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 The GRAS notification can be withdrawn, and the ingredient can still be used.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.
According to Kristi Muldoon Jacobs, head of the FDA’s Office of Food Additive Safety, GRAS is a law that Congress establishes. The administration of the law is our duty. In actuality, we lack the power to enact laws.
Only a few months after Upton Sinclair exposed the unhygienic practices of the meatpacking business in his book The Jungle, Congress passed the Food and Drugs Act in 1906 in response to concerns about the safety and purity of food.The new law prohibited the production and distribution of contaminated, mislabeled, or toxic foods.
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.
According to Jennifer Pomeranz, a public health attorney at New York University’s School of Global Public Health, the legal distinction between the two types of components is regrettably somewhat ambiguous.
In 1958, products that were already widely used, like vinegar, baking powder, salt, and vanilla extract, were classified as GRAS.
If a substance passed a safety review, the FDA added it to its list of GRAS compounds. Outsiders may also request that a specific substance be investigated for possible inclusion on the official GRAS list.
However, the procedure was laborious, and it may take up to six years to review industry requests. The FDA used a speedier, fresher mechanism to make it more appealing for businesses to notify the agency of their GRAS determinations as part of the Clinton administration’s drive to streamline government processes. In response to GRAS warnings, the FDA now promises to act within 180 days.
For food producers, the notification procedure carries no risk.
The FDA essentially endorses the GRAS assessment if everything appears to be in order and states that it has no concerns regarding the substance. According to researchers Thomas Neltner and Maricel Maffini, who examined notices sent to the agency, this occurs almost 80% of the time.
The government might declare it needs more information before it can weigh in if things aren’t entirely apparent. Additionally, a corporation may withdraw from the process and the FDA will claim that it concluded its review at the request of the filer if it chooses not to submit that information.
This was the situation with one of Sleepy Chocolate’s ingredients.
The dark chocolate with lavender and blueberry flavors isn’t just another high-end candy bar; it contains the hormone melatonin, the amino acid L-tryptophan, a combination of calming botanicals, and PharmaGABA, an artificial form of a neurotransmitter that soothes the brain.
Pharma Foods International Co., located in Kyoto, Japan, manufactures PharmaGABA. Although the FDA has expressed significant concerns about the product’s safety twice and has never told the public that its issues have been addressed, the corporation boasts that their product has US-FDA self-affirmed GRAS approval.
There is nothing illegal about this.
To find out why regulators were worried about PharmaGABA, chemical engineer and lawyer Neltner and biochemist and consultant Maffini combed through FDA files on the drug.
Pharma Foods stated in its 2008 initial notice that it had engaged a Canadian consulting firm to ascertain if PharmaGABA should be eligible for GRAS status when used in beverages, candies, chewing gum, and other products.
Three university professors with backgrounds in pharmacology, toxicology, and food science were asked to comment on a study the consulting firm created regarding the product. According to the lawsuit, the three of them unanimously decided that the product was appropriate, safe, and would be GRAS.
However, after reading the entire 155-page PharmaGABA notice, FDA experts expressed concerns about a number of issues, including the product’s purity, the possibility that it could lead to electrolyte imbalances and low blood pressure, and the absence of information regarding PharmaGABA’s metabolism.
The FDA halted its review, and Pharma Foods retracted its warning.
In 2015, the company made another attempt with a GRAS notice for the use of PharmaGABA in a variety of products, including flavored milks, sports drinks, cereals, snack bars, candies, and gum. A scientific panel put together by the same consulting organization said that it was reasonable to assume that ingesting PharmaGABA in the estimated amounts would be safe.
FDA reviewers were concerned as before. They argued that the company’s statements that the medicine would not breach the blood-brain barrier and would be taken into the bloodstream at low levels were not supported by the new filing. The compound’s effects on the pituitary gland and potential harm to youngsters and pregnant women were of particular concern to the reviewers.
Pharma Foods withdrew its notice so it could conduct further studies, and the FDAceased its second evaluationof the product.
According to Maffini, it was common for agency scientists to criticize GRAS judgments that were approved by hired consultants. “They are more likely to be hired again if they give their clients positive reviews,” she said.
Pharma Foods has not yet provided the FDA with any new findings after nine years. 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.
2024 Los Angeles Times. Visit atlatimes.com. Distributed by Tribune Content Agency, LLC.
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