Hospitalizations, Deaths Result From Hands-Off Food Safety Rules

The nation’s top food safety regulator has for decades left it up to manufacturers to decide whether their food ingredients are safe, sometimes with tragic results, a Bloomberg Law investigation reveals.

Last year, nearly 400 people across the US fell ill after eating a lentil and leek meal shipped by the plant-based food company Daily Harvest. Some 133 people were hospitalized, and several had to have their gallbladders removed, government records show.

More than a decade earlier, scores of young adults suffered serious harm and some died after drinking Four Loko, a low-cost but potent alcohol and caffeine drink packaged in a 23.5 ounce can.

Both products were put on the market under a Food and Drug Administration process known as Generally Recognized as Safe (GRAS) that lets private companies bypass a two-year FDA approval process and determine the safety and combinations of substances in their own products.

For a food ingredient to be GRAS, a company is supposed to show there is scientific evidence and consensus that a product is safe for its intended use. But companies can self-designate substances as GRAS with no legal requirement to inform the FDA. By merely putting the new or reconfigured item for sale after its own review, the company is attesting to its safety.

The result is the agency knows little about how companies decide what substances are going into foods. The FDA has said it has no idea how many GRAS determinations companies are making.

A voluntary notification program gives the agency a chance to review companies’ GRAS determinations, but it’s completely up to companies to decide whether to seek FDA review. Few do.

There are more than 10,000 substances allowed in food, yet the FDA had just 1,147 requests for review since 1998 (many of them duplicates). And in the few requests the FDA gets, it rarely acts: the FDA last rejected a company’s voluntary GRAS submission 12 years ago.

For years watchdogs and Congress have questioned the way the FDA regulates food. Earlier this year Bloomberg Law examined the agency’s slow rollout of new guidelines for heavy metals in baby foods, some of which were released just after publication. In 2022 Politico closely detailed structural problems at the agency.

GRAS is an honor system some say is long overdue for reform.

“That’s really dangerous for consumers,” said Melanie Benesh, a vice president for the nonprofit Environmental Working Group. “It means the FDA is flying blind.”

An FDA spokesperson said existing food safety laws limit what they can require of manufacturers.

“The way the law is written, it’s on the companies and manufacturers to ensure the safety of the products they put on the market,” the spokesperson said.

The agency also said in written responses to questions from Bloomberg Law that it has questioned GRAS determinations and “taken action as appropriate.” The FDA noted it has proposed a new food safety program “to develop a faster and more nimble process for evaluating chemicals in the food supply.”

“The safety for GRAS is as rigorous as any authorized additive,” the FDA spokesperson said. “It’s still an ingredient. It needs to be safe.”

Congress set the GRAS system in place in 1958, and some current members agree it is open to abuse. Still, previous efforts at reform have failed to gain traction.

Other efforts are pending. A House bill (H.R. 3927) introduced in June would establish a new office within the FDA to regularly reassess the safety of GRAS substances.

Another proposal from Sen. Edward Markey (D-Mass.) would require companies to publicly disclose the scientific rationale they used to justify GRAS status. The bill was reintroduced in November after failing to gain traction in the prior session of Congress.

Tara Flour and Sickness

Last year, consequences of the government’s lax oversight were revealed in the case of Daily Harvest and its French Lentil + Leek Crumbles.

Starting in April 2022, people across the country got sick after eating the meal. They suffered vomiting, diarrhea, nausea, fatigue, body aches, fever, jaundice, and liver damage. Some had to have gallbladders removed.

“I remember that one night in the ER—the pain was so bad that I was doubled over,” said Carol Ready, who was sickened several times before identifying the cause of her illness. “My husband thought I was dying.”

Nancy Reilly, a mother of two and an endurance athlete who participates in triathlons and Iron Man competitions, was also sickened by the crumbles. She awoke in the middle of the night with “excruciating pain” and was rushed by ambulance to the hospital.

An FDA report last October pointed to tara protein flour as a likely source of the illnesses. Daily Harvest announced in July 2022 that it was the source of the outbreak.

Tara flour is a relatively new product the supplier had on the market for about two years before its inclusion in the crumbles. It is made from the seed of the tara tree and is a separate ingredient from tara gum, a more widely used food additive.

A University of Mississippi study supported the idea that tara flour caused the adverse reactions. It identified high levels of nonprotein amino acids, which can create harmful substances when broken down in the body, as a potential culprit.

It’s unclear what safety review tara flour underwent before entering the US supply chain. The substance was advertised as GRAS by Daily Harvest’s supplier, Smirk’s, according to a June Fast Company interview with Daily Harvest Chief Supply Chain Officer Ricky Silver. It was not submitted to the FDA for a voluntary review, according to the agency’s database.

Daily Harvest declined an interview request, though CEO Rachel Drori said after the outbreak that its internal testing and investigation “validated the safety of our supply chain and manufacturing processes.” Smirk’s did not respond to a request for comment.

The FDA’s report on the Daily Harvest outbreak made no mention of tara flour’s regulatory status. In its written statement to Bloomberg Law and in a follow-up interview, the FDA did not specifically address questions about the Daily Harvest episode, saying it is unable to comment on specific cases. It also denied Bloomberg Law’s FOIA request seeking documents addressing tara flour’s GRAS status.

“It clearly wasn’t approved by the FDA,” said food safety attorney Bill Marler, who represents dozens of clients, including Ready and Reilly, suing Daily Harvest and its suppliers.

Molinos Asociados, the Peruvian company that manufactured the tara flour, did not directly answer whether the substance had been designated GRAS. In a statement, it said it is “unaware of any reliable, peer reviewed, scientific evidence to support the speculative assertions that ingesting tara flour caused any illness.”

Both Ready and Reilly underwent surgery to have their gallbladders removed. “I was scared to death,” Reilly said.

The experience shattered Ready’s views on food safety. She works as an assistant professor of Spanish and linguistics in Stillwater, Okla., but grew up on a farm in Nebraska, where she developed confidence in the food system.

“This whole experience made me realize that not only is our food supply not safe, it’s not trustworthy,” Ready said. “I still have a really hard time going to the grocery store.”

‘Not an Affirmation’

The GRAS system has been streamlined over the years but remains largely unchanged since the 1950s. Any substance added to food is subject to pre-market approval by the FDA—“unless the use of the substance is generally recognized as safe.”

When a company wants to use a new substance, such as a new type of plant protein, or a combination of substances with known effects, such as alcohol and caffeine, it can conduct its own review and then designate the use as GRAS.

And even when the FDA is asked to review a product’s GRAS designation, it tells companies its review “is not an affirmation” a substance is GRAS, according to a review of closure letters.

That language shields the FDA from legal exposure and shifts responsibility to manufacturers, said Maricel Maffini, an environmental health expert and consultant to the Environmental Defense Fund.

Once an FDA review is started, there’s no mandate that the agency finish it. The company can end the review at any time—and still self-determine its additive is safe.

The FDA encourages companies to withdraw their voluntary notifications when safety issues or other deficiencies are identified, offering them a chance to reanalyze or reformulate the product.

About three out of every four voluntary GRAS notifications since 1998 ended with the FDA saying it has no questions. Roughly 17% of the notifications were withdrawn, often after the FDA raised questions, Bloomberg Law’s review of the notices reveals. A detailed review of more than 100 closure letters in the past five years found that companies withdrew notifications at the agency’s suggestion at least 51 times.

In roughly the same time span, 2018-2022, the FDA said its GRAS notification program had reassessed the GRAS status of the use of 40 ingredients.

Critics, supporters, and the FDA all point to a limited budget and overburdened staff as affecting how the agency polices food safety.

In 2021, the government beat back a lawsuit filed by the Environmental Working Group and food safety and science organizations challenging GRAS.

“It was reasonable for FDA to determine that its resources could better be allocated to higher public health priorities,” wrote Judge Vernon Broderick of the US District Court for the Southern District of New York.

The judge cited arguments that “a change to the GRAS Rule would result in confusion and overwhelm FDA with reviewing the status of countless ingredients that are being used in food.”

Food safety organizations, stung by the ruling, say the system remains a recipe for trouble.

The FDA said the ruling made clear that the changes sought by the plaintiffs would have to be remedied by Congress.

Sen. Markey, among those pushing for more industry disclosure, said in a statement to Bloomberg Law that companies can use GRAS as a “loophole” to avoid scrutiny. “If the FDA is to meet its duty to ensure food is safe, it cannot do so without formally reviewing new chemicals and revisiting the safety of existing food chemicals,” he said.

GAO Questions

Industry groups have largely supported the system. The Institute of Food Technologists, Enzyme Technical Association, Defoamer Industry Trade Association, and other organizations have all voiced support over the years.

Chemist Sean Taylor, the scientific secretary for an independent GRAS review program organized by the Flavor and Extract Manufacturers Association, said the process is thorough. “There’s a rigor in the FDA’s consideration of these GRAS determinations,” Taylor said.

The association’s review process has been in place since 1959. Its determinations are published publicly and shared with the FDA.

But a 2010 audit by the US Government Accountability Office raised concerns about substances that aren’t reviewed by the FDA, stating the agency “does not help ensure the safety of all new GRAS determinations.”

The GAO cited safety concerns over the FDA’s inability to track when companies make GRAS determinations, and said the agency failed to systematically ensure the safety of existing GRAS substances. The FDA altered its program after the audit but did not implement recommendations addressing those two concerns.

Asked about those issues, the FDA said the law doesn’t require companies to provide the information and that a court has upheld its process. It said it provides guidance to industry on best practices.

In one instance where a GRAS review was withdrawn, an Icelandic company sought FDA review of a shrimp-derived substance called chitosan. Three times the company submitted its GRAS determination to the FDA for review, withdrawing each time after the agency raised concerns.

The FDA review team’s most recent analysis of chitosan in 2012 raised toxicity concerns that the substance could cause liver or kidney problems with years of exposure, according to documents Bloomberg Law obtained through the Freedom of Information Act. Yet the company is free to sell chitosan: It self-designated the substance as GRAS over a decade ago.

It’s unclear if shrimp-derived chitosan is actively in use in the US, but its 2012 GRAS notice stated it was intended to serve multiple functions, including as a preservative, in food groups from meat and poultry to crackers and chips.

Primex, the company that sells the chitosan, did not respond to a request for comment. The FDA did not address a question about chitosan but acknowledged that companies can designate a substance as GRAS if it’s withdrawn from an FDA review following safety concerns.

The incident is not unusual, said Maffini, as the FDA avoids enforcement action during voluntary reviews so as to not scare away companies from participating in the program. The result is a system in which the FDA’s own experts raise warnings about the safety of a product, such as chitosan, but it yields no preemptive action.

“You see that their scientists have very important safety issues,” Maffini said. “And then the products are in the marketplace without any intervention from the agency.”

The FDA spokesperson pointed to its recent efforts questioning GRAS determinations of CBD and THC in food as evidence of its enforcement on GRAS.

“We’ve come out clearly and said we don’t consider these to be generally recognized as safe,” the spokesperson said. “And people still continue to put them in food, and we continue to go after them. The law allows them to do that.”

Christie Harman, the senior science and policy adviser for the Flavor and Extract Manufacturers Association GRAS panel, said concerns that companies are making GRAS determinations without the FDA’s knowledge are “overstated.”

“Quite frankly, companies that sell ingredients, I think, do notify the FDA in most cases for successful ingredients that move forward,” Harman said. An FDA review that ends with no questions can be economically beneficial to companies that then market those ingredients, she added.

‘Blackout in a Can’

In 2005, three Ohio State University graduates co-founded a Chicago company called Phusion Projects and put to market a signature drink: Four Loko.

It became an instant, buzzy success at college campuses. Sold in a colorful 23.5 ounce can emblazoned with pictures of watermelon, grape, or raspberry, Four Loko was often available at corner marts in the section holding energy drinks. It sold for under $3.

The “four” in Four Loko stood for ingredients taurine and guarana, a stimulant, along with caffeine and wormwood, an herb used in alcoholic drinks vermouth and absinthe.

One can contained the same amount of alcohol found in four beers and caffeine found in two Red Bulls.

Four Loko and tragedy became a steady mix. Its nicknames spoke to its potency: “blackout in a can” and “liquid crack.” Critics say the caffeine masked the drink’s powerful alcohol content.

In Northern Virginia in September 2010, a 15-year-old and his three friends bought Four Loko at a gas station before heading to a concert. The teen, John “Bo” Rupp III, became paranoid and disoriented after drinking two cans, prompting his mother to pick him up.

On the way home, he tried to jump out of the car. Once home, he ran away and hid, and then went into a busy street and fell or sat down. He was struck by a car and killed.

Ten days later in California, a 23-year-old Fresno Pacific University student became wildly paranoid after drinking two Four Lokos and beer. He told his roommates about an impending riot and kept saying, “They’re coming to get us.”

Then he grabbed his shotgun, went into his backyard, and started firing at imaginary targets. His housemates called 911. The student, Ron Fiorini, went to his front porch when police arrived, the shotgun resting on his shoulder. Police shot him eight times, killing him, court records say.

The same year, Jason Keiran, a 20-year-old Florida State University student, accidently killed himself after buying six Four Lokos over two days. Under the legal drinking age, he got the drink at a variety of convenience stores and gas stations in Tallahassee.

Awake for 30 hours, disoriented, and agitated, Keiran began toying with his roommate’s handgun. He accidentally fired it, shooting himself in the head. He died Sept. 17, 2010.

The Keiran family’s next door neighbor, lawyer Donald Van Dingenen, was so shocked by the news of the young man’s death that he and colleagues began pulling back the layers on Four Loko. That led to one of the major lawsuits against Phusion Projects that put pressure on the government to pull Four Loko from the corner marts where it was so easily attained.

“I’m like, what is this thing?” he recounted. “The more research we did, we saw that it was really becoming a college cult type of thing.”

Late Crackdown

In November 2009, four years after Four Loko hit the market, the FDA announced it was examining the safety of caffeinated alcoholic beverages made by multiple manufacturers.

On Nov. 17, 2010, following the spate of deaths in California, Florida, and Virginia, the FDA sent Phusion’s owners a “Warning Letter” saying Four Loko did not meet GRAS standards through its combination of caffeine and alcohol.

“As it is used in your product, caffeine is an unsafe food additive, and therefore your product is adulterated,” the FDA wrote. “We are not aware of any basis to conclude that caffeine is GRAS under these conditions of use.”

The company had long defended Four Loko and told the FDA a panel of scientists it retained concluded that, under GRAS, “adding caffeine to alcohol is safe.”

On the eve of the FDA’s letter, Phusion Projects took an abrupt turn. The company announced it was removing caffeine, guarana, and taurine. “Going forward,” it wrote, “Phusion will produce only non-caffeinated versions of Four Loko.”

Daniel Gerber, a lawyer representing the company in several of the lawsuits, did not answer multiple interview requests. The voicemail at Phusion Projects did not take messages.

Dale Scott, a Florida attorney who worked on the Keiran case and others, said the wave of litigation made a difference. “This stuff isn’t on the shelves anymore,” he said.

But Van Dingenen, his co-counsel in the Keiran case, said the tragedies also exposed the system’s vulnerabilities.

“At the end of the day you could say the GRAS system failed Jason Keiran and all these other kids because if there was any teeth in the GRAS system they would never be able to bring the product to market,” Van Dingenen said in an interview.

The FDA did not address a Bloomberg Law question about whether it could have acted sooner on Four Loko.

“It’s a worst-case scenario of what can happen,” said Benesh of the Environmental Working Group. “The FDA is only acting after people have already been harmed.”