PRESS-NEWS.org - Press Release Distribution
PRESS RELEASES DISTRIBUTION

How a legal loophole allows unsafe ingredients in US foods

Gaps in FDA oversight enable the food industry to determine which substances are “generally recognized as safe”

2024-08-08
(Press-News.org) The Food and Drug Administration (FDA) is tasked with overseeing the safety of the U.S. food supply, setting requirements for nutrition labeling, working with companies on food recalls, and responding to outbreaks of foodborne illness. But when it comes to additives already in our food and the safety of certain ingredients, FDA has taken a hand-off approach, according to a new article in the American Journal of Public Health.

The current FDA process allows the food industry to regulate itself when it comes to thousands of added ingredients—by determining for itself which ingredients should be considered “generally recognized as safe,” or GRAS—and deciding on their own whether or not to disclose the ingredients’ use and the underlying safety data to the FDA. As a result, many new substances have been added to our food supply without any government oversight.

“Both the FDA and the public are unaware of how many of these ingredients—which are most commonly found in ultra-processed foods —are in our food supply,” said Jennifer Pomeranz, associate professor of public health policy and management at NYU School of Global Public Health and study’s first author.

Classifying GRAS

Since 1958, the FDA has been responsible for evaluating the safety of new chemicals and substances added to foods before they go to market. However, food safety laws distinguish between “food additives” and “GRAS” ingredients. While compounds considered “food additives” must be reviewed and approved by the FDA before they are used in foods, ingredients considered GRAS are exempt from these regulations.

The GRAS designation was initially established for ingredients already found in foods—for instance, vinegar and spices. But under a rule used since 1997, the FDA has allowed the food industry to independently determine which substances fall into this category, including many new substances added to foods. Rather than disclose the new use of these ingredients and the accompanying safety data for FDA review, companies can do their own research to evaluate an ingredient’s safety before going to market, without any notification or sharing of the findings. The FDA suggests—but does not require—that companies voluntarily notify the agency about the use of such substances and their findings, but in practice, many such substances have been added without notification.

In their analysis, the researchers review the history of the FDA’s and industry’s approach around adding these new compounds to foods and identify the lack of any real oversight. This includes a federal court case in 2021 upholding the FDA’s hands-off approach.

“Notably, the court did not find that the FDA’s practices on GRAS ingredients support the safety of our food supply,” said Pomeranz. “The court only ruled that the FDA’s practice was not unlawful.”

“As a result of the FDA’s policy, the food industry has been free to ‘self-GRAS’ new substances they wish to add to foods, without notifying FDA or the public,” said study senior author Dariush Mozaffarian, director of the Food is Medicine Institute and distinguished professor at the Friedman School of Nutrition Science and Policy at Tufts University. “There are now hundreds, if not thousands, of substances added to our foods for which the true safety data are unknown to independent scientists, the government, and the public.”

What’s on our shelves?

According to the researchers, the FDA also lacks a formal approach and adequate resources to review those food additives and GRAS substances already on the market. After an ingredient is added to foods, if research later suggests harms, the FDA can review the new data and, if needed, take action to reduce or remove it from foods. In a rare exception, the FDA announced in March that it would be reviewing 21 chemicals found in foods, including several food ingredients—a tiny fraction of the thousands of food additives and GRAS substances used today.

An example of the 21 food additives to be reviewed is potassium bromate, a chemical added to baked goods and drinks with evidence that it may cause cancer. Potassium bromate is banned in Europe, Canada, China, and Japan; California recently passed a law to ban its use, along with three other chemicals, and similar bills have been introduced in Illinois, New York, and Pennsylvania.

“This is a stark example of the FDA’s regulatory gap,” said Pomeranz. “We’re seeing states starting to act to fill the regulatory void left by the FDA’s inaction over substances increasingly associated with harm.”

The FDA’s oversight of GRAS ingredients on the market is also limited. The agency rarely revokes GRAS designation (an FDA inventory only shows 15 substances that were considered GRAS and then later determined to not be), nor does the FDA review foods on an ongoing basis with GRAS ingredients that can be safe when added at low levels but not in large quantities—for instance, caffeine, salt, and sugar.

“In 1977, the FDA approved caffeine as a GRAS substance for use in sodas at a low level: 0.02 percent,” said Pomeranz. “But today, caffeine is added to energy drinks at levels far exceeding this, which is causing caffeine-related hospitalizations and even deaths. Given that the FDA regulates the use of GRAS substances, the agency could set limits on the amount of caffeine in energy drinks.”

“The sheer number of GRAS substances and food additives on the market, combined with the lack of knowledge about the existence of self-GRAS ingredients, insufficient resources, and documented time delays even for well-supported action, renders reliance on post-market authority flawed and unreliable to ensure a safe food supply. FDA is only starting to utilize its post-market powers to review a tiny number of ingredients in the food supply, even though evidence of harm has been present for decades,” said study co-author Emily Broad Leib, director of Harvard Law School Center for Health Law and Policy Innovation and founding director of the Harvard Law School Food Law and Policy Clinic.

Stronger protections                                                           

The authors’ analysis provides the FDA and Congress with several potential actions to better assess and oversee the safety of both GRAS substances and food additives. This could include a new requirement that companies must publicly notify the FDA of the use of GRAS ingredients, and share their underlying safety data, before they are put in foods; creating a robust review process to reevaluate the safety of GRAS ingredients and food additives once they are already on the market; and clarifying the distinction between GRAS ingredients and food additives.

In order to fund this stronger oversight of the food supply, the researchers suggest that Congress could allocate additional resources to the FDA or establish a user fee program in which food companies pay for the FDA to review the safety of their ingredients before they are added to foods.

“Both the FDA and Congress can do more to enable the FDA to meet its mission of ensuring a safe food supply,” said Pomeranz.

The research was supported by the National Institutes of Health (2R01HL115189-06A1).

END


ELSE PRESS RELEASES FROM THIS DATE:

USC researchers develop AI model that predicts the accuracy of protein–DNA binding

2024-08-08
A new artificial intelligence model developed by USC researchers and published in Nature Methods can predict how different proteins may bind to DNA with accuracy across different types of protein, a technological advance that promises to reduce the time required to develop new drugs and other medical treatments. The tool, called Deep Predictor of Binding Specificity (DeepPBS), is a geometric deep learning model designed to predict protein–DNA binding specificity from protein–DNA complex structures. DeepPBS ...

Increasing solid-state electrolyte conductivity and stability using helical structure

Increasing solid-state electrolyte conductivity and stability using helical structure
2024-08-08
Solid-state electrolytes have been explored for decades for use in energy storage systems and in the pursuit of solid-state batteries. These materials are safer alternatives to the traditional liquid electrolyte—a solution that allows ions to move within the cell—used in batteries today. However, new concepts are needed to push the performance of current solid polymer electrolytes to be viable for next generation materials. Materials science and engineering researchers at the University of Illinois Urbana-Champaign have explored the role of helical secondary structure on the conductivity of solid-state peptide polymer ...

The threat of mpox has returned, but public knowledge about it has declined

The threat of mpox has returned, but public knowledge about it has declined
2024-08-08
PHILADELPHIA – It has been two years since the World Health Organization declared a global health emergency over an outbreak of mpox, a disease endemic to Africa that had spread to scores of countries. Now, in the summer of 2024, a deadlier version of the infectious disease has spread from the Democratic Republic of Congo to other African nations, the strain that originally hit the United States has shown signs of a resurgence, and this week the Centers for Disease Control and Prevention (CDC) issued a new alert on mpox to health care providers. But while the American public quickly learned about the disease during the summer of 2022, as ...

How does traumatic brain injury progress to Alzheimer’s disease?

2024-08-08
RIVERSIDE, Calif. -- A traumatic brain injury, or TBI, is caused by a contusion to the head that may result in injury to the brain. This type of injury combined with the inherited genetic risk factors can result in the accelerated development of Alzheimer’s disease and related dementia, or ADRD. TBIs range from mild to severe, with the majority being mild. They are especially common in adolescents engaging in contact sports and in the elderly who tend to fall with greater frequency as they age. Regardless of the source, TBI and how it progresses to ADRD is an understudied area of research. A $3.5 million grant to the University of California, ...

Researchers find unexpectedly large methane source in overlooked landscape

Researchers find unexpectedly large methane source in overlooked landscape
2024-08-08
When Katey Walter Anthony heard rumors of methane, a potent greenhouse gas, ballooning under the lawns of fellow Fairbanks residents, she nearly didn’t believe it. “I ignored it for years because I thought ‘I am a limnologist, methane is in lakes,’” she said. But when a local reporter contacted Walter Anthony, who is a research professor at the Institute of Northern Engineering at University of Alaska Fairbanks, to inspect the waterbed-like ground at a nearby golf course, she started to pay attention. Like others in Fairbanks, they lit “turf bubbles” on fire and confirmed the presence of methane ...

Royal Commission for AlUla collaborates with SETI Institute to support development of Alula Manara Observatory

Royal Commission for AlUla collaborates with SETI Institute to support development of Alula Manara Observatory
2024-08-08
Royal Commission for AlUla Collaborates with SETI Institute to Support Development of AlUla Manara Observatory   Experts from SETI Institute will support the advancement of telescope technology and data analysis at AlUla Manara Observatory.  The collaboration will enhance the future observatory's capabilities as it welcomes global scientists, researchers, and tourists interested in astronomy and space science. Ambitions to foster curiosity, knowledge sharing, and upskilling local capabilities in astronomical and space sciences field Mountain View, CA , 8 August 2024 -- The Royal Commission for AlUla (RCU) and SETI Institute ...

Cutting a few calories won’t hurt your workout

Cutting a few calories won’t hurt your workout
2024-08-08
A new UC Riverside study demonstrates that calorie restriction doesn’t deter mice from exercising, challenging the belief that dieting drains workout energy. The study, published in the journal Physiology & Behavior, shows that cutting calories by 20% did not significantly reduce the distance that mice voluntarily chose to run each day.  The researchers set out to understand what happens to mice when the amount of food available to them is reduced.  The findings, they hoped, would be relevant ...

Study reveals ways in which 40Hz sensory stimulation may preserve brain’s ‘white matter’

Study reveals ways in which 40Hz sensory stimulation may preserve brain’s ‘white matter’
2024-08-08
Early-stage trials in Alzheimer’s disease patients and studies in mouse models of the disease have suggested positive impacts on pathology and symptoms from exposure to light and sound presented at the “gamma” band frequency of 40 Hz. A new study zeroes in on how 40Hz sensory stimulation helps to sustain an essential process in which the signal-sending branches of neurons, called axons, are wrapped in a fatty insulation called myelin. Often called the brain’s “white matter,” myelin protects axons and insures better ...

Record-breaking recovery of rocks that originated in Earth’s mantle could reveal secrets of planet’s history

Record-breaking recovery of rocks that originated in Earth’s mantle could reveal secrets of planet’s history
2024-08-08
Scientists have recovered the first long section of rocks that originated in the Earth’s mantle, the layer below the crust and the planet’s largest component. The rocks will help unravel the mantle’s role in the origins of life on Earth, the volcanic activity generated when it melts, and how it drives the global cycles of important elements such as carbon and hydrogen, according to the team. The nearly continuous 1,268 metres of mantle rock was recovered from a “tectonic window,” a section ...

Surprise: infected bacteria fight back with “hidden” genes that halt cell growth, slow viral spread

2024-08-08
Researchers have uncovered a surprising way bacteria defend themselves: when a bacterium is infected, bacterial enzymes that copy genetic information from RNA into DNA synthesize genes whose protein products help shut down cell growth. This prevents further viral spread in the neighboring bacterial population. The results highlight the potential for other “hidden” genes, like the one found here, to be unearthed in different biological contexts. Bacteria defend themselves from viral ...

LAST 30 PRESS RELEASES:

Study outlines key role of national and EU policy to control emissions from German hydrogen economy

Beloved Disney classics convey an idealized image of fatherhood

Sensitive ceramics for soft robotics

Trends in hospitalizations and liver transplants associated with alcohol-induced liver disease

Spinal cord stimulation vs medical management for chronic back and leg pain

Engineered receptors help the immune system home in on cancer

How conflicting memories of sex and starvation compete to drive behavior

Scientists discover ‘entirely unanticipated’ role of protein netrin1 in spinal cord development

Novel SOURCE study examining development of early COPD in ages 30 to 55

NRL completes development of robotics capable of servicing satellites, enabling resilience for the U.S. space infrastructure

Clinical trial shows positive results for potential treatment to combat a challenging rare disease

New research shows relationship between heart shape and risk of cardiovascular disease

Increase in crisis coverage, but not the number of crisis news events

New study provides first evidence of African children with severe malaria experiencing partial resistance to world’s most powerful malaria drug

Texting abbreviations makes senders seem insincere, study finds

Living microbes discovered in Earth’s driest desert

Artemisinin partial resistance in Ugandan children with complicated malaria

When is a hole not a hole? Researchers investigate the mystery of 'latent pores'

ETRI, demonstration of 8-photon qubit chip for quantum computation

Remote telemedicine tool found highly accurate in diagnosing melanoma

New roles in infectious process for molecule that inhibits flu

Transforming anion exchange membranes in water electrolysis for green hydrogen production

AI method can spot potential disease faster, better than humans

A development by Graz University of Technology makes concreting more reliable, safer and more economical

Pinpointing hydrogen isotopes in titanium hydride nanofilms

Political abuse on X is a global, widespread, and cross-partisan phenomenon, suggests new study

Reintroduction of resistant frogs facilitates landscape-scale recovery in the presence of a lethal fungal disease

Scientists compile library for evaluating exoplanet water

Updated first aid guidelines enhance care for opioid overdose, bleeding, other emergencies

Revolutionizing biology education: Scientists film ‘giant’ mimivirus in action

[Press-News.org] How a legal loophole allows unsafe ingredients in US foods
Gaps in FDA oversight enable the food industry to determine which substances are “generally recognized as safe”