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Medically reviewed by Last updated on Apr 26, 2022.

Excipient (pharmacologically inactive substance)

What is it?

The most common artificial sweeteners available in the U.S. include acesulfame potassium, aspartame, neotame, saccharin, sucralose and stevia glycosides. Consumers may choose these products to lower the risk of tooth decay, manage or help lose weight, or use in the management of diabetes.

Acesulfame potassium, or acesulfame (Sunett, Sweet One) is an artificial sweetener that is 200 times more sweet than sugar but has zero caloric content. Acesulfame has an acceptable daily intake (ADI) of 15 mg/kg of body weight per day. The ADI is defined as the estimated amount that a person can safely consume on average every day over a lifetime without risk. It is estimated that the average daily intake is about 20 percent of the ADI. Acesulfame is not metabolized in the body.

Roughly 90 countries permit the use of acesulfame - the U.S. Food and Drug Administration approved it in 1988. It is approved for use in foods, alcoholic and non-alcoholic beverages, carbonated beverages, and as a general purpose sweetener. The FDA considers acesulfame safe for use within the specified limits based on multiple safety studies, and no human health problems have been reported despite 15 years of extensive use.[1][2]

Top medications with this excipient


  1. Kroger M, Meister K, Kava R. Low calorie sweeteners and other sugar substitutes: A review of the safety issues. Comprehensive Revews in Food Science and Food Safety 2006.Vol. 5:35-47 Accessed 8/20/2012.
  2. NTP toxicology studies of acesulfame potassium (CAS No. 55589-62-3) in genetically modified (FVB Tg.AC Hemizygous) mice and carcinogenicity studies of acesulfame potassium in genetically modified [B6.129-Trp53 (tm1Brd) (N5) Haploinsufficient] mice (feed studies). Natl Toxicol Program Genet Modif Model Rep. 2005 Oct;(2):1-113. Accessed 8/20/2012 mice.

Further information

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