What is the acceptable daily intake of sodium cyclamate?

December 16, 2025 •

3 min read

The Acceptable Daily Intake (ADI) for cyclamate has been set at different levels by global food safety organizations. This variation highlights the different safety considerations across international bodies and is a key topic for consumers.

Quick Summary

The acceptable daily intake for sodium cyclamate is a complex issue, with global regulatory bodies like JECFA and EFSA establishing different safe consumption limits, while the U.S. FDA maintains a ban on the sweetener based on historical studies and precautionary principles.

Key Points

Varied ADI: The acceptable daily intake for cyclamate differs globally, with JECFA setting 11 mg/kg bw and EFSA setting 7 mg/kg bw.
U.S. Ban: Sodium cyclamate is banned in the United States by the FDA, a decision based on a controversial 1969 animal study and the Delaney Clause.
Safe Consumption Levels: The ADI is a conservative estimate of the amount that can be consumed daily over a lifetime without adverse effects.
Metabolism Factor: Some individuals metabolize cyclamate into cyclohexylamine, a consideration factored into regulatory safety assessments.
Approved Use: Despite the U.S. ban, cyclamate is an approved sweetener in over 50 countries, including the EU, Canada, and Australia.
High Consumer Risk: Regulators in some regions note that high consumers, such as diabetics or those consuming large quantities of diet drinks, risk exceeding the ADI.

Understanding the Acceptable Daily Intake (ADI)

The Acceptable Daily Intake (ADI) is a crucial concept in food safety, representing the maximum amount of a substance, such as a food additive, that can be consumed daily over a lifetime without posing an appreciable health risk. This value is not an absolute threshold of danger, but rather a conservative estimate established by expert committees using extensive scientific data. The process involves several steps:

Data Collection: Gathering all available toxicological, biochemical, and animal study data on the substance.
Determining the No-Observed-Adverse-Effect Level (NOAEL): Identifying the highest dose level in animal studies where no adverse health effects are observed.
Applying Safety Factors: Dividing the NOAEL by a safety factor, typically 100, to account for differences between humans and animals, and individual variations within the human population.
Setting the ADI: The final number, often expressed in milligrams per kilogram of body weight per day (mg/kg bw/day), is the ADI.

This methodical approach ensures that even sensitive individuals consuming a substance regularly remain within a safe margin.

Differing ADI Values and Global Regulations

For sodium cyclamate, a synthetic non-caloric sweetener, the ADI has been a subject of different regulatory conclusions, leading to varying standards across the world.

JECFA and EFSA: A Comparative Look

International and European bodies have set different ADI values for cyclamate. JECFA established an ADI of 0-11 mg/kg bw, expressed as cyclamic acid. A reassessment by the European SCF in 2000 led to an ADI of 7 mg/kg bw.

Regulatory Status by Country/Region

Acceptance and maximum use levels differ significantly by region. The U.S. FDA banned cyclamate in 1970, while the European Union (EFSA) approves its use with an ADI of 7 mg/kg bw. Canada approves it for tabletop use with an ADI of 11 mg/kg bw, and Australia and New Zealand also approve it for specific foods using the 11 mg/kg bw ADI, noting risks for high consumers like children. These differences are influenced by varying interpretations of scientific data.

The Case of the U.S. Ban

The U.S. FDA's ban in 1970 followed a controversial 1969 study suggesting a link between high cyclamate/saccharin doses and bladder tumors in rats. The Delaney Clause also played a role. While subsequent studies haven't consistently replicated these findings and JECFA deems it safe within limits, the FDA ban remains despite re-approval petitions.

Metabolic Considerations and Safety

Some individuals' gut bacteria convert cyclamate into cyclohexylamine. This metabolite is considered in safety assessments, and ADI values from JECFA and EFSA account for this.

Conclusion

The acceptable daily intake of sodium cyclamate varies internationally due to different regulatory decisions. While JECFA and EFSA find it safe within their specified limits (11 mg/kg bw and 7 mg/kg bw), the U.S. FDA maintains a ban based on a historical animal study. This creates varied regulations globally. In countries where approved, adhering to the ADI is crucial for safe consumption. High consumers should be mindful of intake from products like diet soft drinks and tabletop sweeteners. Re-evaluations continue, reflecting the dynamic nature of food safety. For more on ADI methodology, see the {Link: World Health Organization https://www.who.int/news-room/fact-sheets/detail/food-additives}.

Frequently Asked Questions

The ADI for cyclamate varies by region, with the Joint FAO/WHO Expert Committee on Food Additives (JECFA) setting it at 11 mg/kg of body weight, and the European Food Safety Authority (EFSA) setting it at 7 mg/kg of body weight.

No, sodium cyclamate is currently banned in the United States by the Food and Drug Administration (FDA).

The ban followed a 1969 study that suggested a link between high doses of cyclamate and bladder tumors in rats, prompting action under the Delaney Clause.

The ADI is based on a conservative evaluation of toxicological data from animal studies, using a safety factor to account for differences between species and human variability.

Exceeding the ADI is not an immediate health risk, but it indicates a potential for harm with consistent overconsumption over a lifetime. Regulatory bodies set the ADI well below any level of observed harm.

Sodium cyclamate is used as a non-caloric sweetener in many products outside the U.S., such as soft drinks, tabletop sweeteners, desserts, and canned fruits.

Concerns include the metabolic conversion into cyclohexylamine in some individuals and the potential for high consumers, such as children or diabetics, to exceed the ADI in certain regions.