Aspartame: When Lobbying Dictates Science

Aspartame is a synthetic sweetener with a sweetening power 150 to 200 times greater than that of sugar. It is used to provide a sweet taste without adding calories.
It can be found in more than 2,500 products in Europe, and about 6,000 worldwide, mainly in so-called “light”, “zero“, or “sugar-reduced” products1,2.

It represents a major economic factor for manufacturers since it is extremely profitable: its sweetening power allows for the use of tiny quantities, at a cost about ten times lower than that of sugar3. The savings made by producers are considerable but rarely passed on to selling prices. Regular drinks and their sugar-free versions are therefore often sold at the same price, or even more expensive in some cases, allowing margins to be maximized.

But the safety of aspartame is now widely questioned. Many scientists and investigative journalists denounce toxic effects downplayed by biased studies, as well as conflicts of interest between industry and health authorities that led to its authorization.

In this article, we shed light on the grey areas surrounding aspartame and take stock of what science really says.

A highly controversial market launch

1965: the birth of a sweetener under influence

Aspartame was discovered by chance in 1965 by a chemist working for the American pharmaceutical company Searle. This chemist, named James Schlatter, was developing a drug for ulcers when he synthesized a new molecule. Upon accidentally tasting the compound on his fingers, he noticed its extremely sweet taste4.

Its sweetening power, far greater than sugar, quickly caught the attention of the company, which then initiated an authorization process with the FDA (Food and Drug Administration) to allow its use in common food products.

Searle subsequently funded several laboratory tests to evaluate the toxicity of aspartame and submitted the results to the FDA in 1973. Following this, in 1974, the FDA approved its market release in dry foods and chewing gums. This decision was based on a preliminary, superficial reading of toxicity studies provided by Searle, and on the simplistic hypothesis that aspartame would be harmless since it breaks down in the body into two compounds that occur naturally in the human body5.

This authorization immediately sparked criticism, notably from neuroscientist John Olney, who warned of the risk of brain lesions and tumors6. The following year, in 1975, the market approval of aspartame was suspended to allow for further investigation by FDA scientists7.

After two years of work, the latter raised serious concerns. They identified numerous instances of negligence and irregularities in the studies conducted on rats and mice: unreported symptoms requiring antibiotics, tumor removal before dissection without mention in the reports, or the inability to examine certain organs that were too deteriorated8,9. In total, 52 major anomalies were found across just three of the fifteen toxicological studies provided by Searle10,11. Due to the seriousness of the findings, the FDA’s chief legal counsel initiated legal proceedings against Searle for “withholding data and false statements12,13. The FDA also commissioned an external scientific panel to assess aspartame’s safety. This was the first time the FDA had used this process, known as a Public Board of Inquiry, to resolve a health safety issue14. In 1980, after several months of investigation, the panel unanimously concluded against the reauthorization of aspartame15.

The election of Ronald Reagan as President of the United States in 1980, however, marked a turning point in the history of aspartame. Donald Rumsfeld, then CEO of Searle, was no stranger to Washington: he had already held senior positions in the administration, notably as U.S. Ambassador to NATO and White House Chief of Staff under President Gerald Ford9.

Ronald Reagan and Donald Rumsfeld, 1983
Ronald Reagan and Donald Rumsfeld, at the White House in 1983 (Photo by David Hume Kennerly/Getty Images)

After leaving politics to join Searle, he became actively involved in Reagan’s presidential campaign. After Reagan’s victory, Rumsfeld returned to government and joined the Interim Foreign Policy Advisory Committee. He then played a key role in nominating the new head of the FDA16. Arthur Hayes, a close associate of Rumsfeld with no experience in food additives, was thus appointed to lead the agency. Less than two months after taking office, in July 1981, Hayes reauthorized aspartame17—first for use in dry foods, then in beverages, before extending it to all food products in 1996. He stated: “I’m not prepared to say there is no risk from aspartame, but I thought it had been demonstrated that there was not a significant risk.”18

Advertisement for NutraSweet, 1980
Advertisement for NutraSweet, the first commercial brand under which Searle sold aspartame in the 1980s.

This decision goes against the conclusions of FDA toxicologists and independent experts from the Public Board of Inquiry19. Even more surprisingly, it also contradicted the stance of the main U.S. beverage lobby, the National Soft Drink Association. This organization had opposed the use of aspartame in sodas, arguing that the substance could degrade into toxic compounds during storage. In 1983, it stated: “Searle has not provided responsible certainty that aspartame and its degradation products are safe for use in soft drinks.”20

To legitimize the reauthorization of aspartame in the United States, two new studies were presented21,22. Both were conducted and funded by Ajinomoto, one of the world’s main… aspartame manufacturers! These studies, focused on cancer risks and other long-term toxic effects of aspartame, concluded there was no toxicity. However, like the previous studies conducted by Searle, Ajinomoto’s research fell far short of being unanimously accepted. First, they had never been submitted for peer review — a fundamental step to ensure a study’s scientific validity23. Moreover, their methodology did not meet the toxicological standards in place at the time24,25.

Furthermore, the 1981 cancer study conducted by Ajinomoto21 — which was used to justify reauthorization — was limited exclusively to brain tumors, thus ignoring the possibility that other organs might also be affected by a cancer risk. This approach had previously been deemed insufficient from a toxicological standpoint by the FDA’s internal scientists at the time26 to justify a market authorization.

Troubling ties between the FDA and aspartame manufacturers

Beyond relying on contested studies, the approval of aspartame also raises the issue of conflicts of interest. And for good reason: six senior FDA officials involved in the 1981 final approval of the sweetener later joined companies linked to the production… of aspartame!27

Another troubling fact: Samuel Skinner, the federal prosecutor in charge of leading the FDA’s legal action against Searle for irregularities in its studies, resigned on July 1st, 1977. Yet only a few months remained to act — until December 1977 — before the statute of limitations would make any action impossible. Shortly afterward, Skinner joined the law firm… that was defending Searle in the case! His replacement, William Conlon, arrived too late and didn’t have time to take over the case. Result: the charges were dropped, and Searle permanently escaped any sanctions. Strangely, Conlon ended up joining the same law firm defending Searle less than a year later12,28.

Another example of conflicts of interest: an investigation revealed that Arthur Hayes, appointed head of the FDA in 1981, accepted several perks offered by industry players29, including access to a private jet owned by General Food Corporation, a distributor of aspartame18. These revelations are said to have contributed to his resignation in 198330. Shortly after, he joined Burson-Marsteller, Searle’s public relations agency, as a senior scientific consultant13.

Europe: EFSA’s review also raises doubts

Despite the many controversies in the United States, the momentum was underway. Other countries began authorizing aspartame in everyday products, relying on the U.S. approval and without requiring additional studies: Canada in 198131, Australia in 198632, and then the European Union in 199433.

A widely criticized re-evaluation in 2013

In 2013, the European Food Safety Authority (EFSA) re-evaluated the safety of aspartame for its use in the European Union and concluded that there was no danger34,35. But this opinion was subsequently met with criticism. In 2019, Erik Millstone and Elizabeth Dawson, two researchers from the University of Sussex in the UK, published a study that questioned this assessment36. They raised concerns about how EFSA selected toxicological studies.

Indeed, they pointed out that each of the 73 studies showing harmful effects of aspartame on health had been excluded without solid justification. Conversely, 43 of the 62 studies that showed little or no impact from aspartame were included in the assessment — either partially or fully. Yet some of the excluded studies were considered by the two experts to be “more robust and more relevant” than those that were kept. Another issue: among the studies included, many were industry-funded, and some had even been described by former FDA toxicologists as “worthless,” “fraudulent,” or even a “disaster37.

In fact, relying on industry-funded studies can introduce bias into the results. That’s the conclusion of two systematic reviews published in 201638 and 201739: studies funded by the food industry were more likely to conclude that sweeteners had no adverse health effects (notably on weight gain) compared to studies conducted independently.

The Ramazzini studies: benchmark research nevertheless dismissed by EFSA
EFSA notably excluded several major studies40,41,42 from its re-evaluation, which addressed cancer risks and were conducted by the Ramazzini Institute, a research center internationally recognized in oncology43. EFSA justified its decision by arguing that the studies did not follow standard experimental protocols. Yet, these studies went beyond usual requirements: the study involved 1,400 rats (compared to 400 in standard protocols), tested six dose levels (instead of the usual three), and allowed the animals to live until their natural death to detect any late-onset carcinogenic effects — while standard protocols call for euthanizing rodents after about two years44.

EFSA’s main criticism focused on the unusual longevity of the rodents: according to the agency, lung infections observed in older animals made “the interpretation of results difficult.” EFSA thus suggested that tumors could have been caused by pulmonary infections rather than aspartame consumption34,45.

However, according to Ramazzini Institute researchers, these infections are part of the “ natural dying process in rodents46. Moreover, such infections were also found in the control group, which was not exposed to aspartame, thus ruling out their involvement in tumor development. The presence of a control group was intended precisely to eliminate this type of bias, ensuring rigorous comparison.

Morando Soffritti, 2006
Morando Soffritti, lead author of the Ramazzini Foundation studies on aspartame, 2006. (Photo by Pigi Cipelli/Archivio Pigi Cipelli/Mondadori via Getty Images)

The quality of Ramazzini Institute research on aspartame has since been recognized on several occasions. A paper published in 2008 by three American scientists — experts in experimental methods for assessing the carcinogenicity of substances — suggested that allowing animals to live longer helped “strengthen the value and validity of results for regulatory agencies47. As researcher Erik Millstone reiterated in an interview, “The Ramazzini studies were more thorough, sensitive, reliable and relevant to human exposure than those conducted in accordance with conventional protocols.

In 2021, the Ramazzini Institute published a new study confirming that the tumors observed in rodents in its early studies were indeed linked to aspartame consumption, and not to lung infections that naturally appear at the end of life48. In 2023, the main controversial study was reanalyzed by new researchers from the Ramazzini Institute, and the conclusions remained unchanged49.

Finally, the International Agency for Research on Cancer (IARC) — a global reference in cancer research — confirmed the robustness of the Ramazzini Institute’s methodology in 2024. It stated that allowing rats to live longer was one of the study’s main strengths. It also emphasized that the purity of the aspartame used had been correctly analyzed. Conversely, the IARC found the studies by Searle and Ajinomoto limited due to the lack of purity data and insufficient histopathological detail50.

By refusing to include Ramazzini’s data, EFSA dismissed some of the strongest available evidence regarding cancer risks, raising questions about its impartiality. The Ramazzini Institute later revealed in 2021 that it had been under intense pressure after publishing its findings on aspartame. The researchers behind these studies had their credibility attacked, and their work was mocked by the agri-food industry51,52,53, leading to a significant reduction in their funding54.

The Center for Science in the Public Interest (CSPI), a U.S. NGO recognized for its work on public health, also denounced these attacks against the Ramazzini Institute back in 201355. The organization reiterated that the institute’s research provides “unequivocal evidence that aspartame is carcinogenic in animals.

EFSA also suspected of conflict of interest

In their 2019 study36on EFSA’s re-evaluation of aspartame, researchers at the University of Sussex suggested that the agency may have been influenced by commercial conflicts of interest. According to them, this could explain why some otherwise robust studies were excluded from the 2013 EFSA review.

This hypothesis is consistent with findings from the NGO Foodwatch. In a report on aspartame published in 202556, the organization stated that, among the 62 studies deemed reliable by EFSA, 45 showed conflicts of interest: they were directly or indirectly linked to aspartame manufacturers, which could have influenced the agency’s assessment.

The analysis published by Réseau Environnement Santé in 201357 went even further, revealing that 6 of the 19 EFSA experts who participated in the re-evaluation of aspartame had close ties to industry — notably with Ajinomoto, the main global manufacturer of aspartame, and with Coca-Cola, whose “light” and “zero” products heavily rely on the sweetener. More concerning still, this analysis found that part of the EFSA’s 2013 report was essentially a copy-paste of a 2007 publication funded by Ajinomoto51. Of the 96 lines in the EFSA report relating to neurological risks linked to aspartame, 60 were identical or very close to the wording of the Ajinomoto-funded publication. In its report, Réseau Environnement Santé concluded that the 2013 EFSA re-evaluation shows serious shortcomings with respect to the core principles of scientific ethics.

Aspartame World Cumulative Consumption (1980 - 2020)
Source : CIRC, 2024

EFSA also appears to have attempted to downplay — or even hide — certain links between its members and industry. This was revealed by investigative journalist Marie-Monique Robin in her documentary Aspartame: Our Daily Poison58, broadcast in 2011 on Arte. It shows that the agency later altered an official conflict-of-interest declaration. The case involved Dominique Parent-Massin, a member of the EFSA working group tasked with evaluating aspartame. In her initial file, this EFSA expert stated that she had worked as a consultant for both Ajinomoto and Coca-Cola — two companies directly involved with  the sweetener. Yet these disclosures reportedly disappeared from her record after the journalist interviewed EFSA staff during her investigation. This change erased all traces of her direct ties with EFSA and two companies that had a major commercial interest in aspartame, raising fundamental concerns about transparency and independence.

These revelations are in line with those from the NGO Corporate Europe Observatory. In a 2011 report59, the organization explained that four members of the EFSA panel evaluating food additives had failed to disclose their current and past collaborations with the International Life Sciences Institute (ILSI Europe). Though officially presented as a non-profit scientific organization, ILSI has long defended the interests of the food industry60. It was founded by a former Coca-Cola vice-president, financed for decades by Coca-Cola (until 2021) and Mars (until 2018), and currently counts Pepsi and Ajinomoto among its members. The NGO’s report concludes that EFSA urgently needs to adopt stricter rules on conflicts of interest and undergo major reform to regain public trust.

Moreover, the European Parliament strongly questioned the independence of EFSA in a report published in 201461,62, calling for a real transparency and conflict-of-interest prevention policy. In response, the agency took several measures: in 201463 it introduced rules to prevent conflicts of interest among its members. In 201564, it revised its methodology for selecting studies to avoid arbitrarily excluding certain findings. Finally, in 201965, a European regulation was adopted to enhance EFSA’s transparency. However, despite these improvements, the 2013 opinion on aspartame has still not been updated.In light of all these revelations, several scientists are now calling for an independent re-evaluation of aspartame at the European level36,48,66,67,68.

Well-documented risks

Cancer: an increased risk from half a can per day

In 2023, the International Agency for Research on Cancer (IARC) classified aspartame as “possibly carcinogenic” (Group 2B)69. This decision was based on a comprehensive synthesis by IARC, which reviewed all studies published since 1974 on the carcinogenic potential of this sweetener. In a 471-page report70, IARC concluded that aspartame is possibly carcinogenic to humans.

In addition to animal studies, this classification also relies on human data — notably from the prestigious French cohort NutriNet-Santé, led by the French National Institute of Health and Medical Research (INSERM) in 202271. This large-scale study has been tracking the dietary habits of over 100,000 French adults for 13 years. It showed that regular consumption of aspartame was associated with a 15% increase in overall cancer risk, with an even higher risk for breast cancer, where the increase reached up to 22%. People who consumed aspartame regularly, equivalent to half a can of soda per day, were more likely to develop these cancers. This is the first study in the world to demonstrate such a precise and rigorously verified association between aspartame exposure and cancer risk. The IARC considers it “the most detailed” and “the most comprehensive study” on human exposure to this sweetener.

% of female rats with leukemia or lymphoma
Source : Landrigan et Straif, 2021

A previous epidemiological study conducted by Harvard University and published in 201272 followed more than 120,000 Americans over 22 years and also found a statistically significant association between the consumption of beverages sweetened with aspartame and a 31% increase in the risk of non-Hodgkin lymphoma, and a 102% increase in the risk of multiple myeloma.

According to some members of the IARC expert group, aspartame should even have been placed in the higher category as a “probable carcinogen” (Group 2A). In their view, the Ramazzini Institute provided sufficient evidence of carcinogenicity in animals70. The researchers at the Ramazzini Institute also disputed the way their data was handled by the IARC. According to them, the IARC underestimated their results. The researchers conclude that the IARC’s evaluation of aspartame “may have been guided by factors other than dispassionate scientific evaluation of the available data”, suggesting a possible conflict of interest within the IARC working group73.

Numerous studies on human and animal cells have identified several mechanisms that could explain tumor development. According to the IARC, the most likely cause is oxidative stress. When digested, aspartame breaks down into substances that can generate free radicals — unstable molecules that, in large quantities, can oxidize — that is, damage — cells. Over time, this cellular damage could impair proper function and increase cancer risk70.

Today, the suspicion of aspartame’s carcinogenicity is based on a body of evidence from three complementary approaches:

  • First, animal studies conducted by the Ramazzini Institute40,41,42, whose more demanding protocols compared to usual standards, produced results that have been widely recognized by the scientific community.
  • Second, epidemiological studies in humans, including one considered by IARC to be the most complete and rigorous on the subject71, have demonstrated a significant association between aspartame consumption and increased cancer risk.
  • Third, mechanistic research has identified a coherent mode of action explaining how tumors develop70.

The convergence of these findings, coming from various disciplines and methods, forms a body of evidence robust enough for IARC to classify aspartame as “possibly carcinogenic to humans“.

Not surprisingly, the few studies that concluded aspartame poses no cancer risk are often funded by industry. Moreover, they frequently exhibit major limitations. Some are based on outdated methodologies, like those used by Searle and Ajinomoto in the 1980s21,22. Others use genetically modified mice, a model the IARC considers inadequate, since such animals may be insensitive to aspartame70. Finally, some studies focus on just one specific type of cancer, or use observation periods that are too short to detect long-term effects. As a result, the scientific quality of these studies is far inferior to those conducted independently and rigorously.

A sweetener that could promote diabetes

Like other artificial sweeteners, aspartame has for several years been suspected of contributing, in the long term, to the development of type 2 diabetes.

This chronic disease involves a progressive dysfunction of the body’s ability to regulate glucose (blood sugar) levels. It is the most common form of diabetes, affecting over 460 million people worldwide, around 6% of the global population. It typically develops in adulthood, influenced by lifestyle factors. The main known risk factors today are: sedentary lifestyle, unbalanced diet, and smoking74. However, in recent years, scientists have begun to suspect that certain sweeteners — especially aspartame — may contribute to the development of this disease.

Since 2008, twelve cohort studies recognized as robust by the WHO75 have shown that regular consumption of artificially sweetened beverages could increase the risk of developing type 2 diabetes. For instance, a French study published in 201376,involving 66,000 women, revealed that regular consumers of artificially sweetened drinks had up to twice the risk of developing type 2 diabetes compared to those who didn’t consume them. Surprisingly, in some cases, the risk was comparable to that observed among people who regularly consume sugary drinks, already known to promote diabetes. Comparable findings were observed in human studies published in 200977 and 201478, as well as in animal studies in 201779.

Three main mechanisms are currently considered to explain these findings:

  • Sweeteners may maintain or reinforce cravings for sweet taste, encouraging higher consumption of sugary products80.
  • Sweeteners, especially aspartame, may trigger physiological responses similar to those caused by sugar, by activating sweet taste receptors not only in the mouth but also in the gut and pancreas. A 2010 American study81 showed that aspartame consumption led to an increase in insulin levels comparable to that caused by sugar consumption 30 minutes after a meal.
  • Lastly, sweeteners could disrupt the gut microbiota, leading to chronic low-grade inflammation, which promotes insulin resistance and increases the risk of type 2 diabetes82.

In 2023, a study from the French NutriNet-Santé cohort83 — praised for its methodological rigor — produced even more precise results. It revealed that regular consumption of even a small amount of aspartame could increase the risk of developing type 2 diabetes by 48% to 63%. The authors concluded that these sweeteners cannot be considered safe sugar substitutes, even when used in low doses.

Many other studies have also shown an association between sweetener consumption and diabetes84. A study published in 2022 even stated that sweeteners, especially aspartame, “may even contribute to the diabetes pandemic in some contexts82.

Increased risk of cardiovascular disease

Aspartame is also suspected of increasing the risk of cardiovascular disease. These conditions — including heart attacks, strokes, venous thrombosis, and pulmonary embolisms — affect the heart and blood vessels, and are the leading cause of death worldwide85.

In April 2022, the World Health Organization (WHO) published a report on the effects of sweeteners75, based on 280 human studies. Of these, 56 focused specifically on cardiovascular disease. The synthesis revealed that regular sweetener consumers had a 32% higher risk of developing cardiovascular disease, and a 19% higher risk of stroke. Moreover, still according to WHO, regular sweetener consumption promotes hypertension and cholesterol imbalance, two key factors in the development of cardiovascular complications.

These results align with those of the French NutriNet-Santé study, published in September 202286, which specifically investigated the impact of aspartame on cardiovascular health. It revealed that regular consumers had a 17% higher risk of stroke, an estimate close to what was cited by the WHO..

In response to these alarming findings, the WHO issued a new guideline in 2023, stating clearly: “Do not consume sweeteners for the purpose of reducing the occurrence of chronic diseases, particularly cardiovascular disease.87

A 2025 study88, using a recent protocol for analyzing chemical interactions, provides further insight into these observations. It suggests that aspartame may interact with several proteins and receptors in the brain, causing multiple interferences that promote hypertension and stroke risk. The researchers even suggested potential incompatibilities between daily aspartame consumption and the use of certain medications meant to lower blood pressure.

A harmful impact on the microbiota

The intestinal microbiota refers to the billions of micro-organisms that inhabit our intestines and play a crucial role in our health89. When disrupted, it may contribute to the development of numerous chronic diseases90,91,92,93 (see our article on the microbiota).

In 2014, a study published in the prestigious journal Nature was the first to reveal a negative effect of sweeteners on the microbiota of healthy individuals94. The researchers observed a decrease in microbial diversity. This phenomenon may contribute, over time, to metabolic disorders such as insulin resistance, glucose intolerance, and the chronic conditions already discussed: cancer, type 2 diabetes, and cardiovascular diseases.

In 2014, another study focused specifically on aspartame95. It showed that even at typical doses — equivalent to two cans of soda per day — aspartame can durably alter the balance of the intestinal microbiota.

Other research published in 202096 highlighted an aggravating factor: aspartame may damage the intestinal epithelium, the thin barrier of cells that protects us from pathogens. Its deterioration promotes chronic gut inflammation and weakens the immune system, increasing the risk of developing chronic diseases.

Further research is needed to better understand the link between sweeteners, microbiota, and chronic diseases. However, this hypothesis is now widely considered plausible by the scientific community97,98,99. In its 2022 report75, the WHO also noted that certain chronic conditions could be linked to microbiota imbalances caused by sweetener consumption.

A suspicion of neurotoxicity

The first warnings about the possible neurological toxicity of aspartame date back to the 1970s. At the time, neuroscientist John Olney observed that even at relatively low doses, the sweetener could destroy neurons in rodent brains still under development100,101. Since then, these concerns have resurfaced several times, fueled by new studies.

In 2008, researchers showed that aspartame breaks down in the body into three substances102: phenylalanine, aspartic acid, and methanol. All are known to interact with the nervous system. They can disrupt neurotransmitters like dopamine and serotonin, and may cause headaches, memory or sleep disorders, mood swings, stress, or depression4,103. Finally, they can generate oxidative stress in the brain, damaging neurons and promoting their degenerationn104.

Two studies from 2023105 and 2024106 showed that these effects occurred in mice at very low aspartame doses, comparable to daily human intake. These effects appeared in just four weeks and — more concerning — were passed on to the offspring, suggesting that aspartame’s effects on the brain could be transmitted across generations.

The WHO states that in humans, results remain mixed: some studies show a link between aspartame and cognitive disorders — including an increased risk of Alzheimer’s disease — while others find no association75. Further in-depth research is needed to determine whether the effects seen in animals also occur in humans.

An outdated and insufficient ADI

The ADI (Acceptable Daily Intake) refers to the maximum quantity of a substance that a person can consume every day over a lifetime without health risk. It is calculated based on body weight, and is expressed in milligrams (mg) of substance per kilogram (kg) of body weight107.

This limit is set by risk assessment agencies, such as EFSA in the EU or the FDA in the United States. To do so, they identify the lowest dose that causes harm in animal studies, then apply a safety factor (usually a factor of 100) to determine a supposed safe value for humans. While useful, this method nevertheless has certain limitations.

A threshold set by manufacturers in the 1970s

The current ADI (Acceptable Daily Intake) for aspartame is based on old and controversial studies. In 1980, the JECFA (the committee in charge of setting global ADIs) established this limit at 40 mg/kg of body weight per day108. This decision was largely influenced by the FDA, whose scientists also sat on JECFA109. Moreover, at the time, the FDA was the only agency in possession of all available toxicological data, but it did not allow JECFA to fully consider the fraud and methodological flaws of the studies in question. In fact, these issues are not mentioned in JECFA’s official reports.

To define this ADI, JECFA relied on studies funded by Ajinomoto and Searle. The key study used to set the ADI was conducted in 1981 on rats by Ajinomoto22 — a highly controversial study, whose methodology was already questioned by many scientists at the time12,110.

In 1983, the FDA adopted an even more lenient ADI of 50 mg/kg/day, without basing this decision on any new studies111.

In Europe, the EFSA also set the ADI at 40 mg/kg/day in 1984, when aspartame was approved for market use112. EFSA relied heavily on the FDA and JECFA’s assessments, without requesting additional studies58. In its report, EFSA admitted to having reviewed a very large amount of toxicological data without specifying which studies or results were considered. Later, during a hearing at the European Parliament in 2011, EFSA admitted that the scientific committee at the time had, in fact, never had access to the original studies from Searle and Ajinomoto, and had authorized aspartame throughout the European Union with its eyes closed112.

A status quo upheld in 2013 without justification

In 201334, EFSA reassessed aspartame and maintained the ADI value set in 1984: 40 mg/kg of body weight per day113. According to WHO estimates, this corresponds to a daily consumption of 9 to 14 cans of soda114,115 — an amount that may seem extreme, and thus falsely reassuring for the average soda drinker.

However, as previously mentioned, this re-evaluation has been widely criticized and raised a major issue: the biased selection of studies. EFSA tended to favor the studies most reassuring about aspartame, and to dismiss those that indicated risks — including ones with a methodology considered more robust than that of the studies it retained36,57.

The agency states that it relies on the highly controversial 1981 study funded by Ajinomoto, the manufacturer of aspartame22. Its report never mentions the major methodological flaws of the study. One of the main limitations of this study is regarding the absence of data on the purity of aspartame: today, nothing makes it possible to state with certainty that the substance administered to the rats in the study was indeed pure aspartame70. To dismiss  this concern, EFSA simply states that in all long-term studies, “the purity of the aspartame used is considered to be 100%34.

Food group contribution to sweetener intake
Source : Debras et al, 2022

The credibility of the 2013 re-evaluation was also weakened by revelations about conflicts of interest involving some EFSA experts and the aspartame industry57,59,62. These concerns led to the adoption of a European law in 2019 aimed at strengthening transparency and scientific integrity within EFSA65,166. This was a step forward, though it never led to reopening the aspartame file or re-evaluating its ADI.

In 2023, JECFA in turn chose to maintain aspartame’s ADI unchanged114,117. Once again, this conclusion was largely based on the 1981 study funded by Ajinomoto118.

However, many stakeholders — including the European NGO Foodwatch119 and the American NGO U.S. Right to Know120 — pointed out similar problems at JECFA: biased selection of studies, the involvement of six committee members also working with ILSI, and major transparency issues regarding conflicts of interest118.

Major risks excluded from evaluation criteria

In addition to relying on old and controversial studies, the ADI for aspartame set in Europe is based on research that does not cover all the potential toxic effects of this substance.

To establish an ADI, health authorities rely exclusively on studies conducted on animals (rats, mice, or rabbits) exposed for two years to a substance whose composition and purity are assumed to be fully known. The only effects considered are those visible during biological assessments, such as: weight changes, anomalies in organ development or function, impacts on reproduction or fertility, effects on offspring, tumor formation, or other abnormalities.

However, these animal models do not always allow for the identification of all harmful effects in humans. Some impacts — on behavior, memory, appetite, or even so-called “cocktail effects” linked to simultaneous exposure to other common substances (drugs, additives, pesticides, etc.) — are difficult, if not impossible, to detect using this approach. This limitation likely leads to underestimating certain risks, such as the possible neurotoxicity of aspartame or the progressive development of insulin resistance. The WHO also pointed out, in the introduction of its 2022 report, that “the long-term health effects of consuming sweeteners at levels below the ADI are not well characterized.

Moreover, human data is not considered when setting ADIs121. In fact, these thresholds are typically determined at the time a new substance receives market authorization. While clinical trials on humans are mandatory for medications, this is not the case for food additives. From an ethical standpoint, it would be hard to justify exposing a group of volunteers to a new molecule solely to validate its commercial approval, especially when a food additive does not offer the same therapeutic benefit as a drug. Human data is therefore analyzed only afterwards, mainly through epidemiological studies. These aim to determine, once the additive is already consumed, whether regular consumers show a higher frequency of certain illnesses than the general population. Several scientists have gone so far as to call the ADI a “makeshift procedure that relies as much on science as on assumptions122 and have called for “a more rigorous approach based on human data123.

Several epidemiological studies – conducted in humans – have highlighted harmful effects of aspartame at doses that are nonetheless authorized, commonly consumed, and well below the ADI. These studies, for example, show an increased risk of cancers124, cardiovascular diseases125, and type 2 diabetes126, at doses nearly 200 times lower than the ADI, i.e. the equivalent of half a can of soda per day. A higher risk of obesity127, as well as higher birth weight in newborns128, has also been observed in people who consume just one “sugar-free” soda per day. However, these studies are not included in the calculation of the ADI, as they do not allow for determining a no-risk dose, unlike animal studies.

Moreover, during EFSA’s 2013 re-evaluation34, animal studies on emerging risks — such as effects on the gut microbiota — were not taken into account. Yet these risks are now considered concerning, given the potentially serious consequences that a microbiota disruption linked to aspartame could cause129.

The current ADI threshold is therefore incomplete and does not fully protect public health, making the lack of revision of the ADI all the more concerning.

A sweetener with no benefit for weight control

Since its authorization, aspartame has been promoted as an alternative to sugar that helps reduce caloric intake and improve weight management. This argument may seem logical on paper.

However, an increasing number of studies are challenging this claim. In 2015, ANSES (the French Agency for Food, Environmental and Occupational Health & Safety) published a report based on 383 scientific publications130. It concluded that sweeteners, including aspartame, have shown no beneficial effect on weight loss or glycemic control. These findings also apply to people in good health as well as those with diabetes.

The conclusions of ANSES echo those of the WHO report published in 202275. In fact, short-term studies (less than 12 months) suggest a small effect on weight or waist circumference in individuals trying to lose weight131. However, over the longer term, cohort studies conducted over 4 to 9 years show the opposite trend: higher sweetener consumption is associated with a 2.6 cm increase in waist circumference132. The WHO even reports that regular sweetener consumption is associated with a 76% increase in the risk of obesity, as well as a significant rise in body mass index (BMI). In conclusion, the WHO explicitly recommends “not to use sweeteners for weight loss purposes.” In children, ANSES also notes that most long-term follow-up studies paradoxically show a link between regular sweetener consumption and weight gain133.

Even more concerning: a Canadian study from 2020128, conducted on more than 2,200 pregnant women, shows that babies exposed to aspartame in utero have a significantly higher birth weight compared to those not exposed. These babies are also at higher risk of metabolic complications, such as insulin resistance or fat accumulation in tissues — factors that increase their susceptibility to later weight gain and promote the development of obesity in childhood or adulthood.The exact mechanism behind this effect is still poorly understood. Several hypotheses have been proposed: inappropriate activation of sweet taste receptors, impaired glucose tolerance134, the progressive development of insulin resistance, or disruption of the gut microbiota135.

Conclusion

The precautionary principle lies at the heart of the European regulatory system, where it has been enshrined in law since 2002136. However, the history of aspartame shows how this principle can be weakened when risk assessment is drowned under the influence of industrial lobbies.

The question is no longer simply whether aspartame poses a health risk, but whether our authorities are still capable of effectively protecting consumers.

Faced with this situation, it is essential  that a clear message be heard: economic interests must not dictate decisions affecting public health. This is the message of the European petition supported by Yuka, Foodwatch and the Ligue Contre le Cancer, which calls on the European Commission to ban aspartame. Health should never be a bargaining chip for economic interests.

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Call for a Ban on Aspartame!

Given the unacceptable risks of this sweetener, it is time to act! Yuka, the League Against Cancer, and Foodwatch are joining forces to call for a European ban on this additive in our food and drink.

Sign the Petition

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