The Cyclamate Ban of 1969: A Historic Food Safety Decision
The Rise of Cyclamate
Discovered in 1937, cyclamate was once the most popular artificial sweetener in the United States. By the late 1960s, it was used in hundreds of food products, most notably diet soft drinks like Diet Pepsi and Tab, as well as canned fruits and jams. It was favored for its clean, sugar-like taste and heat stability, making it versatile for cooking and beverages. It was even included in the iconic pink packets of Sweet'N Low, combined with saccharin. For years, cyclamate was on the FDA's 'Generally Recognized As Safe' (GRAS) list, with the agency seeing no health concerns at the time. The growing demand from diet-conscious consumers and diabetics drove its widespread use.
The Study That Sparked the Ban
The downfall of cyclamate began with a long-term toxicity study commissioned by Abbott Laboratories, the primary manufacturer of the sweetener. In this study, rats were fed a mixture of cyclamate and saccharin at extremely high doses. The initial goal was to evaluate effects on reproduction and fertility. When the rats were autopsied at the study's conclusion in early October 1969, researchers discovered bladder tumors in some of the animals receiving the highest doses. The dose was so high it was equivalent to a human drinking hundreds of cans of diet soda daily.
FDA Action and The Delaney Clause
Upon receiving the preliminary findings, the National Cancer Institute and Abbott Laboratories reported the results to the Department of Health, Education, and Welfare (HEW). At the time, the Delaney Clause was in effect, a provision of the Food, Drug, and Cosmetic Act of 1958. This clause mandated that any food additive shown to induce cancer in animals or humans be removed from the market. While the FDA typically had to prove a substance was unsafe, the Delaney Clause shifted the burden of proof to manufacturers to demonstrate absolute safety. Based on the rat study, Secretary of HEW Robert Finch announced the ban on October 18, 1969, effective February 1, 1970. The cyclamate was officially removed from the GRAS list on October 30.
Market and Consumer Reaction
The announcement sent shockwaves through the food and beverage industry. Manufacturers had to scramble to reformulate products, with most transitioning to saccharin, the only other widely available artificial sweetener. Consumers reacted with a mix of fear and disappointment. Some stocked up on cyclamate-containing products before they were pulled from shelves, while others worried about the loss of low-calorie options. Retailers faced challenges, with some removing products immediately and others holding them until the deadline.
The Cyclamate Controversy Continues
The story didn't end with the ban. Subsequent research raised doubts about the scientific validity of the original 1969 rat study. Factors like the extremely high doses, potential impurities in the saccharin used, and possible bladder parasites in the rats may have influenced the outcome. Over the years, Abbott Laboratories submitted petitions to the FDA for reapproval, and international health bodies, including the World Health Organization (WHO), have re-evaluated and deemed cyclamate safe. Today, cyclamate remains banned in the United States but is approved for use in over 130 countries worldwide, including Canada and the European Union. Its history remains a potent reminder of the complexities of food regulation and risk assessment.
Comparison of Banned vs. Approved Sweeteners
| Feature | Cyclamate (Banned) | Saccharin (Limited/Approved) | Aspartame (Approved) | Sucralose (Approved) |
|---|---|---|---|---|
| FDA Status (USA) | Banned since 1969 | Approved (no longer requires warning label) | Approved since 1981 | Approved since 1998 |
| Discovery Year | 1937 | 1879 | 1965 | 1976 |
| Sweetness (vs. Sugar) | 30-50 times | 200-700 times | 200 times | 600 times |
| Initial Controversy | Bladder tumors in rats at high doses (1969) | Bladder cancer in rats (1970s) | Brain tumors (1970s) | Marketing tactics (2000s) |
| Current Usage | Banned in US, but used in over 130 countries | Wide use in diet foods and drinks | Common in diet sodas, gum, and other products | Common in diet foods, drinks, and baking |
Conclusion
The artificial sweetener banned by the FDA in 1969 was cyclamate. The decision, rooted in preliminary animal studies and the Delaney Clause, reshaped the diet food industry and fueled decades of debate over the safety of artificial sweeteners. While the scientific understanding of cyclamate's risks has evolved, the ban remains in effect in the US, while the sweetener is widely used elsewhere. This historical event serves as a crucial case study in the ever-evolving landscape of food science, consumer health, and government regulation. For more details on the legislative and historical context surrounding food additives, see the FDA's official records.
Frequently Asked Questions
Question: Why was cyclamate banned by the FDA in 1969? Answer: Cyclamate was banned after a laboratory study involving rats fed extremely high doses of the sweetener found evidence of bladder tumors, triggering the Delaney Clause which mandated the removal of cancer-causing food additives.
Question: Is cyclamate still banned in the United States? Answer: Yes, cyclamate remains banned in the United States for use in foods and beverages, despite later studies questioning the validity of the original evidence.
Question: What is the Delaney Clause? Answer: The Delaney Clause is a 1958 amendment to the Food, Drug, and Cosmetic Act that requires the FDA to ban any food additive if it is found to cause cancer in animals or humans, regardless of the dose.
Question: Why is cyclamate still allowed in other countries but not in the US? Answer: Cyclamate is approved in over 130 countries, including Canada and the EU, because regulatory agencies in those regions have reviewed the scientific evidence and concluded that cyclamate is safe for consumption at recommended levels. The original US ban has not been reversed, although manufacturers have petitioned for it.
Question: Did cyclamate's removal affect the market for other artificial sweeteners? Answer: Yes, after the cyclamate ban, manufacturers quickly turned to saccharin as a replacement. This led to a huge increase in saccharin's market share until aspartame was approved years later.
Question: What role did the diet food industry play in the cyclamate controversy? Answer: The diet food and soft drink industries were significantly affected by the ban, as cyclamate was a key ingredient in many popular low-calorie products. Manufacturers were surprised and had to quickly innovate to find alternatives.
Question: Has there been any effort to reapprove cyclamate in the US? Answer: Yes, since the original ban, Abbott Laboratories and other groups have submitted petitions to the FDA for cyclamate's reapproval, but the FDA has so far denied or not acted upon these requests, citing unresolved safety issues.
