Excipient (pharmacologically inactive substance)
What is it?
Acesulfame potassium, or acesulfame K (Sunett, Sweet One, TwinSweet) is a non-nutritive sweetener that is 200 times more sweet than sugar but has zero caloric content. The US Food and Drug Administration (FDA) classifies six non-nutritive sweeteners (NNS) as food additives, including saccharin, aspartame, acesulfame K, sucralose, neotame, advantame, stevia glycosides, and luo han guo fruit (monk fruit) extracts.[1] 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 K is approved by the FDA as a sweetener and flavor enhancer in foods generally (except in meat and poultry). It may be found listed on food labels as acesulfame K, acesulfame potassium, or Ace-K. Acesulfame K may also be added to other non-nutritive sweeteners to extend the sweetness profile and help lower any aftertaste.
In the US, non-nutritive sweeteners, with the exception of saccharin, are not required to be listed on food or drink labels unless a threshold amount per serving is reached.[1]
Acesulfame K has an acceptable daily intake (ADI) for use in food products of 15 mg/kg of body weight per day, which is equal to about 23 tabletop packets of sweetener (for a 60 kg [132 pound] person), according to the FDA.[2] The ADI is defined as the estimated amount that a person can safely consume on average every day over a lifetime without risk. Potassium (K) makes up 20% of the compound by weight.[1] The FDA states, “generally, an additive does not present safety concerns if the estimated daily intake is less than the ADI.”[3]
The Joint FAO/WHO Expert Committee on Food Additives (JECFA), an international committee administered jointly by the Food and Agriculture Organization of the United Nations (FAO) and the World Health organization (WHO), sets a lower acceptable daily intake (ADI) of acesulfame K at 9 mg/kg of body weight per day.[1]
Acesulfame K is also used as an inactive ingredient in approved drug products. The Maximum Daily Exposure (MDE) for drug products varies by dose form and ranges from 5 mg to 400 mg. MDE is the total amount of the excipient (inactive ingredient) that would be taken or used in a day based on the maximum daily dose (MDD) of the drug products in which it is used.[4][5] Inactive ingredients are typically listed in the inactive ingredient list of drug products in the package insert. Ask your pharmacist if you need help determining if any inactive ingredient or additive is present in any drug product.
The FDA first approved acesulfame as a food / beverage additive in 1988. It is approved for use in foods (except meat / poultry), alcoholic and non-alcoholic beverages, carbonated beverages, as an inactive ingredient in medications, and as a general purpose sweetener. The FDA considers acesulfame safe for use within the specified limits. It is heat stable at high temperatures during baking and is a suitable sugar substitute in baked goods. Acesulfame potassium is typically used in frozen desserts, candies, beverages, and baked goods like cakes, pies and breads.[2]
Acesulfame is not metabolized in the body, but there has been a case report of sensitivity to the sulfur moiety (SO3) found in its chemical structure.[6] People with a history of sulfa or sulfonamide allergies should speak to their healthcare provider about the risk of sensitivity reactions with acesulfame. If you think you are having a side effect or severe allergy like anaphylaxis caused by consuming a high-intensity sweetener like acesulfame, stop consuming it and speak to your healthcare provider immediately or call 911 for emergency medical services.
It is not known if replacing sugar with non-nutritive sweeteners like acesulfame can reverse any negative health consequences. Additionally, controversy exists around the possible risk of non-nutritive sweetener effects on the gut microbiome, obesity, gastrointestinal side effects like diarrhea, and other safety concerns. If you have a bowel disorder or are undergoing bariatric surgery speak to your healthcare provider about whether you should avoid non-nutritive sweeteners.[1][7]
Refs:
[1] Heuberger R (author). Overview of non-nutritive sweeteners. Up to Date. Updated: Sep 13, 2022. Accessed Feb. 27, 2023 at https://www.uptodate.com/contents/overview-of-non-nutritive-sweeteners
[2] Additional Information about High-Intensity Sweeteners Permitted for Use in Food in the United States. The US Food and Drug Administration (FDA). 02/08/2018. Accessed Feb 27, 2023 at https://www.fda.gov/food/food-additives-petitions/additional-information-about-high-intensity-sweeteners-permitted-use-food-united-states
[3] High intensity sweeteners. The US Food and Drug Administration (FDA).12/19/2017. Accessed Feb 27, 2023 at https://www.fda.gov/food/food-additives-petitions/high-intensity-sweeteners
[4] Inactive Ingredient Search for Approved Drug Products. The US Food and Drug Administration (FDA). Last Updated: January 26, 2023. Accessed Feb 27, 2023 at https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm
[5] Inactive Ingredients in Approved Drug Products Search: Frequently Asked Questions. The US Food and Drug Administration (FDA). Updated 01/26/2022. Accessed Feb. 27, 2023 at https://www.fda.gov/drugs/drug-approvals-and-databases/inactive-ingredients-approved-drug-products-search-frequently-asked-questions
[6] Stohs SJ, Miller MJ. A case study involving allergic reactions to sulfur-containing compounds including, sulfite, taurine, acesulfame potassium and sulfonamides. Food Chem Toxicol. 2014 Jan;63:240-3. doi: 10.1016/j.fct.2013.11.008
[7] Bian X, Chi L, Gao B, Tu P, Ru H, Lu K. The artificial sweetener acesulfame potassium affects the gut microbiome and body weight gain in CD-1 mice. PLoS One. 2017 Jun 8;12(6):e0178426. doi: 10.1371/journal.pone.0178426
