Understanding Low- and No-Calorie Sweeteners:
Safety, Guidelines (ADI) and Estimated Intakes

Although some internet stories claim that low- and no-calorie sweeteners cause cancer and other illnesses, according to the U.S. National Cancer Institute, the scientific evidence does not show that these sweeteners are linked to cancer risk in humans.

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 that people born a rare genetic disorder called phenylketonuria (PKU) must severely restrict their intake of phenylalanine, a common amino acid that is a component of aspartame and protein foods, including milk and meats. Products containing aspartame provide label information that advises people with PKU about the presence of phenylalanine.

Over the past decade, independent academic experts and regulatory authorities have also untaken additional 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. The results showed that aspartame causes none of these concerns and affirmed its safety. In addition, the U.S. National Cancer Institute has evaluated the research on all low- and no-calorie sweeteners and found that the scientific evidence does not show that they are linked to cancer in humans.

Low-Calorie Sweeteners – Intake Guidelines (ADIs) and Relative Sweetness

*The Argentina food code ADI for saccharin is 2.5 mg/kg of body weight.
** ADI for steviol glycosides is 4 mg/kg/day, which based on molecular weight, translates to 12 mg/kg/day for rebiana.
*** Based on U.S. FDA ADI
**** Based on JECFA ADI.
***** Based on U.S. FDA ADI and an average of 40 mg ace-K per 12oz (300 ml) can.

Acceptable Daily Intake (ADI)

For every low- and no-calorie sweetener used in foods and beverages, qualified scientific experts have established a safe level of consumption. This level, called the Acceptable Daily Intake (ADI), is stated in milligrams per kilograms of body weight and represents the amount that can be safely on a daily basis over a person’s lifetime. However, because each ADI is set based on the available research plus a wide margin of safety, consuming more than the ADI on occasion does not mean an adverse health effect will occur. For example, the ADI for aspartame is 100 times below the No Observed Effect Level (NOEL) found in key animal studies, including studies of lifetime exposure.

Although the use of foods and beverages with low- and no-calorie sweeteners is increasing, the 100-fold safety factor built-in to the ADI, plus the facts that each low- and no-calorie sweetener has a separate ADI and so little is needed to impart a sweet taste, keeps risk of over-consuming any single low or no-calorie sweetener very low. Another reason the risk of over-consumption is low is that many popular products like Coca-Cola Zero™ use blends of low- and no-calorie sweeteners. Using blends not only helps improve the taste, it also reduces both the total amount of sweetener used and the amount of individual sweeteners needed to obtain a desired level of sweetness. Today, the most common blends are acesulfame potassium in combination with either aspartame or sucralose.

The U.S. Food and Drug Administration (FDA) is responsible for setting the ADI for low- and no-calorie sweeteners and other food additives it allows in foods and beverages in the U.S. The ADIs in place for low-and no-calorie sweeteners allowed for use in other countries have been 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.

GRAS (Generally Recognized As Safe)

To be legally added to a food or beverage in the U.S., an ingredient must have status as either an FDA-approved food additive, in which case the FDA will establish an ADI, or be accepted as GRAS (Generally Recognized As Safe). The quality and quantity of scientific evidence required for a substance to achieve GRAS status are the same as are necessary for it to be approved by FDA as a food additive.

GRAS status is based on consensus among the community of relevant scientists as to the ingredient’s safety for its intended use; it is not granted by the FDA. Based on evidence of safety that is generally recognized by qualified experts, any person (or organization) may notify the FDA of its determination that a particular use of a substance is GRAS. If the FDA has no questions regarding that determination after reviewing the relevant research, it issues a no objection letter. In the U.S., rebiana, a natural zero-calorie sweetener from stevia leaves, has GRAS status.

Estimated Intakes

According to the American Dietetic Association Evidence Analysis Library (ADA 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 ADI.*

With regards to intakes of other low- and no-calorie sweeteners, the ADA 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.

Related References

Aspartame: a safety evaluation based on current use levels, regulations, and toxicological and epidemiological studies. Magnuson BA, Burdock GA, Doull J, Kroes RM, Marsh GM, Pariza MW, Spencer PS, Waddell WJ, Walker R, Williams GM. Critical Reviews in Toxicology, 2007; 37:629-727.

American Dietetic Association Evidence Analysis Library on Non-Nutritive Sweeteners. The American Dietetic Association.
http://www.adaevidencelibrary.com/

Position of the American Dietetic Association: Use of Nutritive and Nonnutritive Sweeteners. Journal of the American Dietetic Association 2004; 255-275. www.eatright.org

Artificial Sweeteners and Cancer. National Cancer Institute.
www.cancer.gov

European Commission, Health and Consumer Protection Directorate (2002). Opinion of the Scientific Committee on Food: Update on the Safety of Aspartame.
http://europe.eu.int/comm/food/fs/sc/scf/out155_en.pdf

European Food Safety Authority. Question number EFSA-Q-2005-122. The EFSA Journal, (2006), v 356, p 1-44
http://www.efsa.eu.int/science/afc/afc_opinions/1471_en.html

FDA, HHS. Artificial Sweeteners: No Calories…Sweet! FDA Consumer Magazine. July-August 2006. Internet:
http://www.fda.gov/fdac/features/2006/406_sweeteners.html

French Food Safety Agency (2002). Assessment Report.
http://www.aspartame.org/pdf/AFSSA-Eng.pdf

Low calorie sweeteners and other sugar substitutes: A review of the safety issues. Kroger M, Meister K, Kava R. Comprehensive Reviews in Food Science and Food Safety. 2006; 5:35-47.
http://members.ift.org/NR/rdonlyres/DA941122-00F5-49AA-8BC3-27E32F80B746/0/crfsfsv5n2p3547.pdf

“Artificial Sweeteners and Cancer: Questions and Answers.” National Cancer Institute (NCI) Fact Sheet. Revised 10/2006.
http://www.cancer.gov/cancertopics/factsheet/Risk/artificial-sweeteners

Gestational Diabetes and Low-Calorie Sweeteners: Answers to Common Questions. International Food Information Council Foundation. November 2004.
www.foodinsight.org

IFIC Review, Low-Calorie Sweeteners and Health. International Food Information Council Foundation. October 2000.
www.foodinsight.org

Questions and Answers about Acceptable Daily Intake. International Food Information Council. Internet:
www.foodinsight.org/Resources/Detail.aspx?topic=Questions_and_Answers_About_Acceptable_Daily_Intake_