The Rise and Fall of Cyclamate
Cyclamate is an artificial sweetener discovered accidentally in 1937. By the 1960s, it had become an incredibly popular sugar substitute, used in diet soft drinks like Diet Pepsi and Tab, as well as in canned fruits and powdered drink mixes. Marketed as a calorie-free way to enjoy sweet foods, it was widely consumed by millions of Americans. The Food and Drug Administration (FDA) initially considered cyclamate "generally recognized as safe" (GRAS) in 1958, a designation that allowed it to be used without extensive pre-market testing.
The Critical 1969 Study and the Delaney Clause
In 1969, a study conducted by Abbott Laboratories, the primary manufacturer of cyclamate, revealed potentially malignant tumors in rats fed an extremely high-dose mixture of cyclamate and saccharin. Specifically, eight of 240 rats developed bladder tumors after being fed doses equivalent to a human drinking 550 cans of diet soda per day. This report triggered the application of the Delaney clause, a 1958 amendment to the Food, Drug, and Cosmetic Act. This clause mandated the removal of any food additive from the market if it was found to cause cancer in humans or animals, regardless of the dose.
Aftermath and the Controversial Ban
The ban on cyclamate was announced by then-Secretary of Health, Education, and Welfare, Robert Finch, in October 1969, with an effective date of February 1, 1970. The swift action surprised the food and beverage industry, which had invested heavily in cyclamate-containing products. Consumers reacted with mixed emotions, with some rushing to stock up on their favorite diet products, while manufacturers scrambled to find a replacement sweetener, primarily turning to saccharin. The controversy highlighted a major weakness of the Delaney clause: it did not account for dosage, meaning a cancer-link at any dose, however extreme, triggered the ban.
The Scientific Debate and Current Status
In the decades following the ban, the scientific community revisited the evidence that led to cyclamate's removal. Subsequent research cast significant doubt on the findings of the original 1969 study, with many calling the initial findings flawed. Key issues with the study included:
- Extremely High Doses: The rats were given dosages far exceeding any realistic human consumption, making the study's relevance to human health questionable.
- Bladder Parasites: The presence of bladder parasites in the test rats may have influenced the outcome, confounding the results.
- Impurity of Saccharin: The saccharin used in the study mixture contained an impurity, orthotoluenesulfonamide, which may have also played a role in tumor formation.
Despite the discrediting of the initial research, the ban remained in place due to the strict nature of the Delaney clause. Abbott Laboratories made several attempts to reverse the ban, but the FDA denied these petitions, citing the need for definitive proof of safety. Today, cyclamate is approved and used in over 130 countries, including Canada and many European nations. The European Food Safety Authority (EFSA), for example, sets an Acceptable Daily Intake (ADI) of 7 mg per kilogram of body weight for cyclamate.
Cyclamate vs. Saccharin: A Historical Comparison
| Aspect | Cyclamate (Banned in 1969) | Saccharin (Banned and Unbanned) |
|---|---|---|
| Discovery | 1937 | 1879 |
| Sweetness | 30-50 times sweeter than sugar | ~300 times sweeter than sugar |
| Taste Profile | Closer to sugar with no bitter aftertaste | Often has a metallic or bitter aftertaste |
| Carcinogen Scare | Banned due to flawed rat studies showing bladder tumors | Faced a ban in 1977 over rat studies, but congressional moratorium and new science kept it legal |
| Delaney Clause | Triggered a permanent ban in the US, regardless of dose | Averted a permanent ban due to congressional intervention and later scientific re-evaluation |
| Current US Status | Remains banned for use in food and beverages | Safe for consumption with no warning labels required since 2000 |
The Long-Term Impact of the Ban
The cyclamate ban had a lasting impact on both the artificial sweetener market and food safety regulation in the United States. It solidified the Delaney clause's strict authority, even when supporting evidence was questionable, and spurred increased public skepticism and scrutiny regarding food additives. The controversy led to further research into artificial sweeteners and the eventual rise of newer alternatives like aspartame and sucralose. This saga serves as a textbook case illustrating the complex interplay between science, regulation, and public perception in food safety decisions.
Conclusion
Ultimately, cyclamate was banned in the United States not because it was conclusively proven to cause cancer in humans, but because the strictures of the Delaney clause legally required its removal based on high-dose animal test results. While later research called the original findings into question, the burden of proof under the Delaney clause was too high for the sweetener's manufacturers to overcome, leaving cyclamate banned in the US while it remains approved in many other countries. The story of cyclamate is a powerful example of how a single study, interpreted through a rigid legal framework, can permanently alter a product's fate, even in the face of subsequent conflicting evidence. For those interested in a deeper dive, the FDA's original decision is documented in the Federal Register (34 FR 17063).
