, a popular app in which users publicly document runs, hikes and more to determine how much recreation was happening in each lion’s home range, and to test how it influenced the patterns and timing of their activity.

The “most nocturnal” puma in the study was the late P-41, who inhabited the Verdugo Mountains, a range bounded by freeways and development on the northeast edge of the San Fernando Valley, and a recreation haven. Ranked second was P-22, affectionately called the Brad Pitt of mountain lions when he stalked the Hollywood Hills.

The study revealed that female lions were less nocturnal than males, possibly because males pose a threat to them and their kittens.

(National Park Service via Associated Press)

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Researchers wondered if mountain lions who were exposed to more recreation would become immune to it — and simply not care.

“We saw the opposite,” said Ellie Bolas, lead author and a PhD candidate at UC Davis.

“Seeing that mountain lions are flexible in their activity and sensitive to recreation is, I think, a reason we can feel optimistic that they’re willing to avoid us and want to avoid us,” she added.

Other institutions involved included Cal Poly Pomona, the National Park Service, UCLA, the University of Nebraska and Harvard Westlake High School.

The findings are good news for Angelenos worried about becoming a lion’s lunch — given that the cats are steering clear of people. And it helps explain how the apex predators manage to hack it in an intensely urban environment. Los Angeles is just one of two megacities in the world that are home to a big cat; the other is Mumbai, in India, where leopards prowl the streets.

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So why are local lions rearranging their schedules for people? The new study notes that animals might high-tail it to areas where there are less people when they can. But in the greater L.A. metropolitan area, with more than 18 million people, even natural areas get gridlocked. So they adopted another strategy.

The National Park Service has monitored lions in and around the Santa Monica Mountains for more than 20 years, which is where the long-term data for the recent research came from.

“A major thing that we’ve been studying all along is the effects of urbanization and fragmentation on these animals,” said Seth Riley, study co-author and branch chief for wildlife at Santa Monica Mountains National Recreation Area, a unit of the park service.

The new study revealed that the lions’ timing shifts weren’t more pronounced on weekends when recreation spikes, contrary to what researchers expected.

There were also differences between the sexes, with female mountain lions found to be more active during the day and closer to sunrise. Researchers surmised that they avoid overlapping with male lions who will kill kittens in tow — and sometimes even the females themselves.

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The least nocturnal puma tracked was P-13, a female with a home range in the central and western Santa Monicas.

Beth Pratt, California regional executive director for the National Wildlife Federation, said that while it’s good news that the charismatic cats are “coping,” there are likely tradeoffs.

“By switching their hunting strategy, it’s not ideal,” said Pratt, who was one of P-22’s biggest boosters. “It takes more energy, it doesn’t give them as many options, but the animals here are doing their part.”

People should pitch in, too, by minimizing challenges, she said. Panthers stalking the Santa Monica Mountains are imperiled by inbreeding because of freeways that essentially lock them in — and visitors with needed genetic diversity out.

“At a certain point they’re not going to be able to cope with all these challenges stacked up,” she said, pointing to threats such as cars and rodenticides — both of which took a toll on P-22. He was captured and euthanized in late 2022, deemed too sick to return to the wild because of injuries and infection.

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One way to give lions “the edge” is by putting up wildlife crossings, said Pratt, who is a major force behind the largest such passageway in the world rising over the 101 Freeway in Agoura Hills.

The more than $90-million Wallis Annenberg Wildlife Crossing currently under construction is seen as a potential lifeline for the lions of the Santa Monicas. Without an outlet, the population is at risk of blinking out.

Pratt said the new study shows that actions as seemingly innocuous as how we site trails and enjoy the outdoors can impact the species — and that it would behoove us to consider our approach as we navigate a biodiversity crisis.

“It’s not that we shouldn’t do them, but how can we do them differently so that animals aren’t as impacted,” she said.

Bolas said there’s currently no research to tell us if the lions’ flexibility in the timing of their activity is also a cost to them, but that “it very well may be.”

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Revelations from the study arrive as some Southern California and Central Coast cougars are at a crossroads.

California wildlife officials are poised to decide whether to designate six isolated clans of pumas as endangered or threatened species under state law.

The state Fish and Game Commission in 2020 granted the cougars who are roaming regions between Santa Cruz and the U.S.-Mexico border temporary endangered status as a candidate to be listed under the state Endangered Species Act.

A final decision is expected next year.

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Column: UnitedHealthcare's chief executive was shot dead. Why did thousands react with glee?

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Column: UnitedHealthcare's chief executive was shot dead. Why did thousands react with glee?

The apparent assassination of UnitedHealthcare Chief Executive Brian Thompson on a Midtown Manhattan sidewalk Wednesday has unleashed an extraordinary outpouring of emotion. But it’s not all horror or sadness over a 50-year-old father of two being shot dead in public by a man in a mask.

Thompson’s death has inspired a torrent of fury about the way his insurance company and others treat — or mistreat — people in their moments of greatest need. Some of the reactions, particularly on social media, have been downright gleeful about the killing.

What a stunning illustration of the hatred so many Americans feel toward for-profit health insurance companies, which too often make money for stockholders by withholding care from sick people.

UnitedHealthcare is a particularly awful exemplar. It is infamous for high denial rates and low reimbursement levels.

According to an investigation by the medical news site Stat and a federal lawsuit recently filed in Minnesota, UnitedHealthcare has been using a deeply flawed artificial intelligence algorithm to wrongfully deny healthcare to elderly and disabled patients. Stat reported that the company “pressured its medical staff to cut off payments for seriously ill patients … denying rehabilitation care for older and disabled Americans as profits soared.”

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ProPublica reported last month that the company was using algorithms to identify people it deemed guilty of “therapy overuse” and deny mental health treatment. Both California and Massachusetts determined that the company was breaking the federal law that requires insurers to cover mental health issues the same way they cover physical ailments. UnitedHealthcare denied claims for more than 34,000 therapy sessions from 2013 to 2020 in New York alone, saving the company about $8 million.

Adding to this unsavory picture, four of its top executives, including Thompson, have been under scrutiny for $101.5 million in stock trades they made after the company was informed that it was the target of a federal antitrust investigation but before the news became public and the stock price dropped.

Perhaps all this helps explain why, as of Friday morning, more than 85,000 people had reacted to UnitedHealthcare’s solemn Facebook statement about Thompson’s death with a laugh emoji.

People on other social media platforms also piled on.

“All human life is sacred, so it’s not proper to laugh when serious harm befalls someone,” wrote one Bluesky user. “The moral thing to do is instead charge them hundreds of thousands of dollars.”

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“UnitedHealth CEO meets the same fate as many of his clients,” posted another Bluesky user above photos of the shooter pointing his gun at Thompson’s back before he reportedly rode off on an e-bike.

Stories of terrible interactions with the largest health insurer in the country also poured forth.

Elizabeth Austin, a single mother who lives in Bucks County, Pa., told me she had a miserable experience with UnitedHealthcare after her young daughter, Carolyn, was diagnosed with leukemia during the COVID-19 pandemic. Her chemotherapy caused nausea, so Carolyn’s doctor ordered a nighttime feeding tube to supplement what little she was able to eat while awake. She said United Healthcare wouldn’t pay for the feeding tube unless Carolyn ate no solid food at all.

“I was like, ‘She’s 9! She wants to eat food!’” Austin told me. Unmoved, the insurer forced Austin to pay $900 a month out of pocket for the device.

Later, when Carolyn developed a sensitivity to a sedative used during her monthly lumbar punctures, her doctors switched to another medicine, and the company again denied payment, Austin said. She paid for that herself too.

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Austin said she eventually developed a stress-related heart condition that required ablation surgery. She and her daughter are healthy now, but the scars remain. She said she was saddened but not shocked to learn about Thompson’s death.

“These things are happening because people are really struggling,” she told me. “I don’t think the CEO was responsible for my daughter’s caregiving issues, but it’s smart to ask, ‘Why did this happen?’ Could it be a systemic issue?’ People are buckling under the pressure.”

At this point, the motive for Thompson’s killing is a matter of speculation. But ammunition recovered from the scene was inscribed with words often used to describe insurance companies’ anti-patient strategies, including “deny” and “defend,” the Associated Press and others reported.

In the 2010 book “Delay, Deny, Defend: Why Insurance Companies Don’t Pay Claims and What You Can Do About It,” Jay M. Feinman, a Rutgers law professor, traces the evolution of insurance companies from generally helpful organizations where adjusters — that is, human beings — were responsible for reimbursements into the antagonistic, algorithm-driven behemoths they are today.

In the 1990s, he writes, insurance companies such as Allstate turned to the consulting firm McKinsey & Co. to develop new strategies.

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“McKinsey,” Feinman writes, “saw claims as a ‘zero-sum game,’ with the policyholder and the company competing for the same dollars. No longer would each claim be treated on its merits.” Computers would determine reimbursements, and settlements would be offered on a “take-it-or-litigate basis.” Feinman writes that McKinsey urged Allstate to move “from ‘Good Hands’ to ‘Boxing Gloves.’”

Earlier this year, the insurance giant Anthem Blue Cross Blue Shield announced that it would start limiting reimbursements for anesthesia based on its own time limits for surgeries. The idea, Anthem said, was to prevent overbilling. Doctors, predictably, were outraged.

“This is just the latest in a long line of appalling behavior by commercial health insurers looking to drive their profits up at the expense of patients and physicians providing essential care,” Donald Arnold, the president of the American Society of Anesthesiologists, told NPR.

On Thursday, after the outpouring of rage against health insurers sparked by Thompson’s killing, Anthem reversed course, blaming “significant widespread misinformation” about its proposed policy for the about-face.

No wonder there is so little empathy for Brian Thompson, who was by many accounts a lovely human being. In death, he has become an unwitting symbol of the terrible things health insurance companies do to people for money.

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Bluesky: @rabcarian.bsky.social. Threads: @rabcarian

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USDA says it will start testing milk for H5N1 bird flu virus nationwide

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USDA says it will start testing milk for H5N1 bird flu virus nationwide

Nearly a year after a wild bird infected with H5N1 avian flu presumably passed its viral baggage to a dairy cow in the Texas panhandle — which has subsequently led to the infection of more than 700 herds nationwide and sickened at least 32 dairy workers — the nation’s agriculture department announced Friday that it will sample the nation’s milk supply to test for the virus.

The federal order requires dairy farmers to collect and share raw milk samples for testing — if requested — by the U.S. Department of Agriculture. It also lays out a staged testing strategy that will allow the federal agency to track and monitor the disease.

The National Milk Testing Strategy, which the new milk testing regimen is called, “is a critical part of our ongoing efforts to protect the health and safety of individuals and communities nationwide,” according to a prepared statement from Xavier Becerra, the U.S. secretary of Human and Health Services.

Initially, the order will only apply to six states — California, Colorado, Michigan, Mississippi, Oregon and Pennsylvania.

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Steve Lyle, a spokesman for the California Department of Food and Agriculture, said the order is incidental, bringing “no changes for California. We are already doing this.”

While California, Colorado and Michigan have all reported positive herds, the three others have not. Testing regimens and investigations have already been underway in the infected states — as well as in Pennsylvania, which in late November, began its own “Precautionary Bulk Milk Testing at Processing Plants” program.

While Oregon has not had a H5N1 outbreak in dairy cows, it has reported the disease in commercial poultry, wild birds and, last month, two pigs.

Mississippi has roughly 50 herds statewide, with each farm averaging 149 cows.

The new milking plan is designed as a step-by-step plan, with the end goal of eradicating the disease from the nation’s herds — an objective few epidemiologists or virologists think, at this point, is possible.

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In the first stage, testing will occur at all dairy processing facilities within a given state, allowing the federal agency to determine if and where the virus is residing. The next stage will allow the federal agency to drill down deeper by moving the testing to bulk tanks.

If the virus is found, the third stage goes into action, triggering an even more granular investigation by identifying farms and herds that are positive — allowing for “rapid response measures,” including biosecurity programs such as movement controls and contact tracing.

If, however, no virus is found in a state, bulk tank testing frequency will progressively decrease — going from weekly to monthly to quarterly, assuming the state’s tests remain negative.

Finally, there is the fifth stage, known as “Demonstrating Freedom from H5 in U.S. Dairy Cattle.”

That’s when, according to the statement, states can begin more periodic sampling and testing “to illustrate long-term absence from the national herd.”

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