FDA Response to External Safety Reviews of Aspartame
The FDA is aware of the International Agency for Research on Cancer (IARC) and Joint FAO/WHO Expert Committee on Food Additives (JECFA) conclusions about aspartame issued July 14, 2023. Aspartame being labeled by IARC as "possibly carcinogenic to humans" does not mean that aspartame is actually linked to cancer.
The FDA disagrees with IARC’s conclusion that these studies support classifying aspartame as a possible carcinogen to humans. FDA scientists reviewed the scientific information included in IARC’s review in 2021 when it was first made available and identified significant shortcomings in the studies on which IARC relied. We note that JECFA did not raise safety concerns for aspartame under the current levels of use and did not change the Acceptable Daily Intake (ADI).
Aspartame is one of the most studied food additives in the human food supply. FDA scientists do not have safety concerns when aspartame is used under the approved conditions. The sweetener is approved in many countries. Regulatory and scientific authorities, such as Health CanadaExternal Link Disclaimer and the European Food Safety AuthorityExternal Link Disclaimer have evaluated aspartame and also consider it safe at current permitted use levels.
Some consumers may rely on products with aspartame and other sweeteners to help reduce their sugar consumption. We recognize that navigating different information from health organizations is challenging. We will continue to provide reliable, science-based information on aspartame and other sweeteners on the FDA’s web site to help consumers make informed choices.
Sweeteners or sugar substitutes, such as aspartame, sucralose, and stevia derived substances, are ingredients used to sweeten and in some cases enhance the flavor of foods. Some sweeteners are much sweeter than table sugar, and smaller amounts are needed to achieve the same level of sweetness as sugar in food. People may choose to use sweeteners instead of sugar for various reasons. For example, sweeteners contribute only a few or no calories to the diet and generally will not raise blood sugar levels.
Sweeteners are widely used in foods and beverages marketed as "sugar-free" or "diet," including baked goods, soft drinks, powdered drink mixes, candy, puddings, canned foods, jams and jellies, dairy products, and many other foods and beverages. Consumers can identify whether a product has a sweetener by looking for the sweetener’s name in the ingredient list on the product label.
By law, like all other ingredients added to food in the U.S., sweeteners must be safe for consumption. Companies are responsible for ensuring the regulatory status and safety of the ingredients in their products before marketing. Under its legal authorities, the FDA administers pre-market regulatory programs that assist companies in meeting their obligations. To market a new food additive or before using a food additive in a different way than how the FDA has currently approved it, a manufacturer or other sponsor must first seek approval from the FDA by submitting a food additive petition. Under the law, certain ingredients do not require pre-market food additive approval by FDA, for example, if they are generally recognized as safe (GRAS) by qualified experts. If a company concludes that the specific use of a sweetener is GRAS, they may submit their information to the FDA through the FDA’s GRAS Notification Program. Information about the regulatory status of sweeteners is available in the Code of Federal Regulations and the FDA’s public GRAS Notice Inventory and Substances Added to Food (formerly EAFUS) Inventory.
The FDA continues to monitor the latest science available on sweeteners in a variety of ways. FDA scientists reassess the science about the exposure and safety of a sweetener each time the agency files a food additive petition or a GRAS notice for that sweetener. We also stay abreast of published literature and the current level of consumer exposure and participate in international scientific and standard-setting activities related to food ingredient safety.
Sweeteners Authorized as Food Additives in the U.S.
Based on the available scientific evidence, sweeteners authorized by the FDA are safe for the general population under certain conditions of use. There are food additive listings for six sweeteners, including:
Plant and Fruit Based Sweeteners
In addition to the six sweeteners listed as food additives, the agency evaluated GRAS notices and has no questions about the GRAS conclusions for three types of plant and fruit-based high-intensity sweeteners:
Sweetness Intensity of Sweeteners Compared to Table Sugar
The image below shows the sweetness intensity of sweeteners compared to table sugar or sucrose.
Download in PDF 82KB
Safe Levels of Sweeteners
The FDA assesses the safety of a sweetener by evaluating the available safety information about the sweetener to identify potential hazards and determine a safe level of exposure. During pre-market review, the FDA established an acceptable daily intake (ADI) level for each of the six sweeteners approved as food additives. An ADI is the amount of a substance considered safe to consume each day over the course of a person’s lifetime. The ADI is typically based on evaluating toxicological studies to determine the highest appropriate experimental exposure dose level in animal studies that was shown to cause no adverse effect, multiplied by an appropriate safety factor. In general, a safety factor is intended to provide an adequate margin of safety for consumers by accounting for variability, such as differences between animals and humans and differences in sensitivity among humans.
For each of these sweeteners, the FDA determined that the estimated daily intake of the substance would not exceed the ADI, even when considering high exposure estimates. An additive does not pose safety concerns if the estimated daily intake is less than the ADI. In the case of steviol glycosides, an ADI was established by the Joint Food and Agricultural Organization/World Health Organization Expert Committee on Food Additives (JECFA). An ADI has not been specified for monk fruit or thaumatin. An ADI may not be necessary for several reasons, including evidence of the ingredient's safety at levels well above the amounts needed to achieve the desired effect (such as sweetening) in food.
The chart below shows the safe limit for each sweetener and the amount a person would need to consume to equal that limit based on its sweetness intensity.
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Other Types of Sweeteners Allowed in the U.S.
The FDA permits the use of sugar alcohols, another class of sweeteners, as sugar substitutes. Examples include sorbitol, xylitol, lactitol, mannitol, erythritol, and maltitol. The sweetness of sugar alcohols varies from 25% to 100% as sweet as sugar. Sugar alcohols are slightly lower in calories than sugar and do not promote tooth decay or cause a sudden increase in blood glucose. They primarily sweeten sugar-free candies, cookies, and chewing gums.
Another class of sweeteners are sugars that are metabolized differently than traditional sugars. These sugars meet the chemical definition of a sugar, but they are metabolized, or used by the body, differently than traditional sugars like sucrose. The FDA has evaluated GRAS notices for D-allulose (also referred to as D-psicose), D-tagatose, and isomaltulose and has no questions about the GRAS conclusions under certain intended conditions of use. The FDA’s response letters on D-allulose (also referred to as D-psicose), D-tagatose, and isomaltulose are available at the agency’s GRAS Notice Inventory website.
Sweeteners that are Not Allowed in the U.S.
The FDA prohibits the use of cyclamates and their salts (such as calcium cyclamate, sodium cyclamate, magnesium cyclamate, and potassium cyclamate) in the U.S. Whole-leaf and crude stevia extracts are subject to an Import Alert. They are also not permitted for use as sweeteners. These forms of stevia differ from certain highly purified steviol glycosides obtained from stevia leaves, which have been the subjects of GRAS notices; the FDA has not objected to the use as sweeteners of these highly refined substances.
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