Aspartame

Aspartame and Cancer Risk

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Aspartame — the ubiquitous artificial sweetener sold under the brand names NutraSweet, Equal, and Sugar Twin — has sparked controversy for decades, but in 2023 a leading health watchdog for the first time ­officially labeled it as a possible carcinogen.

The International Agency for Research on Cancer (IARC), a body of the World Health Organization (WHO), ruled that the faux sugar may cause liver cancer in humans.

The IARC based its conclusion on observational studies connecting the consumption of artificially sweetened drinks to an increase in cases of the cancer.

Other organizations rushed to refute this finding, however. “Our results do not indicate that occasional consumption should pose a risk to most,” Francesco Branca, MD, director of the WHO Department of Nutrition and Food Safety, said at a press conference. Still, he added, people who consume large amounts of aspartame should consider switching to water or other unsweetened drinks.

The U.S. Food and Drug ­Administration (FDA) and the American Beverage Association (ABA) ­continue to maintain that aspartame is safe to consume. The ABA cited the Department of Nutrition and Food Safety announcement, which ­described the evidence for aspartame causing cancer in humans as “not convincing.”

The FDA, which approved aspartame in 1974, stated it “disagrees with IARC’s conclusion that these studies support classifying aspartame as a possible carcinogen to humans.”

The agency has previously set the acceptable daily intake of aspartame at 50 mg per kilogram of a person’s body weight. So, for a 150-pound person, approximately 3,400 mg a day is deemed safe. A 12-ounce can of diet soda contains around 200 mg of aspartame.

Carcinogenicity of aspartame, methyleugenol, and isoeugenol

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In June, 2023, a Working Group of 25 scientists from 12 countries met at the International Agency for Research on Cancer (IARC) in Lyon, France, to finalise their evaluation of the carcinogenicity of aspartame, methyleugenol, and isoeugenol. Aspartame was classified as “possibly carcinogenic to humans” (Group 2B) based on “limited” evidence for cancer in humans. There was also “limited” evidence for cancer in experimental animals and “limited” mechanistic evidence. Methyleugenol was classified as “probably carcinogenic to humans” (Group 2A) based on “sufficient” evidence for cancer in experimental animals and “strong” mechanistic evidence, including studies in humanised mice and supported by mechanistic studies in exposed humans. Isoeugenol was classified as “possibly carcinogenic to humans” (Group 2B) based on “sufficient” evidence for cancer in experimental animals. For both methyleugenol and isoeugenol, the evidence regarding cancer in humans was “inadequate”, as no epidemiological studies were available. These assessments will be published in Volume 134 of the IARC Monographs.

Immediately following IARC’s meeting on cancer hazard identification, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) conducted a risk assessment exercise, including a review of the acceptable daily intake of aspartame. A summary of these results has been published.

Aspartame is a low-calorie artificial sweetener widely used in foods and beverages since the 1980s. The highest concentrations are found in tabletop sweeteners, chewing gums, and food supplements; historically, artificially sweetened beverages have been the major source of aspartame exposure (>90% of total exposure in some populations). Currently, artificially sweetened beverages remain an important source of aspartame exposure, but aspartame is typically used in mixtures with other sweeteners. Other sources of aspartame exposure include cosmetics and medicines. Occupational exposure by inhalation during the production of aspartame-containing products has been reported, but data are sparse. Available information indicates that the metabolism of aspartame is similar in humans and experimental systems; aspartame is hydrolysed to aspartic acid, to the essential amino acid phenylalanine, and to methanol. In experimental systems (primates), aspartic acid and methanol are predominantly excreted as CO2; however, most of the phenylalanine is retained.

For cancer in humans, there was “limited” evidence that aspartame causes hepatocellular carcinoma. Prospective cohort studies assessing consumption of artificially sweetened beverages in time periods and countries in which artificially sweetened beverages predominantly contained aspartame and were the main source of aspartame exposure were considered informative for the evaluation, because artificially sweetened beverage consumption was judged to be a reliable proxy for aspartame exposure. The NutriNet-Santé study is the only large prospective cohort study that comprehensively assessed aspartame exposure from all dietary sources.

Although this study reported an association of aspartame with increased breast, obesity-related, and overall cancer risk, such findings were not consistent across all available studies. The NutriNet-Santé study did not investigate the association of aspartame with liver cancer risk. The Working Group identified three studies, comprising four prospective cohorts, that assessed the association of artificially sweetened beverage consumption with liver cancer risk. These included a large cohort study, conducted within ten European countries, that assessed the association of artificially sweetened beverages with incidence of hepatocellular carcinoma;

a second study, pooling data from two large US cohorts, that investigated the association between artificially sweetened beverage consumption and liver cancer incidence by diabetes status;

and another large US prospective cohort study that evaluated the association between artificially sweetened beverages and liver cancer mortality.

Among all three studies, positive associations between artificially sweetened beverage consumption and cancer incidence or cancer mortality were reported in the overall study population

All three studies were of high quality and controlled for many potential confounders. However, the Working Group concluded that chance, bias, or confounding could not be ruled out with reasonable confidence in this set of studies. Thus, the evidence for cancer in humans was deemed “limited” for hepatocellular carcinoma and “inadequate” for other cancer types.

The Working Group evaluated several carcinogenicity studies in multiple species (mouse, rat, dog, and hamster), including regulatory study reports made publicly available by the European Food Safety Authority, which reported negative findings after oral exposure to aspartame. It was noted that several of the negative studies were conducted before the advent of Good Laboratory Practice (GLP) guidelines and had some limitations—eg, lack of information on the test substance purity and selective histopathology. No significant increase in the incidence of tumours was observed in three well-conducted GLP studies in male and female transgenic mice.

The Working Group noted that these new transgenic mouse models may not have been sufficiently sensitive to detect a carcinogenic effect of chronic aspartame exposure. In Swiss mice and Sprague-Dawley rats exposed perinatally followed by postnatal oral administration (feed), aspartame caused hepatocellular carcinoma, hepatocellular adenoma or hepatocellular carcinoma (combined), bronchioloalveolar carcinoma, bronchioloalveolar adenoma or carcinoma (combined), lymphoblastic leukaemia, monocytic leukaemia, and total myeloid tumours in male mice; lymphoblastic leukaemia and leukaemia (all types) in female mice; malignant schwannoma in male rats; and mammary gland carcinoma, renal pelvis papilloma, and leukaemia (all types) in female rats.

In Sprague-Dawley rats exposed by oral administration (feed), aspartame caused renal pelvis and ureter carcinoma, renal pelvis and ureter papilloma or carcinoma (combined), and mammary gland carcinoma in females; and monocytic leukaemia, histiocytic sarcoma, and total myeloid tumours in males.

Because of concerns regarding some of the diagnoses for lymphomas and related combinations and other lymphoid proliferations in these studies, the Working Group focused its evaluation on all the other neoplastic lesions. Although the data from the above studies

suggested that aspartame had carcinogenic activity, overall, the Working Group considered the evidence for cancer in experimental animals to be “limited” because of questions about adequacy of the design, conduct, interpretation, and reporting of each of the studies. For example, the lack of adjustment for litter effect

may have led to false positive results for incidence and trend. A minority of the Working Group did not share these concerns about this set of studies and considered the evidence for cancer in experimental animals to be “sufficient”; thus, they supported a Group 2A classification rather than Group 2B classification for aspartame.

Regarding the key characteristics of carcinogens, in experimental systems, aspartame induced oxidative stress, shown by the alteration of oxidative stress biomarkers, including lipid peroxidation, in several tissues, including the liver, in multiple rodent studies. In different experimental systems, several studies suggested that aspartame induced chronic inflammation, and a small set of studies suggested that angiogenesis was increased. Although there were some positive findings regarding genotoxicity in several studies, many had limitations in design, data analysis, and interpretation. Based on the above findings, the mechanistic evidence for aspartame was “limited” for the key characteristics of carcinogens. Additionally, relevant studies in rodents showed that exposure to aspartame increased insulin serum levels.

Although these findings indicate alterations in insulin sensitivity, the Working Group considered the relevance of the findings to mechanisms of carcinogenesis to be a notable research gap.

Methyleugenol is a flavour and fragrance compound occurring naturally in essential oils of various plants. It is used in cosmetics and personal care products and as an insect attractant. Its use as a flavouring agent has been prohibited in the EU and the USA, but it is still present in various foods and consumer products due to its natural occurrence in herbs and spices. No data on occupational exposure were available. The general population is ubiquitously exposed, mostly to low levels, through the ingestion of food or dermally through personal care products. Although data were scarce, in humans, methyleugenol appears to be absorbed after oral exposure and to permeate the derma. In rodents, methyleugenol forms active metabolites in the liver (eg, 1′-hydroxymethyleugenol) and is excreted in the urine as sulfate or glucuronide conjugates after oral exposure.

The “sufficient” evidence for cancer in experimental animals for methyleugenol was based on an increase in the incidence of malignant neoplasms and a combination of benign and malignant neoplasms in two species in two studies that complied with GLP. In B6C3F1 mice and F344 rats exposed by oral administration (gavage), methyleugenol caused hepatocellular adenoma, hepatocellular carcinoma, and hepatocellular adenoma or carcinoma (combined), in male and female mice and rats; hepatoblastoma in male and female mice; hepatocholangioma, hepatocholangiocarcinoma, and benign and malignant neuroendocrine tumours of the glandular stomach in male and female rats; and renal tubule adenoma, mammary gland fibroadenoma, skin fibroma, skin fibroma or fibrosarcoma (combined), and mesothelioma in male rats.

Methyleugenol exhibits multiple key characteristics of carcinogens in experimental systems including humanised mice, supported by human studies. Pro-mutagenic methyleugenol DNA adducts were detected in human liver and lung samples, in the livers of mice transgenic for human sulfotransferase (SULT1A1/2), and in other experimental systems. Methyleugenol RNA and protein adducts were found in rodents. Methyleugenol and 1′-hydroxymethyleugenol caused DNA strand breaks, but not micronuclei, in human cells in vitro and in experimental systems. Methyleugenol induced unscheduled DNA synthesis, sister-chromatid exchange, and gene mutagenicity in rodents. It was mutagenic in bacteria strains expressing human SULT isoforms. There is suggestive evidence that methyleugenol induces cell proliferation, alters related biomarkers and hyperplasia in the liver and other tissues in rodents, and induces chronic inflammation in experimental systems in a small set of data. Based on the above findings, the Working Group considered that there is “strong” mechanistic evidence for methyleugenol.

Isoeugenol is a fragrance and flavour compound that occurs in many plant species and in wood smoke. It is used in food, cosmetics, household products, animal feed, and veterinary medicines. Workers involved in isoeugenol synthesis or handling isoeugenol-containing products and firefighters may be exposed by dermal and inhalation routes. Exposure of the general population occurs through the diet and use of household products and cosmetics. Evidence on absorption, distribution, metabolism, and excretion of isoeugenol in humans is sparse and limited to dermal exposure. In rodents, after oral and dermal exposure, isoeugenol is rapidly absorbed and excreted predominantly in the urine as glucuronide or sulfate conjugates, with little retention in tissues.

In B6C3F1 mice and F344 rats exposed by oral administration (gavage), isoeugenol caused hepatocellular adenoma, hepatocellular carcinoma, and hepatocellular adenoma or carcinoma (combined) in male mice; a significant increasing trend in histiocytic sarcoma (multiple sites) in female mice; and a significant increasing trend in mammary gland carcinoma and benign or malignant thymoma in male rats.

Significant increasing trends were observed with dose in the male rats and the female mice, leading the Working Group overall to conclude that the evidence for cancer in experimental animals was “sufficient” when considered alongside the findings in male mice. However, a minority of the Working Group considered the evidence to be “limited” and supported a Group 3 classification for isoeugenol because the pairwise comparison with the controls for male rats and female mice did not reach statistical significance in any of the treated groups.

Isoeugenol is a skin sensitiser that can be converted photochemically to electrophiles that form protein adducts. However, isoeugenol–DNA adducts were not detected in experimental systems. Overall, the mechanistic evidence for isoeugenol was “inadequate”.

Aspartame hazard and risk assessment results released

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Assessments of the health impacts of the non-sugar sweetener aspartame are released today by the International Agency for Research on Cancer (IARC) and the World Health Organization (WHO) and the Food and Agriculture Organization (FAO) Joint Expert Committee on Food Additives (JECFA). Citing “limited evidence” for carcinogenicity in humans, IARC classified aspartame as possibly carcinogenic to humans (IARC Group 2B) and JECFA reaffirmed the acceptable daily intake of 40 mg/kg body weight.

Aspartame is an artificial (chemical) sweetener widely used in various food and beverage products since the 1980s, including diet drinks, chewing gum, gelatin, ice cream, dairy products such as yogurt, breakfast cereal, toothpaste and medications such as cough drops and chewable vitamins.

“Cancer is one of the leading causes of death globally. Every year, 1 in 6 people die from cancer. Science is continuously expanding to assess the possible initiating or facilitating factors of cancer, in the hope of reducing these numbers and the human toll,” said Dr Francesco Branca, Director of the Department of Nutrition and Food Safety, WHO. “The assessments of aspartame have indicated that, while safety is not a major concern at the doses which are commonly used, potential effects have been described that need to be investigated by more and better studies.”

The two bodies conducted independent but complementary reviews to assess the potential carcinogenic hazard and other health risks associated with aspartame consumption. This was the first time that IARC has evaluated aspartame and the third time for JECFA.

After reviewing the available scientific literature, both evaluations noted limitations in the available evidence for cancer (and other health effects).

IARC classified aspartame as possibly carcinogenic to humans (Group 2B) on the basis of limited evidence for cancer in humans (specifically, for hepatocellular carcinoma, which is a type of liver cancer). There was also limited evidence for cancer in experimental animals and limited evidence related to the possible mechanisms for causing cancer.

JECFA concluded that the data evaluated indicated no sufficient reason to change the previously established acceptable daily intake (ADI) of 0–40 mg/kg body weight for aspartame. The committee therefore reaffirmed that it is safe for a person to consume within this limit per day. For example, with a can of diet soft drink containing 200 or 300 mg of aspartame, an adult weighing 70kg would need to consume more than 9–14 cans per day to exceed the acceptable daily intake, assuming no other intake from other food sources.

IARC’s hazard identifications are the first fundamental step to understand the carcinogenicity of an agent by identifying its specific properties and its potential to cause harm, i.e. cancer. IARC classifications reflect the strength of scientific evidence as to whether an agent can cause cancer in humans, but they do not reflect the risk of developing cancer at a given exposure level. The IARC hazard evaluation considers all types of exposures (e.g. dietary, occupational). The strength-of-evidence classification in Group 2B is the third highest level out of 4 levels, and it is generally used either when there is limited, but not convincing, evidence for cancer in humans or convincing evidence for cancer in experimental animals, but not both.

“The findings of limited evidence of carcinogenicity in humans and animals, and of limited mechanistic evidence on how carcinogenicity may occur, underscore the need for more research to refine our understanding on whether consumption of aspartame poses a carcinogenic hazard,” said Dr Mary Schubauer-Berigan of the IARC Monographs programme.

JECFA’s risk assessments determine the probability of a specific type of harm, i.e. cancer, to occur under certain conditions and levels of exposure. It is not unusual for JECFA to factor IARC classifications into its deliberations.

“JECFA also considered the evidence on cancer risk, in animal and human studies, and concluded that the evidence of an association between aspartame consumption and cancer in humans is not convincing,” said Dr Moez Sanaa, WHO’s Head of the Standards and Scientific Advice on Food and Nutrition Unit. “We need better studies with longer follow-up and repeated dietary questionnaires in existing cohorts. We need randomized controlled trials, including studies of mechanistic pathways relevant to insulin regulation, metabolic syndrome and diabetes, particularly as related to carcinogenicity.”

The IARC and JECFA evaluations of the impact of aspartame were based on scientific data collected from a range of sources, including peer-reviewed papers, governmental reports and studies conducted for regulatory purposes. The studies have been reviewed by independent experts, and both committees have taken steps to ensure the independence and reliability of their evaluations.

IARC and WHO will continue to monitor new evidence and encourage independent research groups to develop further studies on the potential association between aspartame exposure and consumer health effects.

Unpacking WHO guidelines on non-sugar sweeteners.

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The World Health Organization (WHO) released a new guideline on non-sugar sweeteners (NSS)—often referred to as artificial or low-calorie sweeteners—that advises against use of NSS to control body weight or reduce the risk of noncommunicable diseases. After conducting a research review, they concluded that replacing sugar sweeteners with NSS did not promote weight loss in the long term in adults and children. However, clinical trial data showed that higher intakes of NSS resulted in lower calorie intake when they replaced sugar and sugar-sweetened foods/beverages. There was no significant effect of NSS on hunger or satiety levels. Some trials showed less hunger with use of NSS, but others showed a stronger appetite in participants with higher intakes of NSS-containing beverages.

When looking at observational cohort studies, long-term use of NSS-containing beverages was associated with an increased risk of cardiovascular disease and early death in adults. A higher intake of NSS, either in beverages or added to foods, was also associated with increased risk of developing type 2 diabetes. The WHO noted that “reverse causation” may have contributed to the positive association: participants with the highest intakes of NSS tended to have a higher body mass index and obesity or metabolic risk factors, and therefore may have already been predisposed to chronic disease (for which they were choosing NSS as a health measure). No association was found with intakes of NSS-containing beverages and cancer or cancer deaths.

Based on these findings, WHO advised that people work to lower the overall sweetness in the diet starting early in life, as NSS do not provide nutritional value. Examples of NSS include acesulfame K, aspartame, saccharin, sucralose, and stevia. Their analysis did not study sugar alcohols (polyols) such as maltitol, xylitol, and sorbitol that are added to many foods and beverages.

Harvard Chan School experts agreed with the WHO recommendation to tame our sweet tooths, but had some criticisms that the meta-analysis excluded certain large studies. [1-3] The omitted cohort studies—which included more than 100,000 people—found that increasing consumption of artificially sweetened beverages at the expense of sugar-sweetened beverages was associated with less weight gain over time, consistent with findings from small, short-term randomized controlled trials. Based on statistical modeling, it was estimated that replacing one serving of sugar-sweetened beverage with an artificially sweetened beverage was associated with a 4% lower risk of total mortality, 5% lower risk of cardiovascular disease-related mortality, and 4% lower risk of cancer-related mortality.

Of course, when it comes to optimal beverages for long-term health, we should look to other options. Frank Hu, Chair of the Department of Nutrition at the Harvard T.H. Chan School of Public Health, explains that “for habitual consumers of sugar-sweetened beverages, artificially sweetened beverages can be used as a temporary replacement, although the best choices would be water and unsweetened coffee or tea.”

Related

Spotlight on aspartame

The International Agency for Research on Cancer, the World Health Organization, and the Joint Expert Committee on Food Additives recently released a risk assessment of and cancer.

It classified aspartame as a Group 2B carcinogen having “limited evidence” for cancer in humans, specifically liver cancer. Their prior recommendation of an acceptable daily intake of aspartame of 40 mg/kg of body weight did not change, as they acknowledged that their research review did not provide differing evidence to alter this guideline, and affirmed that an intake within this range is safe. For a 150-pound (68 kg) woman, this would mean a limit of 2,727 mg of aspartame daily, equivalent to about eleven 12-ounce cans of diet soda (one can contains about 250 mg). They stated that the evidence on cancer risk in humans based on animal and human studies was not convincing, and that more research, specifically longer-term studies with follow-up and randomized controlled trials, were needed.

The WHO Is About to Declare Aspartame a Possible Carcinogen

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That’s a huge decision.

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Aspartame, one of the most widely used artificial sweeteners in the world, will be declared as a possible carcinogen by the cancer research arm of the World Health Organization (WHO), Reuters reports.

The upcoming July ruling from the WHO group, the International Agency on Cancer Research (IARC), will list aspartame as “possibly carcinogenic to humans.” According to the report, the assessment considers all published evidence, but does not account for the amount a person can safely consume.

It’s ample cause for alarm. The sugar substitute has long been a staple of low or zero calorie drinks like Diet Coke, and is also used in thousands of other products including ice cream, chewing gum, and cereal.

But it’s worth noting that the classification of “possibly carcinogenic” only denotes that there is some evidence that a substance can cause cancer, and that the findings are overall considered inconclusive. There are still two categories above this: “probably carcinogenic,” indicating strong evidence, and simply “carcinogenic,” meaning there is consensus on a proven link.

Those are important distinctions. But no matter the technicalities involved, putting a “possibly” next to cancer is always ominous.

As such, the IARC has repeatedly faced criticism for causing alarm from its rulings. Over the years, it’s faced backlash for categorizing eating red meat or working night shifts as “probably carcinogenic,” as well as using cell phones as “possibly carcinogenic.”

Given the stakes involved, the food industry has already began to speak against the IARC’s impending ruling.

“IARC is not a food safety body and their review of aspartame is not scientifically comprehensive and is based heavily on widely discredited research,” said Frances Hunt-Wood, the secretary general of the International Sweeteners Association, as quoted by Reuters.

Though aspartame has been deemed safe by regulators worldwide for decades, including the US Federal Drug Administration (FDA) and the European Food Safety Authority (EFSA), the substitute has never shaken off its stigma.

For its part, the FDA has repeatedly reviewed aspartame’s safety since it was first approved in the 1970s. In 2021, the agency deemed that “no valid conclusion” could be derived from a major Ramazzini Institute study that supposedly found a link between aspartame and cancer in rodents.

That study, along with a large observational study in France involving 100,000 people that also linked aspartame to cancer, have both been criticized for their methodologies. By and large they’re both outliers among an extensive body of research, but in the IARC’s view, it’s enough to warrant concern.

All in all, it’s a bold decision from the WHO group — but according to Reuters, the intent is to encourage more research into aspartame, not to stoke panic.

The WHO Is About to Declare Aspartame a Possible Carcinogen

Posted by

0


That’s a huge decision.

Getty

Aspartame, one of the most widely used artificial sweeteners in the world, will be declared as a possible carcinogen by the cancer research arm of the World Health Organization (WHO), Reuters reports.

The upcoming July ruling from the WHO group, the International Agency on Cancer Research (IARC), will list aspartame as “possibly carcinogenic to humans.” According to the report, the assessment considers all published evidence, but does not account for the amount a person can safely consume.

It’s ample cause for alarm. The sugar substitute has long been a staple of low or zero calorie drinks like Diet Coke, and is also used in thousands of other products including ice cream, chewing gum, and cereal.

But it’s worth noting that the classification of “possibly carcinogenic” only denotes that there is some evidence that a substance can cause cancer, and that the findings are overall considered inconclusive. There are still two categories above this: “probably carcinogenic,” indicating strong evidence, and simply “carcinogenic,” meaning there is consensus on a proven link.

Those are important distinctions. But no matter the technicalities involved, putting a “possibly” next to cancer is always ominous.

As such, the IARC has repeatedly faced criticism for causing alarm from its rulings. Over the years, it’s faced backlash for categorizing eating red meat or working night shifts as “probably carcinogenic,” as well as using cell phones as “possibly carcinogenic.”

Given the stakes involved, the food industry has already began to speak against the IARC’s impending ruling.

“IARC is not a food safety body and their review of aspartame is not scientifically comprehensive and is based heavily on widely discredited research,” said Frances Hunt-Wood, the secretary general of the International Sweeteners Association, as quoted by Reuters.

Though aspartame has been deemed safe by regulators worldwide for decades, including the US Federal Drug Administration (FDA) and the European Food Safety Authority (EFSA), the substitute has never shaken off its stigma.

For its part, the FDA has repeatedly reviewed aspartame’s safety since it was first approved in the 1970s. In 2021, the agency deemed that “no valid conclusion” could be derived from a major Ramazzini Institute study that supposedly found a link between aspartame and cancer in rodents.

That study, along with a large observational study in France involving 100,000 people that also linked aspartame to cancer, have both been criticized for their methodologies. By and large they’re both outliers among an extensive body of research, but in the IARC’s view, it’s enough to warrant concern.

All in all, it’s a bold decision from the WHO group — but according to Reuters, the intent is to encourage more research into aspartame, not to stoke panic.

Aspartame hazard and risk assessment results released

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Assessments of the health impacts of the non-sugar sweetener aspartame are released today by the International Agency for Research on Cancer (IARC) and the World Health Organization (WHO) and the Food and Agriculture Organization (FAO) Joint Expert Committee on Food Additives (JECFA). Citing “limited evidence” for carcinogenicity in humans, IARC classified aspartame as possibly carcinogenic to humans (IARC Group 2B) and JECFA reaffirmed the acceptable daily intake of 40 mg/kg body weight.

Aspartame is an artificial (chemical) sweetener widely used in various food and beverage products since the 1980s, including diet drinks, chewing gum, gelatin, ice cream, dairy products such as yogurt, breakfast cereal, toothpaste and medications such as cough drops and chewable vitamins.

“Cancer is one of the leading causes of death globally. Every year, 1 in 6 people die from cancer. Science is continuously expanding to assess the possible initiating or facilitating factors of cancer, in the hope of reducing these numbers and the human toll,” said Dr Francesco Branca, Director of the Department of Nutrition and Food Safety, WHO. “The assessments of aspartame have indicated that, while safety is not a major concern at the doses which are commonly used, potential effects have been described that need to be investigated by more and better studies.”

The two bodies conducted independent but complementary reviews to assess the potential carcinogenic hazard and other health risks associated with aspartame consumption. This was the first time that IARC has evaluated aspartame and the third time for JECFA.

After reviewing the available scientific literature, both evaluations noted limitations in the available evidence for cancer (and other health effects).

IARC classified aspartame as possibly carcinogenic to humans (Group 2B) on the basis of limited evidence for cancer in humans (specifically, for hepatocellular carcinoma, which is a type of liver cancer). There was also limited evidence for cancer in experimental animals and limited evidence related to the possible mechanisms for causing cancer.

JECFA concluded that the data evaluated indicated no sufficient reason to change the previously established acceptable daily intake (ADI) of 0–40 mg/kg body weight for aspartame. The committee therefore reaffirmed that it is safe for a person to consume within this limit per day. For example, with a can of diet soft drink containing 200 or 300 mg of aspartame, an adult weighing 70kg would need to consume more than 9–14 cans per day to exceed the acceptable daily intake, assuming no other intake from other food sources.

IARC’s hazard identifications are the first fundamental step to understand the carcinogenicity of an agent by identifying its specific properties and its potential to cause harm, i.e. cancer. IARC classifications reflect the strength of scientific evidence as to whether an agent can cause cancer in humans, but they do not reflect the risk of developing cancer at a given exposure level. The IARC hazard evaluation considers all types of exposures (e.g. dietary, occupational). The strength-of-evidence classification in Group 2B is the third highest level out of 4 levels, and it is generally used either when there is limited, but not convincing, evidence for cancer in humans or convincing evidence for cancer in experimental animals, but not both.

“The findings of limited evidence of carcinogenicity in humans and animals, and of limited mechanistic evidence on how carcinogenicity may occur, underscore the need for more research to refine our understanding on whether consumption of aspartame poses a carcinogenic hazard,” said Dr Mary Schubauer-Berigan of the IARC Monographs programme.

JECFA’s risk assessments determine the probability of a specific type of harm, i.e. cancer, to occur under certain conditions and levels of exposure. It is not unusual for JECFA to factor IARC classifications into its deliberations.

“JECFA also considered the evidence on cancer risk, in animal and human studies, and concluded that the evidence of an association between aspartame consumption and cancer in humans is not convincing,” said Dr Moez Sanaa, WHO’s Head of the Standards and Scientific Advice on Food and Nutrition Unit. “We need better studies with longer follow-up and repeated dietary questionnaires in existing cohorts. We need randomized controlled trials, including studies of mechanistic pathways relevant to insulin regulation, metabolic syndrome and diabetes, particularly as related to carcinogenicity.”

The IARC and JECFA evaluations of the impact of aspartame were based on scientific data collected from a range of sources, including peer-reviewed papers, governmental reports and studies conducted for regulatory purposes. The studies have been reviewed by independent experts, and both committees have taken steps to ensure the independence and reliability of their evaluations.

IARC and WHO will continue to monitor new evidence and encourage independent research groups to develop further studies on the potential association between aspartame exposure and consumer health effects. 

Do You Need To Cut Out Aspartame?

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Moderation is important for lowering risks

Closeup of sugar substitute in granulated and pill form on a blue background.

Some things are well-understood to be healthy for our bodies: fruits, vegetables, exercise.

And some things are almost universally agreed as a danger to your well-being: smoking, drug use, driving without a seatbelt.

But not everything is so clear-cut. Not every food we eat or activity we do can fall neatly into the category of “good for you” or “bad for you.” There are gray areas. Questions of quantity. Matters of how you personally react to one thing or another.

That’s the case with the artificial sweetener aspartame.

On one hand, aspartame can be a saving grace for people with diabetes (“Sweet taste without the calories, and no impact on your blood sugar!”). On the other, there’s reason to be cautious.

Amid reports declaring aspartame a possible carcinogen (cancer-causing agent), we talked with oncologist Dale Shepard, MD, PhD, about aspartame — the good, the bad and what to do about it.

What is aspartame?

Aspartame is an artificial sweetener that goes by brand names like NutraSweet®, Equal® and Sugar Twin®.

Like other artificial sweeteners — including saccharine (Sweet’n Low®) and sucralose (Splenda®) — it’s a common ingredient in foods labeled “sugar-free” or “no added sugar.” That can include products like:

  • Diet soda.
  • Juice.
  • Gum.
  • Candy.
  • Baked goods.
  • Ice cream.
  • Packaged snacks and desserts.
  • Yogurt.

Aspartame and other non-nutritive sweeteners are popular among people looking for a sugarless route to satisfying their sweet tooth. That includes people with diabetes, people on sugar-restricting diets like keto and people who are trying to lose weight.

A gram of aspartame contains 4 calories, which is the same as sugar. But aspartame is 200 times sweeter than sugar. So, you don’t have to use nearly as much to get the same sweetness factor.

So, if you switch from sugar to aspartame, you essentially cut the calories to zero. And aspartame doesn’t impact your blood sugar, so it’s marketed as a good choice for people with diabetes and other people who need to be monitor their blood sugar.

Does aspartame cause cancer?

The latest scientific evidence suggests that aspartame may be associated with cancer. And the World Health Organization (WHO) lists aspartame as a possible cause of cancer. None of that means that aspartame directly causes cancer. There’s a difference.

Let’s look at the research.

In the largest trial to date on the effects of aspartame, researchers followed more than 100,000 people over about eight years and documented what they ate and drank. They found that people who consumed aspartame at high levels were about 15% more likely to develop cancer than people who didn’t have aspartame in their diet. That included an increased risk of:

  • Breast cancer.
  • Endometrial cancer.
  • Colon cancer.
  • Stomach cancer.
  • Prostate cancer.

“When we research foods and their connection to cancer, we can see when people who eat a particular type of food are more likely to develop cancer, but that’s not proving a causal relationship,” Dr. Shepard clarifies. “We don’t know necessarily whether aspartame causes cancer.”

It’s a complicated question to research. Do people who eat a lot of aspartame get cancer because of aspartame? Or do high-aspartame consumers have something else in common — like a chronic health condition, vitamin deficiency or lifestyle choices — that leads to their increased cancer risk? After all, aspartame use is likely to be higher among people living with diabetes and obesity. Might those conditions be the root cause of a higher cancer risk?

As of now, we don’t know for sure, and the WHO’s designation of aspartame reflects that uncertainty.

The WHO ranks carcinogens into four groups based on how likely they are to cause cancer. Aspartame is listed as a “Group 2B carcinogen.” That’s the designation reserved for things believed to possibly cause cancer but that don’t have sufficient evidence to say they do for sure.

“Group 1 carcinogens are things we know cause cancer, like tobacco use and sun exposure,” Dr. Shepard explains. “Then, there’s Group 2A, which are things that probably cause cancer, like red meat. Group 2B is a step below that and includes things like car exhaust, lead and aspartame.”

Aspartame risks and side effects

In addition to its association with cancer, aspartame can come with some other unwanted effects.

Some scientists and physicians say sugar and artificial sweeteners like aspartame can be addictive in a way. They light up your nervous system, sending loads of feel-good hormones, like dopamine, throughout your body. It makes your body want more and more of the sweet stuff, which can lead to overconsumption.

What’s more is that some people may not react well to aspartame and other artificial sweeteners. The sugar alcohols used in making some artificial sweeteners can cause stomach discomfort, like bloating, cramps and diarrhea. And one common sugar alcohol, erythritol, has been linked to increased risk for heart attack and stroke.

Research on the long-term effects of aspartame has also linked it to a range of health conditions, like:

  • Obesity.
  • Diabetes.
  • Early menstruation.
  • Mood disorders.
  • Mental stress.
  • Depression.
  • Autism (when consumed during pregnancy).

But keep in mind that, like the connection between cancer and aspartame, more research is needed to determine the extent of the association between aspartame and those conditions.

Is it safe to have aspartame in your diet?

The WHO says that up to 40 milligrams (mg) of aspartame per kilogram (kg) of body weight is an acceptable daily intake. For context, one can of diet soda contains about 200 mg of aspartame. So, an adult who weighs 150 pounds (68 kg) could, in theory, drink about 13 diet sodas a day and stay within that limit, if they didn’t have any other aspartame in their diet.

But based on our current understanding of aspartame, Dr. Shepard advises caution and moderation. As in, even if the limits suggest 13 cans of diet soda is “acceptable” for you, it’s not recommended. Especially when you factor in the other potential effects of aspartame on your health.

“The risks of aspartame don’t mean that you should never have another diet soda or that you have to avoid aspartame at all costs,” Dr. Shepard clarifies. “But I see it as a reminder that moderation is important to lowering your risk.”

Alternatives to aspartame

If you’re looking to cut back (or cut out) sugar, aspartame and other artificial sweeteners, there are some better-for-you options to satisfy your sweet tooth.

Fresh and frozen fruit are the best choices for sweetening your food and drinks. That’s because, in addition to natural sugars, they’re packed with nutritional benefits, like fiber, vitamins and minerals. Try infusing water with sliced strawberries or slice of lime.

And some natural sugars, like raw honey, maple syrup and monk fruit may provide some health benefits. They’re still sugar, though, so you’ll want to go easy.

When considering your intake of aspartame, sugar, sugar substitutes and other less-than-ideal foods, Dr. Shepard says it’s a matter of being mindful about how you’re treating your body.

“It’s all about taking stock of whether, on balance, you’re doing good things for your body,” he continues. “Are you avoiding things that we know are very serious health risks? Are you managing your health conditions? Are you watching your weight? I don’t recommend doing anything drastic because most people aren’t likely to stick highly restrictive diets. Just be mindful that the things you eat and drink come with risk.”

Aspartame and Anxiety Connection

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If you are looking for yet one more reason to avoid consuming the artificial sweetener aspartame, the results of a new study may help. According to researchers at Florida State University College of Medicine, results of their four-year animal study showed an increased risk of anxiety associated with the use of aspartame. And there’s more: the increased risk was found to extend for up to two generations of the animals, as the trait was passed to both male and female offspring.

The Aspartame and Anxiety Study

In the study, which appeared in the December 2, 2022 issue of the Proceedings of the National Academy of Science, the researchers gave drinking water that contained aspartame to mice daily. The dose used was approximately 15 percent of what the Food and Drug Administration has determined to be the approved maximum daily for humans to consume. According to the FDA, the acceptable daily intake of aspartame for adults and children in the United States is 50 milligrams per kilogram (50 mg/kg) of body weight daily. Since 1 kilogram equals 2.2 pounds, a person weighing 110 pounds could safely consume 2,500 mg (or 2.5 gm) of aspartame daily, according to the FDA.

In this study, which lasted 12 weeks and was conducted over four years, the dosage was equal to six to eight 8-ounce cans of diet soda daily for humans. The length of the study allowed the researchers to track the impact of aspartame use over several generations of mice.

The researchers noted what was called “such a robust anxiety-like trait” that was much more significant than they had anticipated. They also noticed that anxiety was passed along to several generations of male and female offspring by the aspartame-exposed males. When the mice were given the commonly used human antianxiety drug diazepam, the mice in all generations were relieved of their anxiety.

The passage of anxiety to succeeding generations is an example of epigenetic (temporary) change. Unlike genetic changes (i.e., mutations), epigenetic changes do not alter DNA, but they do change how the body interprets DNA sequences. They are also reversible. According to co-author Pradeep Bhide, the results of this study show that “we need to look back at the environmental factors because what we see today is not only what’s happening today, but what happened two generations ago and maybe even longer.”

Aspartame 101

Aspartame was approved by the FDA in 1981 as an artificial sweetener and is about 200 times sweeter than regular sugar. It can be found in nearly 6,000 food and beverage items around the world, and as a tabletop sweetener as well.

Once you consume aspartame, it transforms into aspartic acid, methanol, and phenylalanine. All of these metabolites can have significant effects on the function of the central nervous system. For example, the metabolites have an impact on the brain and neurotransmitter levels and have thus been associated with depression, headache, and convulsions.

Another example is methanol, which affects the liver. Methanol is oxidized in the liver to formaldehyde and then formic acid, both of which can damage liver cells. A recent report also noted that aspartame “could have carcinogenic properties” and that “exposure to aspartame from prenatal age increases the incidence of lymphomas/leukemias in females.”

Bottom Line

Aspartame is an artificial sweetener—one of the scary 7—that should be avoided at all costs by people of all ages. Artificial sweeteners have been linked to a number of serious health problems, and this latest study adds the possibility of anxiety to the list. Protect yourself and your family by always choosing whole foods and naturally sweet fruits, and avoiding the chemicals that can damage your health.

Complete Guide to Diabetes-Friendly Sugar Substitutes

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Today, it is easier than ever to cook and bake with sugar substitutes thanks to the wide variety of products available.

It wasn’t so long ago that most available sugar substitutes had strong off-flavors or, even worse, unfortunate gastrointestinal effects. (Check out the hilarious and horrifying review comments on this Amazon listing for the maltitol syrup-sweetened sugar-free gummy bears to see why the fear is very real.)

Nowadays there are so many options that it’s tough to know where to begin. How do they impact blood glucose? Are they easy on one’s stomach?

Some of these sweeteners have been widely available for decades, and others have gained popularity only recently.

A note: we have excluded popular sugar alternatives like agave syrup and coconut sugar. These may or may not be healthier than pure sugar, but they definitely have an identical blood sugar impact. This article will concentrate on sweeteners that do not provoke a blood sugar increase, and are therefore of special interest for people managing diabetes. That said, some of the sweeteners on this list are more diabetes-friendly than others, depending on what your personal needs are.

Check them out:

The New Sugar Substitutes

If you’re new to low-carb, you might not be aware of how many good new options there are for sugar alternatives.

Allulose: 

Allulose may be our favorite zero-carb sweetener. The reasons are simple:

  1. Of every alternative sweetener we’ve tried, it tastes the best, which is to say that it tastes the most like true sugar. There is no aftertaste, no chemical flavor, no strange mouthfeel issues.
  2. It appears to have zero impact on blood sugar.

The science backs us up. In a 2018 study, allulose was actually found to slightly reduce the blood sugar of people with type 2 diabetes.

Allulose is not as sweet as sugar, but it works extremely well in baking recipes, and can even be turned into caramel.

Monk Fruit:

Monkfruit powder is another sugar alternative that we can recommend highly. It’s extremely popular in the keto community, especially when sold under the brand name Lakanto. The Lakanto company sells monk fruit sugar in multiple varieties, including brown sugar, granulated white sugar, powdered white sugar, and has a range of products, from maple sugar and chocolate sauce to brownie mixes.

Monk fruit comes from the lo han guo fruit, found in China. It does not impact blood glucose and does not seem to cause gastrointestinal symptoms in users. It’s much sweeter than sugar, so a little goes a long way. Low-carb bakers love the way it behaves in recipes.

Users should be aware that monk fruit products often contain a smaller amount of erythritol, for an improved flavor profile and usability.

Erythritol:

You’ll find this under many brands, most notably as Swerve. You can find granular, powdered, and brown sugar versions of erythritol, often formulated so as to offer a 1:1 replacement for sugar, making it easy to use for baking. Many popular low-carb or sugar-free recipes use Swerve.

Erythritol is a sugar alcohol. It is almost completely calorie-free and has no known impact on blood sugar.

PubChem states erythritol is two times as sweet as sucrose. While most people seem to tolerate it well, there are some reports of eaters experiencing gas or bloating, so it may be smart to watch how much you include in your diet.

Stevia:

Stevia is a newly popular alternative sweetener. You can find it in grocery stores as SweetLeaf, Pyure, Stevia in the Raw, and several other brands. Derived from the leaves of a plant native to South America, stevia is an all-natural sweetener that is several hundred times sweeter than sugar, according to the FDA. It is calorie-free and won’t raise blood sugar.

Stevia is divisive because many tasters find that it has a bitter aftertaste. Many low-carb eaters absolutely love it, though. If you’re buying low-sugar packaged foods that use stevia, be sure to check the ingredients, because it’s often combined with sugar.

There are actually different types of stevia, and one of our staff members strongly prefers a type called “Reb A,” which is made from only a certain extra-delicious part of the plant. If you’ve tried stevia and haven’t liked it, it might be worth looking for the Reb A variety.

Xylitol:

Xylitol is another sugar alcohol: it’s about as sweet as sucrose but lower in calories. It does raise blood glucose a little bit, which may make it a less optimal choice than its cousin erythritol. PubChem explains that xylitol is a five-carbon sugar alcohol that can be found naturally in many fruits and vegetables.

This sugar alcohol may cause gastrointestinal distress in some individuals at a certain threshold intake. It may be possible that once the body acclimates to the sweetener, more can be consumed with no unwanted side effects.

Xylitol is often found in candy and sugar-free gum because it inhibits the growth of bacteria in the mouth.

Beware: xylitol is extremely toxic to dogs, so probably not ideal for a pet owner.

Traditional Sugar Substitutes

You’re probably already familiar with the flavor of these – most of them have been ubiquitous for decades. In our opinion, the alternative sugars below are more likely to have strange flavors and chemically aftertastes, and they’re also less likely to be useful in low-carb baking recipes. But many people love them! And they also probably won’t raise your blood sugar.

Aspartame:

Found on the market as NutraSweet and Equal. According to the American Cancer Society, it is about 200 times sweeter than sugar and is not for those with phenylketonuria disease. It’s also calorie-free and does not raise blood sugar but is not recommended for use in cooking or baking.

Maltitol:

Maltitol is a sugar alcohol commonly used as a way to make foods “sugar-free.” It doesn’t make foods “carbohydrate-free” however, as it still affects blood glucose somewhat. An analysis on PubChem references a study that found that Malitol has 38% the blood sugar impact of pure sugar, and that it was absorbed more slowly. However, beware: this chemical is known to provoke gastrointestinal problems.

Saccharin:

Sold as Sweet and Low, Sweet Twin, Sweet’N Low, and Necta Sweet. According to the FDA, saccharin was discovered in 1879. It is 200-700 times sweeter than sugar and is not as popular as it used to be, due to its bitter aftertaste and difficulty for use in baking.

Sorbitol:

According to the PubChem Chemistry Database, “Sorbitol is a sugar alcohol found in fruits and plants with diuretic, laxative and cathartic property.” Also, it contains “one-third fewer calories and 60 % the sweetening activity of sucrose and is used as a sugar replacement in diabetes.” As you can see, sorbitol can be a laxative, and still raises blood sugar. Be aware of this when choosing sorbitol!

Sucralose:

This is most commonly known as the brand name Splenda. Sucralose is calorie-free and doesn’t raise blood sugar. It can be tricky to bake with due to how sweet it is (about 600 times sweeter than sugar).

Use What Works for You

When choosing a sugar substitute, your goal is to enjoy the flavor as much as possible while maintaining steady blood sugar levels and avoiding unpleasant side effects. Your own experience will be unique. Some people are sensitive to some of these sweeteners, and some are not, so individual results have to be prioritized. It’s also possible that you’ll have different blood sugar responses than predicted in this article. And in matters of taste, of course, there can be no disputes.