Acesulfame potassium in food.

What 21 CFR 172.800 covers

Section 172.800 is in part 172 of Title 21, food additives permitted for direct addition to food for human consumption. It is short: an opening authorization and three paragraphs. The eCFR version on this page is current through October 29, 2026. Its history line starts at 53 FR 28382 (July 28, 1988) and ends at 88 FR 17720 (March 24, 2023). This page reports the printed text only.

The authorization

The opening sentence says the additive "may be safely used as a general-purpose sweetener and flavor enhancer in foods generally, except in meat and poultry, in accordance with current good manufacturing practice and in an amount not to exceed that reasonably required to accomplish the intended technical effect in foods for which standards of identity established under section 401 of the Federal Food, Drug, and Cosmetic Act do not preclude such use." Three conditions are packed into that sentence: the exclusion of meat and poultry, the good manufacturing practice and technical effect standard, and the dependence on standards of identity. Compare this with the polysorbate 80 section, which prints a numeric maximum for each permitted use. Section 172.800 prints no per-food numeric cap; the quantity limit is the technical-effect language.

Reading the three conditions one at a time

• Meat and poultry excluded. The permission is for foods generally "except in meat and poultry." A formulator working on a meat or poultry product cannot rely on this section for the sweetener.
• Good manufacturing practice and technical effect. The amount may not exceed what is "reasonably required to accomplish the intended technical effect." In practice this turns on the purpose the sweetener serves in the food, which a spec sheet or lab report does not show.
• Standards of identity. The permission applies to foods for which a section 401 standard of identity "do[es] not preclude such use." A standardized food whose standard does not list the sweetener is a separate question that this page cannot answer.

Taken together, the opening sentence is a permission with built-in limits rather than a table of amounts. That is a different shape from sections that give a maximum for each use, and it is why a checker for this additive can only test the specifications in paragraph (b).

Identity and specifications: (a) and (b)

• (a) Identity. Acesulfame potassium is the potassium salt of 6-methyl-1,2,3-oxathiazine-4(3H)-one-2,2-dioxide.
• (b)(1) Purity. Not less than 99 percent on a dry basis, determined by a method titled "Acesulfame Potassium Assay," which is incorporated by reference. The section says where copies are available, including from FDA's Office of Food Additive Safety and for inspection at the National Archives.
• (b)(2) Fluoride. Not more than 30 milligrams per kilogram, as determined by method III of the Fluoride Limit Test of the Food Chemicals Codex, 7th ed. (2010), p. 1151, which is incorporated by reference.

Labeling: paragraph (c)

If the food containing the additive is represented to be for special dietary uses, it must be labeled in compliance with part 105 of Title 21. The section does not itself print a name or concentration statement of the kind found in some other additive sections. How the additive is named on an ordinary ingredient list is governed separately by the ingredient labeling rules of 101.4.

Worked example

A supplier reports a lot at 99.4 percent purity on a dry basis and 12 mg/kg fluoride. Purity of 99.4 is not less than 99, and 12 is not more than 30, so both reported values are within the printed specifications. A lot at 98.8 percent purity would not meet (b)(1), and one with 31 mg/kg fluoride would not meet (b)(2), even if the other value is fine. Two details matter in practice: the purity value is on a dry basis, so a result reported on an as-is basis is not directly comparable, and the fluoride value must come from the Food Chemicals Codex method named in the section. The checker only compares numbers you enter.

What the checker and page do not cover

The page does not tell you how much acesulfame potassium a product may contain, because the section expresses that as good manufacturing practice and technical effect rather than a number. It does not test whether a given food has a standard of identity that precludes the use, does not interpret part 105, and does not apply the separate regulations for foods containing meat or poultry. It reports no safety conclusion. For a real product, confirm with the full regulation and FDA or a qualified food regulatory professional.

Sources

Sources opened and read November 2, 2026.

• eCFR: 21 CFR 172.800, Acesulfame potassium (current through October 29, 2026) (read November 2, 2026)
• eCFR: 21 CFR part 172, Food additives permitted for direct addition to food for human consumption (read November 2, 2026)