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What Sweetener is Banned in the USA? The Full Story of Cyclamate

4 min read

In 1970, the US government banned cyclamate, a popular artificial sweetener at the time, following a controversial rat study that linked it to cancer. The decision sparked a major controversy and reshaped the landscape of artificial sweeteners in the United States, even though it remains permitted in more than 100 other countries.

Quick Summary

Cyclamate, an artificial sweetener, was banned in the U.S. in 1970 after animal studies suggested a link to cancer. Although many countries still allow it, the FDA's decision removed it from the American food supply. The ban highlighted regulatory differences regarding sweetener safety.

Key Points

  • Cyclamate Ban: The artificial sweetener cyclamate was banned in the U.S. in 1970 after animal studies linked it to cancer, based on the Delaney Clause.

  • International Discrepancy: Unlike the U.S., many other countries, including Canada and members of the European Union, permit the use of cyclamate within set safety limits.

  • Crude Stevia Restriction: Whole-leaf and crude extracts of the stevia plant are also banned for use as sweeteners in the U.S., though highly purified extracts are permitted as 'Generally Recognized as Safe' (GRAS).

  • Saccharin's Survival: Saccharin, which also faced controversy, was ultimately not banned in the U.S. after later studies found the original animal data irrelevant to human risk, leading to the removal of its warning label.

  • Common Approved Sweeteners: A range of FDA-approved sweeteners, including aspartame, sucralose, acesulfame potassium, and monk fruit extract, are widely available in the U.S. today.

  • Ongoing Regulatory Review: The FDA continues to review the safety of food additives and new scientific data, emphasizing that regulatory status can evolve based on evidence.

In This Article

The Cyclamate Ban: A Controversial History

The story of cyclamate is a prime example of how scientific evidence, public pressure, and legislation can profoundly impact the food supply. Discovered in 1937, cyclamate quickly gained popularity as a low-calorie alternative to sugar, particularly in diet sodas and canned fruits throughout the 1950s and 1960s. It was initially classified by the FDA in 1958 as 'Generally Recognized as Safe' (GRAS), but this status was revoked just over a decade later, in 1969.

The Study That Triggered the Ban

The ban was precipitated by a 1969 study by Abbott Laboratories, the primary producer of cyclamate. The study involved rats being fed a 10:1 mixture of cyclamate and saccharin, leading to the development of bladder tumors in some of the subjects. This finding, combined with the stringent requirements of the Delaney clause—a 1958 law mandating that any food additive found to cause cancer in humans or animals must be banned—led the FDA to act swiftly. Robert Finch, the Secretary of Health, Education, and Welfare, announced the ban in October 1969, with an effective date of February 1, 1970.

Subsequent Re-evaluations and International Status

Interestingly, the controversy did not end with the ban. Subsequent studies failed to conclusively replicate the original findings, and many health organizations and government bodies outside the U.S. have since approved its use. In countries like Canada and those within the European Union, cyclamate is still permitted within established acceptable daily intake (ADI) limits. There have been repeated petitions to the FDA for re-approval in the U.S., but as of today, they have not been successful, and the ban remains in place.

Other Restricted and Approved Sweeteners

While cyclamate is the most famous example of a sweetener banned in the U.S. for safety concerns, it is not the only one with regulatory nuances. It is also important to distinguish between outright banned additives and forms of sweeteners that are not permitted under specific conditions.

Restrictions on Stevia

It is a common misconception that stevia was once fully banned by the FDA. The reality is more nuanced. The ban was on whole-leaf and crude stevia extracts, which were not permitted for use as sweeteners because they lacked the necessary safety data. However, highly purified steviol glycosides from the stevia plant have been granted 'Generally Recognized as Safe' (GRAS) status by the FDA and are widely available in products like Truvia and PureVia.

The Complex Case of Saccharin

Saccharin, another non-caloric sweetener, also has a complex history with U.S. regulators. Concerns over potential carcinogenicity arose in the 1970s, similar to cyclamate. Congress intervened to prevent a full ban, instead requiring a warning label on products containing it. Years later, scientific re-evaluation determined that the mechanism causing bladder tumors in male rats was not relevant to humans, and the warning label requirement was eventually dropped. Saccharin is currently an FDA-approved food additive.

Understanding FDA-Approved Sweeteners

For consumers seeking non-sugar alternatives, understanding the FDA-approved options is crucial. The FDA regulates sweeteners as either food additives or substances that are 'Generally Recognized as Safe' (GRAS). Here are some of the most common FDA-approved sweeteners.

  • Acesulfame Potassium (Ace-K): Often used in conjunction with other sweeteners, it is approximately 200 times sweeter than sugar and is heat-stable.
  • Aspartame: Composed of two amino acids, it is about 200 times sweeter than sugar but is not heat-stable. It is famously found in Equal® and NutraSweet®.
  • Sucralose: Derived from sugar, sucralose is about 600 times sweeter than sugar and is heat-stable, making it suitable for baking. It is marketed as Splenda®.
  • Monk Fruit Extract: Extracts from the monk fruit are generally recognized as safe (GRAS) and are 100-250 times sweeter than sugar.
  • Sugar Alcohols: These include sorbitol, xylitol, and erythritol. They are carbohydrates that are less sweet than sugar and provide fewer calories, but can cause digestive issues in large amounts.

Comparison of Banned vs. Approved Sweeteners in the US

Feature Cyclamate (Banned) Sucralose (Approved) Aspartame (Approved) Saccharin (Approved)
Approval Status Banned in 1970 by the FDA FDA-approved since 1998 FDA-approved since 1974 FDA-regulated food additive
Reason for Regulation Linked to bladder cancer in high-dose animal studies under the Delaney clause Rigorous safety studies reviewed by FDA Requires PKU warning, safety reassessed numerous times Historical link to cancer in rats deemed irrelevant to humans
Relative Sweetness 30-50 times sweeter than sugar ~600 times sweeter than sugar ~200 times sweeter than sugar 200-700 times sweeter than sugar
Heat Stability Stable under heating Heat-stable Not heat-stable; breaks down when heated Heat-stable
International Status Approved in over 100 countries (e.g., Canada, EU) Approved globally, often used in baked goods Approved globally, common in diet sodas Approved in many countries, warning labels now removed in the US
Taste Profile Generally described as sweet, often blended with other sweeteners Sugar-like taste, no aftertaste Clean sweet taste, no aftertaste, but breaks down with heat Often has a metallic or bitter aftertaste at high concentrations

Conclusion

The sweetener banned in the USA is cyclamate, a substance prohibited by the FDA in 1970 based on animal studies. While these findings were later questioned and cyclamate is still used globally, it remains off-limits in the American food supply under federal regulation. The story of cyclamate, alongside the regulatory journeys of other non-nutritive sweeteners like saccharin and purified stevia extracts, illustrates the dynamic and often debated nature of food safety science and public health policy. Today, a variety of FDA-approved alternative sweeteners are available to consumers, each with its own safety profile and characteristics, allowing for choice within a strictly regulated market. For a comprehensive overview of sweeteners currently approved by the FDA, you can refer to the official resource on high-intensity sweeteners.

Frequently Asked Questions

Cyclamate is a non-caloric, artificial sweetener that is 30 to 50 times sweeter than sugar. It was widely used in diet foods and drinks in the U.S. until it was banned in 1970.

The FDA banned cyclamate in 1970 after a rat study conducted by Abbott Laboratories linked the substance to the development of bladder cancer when consumed in high doses. The ban was enacted under the Delaney clause of the Food, Drug, and Cosmetic Act.

No, cyclamate is not banned globally. It is currently approved and used as a sweetener in over 100 countries, including Canada and the European Union, which have reviewed and set acceptable daily intake levels.

Saccharin is not banned in the U.S. It faced a potential ban in the 1970s due to animal studies, but Congress intervened. After subsequent research concluded the findings were not relevant to humans, its mandatory warning label was removed, and it remains an FDA-approved sweetener.

No, not all forms of stevia are permitted. While highly purified steviol glycosides derived from the stevia plant are deemed 'Generally Recognized as Safe' (GRAS) by the FDA, whole-leaf stevia and crude stevia extracts are not allowed for use as sweeteners.

No, cyclamate cannot be added to any food or drug products in the U.S. for human consumption. It remains an entirely prohibited substance under FDA regulations.

While it is possible for the ban to be lifted, it would require a new petition with compelling, modern safety data demonstrating its safety under the conditions of its intended use. The FDA would need to formally re-approve it, as it has done for other substances.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.