What Health Professionals Need to Know About Aspartame
An interview with noted toxicologist, Bernadene Magnuson, PhD
Millions of people worldwide regularly enjoy foods and beverages sweetened with aspartame, and many have done so for more than 30 years. Yet others steer clear of this low-calorie sweetener, citing information concerning its safety and supposed potential to increase appetite, body weight and sweet cravings found on the internet.
To clarify the science, the Coca-Cola Beverage Institute For Health & Wellness asked noted toxicologist and aspartame expert Dr. Bernadene Magnuson to share the facts health professionals need to know to address consumer questions about aspartame.
Let’s start with the basics. What is the composition of aspartame?
Dr. Magnuson: Many people are surprised to learn that aspartame is made from two of the same nutritional building blocks that make protein: the amino acids aspartic acid and phenylalanine.
While neither amino acid by itself is sweet to the taste, when you link aspartic acid to a molecule of phenylalanine that has had a methyl group attached, you get a compound that we call aspartame, which tastes extremely sweet to humans.
How can aspartame be a low-calorie sweetener when amino acids yield four calories per gram?
Dr. Magnuson: Aspartame yields four calories per gram just like other proteins and carbohydrates, including sugar. However, it’s also 200 times sweeter than sugar. This means just 250 milligrams, or one calorie, of aspartame provides the same level of sweetness as 50 grams (200 calories) of sugar.
Did aspartame meet the same safety standards set for other food ingredients before it was approved for use in foods and beverages?
Dr. Magnuson: Yes. Aspartame underwent the same intensive safety testing and assessment that regulatory agencies require of all new food ingredients before it was approved for use in foods and beverages. This safety assessment has two parts: toxicology testing and exposure assessment.
Toxicology testing takes years to complete. The testing for aspartame included animal studies to determine whether aspartame could have any adverse effects on health, behavior or development, including changes in genetic material, reproductive problems or birth defects, as well as studies to determine how aspartame is metabolized and used by the body.
After the animal studies established the safety of aspartame, human metabolism studies were conducted to ensure that the animal data represented how the human body actually handles aspartame. Human studies looked at blood chemistry, as well as any effects in populations likely to be high consumers of low- and no-calorie sweeteners, such as people with diabetes.
Exposure assessment projects the amount of the new ingredient different population groups are likely to consume once the new ingredient is allowed on the market and added to foods. This assessment looks at all age and gender groups and is based on food intake surveys. This was done for aspartame as well.
Before aspartame was approved for use, the toxicology and intake assessment study results on aspartame were independently reviewed by the major international food authorities, including the Joint FAO/WHO Expert Committee on Food Additives (JECFA), the U.S. Food and Drug Administration (FDA), Health Canada, the European Food Safety Authority (EFSA), and the Food Standards Australia New Zealand.
Today, aspartame is permitted for use as a low-calorie sweetener in more than 130 countries and hundreds of products including tabletop sweeteners, low-calorie beverages and dry mixes, chewing gum, confections, gelatins, dessert mixes, puddings and fillings, frozen desserts and yogurt. It’s also used to sweeten some vitamin supplements and sugar-free cough drops.
How much aspartame can people safely consume each day?
Dr. Magnuson: International food authorities set a safe daily intake level, called the Acceptable Daily Intake (ADI), for all new approved food ingredients, including aspartame. The ADI is considered the amount that individuals can safely consume every day over their lifetime without any adverse effect.
In the U.S., the FDA set the ADI for aspartame at 50 milligram/kg of body weight per day. To put this in perspective, a 70 kg (154 pound) person can safely consume 3,500 milligram of aspartame a day. An aspartame-sweetened soft drink typically contains about 185 milligrams (mg) of aspartame per 12 fl. oz. (~330 ml) serving.
This means a 150-pound adult would need to consume almost 19 soft drinks or 97 packets of tabletop sweetener per day to exceed the ADI.
Thus, it is not surprising to learn that the average consumption of aspartame is far below the ADI. [Note: A milligram (mg) is 1/1000 of a gram; 185 mg is equal to about 0.007 oz.]
Aspartame Content of Common Foods
|Food/Beverage||Serving Size||Aspartame (mg)|
|Diet Coke||12 oz.||185|
|Flavored Sweetened Gelatin||4 oz.||81|
How did experts establish the ADI for aspartame?
Dr. Magnuson: The ADI for all food ingredients is established using a very conservative assessment with a large safety factor built in.
For all ingredients, including aspartame, the ADI is based on data from long-term animal studies that determine the amount animals can consume every day for life without any adverse effects being observed.
This level is called the “No Observed Effect Level” (NOEL). The experts then divide this number by a safety factor to account for the potential differences between humans and animals. The safety factor is usually 100.
So, you start with a level that when consumed by animals every day over their lifetime has no adverse effect and then divide that by at least 100. That becomes the Acceptable Daily Intake value.
With aspartame in so many products, how do we know people aren’t consuming too much?
Dr. Magnuson: Intakes of aspartame and other food ingredients are monitored through surveys and studies of what people eat and drink that are conducted in countries all over the world. Results from these studies show that even among the highest consumers of low-calorie sweeteners, daily consumption of aspartame is far below the ADI for all population groups.
For example, a 2008 study that used U.S. food intake survey data and the conservative assumption that aspartame was the only low-calorie sweetener present in the food supply found intakes among those in the top tier (95th percentile) of low-calorie sweetener users was only about 27% of the U.S. ADI. Similar results have been found in studies looking at consumption of aspartame in other countries.
U.S. Aspartame Intakes (Estimated)* vs. ADI
|Low-Calorie Sweetener Users||Est. Intake
|Percent of ADI
(FDA ADI=50 mg/kg bw/day)
|Children, 6-11 yrs (subgroup)|
Source: Magnuson et al, 2007.
*Because information on individual sweetener intakes in the U.S. was not available, Magnuson et al, used the 2001-2002 National Health and Nutrition Examination Survey (NHANES) dataset for its analysis and made the conservative assumption that aspartame was the sole sweetener in every product in the data set that contained a low-calorie sweetener.
Some people worry that aspartame could build up in body tissues. Is this possible?
Dr. Magnuson: No. Aspartame cannot build up in body tissues because it never enters the bloodstream.
Aspartame is fully digested in the small intestine by the same enzymes that break down the amino acids found in meat and other proteins and digest the naturally occurring methyl esters present in ripe fruits, vegetables and their juices. These enzymes split aspartame into its individual amino acids and a molecule of methanol, which enter the bloodstream. This is the same thing that happens when you digest a banana smoothie, which will also contains protein (amino acids) and methyl esters.
How much aspartic acid, phenylalanine and methanol do aspartame-sweetened soft drinks release into the bloodstream?
Dr. Magnuson: Aspartame-sweetened soft drinks release far less aspartic acid, phenylalanine and methanol into the bloodstream than many people assume.
For example, digesting 185 milligrams of aspartame, which is the amount found in 330 ml (12 fl. oz.) of Diet Coke, releases 90 milligrams phenylalanine, 72 milligrams of aspartic acid, and 18 milligrams of methanol into the blood stream. In comparison, digesting a smoothie made with 240 ml (8 fl. oz.) of milk and a medium banana releases 404 milligrams phenylalanine, 592 milligrams of aspartic acid, and 21 milligrams of methanol into the blood stream.
So, just as consuming milk and bananas doesn’t cause any safety concerns from these ingredients, neither does the small amount of amino acids and methanol in aspartame-sweetened foods or beverages.
Phenylalanine, Aspartic Acid & Methanol Following Digestion of Common Foods
|Food/Beverage||Phenylalanine (mg)||Aspartic Acid (mg)||Methanol (mg)|
|Diet Coke (12 fl. oz.)||90||72||18|
|Milk (8 fl. oz.)||404||592||-|
|Tomato juice (8 fl. oz.)||-||-||71|
|Orange juice (8 fl. oz.)||-||-||15|
So, the body handles the amino acids and methanol released during the digestion of aspartame and a banana and milk smoothie in exactly the same way?
Dr. Magnuson: Correct. The source of the dietary components aspartic acid, phenylalanine, and methanol has no impact on the way the body handles them, regardless of whether they came from the digestion of a banana and milk smoothie or an aspartame-sweetened soft drink. Scientific studies have been conducted in both animals and humans to confirm that this is true.
Some people cite the fact that the body converts methanol into formaldehyde as a reason to avoid aspartame. Is this concern backed by sound research?
Dr. Magnuson: No. This is a good example of a myth based on a kernel of truth.
As I mentioned earlier, aspartame is completely broken down in the intestine into two amino acids, aspartic acid and phenylalanine, and a small amount of methanol. So, yes, aspartame digestion releases methanol and methanol is changed by the body into formaldehyde—but as we discussed above, the small amount of aspartame used in foods and beverages produces no more methanol, and therefore formaldehyde, than digestion of fruit and vegetable juices.
In fact, just one cup (about 240 ml) of caffeinated coffee releases enough methanol to produce 30 milligrams of formaldehyde. Yet, no one raises concerns over coffee and formaldehyde. The fact is that the body is very well adapted to small amounts of methanol, and thus the amount in aspartame, fruit juice or coffee, is far too low to cause toxicity.
Another little-known fact is that low levels of formaldehyde are naturally found in the body as the human body actually constantly produces small amounts of a metabolite of formaldehyde called formic acid to make nucleotides for DNA.
Because this issue is so misunderstood, could you explain in more detail how the body handles methanol?
Dr. Magnuson: Sure. It’s true that the digestion and metabolism of aspartame’s methyl ester generates a small amount of formaldehyde, but this is rapidly converted into formic acid, which can be further broken down to carbon dioxide and water.
Now, if very large amounts of methanol are consumed in a short time, it’s true that this metabolic pathway can be overloaded and cause a build-up of formic acid, which can be harmful. But again, the dose required for harm is hundreds of times higher than the amount produced from methanol found in aspartame or ripe fruit.
Have studies looked at blood levels of methanol and formic acid following aspartame consumption?
Dr. Magnuson: Yes, the question of whether aspartame raises blood methanol and formic acid levels has been studied in humans. The findings show that it’s not possible for the small amount of aspartame we consume to overload the metabolic pathway.
For example, studies in healthy adults showed that doses up to 200 mg/kg body weight did not raise blood methanol levels above normal levels and had no impact on blood formic acid levels whatsoever.
Considering that the average daily intake of people who use aspartame is about 5 mg/kg of body weight, it’s evident that these doses were much higher than anyone would consume. Similarly, studies conducted to determine if children can metabolize aspartame also showed aspartame was quickly digested, and blood levels of methanol, formaldehyde and formic acid didn’t change.
Concerns linking aspartame to cancer seem to linger. What does the research show on this issue?
Dr. Magnuson: More studies have been done on aspartame than any other food ingredient, including extensive studies for cancer-causing effects. Based on the quality and number of these studies, experts and regulatory agencies around the world have agreed that aspartame does not cause cancer. More specifically, genotoxicity studies using animals, cells and bacteria have consistently shown that aspartame does not causes mutations—or changes—in the DNA of cells. Mutation is usually the first step in cancer development.
Aspartame has also been extensively tested through animal feeding studies to determine if it can cause or promote cancer. Results from all these studies showed no increase in cancers, except for three studies conducted by the Soffritti group in one laboratory in Italy.
Those studies prompted major investigations by international authorities around the world, including EFSA, the FDA, Health Canada and the US National Toxicology Program. These expert bodies unanimously concluded that due to serious flaws in methodology and interpretation, the Soffritti studies provided no credible evidence that aspartame is carcinogenic and did not warrant a change to established ADIs for aspartame.
Epidemiological studies on aspartame and cancer have also consistently found no association between aspartame consumption and cancer. One conflicting report on brain tumor risk looked at brain tumor incidence in several locations in the US before and after aspartame came on the market, but the researchers did not determine whether the subjects who developed brain tumors had actually consumed aspartame. All subsequent studies that actually measured aspartame consumption have found no effect.
Is there any scientific support for concerns that aspartame causes neurological problems such as learning and behavior issues, and seizures?
Dr. Magnuson: Again, no. Despite what you may find on the Internet, well-conducted studies using high doses of aspartame have consistently demonstrated that aspartame has no effect on neurological function.
In animal studies on learning and behavior, animals were fed aspartame at levels up to 9% of the diet. This is about 1,000 times more aspartame than the average person would consume. Yet, despite such extremely high doses, the studies consistently showed aspartame had no effect on neuronal function, learning or behavior. I think this also illustrates the amazing ability of the body to adapt to different diets and sources of amino acids, something that, again, many people don’t think about.
The effect of aspartame on learning or behavior has also been tested in human controlled studies. These included studies with healthy adults and children; children who were hyperactive or aggressive; adults with Parkinson’s disease and depression; and even a large group of airline pilots for whom neurological response is critical.
These studies consistently showed no effect on neurological function from aspartame, except for one small study in which depressed adults reported slightly greater depression following aspartame consumption. That study has not been replicated.
Animal and human studies have also tested the effect of aspartame on seizures. Human studies included children with a history of seizures, individuals with epilepsy, and people with self-reported aspartame sensitivity. In many of these studies, the subjects were given a placebo on one day and a large single dose of aspartame on other days. EEG tests that monitored brain signals showed no difference between placebo and aspartame.
What does the research show regarding aspartame and headaches?
Dr. Magnuson: Studies conducted with individuals who self-reported a susceptibility to headaches from aspartame showed no consistent effect, although some findings were positive. This suggests that a small subset of the population may be susceptible to headaches related to aspartame, although a mechanism is not clear.
As you may appreciate, headaches are really difficult to study. We cannot actually measure a headache, and so must rely on self-reporting where the power of suggestion comes into play.
Is aspartame safe for children?
Dr. Magnuson: Yes. Aspartame was extensively tested and found safe for children (>1 yr) at levels currently consumed. Studies have confirmed that there is no difference in the way children and adults metabolize aspartame. Aspartame’s effect on children’s behavior has also been extensively tested, with no effect found even with habitual use. And there is no association between aspartame use by children and cancer.
The only exception is for individuals, especially children, born with the rare inherited disease phenylketonuria (PKU) who must limit intake of aspartame as well as all protein foods, as they can’t metabolize the amino acid phenylalanine that is released during digestion. Babies are routinely tested for PKU as well as other inherited diseases, at birth as it must be managed from birth. Thus there is no concern that someone has PKU and is not aware of it.
Is aspartame safe for pregnant and nursing women?
Dr. Magnuson: Yes. Let me re-emphasize that in order for aspartame to be approved for use in foods and beverages, animal studies had to show no evidence of adverse effects during pregnancy and development. Based on safety studies, plus the fact that aspartame never enters the bloodstream but is fully digested into common food components, we can be confident that pregnant and lactating women can consume products containing aspartame with no risk of adverse effects on themselves or their newborn.
Women, especially those who are diabetic or overweight, need to know the use of aspartame sweeteners is safe during their pregnancy. To not control body weight or diabetes has clearly established risk during pregnancy.
Is the recent paper by Englund-Ögge that links artificially sweetened soft drinks and preterm delivery a cause for alarm?
Dr. Magnuson: No. Preventing preterm birth is important, but the Englund-Ögge (2012) suggestion that artificially sweetened soft drinks increase the risk of preterm delivery is simply not supported by their own data.
In fact, I would argue that their data actually provide pretty good evidence for no effect of low-calorie sweetener intake on preterm birth. To understand why, look at the study data summarized below.
|Artificially Sweetened Beverage Consumption and Preterm Birth
Englund-Ögge (2012). Consumption data based on food frequency questionnaires (type of sweetener not reported)
|Servings||Number||Adjusted OR (95% CI)|
|<1/wk||14,919||1.01 (0.92, 1.12|
|1-6 /wk||13,204||1.09 (0.99, 1.20)|
|1 /day||4,309||1.20 (1.04, 1.39)|
|2-3 /day||3,998||1.01 (0.87, 1.18)|
|≥ 4/day||2,102||1.12 (0.92, 1.36)|
First, note that all but one Confidence Interval (CI) includes the null value of 1.0. According to basic statistics, when the CI includes the null value, the effect should be considered statistically not significant regardless of the p value. Also problematic is the overlapping CIs for different levels of intake.
Next, note that the Odds Ratio (OR) for 2-3 servings per day is exactly the same as the OR for <1 serving per week (1.01), so there is no clear evidence of a dose-response. And finally, the ORs are very small. ORs of true consistent effects are much greater.
Some may recall that a study by Halldorsson et al. (2010) also reported an association between intake of artificially sweetened soft drinks and preterm delivery in a cohort of pregnant Danish women. Again, many experts who evaluated that study found the data did not support the authors’ statements.
The increasingly accepted view, which is reinforced by a recent study by Dekker et al. (2012), is that the different types of spontaneous preterm birth result from very diverse and overlapping risk factors. The Dekker paper did not list low-calorie sweeteners among factors of concern for spontaneous preterm birth.
What does the evidence show regarding aspartame use and weight gain?
Dr. Magnuson: There is animal and epidemiological evidence linking increased body weight to low-calorie sweetener use, but the link simply does not hold up under clinical investigation. Let me explain why I can be definitive about this.
I was part of the expert workgroup convened by the Academy of Nutrition and Dietetics to evaluate research on the impact of aspartame on appetite, food intake and preference for a sweet taste for their Evidence Analysis Library (EAL). To be included in the EAL review, research had to meet very high standards, such as including only human subjects and being peer-reviewed and published in a juried publication.
The EAL also requires the use of a rigorous, multi-step, evidence analysis process to analyze, assess, summarize and grade the scientific evidence related to specific nutrition and health questions on a given topic. In this case, the questions were related to the impact of aspartame on weight and appetite. The result of our analysis was that we found NO support for the theory that aspartame causes weight gain.
Specifically, in response to the question, “In adults, does using foods or beverages with aspartame in a calorie-restricted or ad libitum diet effect energy balance (weight)?” we found strong and consistent (Grade 1) evidence that the use of aspartame and aspartame-sweetened products, as part of a comprehensive weight loss or maintenance program by individuals, may be associated with greater weight loss and may assist individuals with weight maintenance over time.
We also found strong and consistent (Grade 1) evidence showing that aspartame does not affect appetite or food intake. The workgroup considered all available, quality studies related to the question, “In adults, does using foods or beverages with aspartame affect appetite or food intake?” Subjects in these studies were primarily young adults ages 20 to 30 and of both genders.
However, we did not find adequate studies addressing the question, “Does aspartame affect preference for sweetness?” As a result, that question was given a Grade V (Not Assignable), which reflected a lack of available evidence to directly support or refute a conclusion.
Since the completion of the EAL, three additional clinical studies have been published on aspartame. All three support the EAL conclusions.
Does aspartame raise blood insulin and glucose levels?
Dr. Magnuson: The short answer is no, aspartame does not affect blood insulin or glucose levels.
Aspartame’s lack of effect on blood insulin and glucose levels was demonstrated in the studies required prior to its approval as a low-calorie sweetener suitable for people with diabetes.
Many studies were conducted in the 1980s to determine if aspartame altered insulin release from isolated pancreatic cells, in rats and mice, in young and older healthy humans, in individuals with diabetes, and in overweight individuals. All studies consistently found that aspartame had no effect on blood insulin or glucose levels.
I want to talk about this a bit further in light of a recent report published by scientists in Saudi Arabia. This report stated that mice given aspartame in their drinking water had elevated glucose levels and developed insulin resistance. Sadly, this report has led to Internet headlines saying that aspartame causes diabetes, which is simply not true. It is very frustrating that this paper was published without requiring the authors to explain their results, which are in direct opposition to every other study I know of.
The important conclusion is that in every human clinical study conducted, aspartame had no effect on blood insulin or glucose levels.
With all the research supporting the safety of aspartame, why do safety concerns continue to surface?
Dr. Magnuson: This is a tough question, because there is no good answer. There are clearly individuals who are making a great effort to generate and spread unfounded safety concerns about aspartame and other approved low-calorie sweeteners using the Internet, email and other public media. I cannot speculate as to what their motivation may be, but it is very unfortunate as many people become afraid to use these safe and useful products.
What’s the bottom line on aspartame?
Dr. Magnuson: Aspartame is safe. Scientific evidence does not support allegations of adverse effects from aspartame consumption, including toxicity, increased cancer risk, or neurological problems. Aspartame has undergone extensive testing and international regulatory agency reviews and has been deemed safe for all populations, including children, people with diabetes, and women who are pregnant or lactating.
Aspartame use does not increase appetite, body weight or raise blood insulin levels. With regard to sweet preference, there is no evidence to support or refute this at this time.
What aspartame does do is make a calorie-controlled diet more palatable, which can help support adherence to long-term weight maintenance.
With so many people facing health risks associated with obesity-related chronic diseases such as type 2 diabetes, I believe health professionals can best help their patients if they know what the evidence says about aspartame. They should feel comfortable and secure in supporting their patients’ use of aspartame-containing products as part of an overall energy-balance plan that includes a nutrient-rich diet and regular physical activity.
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Dr. Bernadene Magnuson is a toxicology consultant in the areas of food, dietary supplements and nutrition who helps clients address ingredient safety and regulatory issues. Her clients include industry, government and various associations. Recently, her work has included safety assessments of nanomaterials for various applications. She also is an Associate Professor in the Department of Nutritional Sciences at the Faculty of Medicine, University of Toronto.
Dr. Magnuson has published more than 60 peer-reviewed articles, book chapters and professional articles, is an Associate Editor, on the editorial board of two journals, and is an active member of various professional associations. She was recently honored to become a Fellow of the Academy of Toxicological Sciences (ATS).
Dr. Magnuson obtained a BSc degree in food science, MSc degree in toxicology, and a PhD in Food and Nutritional Sciences from universities in Canada. She then completed post-doctoral training in cancer research, and was a faculty member at the Universities of Idaho and Maryland in the US before returning to Canada.