FDA refusal charge CYCLAMATE: cyclamate
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The CYCLAMATE charge appeared in 37 FDA import refusals between 2020 and 2026 — 0.2% of the 19,123 refusals that identify a hazard. The origins cited most often are China, Russia, Thailand. The most-affected product category is Bakery Products, Doughs, Bakery Mixes, and Icings. Volume in 2025 was up 500% on 2024.
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What FDA's charge says
CYCLAMATE is the code FDA prints on a refusal; below is the charge language FDA publishes for it, quoted from its charge table, with the sections of the FD&C Act it cites.
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated because it appears to bear or contain an unsafe food additive that is unsafe within the meaning of Section 409.
The article appears to bear or contain cyclamate, an unsafe food additive within the meaning of Section 409
CYCLAMATE refusals by year
| Year | Refusals | YoY | |
|---|---|---|---|
| 2020 | 1 | — | |
| 2021 | 2 | +100.0% | |
| 2022 | 12 | +500.0% | |
| 2023 | 5 | -58.3% | |
| 2024 | 2 | -60.0% | |
| 2025 | 12 | +500.0% | |
| 2026 | 3 | — | YTD |
| Total | 37 |
Origins most often refused under CYCLAMATE
| # | Origin country | Refusals |
|---|---|---|
| 1 | China | 16 |
| 2 | Russia | 11 |
| 3 | Thailand | 4 |
| 4 | Myanmar | 3 |
| 5 | Pakistan | 2 |
| 6 | Ukraine | 1 |
Product categories refused under CYCLAMATE
| # | Product category | Refusals |
|---|---|---|
| 1 | Bakery Products, Doughs, Bakery Mixes, and Icings | 10 |
| 2 | Snack Food Items (Flour, Meal, or Vegetable Base) | 10 |
| 3 | Fruit and Fruit Products | 8 |
| 4 | Nuts and Edible Seeds | 2 |
| 5 | Vegetables and Vegetable Products | 2 |
| 6 | Beverage Bases | 1 |
| 7 | Fishery/Seafood Products | 1 |
| 8 | Food Sweeteners (Nutritive) | 1 |
| 9 | Ice Cream and Related Products | 1 |
| 10 | Soft Drinks and Waters | 1 |
Latest refusals citing CYCLAMATE
- EPS-2161423-3 MELON SEEDS (EDIBLE SEED)From China, Nuts and Edible Seeds. cyclamatenutrition labeling
- 9SB-0412626-9 PLUM, DRIED OR PASTEFrom China, Fruit and Fruit Products. cyclamate
- EVY-0059419-8 ICE CREAM, REGULAR, NOT VANILLA OR VANILLIN FLAVOREDFrom China, Ice Cream and Related Products. unsafe color additiveno net quantityno common nameingredients not listed+2 more
- BQL-0108928-1 RED CABBAGE (LEAF & STEM VEGETABLE)From Ukraine, Vegetables and Vegetable Products. cyclamate
- NMR-6730544-9 SNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.From China, Snack Food Items (Flour, Meal, or Vegetable Base). cyclamate
- BQL-0106537-2 BREAD STICKS (FLAVORED OR UNFLAVORED), BAKEDFrom Russia, Snack Food Items (Flour, Meal, or Vegetable Base). cyclamate
- B4S-1011134-0 BETEL NUT, PASTEFrom Pakistan, Nuts and Edible Seeds. unsafe food additivepoisonous substancecyclamate
- 8XG-0168359-8 PLUM, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIEDFrom Myanmar, Fruit and Fruit Products. cyclamate
- 8XG-0168029-7 PLUM, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIEDFrom Myanmar, Fruit and Fruit Products. poisonous or deleterious substancecyclamate
- NMR-6725753-3 SNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.From China, Snack Food Items (Flour, Meal, or Vegetable Base). cyclamate
- 277-0194806-2 MANGO (SUBTROPICAL AND TROPICAL FRUIT)From Thailand, Fruit and Fruit Products. cyclamatesaccharin labelingfalse or misleading labelingredients not listed+3 more
- K09-0095359-5 CAKE WITHOUT CUSTARD OR CREAM FILLINGFrom China, Bakery Products, Doughs, Bakery Mixes, and Icings. cyclamateinadequate process controlno acidified-food filingnutrition labeling+12 more
- K09-0094541-9 SOFT DRINK, MILK BASED (CHOCOLATE FLAVORED, ETC.), NONCARBONATEDFrom China, Soft Drinks and Waters. cyclamateno net quantityno common nameinadequate process control+7 more
- W69-5123236-3 PLUM, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIEDFrom Myanmar, Fruit and Fruit Products. unsafe color additiveingredients not listedcyclamatenot in English+6 more
- NMR-6720344-6 CRACKERS (NON FILLED) N.E.C.From China, Bakery Products, Doughs, Bakery Mixes, and Icings. not in Englishlabelingmelaminenutrition labeling+1 more
- BQL-0102684-6 BREAD STICKS (FLAVORED OR UNFLAVORED), BAKEDFrom Russia, Snack Food Items (Flour, Meal, or Vegetable Base). cyclamatesaccharin labeling
- ES6-4055125-6 BREAD/ROLLS/BUNS, N.E.C.From China, Bakery Products, Doughs, Bakery Mixes, and Icings. cyclamatepoisonous or deleterious substance
- 8BL-0019545-8 SYRUPS AND MOLASSES, N.E.C.From China, Food Sweeteners (Nutritive). cyclamate
- 9NK-0020703-3 OTHER BAKERY PRODUCTS, N.E.C.From China, Bakery Products, Doughs, Bakery Mixes, and Icings. cyclamateno net quantitynutrition labelingunsafe color additive+6 more
- 8PY-0022415-3 BEVERAGE BASE OF NON-FRUIT ORIGIN, LIQUID, N.E.C.From China, Beverage Bases. cyclamatecolor not declaredpreservative not declaredunsafe food additive
About CYCLAMATE
What does the FDA import refusal charge CYCLAMATE mean?
FDA uses CYCLAMATE for: cyclamate. Its published charge language reads: “The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated because it appears to bear or contain an unsafe food additive that is unsafe within the meaning of Section 409.”
Is CYCLAMATE a food safety finding?
Yes. This site counts CYCLAMATE as a hazard finding, so a refusal citing it is on the hazard side of the hazard and paperwork split, whatever else the refusal cites.
What happens to a shipment refused under CYCLAMATE?
Under section 801(a) of the FD&C Act a refused entry has to be exported or destroyed, normally within 90 days of the notice of refusal. Bringing a product into compliance, for instance by relabelling, is something the importer asks FDA for before the decision is final. The notice itself and FDA's guidance govern a particular case; this page describes the published data and is not legal advice.