Skip to content

What sweetener has been banned? The full story of cyclamate

4 min read

In a landmark 1969 decision, the US Food and Drug Administration (FDA) banned the artificial sweetener cyclamate following controversial animal studies. This action definitively answered the question, what sweetener has been banned?, and reshaped the diet food industry by removing a widely used ingredient.

Quick Summary

This article explores the history and impact of the US ban on the artificial sweetener cyclamate. It covers the discovery, rise, and subsequent prohibition based on animal testing. The text also contrasts cyclamate with saccharin and details the sweetener's varying legal status around the world.

Key Points

  • Cyclamate is the banned sweetener: The artificial sweetener cyclamate was banned by the FDA in the US in 1969 due to concerns raised by high-dose animal studies suggesting a link to bladder cancer.

  • International Status Differs: Despite the US ban, cyclamate is approved for use in over 100 countries, including Canada and many European nations, where scientific assessments differ.

  • Delaney Clause's Role: The 1969 ban was influenced by the Delaney Clause, a US law prohibiting food additives shown to cause cancer in animals or humans.

  • Saccharin's Close Call: Saccharin also faced a ban attempt in the US in 1977 but was saved by Congress, which instead mandated a temporary warning label. Scientific findings later invalidated the original concerns.

  • Controversy Reshaped Industry: The cyclamate ban prompted a shift in the diet food industry towards other sweeteners like saccharin and, later, aspartame, sparking continued debate and research into food additive safety.

  • Safety Debates Continue: The history of cyclamate highlights the ongoing debate surrounding the interpretation of animal study data and its relevance to human health in the context of food regulation.

In This Article

The Cyclamate Ban: A 1960s Food Controversy

The artificial sweetener cyclamate, a compound 30 to 50 times sweeter than sugar, was discovered by chance in 1937. By the 1960s, it had become a cornerstone of the burgeoning diet industry, finding its way into diet soft drinks, canned fruits, and tabletop sweeteners like Sucaryl. Its popularity stemmed from its sugar-like taste, low cost, and lack of a metallic aftertaste that was common with saccharin. However, this success story came to an abrupt halt in 1969 due to a controversial scientific study.

The Study That Triggered the Ban

The downfall began with a laboratory study on rats conducted by Abbott Laboratories, a primary manufacturer of cyclamates. In this study, rats were fed a 10:1 mixture of cyclamate and saccharin at extremely high doses, equivalent to a human drinking hundreds of cans of diet soda per day. The results suggested a link to bladder cancer in some rats. The findings were alarming and led to a chain of events that ended the sweetener's run in the United States.

The Delaney Clause and the FDA's Action

The FDA's swift and decisive action was largely driven by the Delaney Clause, an amendment to the Food, Drug, and Cosmetic Act of 1958. This clause mandated that any food additive shown to cause cancer in animals or humans must be removed from the market. Although subsequent research would cast doubt on the relevance of the rat study to human health, the initial findings compelled the Secretary of Health, Education, and Welfare to declare that cyclamates were no longer "generally recognized as safe" (GRAS). The ban was announced in October 1969 and took effect in early 1970.

Timeline of the Cyclamate Ban:

  • 1937: Cyclamate is discovered accidentally.
  • 1950s: Products containing cyclamates, like Sucaryl, gain popularity in the U.S.
  • 1969 (October): High-dose animal studies suggest a link to cancer, and the FDA announces its intent to ban the sweetener.
  • 1970 (February): The ban officially takes effect, removing cyclamates from food products in the US.
  • Subsequent Decades: Extensive research fails to definitively link cyclamate to cancer in humans, and petitions for re-approval are submitted to the FDA but remain in abeyance.

Cyclamate vs. Saccharin: A Tale of Two Sweeteners

Following the cyclamate ban, manufacturers scrambled for a replacement, and saccharin became the primary substitute. However, saccharin had its own regulatory troubles, primarily due to a similar high-dose rat study in the 1970s that also suggested a link to cancer. Unlike cyclamate, saccharin's ban was averted by an act of Congress, which instead mandated a temporary warning label on products. Further research revealed that the mechanism for bladder tumor formation in male rats did not apply to humans, and the warning label was eventually removed in 2000. This regulatory outcome highlights the complex and sometimes inconsistent nature of food safety policy and the interpretation of animal studies.

Cyclamate's Global Status: Banned in Some, Approved in Others

The story of cyclamate is not uniform across the globe. While it remains banned in the United States, South Korea, and Bangladesh, it is approved for use in over 100 countries, including Canada, Australia, and the European Union. Regulatory bodies in these regions have reviewed the available data and concluded that cyclamate is safe for consumption within an acceptable daily intake (ADI). This international divergence is a testament to the varying scientific interpretations and risk assessment standards applied to food additives worldwide.

Comparing Cyclamate and Saccharin Controversies

Feature Cyclamate Controversy (Late 1960s) Saccharin Controversy (Late 1970s)
Triggering Event High-dose animal study showing possible bladder tumors in rats. High-dose animal study showing possible bladder tumors in rats.
Regulatory Action (US) Full ban, effective in 1970, invoking the Delaney Clause. Attempted ban blocked by Congress; warning label required instead.
Scientific Reassessment Later research failed to provide conclusive evidence of carcinogenicity in humans. Later research found that the cancer mechanism in rats was not relevant to humans.
Current US Status Remains banned. No longer requires a warning label; widely permitted.
Current Global Status Permitted in over 100 countries (e.g., EU, Canada). Widely permitted in most countries, with varying restrictions.

Other Sweeteners with Regulatory Scrutiny

Cyclamate is not the only sweetener to have faced bans or intense scrutiny. Historically, other compounds were also prohibited based on safety concerns:

  • Dulcin and P-4000: These artificial sweeteners were banned by the FDA in the 1950s due to concerns over their safety. They never achieved the widespread market presence of cyclamate and are now largely forgotten in public memory.
  • Aspartame: Discovered in 1965, aspartame also faced its own share of controversy, including temporary approval pauses due to potential links to brain tumors. However, rigorous testing has consistently upheld its safety for consumption, and it is widely approved by regulatory bodies worldwide.
  • Stevia: The natural sweetener stevia also faced resistance from the FDA, which issued a ban in 1987 due to lack of approved data. It was later given "no objection" status as GRAS for its purified extracts and is now a popular sugar substitute.

Conclusion

The definitive answer to the question "what sweetener has been banned?" in the US is cyclamate. This single event in 1969 served as a catalyst for a decades-long conversation about the safety of artificial sweeteners and the role of regulatory bodies in protecting public health. While cyclamate remains off-limits in the American food supply, its complex history, alongside the regulatory journey of saccharin, illustrates the shifting landscape of food science and public perception. For consumers today, the story serves as a reminder that the path to a product's approval is often fraught with scientific debate and regulatory oversight, and that a product's safety status can vary significantly depending on the country. You can learn more about food additives and regulations on the FDA's official website.

Frequently Asked Questions

Yes, the artificial sweetener cyclamate remains banned in the United States. The Food and Drug Administration (FDA) has not reversed its 1969 decision, although several petitions for re-approval have been filed.

Cyclamate was banned after a high-dose animal study in 1969 indicated a potential link to bladder cancer in rats. This triggered the Delaney Clause, a US law requiring the prohibition of any food additive found to cause cancer in animal or human tests.

Yes, cyclamate is approved and widely used as a sweetener in over 100 countries worldwide, including Canada, Australia, and many nations within the European Union.

Saccharin was never fully banned in the US, but it faced a ban attempt in 1977 due to similar animal study results. Congress placed a moratorium on the ban, and subsequent research showed that the cancer mechanism in rats did not apply to humans. The required warning label was later removed.

The key difference lies in the outcome. The cyclamate ban was fully implemented and remains in effect in the US, while the attempted saccharin ban was averted by Congress. Later scientific reevaluation cleared saccharin of human carcinogenic risk at normal consumption levels, a fate cyclamate has not shared in the US.

The Delaney Clause was a 1958 amendment to the US Food, Drug, and Cosmetic Act requiring the FDA to ban any food additive found to cause cancer in animal or human tests. It provided the legal basis for the cyclamate ban following the controversial animal study results.

Yes, other sweeteners like dulcin and P-4000 were also banned by the FDA in the 1950s. Additionally, some other sweeteners like Stevia initially faced restrictions before receiving approval.

References

  1. 1
  2. 2
  3. 3
  4. 4

Medical Disclaimer

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