For decades, Robert Scully has started the day by sprinkling a little pink packet of Sweet 'N Low into his coffee.
He didn't stop 16 years ago, when the government concluded that saccharin, the sugar substitute's main ingredient, could be "reasonably anticipated" to cause cancer in humans. "There's so much b.s. in those government reports," says the 70-year-old retired businessman in St. Michaels, Md. "I don't worry about them."
And he is one person who won't be surprised Friday if, as now seems possible, a group of outside advisers to the National Institutes of Health vote to take saccharin off its list of carcinogens, signaling what could be the end of one of the nation's highest-profile cancer scares.
Such a move could ultimately mean the elimination of labels warning: "Use of this product may be hazardous to your health. This product contains saccharin which has been determined to cause cancer in laboratory animals." Saccharin could also gain some of the ground it has lost to the newer, more-expensive sweetener aspartame -- though it must still overcome a reputation for leaving a bad aftertaste.
The case for clearing saccharin's name "is pretty good, I must say," says Arnold Brown, chairman of the nine-member advisory panel to the NIH and dean emeritus of the University of Wisconsin Medical School in Madison. Two internal government reviews have concluded that saccharin isn't a threat to humans and should be delisted. The Canadian government, which got saccharin into hot water in the first place, is considering a change as well. A small coterie of scientists is trying to block any change by the NIH, but it isn't clear they will be able to prevent the panel from voting to delist saccharin.
Only a 10% BoostAmericans are big users of tabletop artificial sweeteners, and half drink diet sodas. But aspartame, the sweetener known by the brand name NutraSweet and approved by the Food and Drug Administration in the early 1980s, dominates the low-calorie food and beverage market. On a per-capita basis, Americans consume about three times as much aspartame as saccharin, according to SRI Consulting in Menlo Park, Calif.
While removing saccharin from the carcinogen list would be good news for Sweet 'N Low maker Cumberland Packing Corp., the company isn't holding its breath. "I've been disappointed so many times," says Marvin Eisenstadt, president of the family-owned firm in New York's Brooklyn borough. He figures that if saccharin is exonerated his business would increase by about 10%. "Most people don't believe the warning label, anyway" he says. "It has lost its credibility."
Saccharin was added to the government's Report on Carcinogens in 1981 and is one of 169 substances, including chloroform, that can be "reasonably anticipated" to cause cancer in humans, according to the government. Another 29 compounds are described as "known" human carcinogens, including asbestos, benzene and aflatoxin. Work is under way on the next edition of the government's list, due out in 1999, which is why the advisory panel is meeting this week at the National Institute of Environmental Health Sciences in Research Triangle Park, N.C.
A synthetic compound derived from coal tar, saccharin was discovered in 1879 by a student researcher at Johns Hopkins University. Its tantalizing commercial appeal as a noncaloric sugar substitute -- it is 300 times sweeter than sugar -- was obvious from the start. In 1901, Monsanto Co., the St. Louis chemicals company, was founded to produce it.
Safety QuestionsFrom the beginning, the chemical was dogged by safety questions. In 1907, a top food-safety official tried to ban it but was proclaimed "an idiot" by President Theodore Roosevelt. Critics had better luck a few years later during the presidency of William Howard Taft, but the prohibition fell by the wayside during the sugar shortages of the first and second world wars. Still, saccharin-based diet foods weren't widely used other than by diabetics, partly because of the compound's metallic aftertaste. That began to change after the 1937 discovery of cyclamate, another artificial sweetener, which reduces the aftertaste when blended with saccharin.
Enter Mr. Eisenstadt's late father, Benjamin, a New York entrepreneur who transformed both the sugar and artificial-sweetener business. After World War II, he opened a tea-bag factory in Brooklyn, then invented the modern sugar packet after his wife remarked that sugar bowls in restaurants seemed unsanitary. In 1958, on the eve of the country's diet-food craze, he began buying truckloads of saccharin from a manufacturer, combining it with cyclamate and selling it as Sweet 'N Low, which he named after a musical rendition of an Alfred, Lord Tennyson poem. The product was a hit; one packet offered the sweetness of two teaspoons of sugar, but without the 30 calories.
Food and beverage companies scrambled to offer saccharin-sweetened products. Coca-Cola Co. introduced Tab in 1963. Soon to follow were gelatins, candies and baked goods with saccharin.
But in 1969, cyclamate was banned for causing cancer in lab animals, and those safety problems prompted researchers to take a closer look at saccharin. While conflicting tests showed it caused cancer in some laboratory animals, the fact that at least some of the research was financed by the sugar industry raised credibility questions. Canadian officials decided to try to resolve the issue.
At the center of the Canadian effort was Douglas Arnold, a Massachusetts native who moved to Ottawa in the mid-1970s and took over a saccharin study from a colleague on maternity leave. The research involved stuffing rats with extremely high doses of saccharin, equivalent to 5% of their diet.
Calling for a BanIn early 1977, FDA officials rushed from Washington to Ottawa to hear the results: Of 200 rats fed saccharin, 17 (15 of them male) developed bladder tumors; by comparison, of 100 "control animals" not fed saccharin, only two developed tumors. The Canadian government quickly decided to ban saccharin in food and beverages, while allowing its continued sale in drugstores for diabetics.
In the U.S., FDA officials huddled secretly to figure out what to do. By this point, Americans were consuming more than five million pounds of saccharin a year, much of it in diet sodas. Nevertheless, the officials felt they had no choice but to ban the sweetener. A 1958 federal law called the Delaney Clause prohibits the use of any food additive shown to cause cancer in animals or humans, no matter how small the amount of that additive in a given product.
Agency officials were still smarting from criticism that they hadn't moved fast enough the year before to ban Red Dye No. 2, a widely used food coloring. "Mothers called the FDA to find out if their children would get cancer from eating cherry gelatin," says Wayne Pines, a former FDA spokesman who edited a book about public-relations disasters called "When Lightning Strikes." To temper fears, the FDA stressed in a news release in March 1977 announcing its planned saccharin ban that the Canadian rats had been fed the equivalent of 800 cans of diet soda a day.
Consumer ComplaintsNonetheless, the news hit like a bomb. Consumers howled, outraged that their diet drinks and low-cal foods were going to be taken away. FDA officials were stunned by the reaction. "They wanted their diet foods more than they were worried about cancer," Mr. Pines says.
The Calorie Control Council, which represents the artificial-sweetener and low-calorie-food industry, took out full-page ads denouncing "the arbitrary nature of big government." In one, the younger Mr. Eisenstadt stood neck-deep in Sweet 'N Low packets to show how much saccharin would have to be consumed to pose a problem. Editorial cartoonists lampooned the 800-cans-a-day figure by showing bloated rats staggering around holding cans of diet soda.
One congressman suggested saccharin products carry a warning label saying, "The Canadians have determined saccharin is dangerous to your rat's health."
Belatedly, the FDA tried to defend such high-dose studies as standard operating procedure in the world of cancer research. Though sometimes controversial, the studies are a legitimate, scientifically accepted way to test for the impact of a lifetime of human use; at lower doses, many more animals and much more time would be needed to judge the effect of a particular chemical.
But the public-relations damage had been done. Demand for saccharin products surged as consumers bought diet goods and hoarded them. Deluged with protests, Congress in November 1977 passed a law prohibiting the FDA from banning saccharin -- a law that is still in effect. Congress did, however, order that saccharin-based products carry warning labels.
Switching to HoneySome people took the warnings seriously. Cindy Yeast, who was a flight attendant at the time, remembers sprinkling Sweet 'N Low in her coffee while visiting a friend in Boulder, Colo. Her friend was appalled. "She said that it was poisonous," says Ms. Yeast, now a spokeswoman for the American Psychological Association in Washington. Chastened, she began using honey instead.
The year 1981 brought new challenges. Not only was saccharin put on the NIH's carcinogen list, but saccharin faced its most-serious challenge from an alternative sweetener: aspartame.
Monsanto, which makes aspartame, began selling blue packets of Equal for tabletop use. Two years later the sweetener was cleared for use in diet drinks. The beverage industry, the biggest user of artificial sweeteners, embraced aspartame because it didn't have an aftertaste or require a warning label, says Laszlo Somogyi, a senior consultant at SRI Consulting. In 1985, for the first time, Americans consumed more aspartame than saccharin. (For the 52 weeks ended this past Sept. 14, Equal's retail sales, excluding restaurants, totaled about $132 million, compared with Sweet 'N Low's $67 million, according to Information Resources Inc., a Chicago market-research firm. Packet sales of the cheaper Sweet 'N Low exceed Equal, however.)
As the years passed, scientists began unraveling the mysteries of how saccharin actually produces malignant tumors in rats. The general theory goes like this: The combination of high doses of saccharin and the highly concentrated, highly acidic urine of the male rat results in the formation of jagged crystals, which irritate the innermost lining of the rat's bladder. That causes a rapid proliferation of cells that eventually results in cancerous tumors.
A 'Rat-Specific' Problem?Samuel Cohen, chairman of the department of pathology and microbiology at the University of Nebraska Medical Center in Omaha, believes the crystallization occurs because of a specific protein in male-rat urine that isn't present in humans. "Saccharin," he says, "is both rat-specific and high-dose specific."
Some of his research has been underwritten by the Calorie Control Council, which has petitioned the NIH to delist saccharin as a carcinogen. Nonetheless, he has won several converts, including Dr. Arnold, the Canadian-government scientist who did the original rat study. In addition, the Journal of the National Cancer Institute will report in the next few months the results of a 23-year monkey study that found saccharin didn't have any cancer-causing effect on the primates.
In recommending the delisting, the staff of the National Toxicology Program, the NIH's arbiter of chemical carcinogens, writes that "although it is impossible to conclude that it poses no threat to human health," saccharin isn't "reasonably anticipated to be a human carcinogen under conditions of general usage as an artificial sweetener." It adds that "the factors thought to contribute to tumor induction by sodium saccharin in rats would not be expected to occur in humans."
After the advisory panel makes its recommendation, yet another group of government reviewers will take a look at the issue. The ultimate decision on saccharin will be made by Kenneth Olden, director of NIH's National Institute of Environmental Health Sciences.
A Foolish Move?Some scientists, including a few who work for the toxicology program, say it would be foolish to delist saccharin now, and that more research needs to be done involving female rats, mice and other species.
Some are worried about what will happen if people start consuming much larger quantities of saccharin. Emmanuel Farber, who was chairman of a 1979 report on saccharin by the National Academy of Sciences and is now a professor of pathology at Jefferson Medical College in Philadelphia, says he remains convinced that saccharin is a weak carcinogen and that it should stay on the list. "My concern," he says, "is that kids start using it at two or three years old, and this goes on year after year, and after 20 years you don't have a weak carcinogen any more, you have a strong carcinogen."
Michael Jacobson, executive director of the Center for Science in the Public Interest, a Washington-based consumer group, is trying to rally opposition to the delisting, which he calls "grossly premature." He argues that the toxicology-program staff is giving short shrift to studies conducted in the early 1980s that point to increased risk of cancer among some subgroups of artificial-sweetener users, including some women and heavy users of sweeteners.
Declining ConsumptionCurrently, saccharin is used in pharmaceuticals and some food products, including ice cream, beverages and health and beauty aids, and in fountain diet soft drinks. Saccharin consumption in the U.S. peaked in 1984, at an annual 10 pounds per person, figured on a sugar-sweetness equivalent basis, and is now about seven pounds. Annual aspartame consumption is about 21 pounds.
Today, there is only one bulk maker of saccharin in the U.S., Cincinnati Specialties Inc., the manufacturing arm of PMC Specialties Inc., a privately held Cleveland-based company that was once part of Sherwin-Williams Co. James McKenna, president of Cincinnati Specialties, figures that if saccharin is delisted and Congress responds to industry pleas to stop requiring the health-warning label, the demand for saccharin will increase. But not drastically. The reason? Continued competition from aspartame and other, newer rivals, some of which are still under FDA review.
Still, he might be surprised. Kelly Back, a lawyer in Alexandria, Va., is a self-described "artificial-sweetener addict," who switches back and forth between aspartame and saccharin; she figures if either one causes health problems, she can cut her risk by ingesting only half the normal amount. If saccharin is delisted, she says, "I'll give up NutraSweet, definitely," she says.
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