Most Americans are unaware of this U.S. Food and Drug Administration regulation, which permits companies to add potentially hazardous substances to meals without public notice or regulatory supervision.
Food manufacturers have been able to make their own decisions about the safety of novel chemicals for decades thanks to the FDA’s generally recognized as safe, or GRAS, classification, even in the absence of proof presented to agency scientists.
Advocates for consumers assert that the system has permitted businesses to include dangerous chemicals, including those that may cause cancer, in items like cereals, baked goods, ice cream, potato chips, and chewing gum.
The problem is now expected to gain more attention after President-elect Donald Trump nominated Robert F. Kennedy Jr. to head the Department of Health and Human Services. Kennedy’s promise to crack down on chemical additives in food has struck a chord with consumer health activists, despite the fact that his propensity for exaggerating medical conspiracies and his anti-vaccination advocacy have frightened many public health specialists.
The issue, according to detractors, is that a GRAS conclusion should be made after a scientific evaluation, preferably one carried out by impartial specialists.
However, corporations are free to choose whether or not to disclose their assessments with FDA reviewers under the statute. This implies that hundreds of chemicals used in processed meals are unknown to the FDA and American consumers.
Thomas Galligan, chief scientist for food additives and supplements at the Center for Science in the Public Interest, stated that the FDA cannot guarantee the safety of our food supply if it does not know what is in our food.
When a novel substance is discovered, the agency reviews the company’s safety report to determine whether it agrees. The business is not required to offer further information if FDA scientists identify issues and ask for it. The GRAS notification can be withdrawn, and the ingredient can still be used.
The FDA sees food additives like criminal defendants: innocent until proven guilty, safe unless proven otherwise, according to Natalie Mihalek, a former prosecutor and current Pennsylvania state representative.
Mihalek, a Republican who has sponsored a bill to ban six food dyes in her state, stated that at the moment, we are depending on the businesses who stand to gain financially from the sale of these compounds to conduct the research for us. It simply amazes me.
Although FDA officials admit the GRAS system has limitations, they claim they lack the power to alter it.
Congress sets GRAS as part of the law, saidKristi Muldoon Jacobs, director of the FDA s Office of Food Additive Safety. The administration of the law is our duty. In actuality, we lack the power to enact laws.
Concern about the safety and purity of food prompted Congress to pass theFood and Drugs Actin 1906, just months after Upton Sinclair brought the meatpacking industry s unsanitary practices to light in his bookThe Jungle.The new law forbade the manufacture and sale of foods that were adulterated or misbranded or poisonous.
The Food, Drug and Cosmetic Act of 1938 gave the FDA more regulatory authority, and a 1958 amendment separated food ingredients into two groups: additives that need to be evaluated for safety and substances that can be added directly to food because they are widely accepted to be safe.
Unfortunately, the legal distinction between the two kinds of ingredients is very vague, saidJennifer 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 takesix years or moreto evaluate. As part of the Clinton-era initiative tostreamline government operations, the FDA embraceda newer, faster systemdesigned 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 noticeswithin 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 researchersThomas Neltnerand Maricel Maffini, who analyzednotices 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 inSleepy Chocolate.
Not just another gourmet candy bar, the dark chocolate with lavender and blueberry flavors is infused with the hormonemelatonin, the amino acidL-tryptophan, a blend of soothing botanicals and something calledPharmaGABA, an artificial version ofa neurotransmitterthat calms the brain.
PharmaGABA is made byPharma 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 itsinitial noticefiled in 2008, Pharma Foods said it hired aCanadian consulting firmto 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 FDAended its evaluation.
The companytried again in 2015with aGRAS noticefor 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 FDAceased its second evaluationof 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 inSleepy Chocolatebased on Pharma Foods’ determination that the compound should be generally recognized as safe.
Pharma Foods International andFunctional 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 aFreedom 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. Tomake 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 calledtara flourwas able tosicken hundreds of peoplewho 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, andmore than 100 were hospitalized, according to the FDA. The companyissued a voluntary recallandblamed a compound in tara flourfor the illnesses.
Tara flour is a high-protein substance made from the seeds ofan evergreen treefound in South America. There is no GRAS notice for the ingredient in the FDA s database. Tests conducted after the outbreak found thatan amino acidin the flour caused liver damage in mice.
In May, nearly two years after the recall, the FDA concluded that tara flourdoesn t meet the scientific standardto 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, saidJensen 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 introducedin the U.S. Houseand Senatewould 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 ina billthat 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 acknowledgedthe growing public demand for the FDA to do more to ensure the safety of chemicals currently in the U.S. food supply.
Californiaand other states have sought to fill the void by regulating or banningselect food additiveswithin 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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