Acesulfame potassium

Acesulfame potassium is a calorie-free sweetener that has been used in foods and beverages around the world for 15 years. The ingredient, which is 200 times sweeter than sugar, has been used in numerous foods in the United States since 1988. In the U.S., it is used in such products as candies, baked goods, frozen desserts, beverages, dessert mixes and tabletop sweeteners. Acesulfame potassium, which is also known as acesulfame K, is often used in combination with other low-calorie sweeteners because it enhances the sweet taste of foods and beverages.

The Acceptable Daily Intake or ADI of 15 milligrams per kilogram body weight per day (mg/kg bw/d) or 900 mg per person per day (mg/p/d) was established for Acesulfame potassium as a result of FDA's review of FAP 2A3659 (53 FR 28379, July 28, 1988), which resulted in the agency's initial approval of Acesulfame potassium in several food categories. The ADI is the level of consumption that has been determined to be safe for human consumption every day over an entire lifetime. The present petition does not contain any new information that would cause FDA to alter this previously determined ADI for Acesulfame potassium.

FDA's review of the petitions submitted subsequent to FAP 2A3659 involved primarily the following factors:

  1. An assessment of the estimated exposure from each additional use; and
  2. A determination of whether the cumulative estimated exposure, including the newly requested use, would cause the ADI for Acesulfame potassium to be exceeded over a lifetime by individuals who consume Acesulfame potassium at high levels.

In its evaluation of Acesulfame potassium for use in nonalcoholic beverages, including beverage bases, FDA also assessed the safety from exposure to acetoacetamide-N- sulfonic acid (AAS) and acetoacetamide (AAA), the two principal hydrolysis products of Acesulfame potassium (63 FR 36344 at 36346 to 36355, July 6, 1998).

Acesulfame potassium is a calorie-free artificial sweetener, also known as Acesulfame K or Ace K, which was discovered in 1967 by Hoechst AG.

Acesulfame potassium is the potassium salt of 6-methyl-1,2,3- oxathiazine-4(3H)-one-2,2-dioxide and the potassium salt of 3,4-dihydro-6-methyl-1,2,3-oxathiazin-4-ONE-2,2-dioxide

Acesulfame K is about 200 times sweeter than sucrose (table sugar) with a slightly bitter flavor when used in large quantities. Unlike aspartame, it is stable under heat, allowing it to be used in baking. Acesulfame K is often used in combination with aspartame or other sweeteners because it has a synergistic effect of enhancing and sustaining the sweetness of foods and beverages. This artificial sweetener is white crystalline powder with molecular formula of C4H4NO4KS and molecular weight of 201.24.

Acesulfame K was first approved by the FDA on July 6, 1988. In December of 2003 a general approval was granted. Safety of usage of Acesulfame K was also examined by JECFA, with the conclusion that Acesulfame K is safe to use. This examination also established an ADI of 15 mg/kg of body weight.

The Scientific Committee for Food of the European Union published a comprehensive assessment of sweetening agents in 1985. This committee of toxicological experts from the EU member countries accepted Acesulfame K for use in foods and beverages. Acesulfame K has been used in Europe since 1983 and in the U.S. since 1988.

Some individuals and organizations suggest that artificial sweeteners, such as Acesulfame K and aspartame, pose severe health risks. In this case, most studies show that Acesulfame K is not metabolized by the human body; rather, it is rapidly absorbed and then excreted unchanged, causing no adverse effects in the process.

Popular products containing acesulfame K include Pepsi One/Pepsi Max, Trident gum, and sugarfree Jell-O. Acesulfame K is sold under the brand names Sunett™ and Sweet One. In diet sodas it is almost always used in conjunction with another sweetener, such as aspartame or sucralose

  

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