U.S. · Food additives · 21 CFR 180.37
Saccharin in food.
21 CFR 180.37 lists saccharin, ammonium, calcium and sodium saccharin with per-ounce, per-teaspoon and per-serving limits and labeling requirements.
21 CFR 180.37 covers saccharin, ammonium saccharin, calcium saccharin and sodium saccharin as sweetening agents, with limits calculated as saccharin: 12 mg per fluid ounce in beverages, fruit juice drinks and bases or mixes, 20 mg per teaspoonful of sugar sweetening equivalency in sugar substitutes for cooking or table use, and 30 mg per serving in processed foods, for a valid special dietary purpose. It also lists three technological uses and requires labeling of the additive and finished food. The printed paragraph (c) ties the section's authority to a later order, so confirm current status.
Check an amount against the listed maximum
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What 21 CFR 180.37 covers
Section 180.37 sits in part 180 of Title 21, "Food additives permitted in food or in contact with food on an interim basis pending additional study." It names four additives: saccharin, ammonium saccharin, calcium saccharin and sodium saccharin. The opening sentence says they "may be safely used as sweetening agents in food in accordance with the following conditions, if the substitution for nutritive sweeteners is for a valid special dietary purpose and is in accord with current special dietary food regulations and policies or if the use or intended use is for an authorized technological purpose other than calorie reduction." The text on this page is the eCFR version current through October 29, 2026, with a section history running from 42 FR 14636 (March 15, 1977) to 78 FR 71467 (November 29, 2013).
Identity and specifications: (a) and (b)
- (a) Saccharin is the chemical 1,2-benzisothiazolin-3-one-1,1-dioxide (C7H5NO3S). The named salts are produced by neutralizing saccharin with the proper base to yield the desired salt.
- (b) The additives meet the specifications of the Food Chemicals Codex, 7th ed. (2010), pages 52 to 54, 153 to 154, 898 to 899 and 961 to 962, incorporated by reference.
A sunset-style paragraph: (c)
Paragraph (c) reads: "Authority for such use shall expire when the Commissioner receives the final reports on the ongoing studies in Canada and publishes an order on the safety of saccharin and its salts based on those reports and other available data." The section as printed still contains this paragraph and the conditions below it. This page only reports the printed text; it does not say what FDA has since done with the underlying authority, and a reader who needs the current legal position should check the regulation in force and ask FDA or counsel.
Special dietary uses: paragraph (d)
Paragraph (d) says the additives are used or intended for use "as a sweetening agent only in special dietary foods," in three situations. Every limit is calculated as saccharin.
| Use | Maximum | Paragraph |
|---|---|---|
| Beverages, fruit juice drinks, and bases or mixes when prepared for consumption in accordance with directions | 12 milligrams per fluid ounce | (d)(1) |
| Sugar substitute for cooking or table use | 20 milligrams for each expressed teaspoonful of sugar sweetening equivalency | (d)(2) |
| Processed foods | 30 milligrams per serving of designated size | (d)(3) |
Technological uses: paragraph (e)
Separately from the special dietary uses, paragraph (e) lists three technological purposes for which the additives may be used:
- (e)(1) To reduce bulk and enhance flavors in chewable vitamin tablets, chewable mineral tablets, or combinations of them.
- (e)(2) To retain flavor and physical properties of chewing gum.
- (e)(3) To enhance flavor of flavor chips used in nonstandardized bakery products.
Labeling: paragraph (f)
Paragraph (f) starts "To assure safe use of the additives, in addition to the other information required by the Act" and has two parts.
- Additive and intermediate mix labels (f)(1): the name of the additive; a statement of its concentration, expressed as saccharin, in any intermediate mix; and adequate directions for use to give a final food that complies with the limits in paragraphs (d) and (e).
- Finished food labels (f)(2): the name of the additive; and the amount of the additive, calculated as saccharin: in milligrams per fluid ounce for beverages, in milligrams per dispensing unit for cooking or table use products, and for processed foods in terms of the weight or size of a serving, which is that quantity of food containing 30 milligrams or less of the additive.
- Calorie reduction (f)(2)(iii): when the additive is used for calorie reduction, such other labeling as part 105 of Title 21 requires.
Worked example
A drink mix, prepared as directed, contains 10 milligrams of saccharin in each fluid ounce. Against (d)(1) the limit is 12 milligrams per fluid ounce, so 10 is within it and 14 would not be. The label of that finished product would also need to state the amount in milligrams per fluid ounce under (f)(2)(ii)(a). A table-top packet is measured differently: the comparison is milligrams of saccharin per teaspoonful of sugar sweetening equivalency, with 20 as the ceiling. Convert any salt to its saccharin content first, as the section says the amounts are "calculated as saccharin."
Limits of this page
This page is a reading of one printed section. It does not decide whether a particular product qualifies as a special dietary food, does not read part 105, and does not evaluate any other rule on warnings or sweetener claims. It cannot tell you whether the conditions in 180.37 are the right route for your product today.
Sources
Sources opened and read November 2, 2026.
Frequently asked questions
What does 21 CFR 180.37 cover?
Saccharin, ammonium saccharin, calcium saccharin and sodium saccharin as sweetening agents in special dietary foods and for listed technological purposes.
What are the saccharin limits in 180.37(d)?
12 mg per fluid ounce in beverages, fruit juice drinks and bases or mixes; 20 mg per teaspoonful of sugar sweetening equivalency in sugar substitutes for cooking or table use; 30 mg per serving in processed foods; all calculated as saccharin.
Which technological uses does the section allow?
Reducing bulk and enhancing flavor in chewable vitamin or mineral tablets, retaining flavor and physical properties of chewing gum, and enhancing flavor of flavor chips in nonstandardized bakery products (180.37(e)).
What must the finished food label show?
The name of the additive and the amount calculated as saccharin: mg per fluid ounce for beverages, mg per dispensing unit for cooking or table use products, and a serving of 30 mg or less for processed foods (180.37(f)(2)).
What does paragraph (c) of 180.37 say?
That authority for the use expires when the Commissioner receives final reports on the ongoing studies in Canada and publishes an order on the safety of saccharin and its salts based on them.
Which food chemicals specifications apply?
Food Chemicals Codex, 7th ed. (2010), pages 52 to 54, 153 to 154, 898 to 899 and 961 to 962, incorporated by reference (180.37(b)).
Does this page tell me whether saccharin is safe?
No. It reports the printed regulation. For health questions ask a clinician, and for current regulatory status check FDA or counsel.
Not legal or compliance advice
This page is general information drawn from the sources listed, not legal, tax or compliance advice, and it is not run by any government agency. Rules, forms and dates change and your agency, base jurisdiction or enforcement officer decides your case, so confirm with the office named on this page before you rely on it. Everything runs in your browser; nothing you enter is sent anywhere.