Low- and No-Calorie Sweetener Safety and Estimated Intakes
Low- and No-Calorie Sweetener Safety and Estimated Intakes
Low and no-calorie sweeteners allowed for use in foods and beverages have been extensively studied and found safe for use by all populations, including children, people with diabetes, and women who are pregnant or lactating. The only exception is people born with a rare genetic disorder called phenylketonuria (PKU) who should avoid all foods and beverages containing the common amino acid phenylalanine. This includes nearly all protein-rich foods, including milk, eggs, fish, and meat, as well as aspartame because it is made with phenylalanine. Products containing aspartame provide label information that advises people with PKU about the presence of phenylalanine.
Over the past decade, academic experts and regulatory authorities have also undertaken additional independent reviews to address lingering consumer concerns regarding internet stories that often link the low-calorie sweetener aspartame with adverse health effects, such as cancer, seizures and weight gain. In 2013, the European Food Safety Authority (EFSA) reaffirmed the safety of aspartame, following the “most comprehensive review of aspartame that has ever been undertaken.” (EFSA 2013) EFSA initiated the safety assessment in order to address lingering consumer concerns regarding alleged links between the low-calorie sweetener and adverse health effects, such as cancer, seizures and weight gain. The assessment found that aspartame causes none of these concerns and once again affirmed aspartame’s safety. (EFSA had previously confirmed the safety of aspartame in 2006, 2009, and 2011.) The US National Cancer Institute has also evaluated the research on low- and no-calorie sweeteners and found no evidence of cancer in humans. (NCI 2009)
Understanding the Acceptable Daily Intake (ADI)
Before any food additive, including low- and no-calorie sweeteners, are allowed to be used in foods and beverages, qualified scientific experts conduct a detailed review of all the available scientific data from both human and animal studies to determine the maximum daily dietary level that can be safely ingested every day over a person’s entire lifetime without any appreciable risk to health. Government food safety authorities, such as the Food and Drug Administration (FDA) in the US, use this information to establish an Acceptable Daily Intake (ADI) for the ingredient, which is stated in milligrams per kilograms of body weight (mg/kg bw). It’s important to note that the ADI includes a large safety factor (usually 100). For example, the ADI for aspartame is set 100 times below the No-Observed-Adverse-Effect Level (NOAEL) found in lifetime exposure and other key animal studies. Each low- and no-calorie sweetener has a separate ADI.
The amount of low- and no-calorie sweeteners used to sweeten foods and beverages is very small, and far below ADI levels, because most are 200 times or more sweet than table sugar. In addition, many products contain a blend of sweeteners. Using blends not only improves taste, it also reduces the amount of individual sweeteners used and helps keep the risk of possibly over-consuming any single low or no-calorie sweetener very low. Today, the most common blends are acesulfame potassium in combination with either aspartame or sucralose.
In the U.S., the FDA is responsible for setting the ADI for all food additives, including the low- and no-calorie sweeteners aspartame, sucralose, saccharin, and acesulfame potassium. In other countries, ADIs are established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), and the European Food Safety Authority (EFSA). The JECFA recommendations have been adopted by many countries in their regulatory frameworks, including Argentina, Chile, Brazil, and Mexico. The EFSA values serve as references for the 27 countries in the European Union.
To learn more about the regulation and safety assessment of food substances in various countries, see: Magnuson B, et al. Review of the regulation and safety assessment of food substances in various countries and jurisdictions. Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2013;30(7):1147-220. (full-text)
Understanding GRAS (Generally Recognized As Safe)
If the FDA, after reviewing the relevant research, has no questions regarding the ingredient’s safety, it issues a no objection letter to the GRAS determination. The quality and quantity of scientific evidence required for a substance to achieve GRAS status is equal to that required by the FDA for the approval of a food additive. Steviol glycosides, which are purified stevia leaf compounds, have been accepted as GRAS since 2009 in the U.S.
To learn more about the GRAS process, see: Rulis AM and Levitt JA. FDA’S food ingredient approval process: Safety assurance based on scientific assessment. Regul Toxicol Pharmacol. 2009 Feb;53(1):20-31. (full-text)
According to the Academy of Nutrition and Dietetics Evidence Analysis Library (EAL), limited data exists on intakes of individual low- and no-calorie sweeteners except aspartame, the most widely used sweetener in the food supply. That research shows that, even using the “worst case” assumption that aspartame is the only low- and no-calorie sweetener people consume, the highest level of consumption among adults is less than 15 mg/kg body weight in the U.S., which is less than 30 percent of the U.S. ADI. To provide perspective, a woman weighing 150 pounds would have to consume 97 aspartame sweetener packets about 18 cans of aspartame-sweetened soft drinks every day during her lifetime in order to reach the 50 mg/kg of bodyweight per day ADI that the FDA has established for aspartame.
With regards to intakes of other low- and no-calorie sweeteners, the EAL found that, “cross-sectional research conducted outside the United States is consistent in finding that non-nutritive sweetener intakes for adults and children are below the Acceptable Daily Intake (ADI) set by regulatory bodies.” Statistics from the U.S. Department of Agriculture also show that the average combined consumption of low- and no-calorie sweeteners is less than two ounces per person per year.
Relative Sweetness, Acceptable Daily Intakes (ADIs) and Amount in Representative Beverages Sold by The Coca-Cola Company in the U.S.*
|Low- and No-Calorie Sweeteners||Acesulfame K||Aspartame||Saccharin||Sucralose||Stevia Leaf Extracts|
|Sweetness relative to table sugar||200 times sweeter||200 times sweeter||300-500 times sweeter||600 times sweeter||200 times sweeter|
|US FDA ADIs
(mg/kg body weight)
|Amount (mg/day) to equal the ADI for a 150 pound (68 kg) person||1020||3400||340||340||816*|
|Amount in representative beverages sold by The Coca-Cola Company in the U.S.
(mg per 12-fl.oz. serving)**
|50||185||7 to 95||60||60|
|Number of 12-fl. oz. servings to equal the ADI for a 150 pound person*||20.5||17 – 18||3.5 to 48||5.5||12 to 14*|
* Based on GRAS Notification; 4 mg/kg/day expressed as steviol equivalents. This translates into 12 mg/kg/day of steviol glycosides, which are the sweet-tasting components of the stevia leaf extract used in Coca-Cola beverages.
** Representative Beverages: Coke Zero (acesulfame K); Diet Coke (aspartame); Diet Fanta Wild Cherry frozen carbonated beverage (7 mg saccharin); Tab (95 mg saccharin); Diet Coke with Sucralose (sucralose); VitaminWater Zero Glow (stevia leaf extract). Coke Zero contains a blend of acesulfame K and aspartame. Tab contains a blend of saccharin and aspartame. Amounts as of May 2012; rounded up to the nearest gram.
Scientific Opinion on the re-evaluation of aspartame (E 951) as a food additive. EFSA Journal. 2013;11(12):3496 [263 pp.]. (full-text)
The Truth about Artificial Sweeteners or Sugar Substitutes: How Much Is Too Much? Presented by the ADA Evidence Analysis Library® http://www.andeal.org/files/Docs/NNSResourceDraft3.pdf Accessed June 15, 2015.
Magnuson BA, et al. Review of the regulation and safety assessment of food substances in various countries and jurisdictions. Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2013;30(7):1147-220. (full-text)
Rulis AM and Levitt JA. FDA’S food ingredient approval process: Safety assurance based on scientific assessment. Regul Toxicol Pharmacol. 2009;53(1):20-31. (full-text)
Magnuson BA, et al. Aspartame: a safety evaluation based on current use levels, regulations, and toxicological and epidemiological studies. Crit Rev Toxicol. 2007; 37:629-727. (abstract)
Renwick AG. The intake of intense sweeteners – an update review. Food Addit Contam. 2006;23(4):327-38. (abstract)
Academy of Nutrition and Dietetics Evidence Analysis Library on Non-Nutritive Sweeteners. http://www.adaevidencelibrary.com/ (Accessed May 29, 2015)
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European Commission, Health and Consumer Protection Directorate (2002). Opinion of the Scientific Committee on Food: Update on the Safety of Aspartame. http://ec.europa.eu/food/fs/sc/scf/out155_en.pdf
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