" . . . Last year . . . 'my firm of fruit packers saved $4,000 by using saccharin instead of sugar in sweet corn.'
"'Yes, Mr. President,' I interjected, 'and everybody who ate that corn thought they were eating sugar, whereas they were eating a substance which was highly injurious to health.'
"'You say saccharin is injurious to health? Why, Dr. Rixey gives it to me every day. Anybody who says saccharin is injurious to health is an idiot.'"
That exchange took place 71 years ago between the father of the Food and Drug Administration, Dr. Harvey Wiley, President Theodore Roosevelt, who was getting saccharin from his doctor (for only heaven know what; it certainly didn't help him to lose weight), and the fruit packer. It is recorded in Wiley's autobiography. Wiley was a crusader against adulterants in food and believed in 1906 that saccharin was harmful. Today the controversy rages on.
It threatens to undermine the Delaney Amendment, a law that was so carefully drafted it protects the public in spite of the government.
On March 9 - as almost everyone must know - FDA announced a ban on the only artificial sweetener permitted in the American food supply, saccharin. The agency was required to ban the substance because of the Delaney Amendment, which was added to the Food, Drug and Cosmetic Act in 1958. According to the amendment, which is named for New York Rep. James Delaney, any substance that causes cancer when ingested by man or animal must be banned.
Ironically, FDA has full powers to ban any harmful substance in the food supply without the Delaney Amendment. Exactly why it was invoked in this case is unclear since the Canadian rat study on which the saccharin ban was based clearly demonstrated that saccharin caused a significant number of bladder tumors in the test animals. With less clean results FDA has banned other substances without invoking the Delaney Amendment Red No. 2 food coloring, which was banned in March, 1976, being a case in point.
Under the general food additive law, an additive that is not "generally recognized as safe" must be proven safe by the manufacturer. As Dr. Sidney Wolfe, director of Ralph Nader's Health Research Group, said in testimony given at congressional hearings last week on saccharin: "Once an additive is shown to cause cancer in animals, this burden of proof cannot be sustained.
"Changes in the language of the Delaney Clause would not affect the saccharin ban."
Testifying at the same hearing, Acting FDA Commissioner Sherwin Gardner said the dangers of saccharin were so clear that the agency would probably have proposed a ban even without the Delaney Clause.
Jim Turner, a lawyer and expert in food regulations, writing in the March 24 issue of the Community Nutrition Institute Report, said FDA's announcement of the ban was so poorly handled that it has led "some cynics to suggest that the agency wished to undermine its own anticancer authority."
Sen. Gaylord Nelson (D-Wis.), who has held many hearings on FDA's role in regulating food additives and drugs, is one of the cynics. "Some members of FDA are trying to undermine the Delaney Amendment," Nelson said. "There is a tremendous anti-Delaney campaign on and it would be disastrous to eliminate it." Nelson agrees with Turner, who said: "The saccharin debate is being turned into a Delaney debate. This is a diversionary tactic designed to save diet sodas."
Several scientists are concerned about what one of them called "all the noise about Delaney." Dr. Marvin Schneiderman, associate director for field studies and statistics at the National Cancer Institute, said: "The people who have hollered about it before are hollering about it now - food manufacturers and chemical manufacturers."
But why the Delaney Amendment was made part of the food additive regulations is crystal clear: so that scientists would have no discretion whatsoever in deciding whether the benefits derived from a cancer-causing agent outweigh the risks. Charles Wurster, associate professor of environmental sciences at the State University of New York said: "The Delaney Amendment wisely allows no human discretion based on dosage in administering the act, since there is no valid scientific basis for such discretion."
It is an almost universal belief among scientists that there is no known minimal dose below which a carcinogen can be considered safe and the effects of repeated exposure to carcinogens, even in small quantities, may not show up for 40 years. But there is a well-established relationship between the dose of a cancer-causing agent and its effect. The higher the dose, the higher the risk. This rule is put to use in animal experiments, such as those conducted in Canada that confirmed what scientists have long suspected: saccharin is a carcinogen.
Massive doses are administered in order to minimise the number of animals needed to detect any possible effect. According to Dr. Schneiderman: "If we don't get a response at high levels, then the substance is probably safe in the amounts to which humans are exposed."
Anti-ban forces have been trying to undermine the validity of the Canadian test results by pointing out that the amount of saccharin the rats ate would be the equivalent of a human drinking 800 cans of diet-soda a day. They say if you drank 800 cans of anything in a day it would kill you or, put another way, if you consume anything in large enough doses it will cause cancer.
This is simply no true. Hundreds and hundreds of laboratory tests have shown just the opposite to be the case. While huge quantities of anything, including water, are likely to be toxic, few of them will cause cancer. Only a fraction of the compounds that have been studied, using the same techniques used in the Canadian study, cause cancer.
This method for determining the safety of food additives was not invented by the Canadians just for the saccharin studies. According to Wolfe: "A number of expert committies over the last two decades have formulated general principles for such testing and these committees have shown remarkable unanimity in their recommendations . . . "The committees represent such organizations as the U.S. Public Health Service and World Health Organization as well as FDA.
The Calorie Control Council, an Atlanta-based trade association for the $2-billion-a-year diet drink and food industry, which is spearheading the campaign against the saccharin ban, redicules the studies because rats aren't people. But there is a very good possibility, according to Dr. David Rall, director of the National Institute of Environmental Health Sciences, that humans may be even more vulnerable to carcinogens than animals. Rall wrote: "One man may represent-anywhere from a 160-to a 3,000-mouse experiment in terms of susceptible cells. And if there is a relationship between the initiation of a (malignancy) and the number of susceptible cells, then one man is certainly much more susceptible than one mouse."
What is more, of the "17 chemicals known to cause cancer in humans," according to Dr. Wolfe, "with the exception of inorganic arsenic . . . all cause cancer in laboratory animals."
But the anti-ban forces, with some assistance from scientists, point out that there has been no increase in bladder cancer among humans in the 80 years saccharin has been in use.
There are at least two probable reasons for this. Until very recently saccharin has not be consumed in significant amounts and it takes 20 to 40 years for tumors to show up in humans. In addition, as Dr. Wolfe explained, the percentage of cancer traceable to saccharin is not likely to be large enough to be detectable in human epidemiological studies.
Dr. Guy Newell, acting director of the National Cancer Institute, said at last week's congressional hearing: "We have no evidence that saccharin causes cancer in humans." Dr. Schneiderman noted that what Newell said is "literally true" because the relationship between saccharin and bladder tumors "would be pretty hard to detect in the human studies that have been conducted so far."
What "concerns" Scneiderman is that "if the animal studies are pointing in the right direction, we will be seeing increased bladder cancers in children born to mothers who used saccharin during World War II. Bladder cancers," Schneiderman said, "do not appear until about the age of 50 or after. Those children are 35 years old now."
In addition, he said: "The first 40 years saccharin was around very little was used in this country, even by diabetics. Not until World War II was it used in place of sugar and then its use fell off until the late '50s when diet drinks were introduced. "Today," Schniederman said, "the use of saccharin is almost double what it was in World War II."
Schneiderman is also concerned because "diet drinks are consumed largely by adolescents, not fat old ladies or diabetes."
If, as the Canadian rat studies indicated, the population most vulnerable to saccharin is the unborn fetus, consumption of the artificial sweetener by those entering their child-bearing years poses the greates hazards for those who have absolutely no control over it.
As the labels of most products containing saccharin state: "for use by those who must restrict their intake of ordinary sweets." This languge was directed larglely at diabetics.
But there is no evidence that saccharin has reduced the incidence of death from diabetes.On the contrary, Dr. Schneiderman points out, the mortality rate has increased in recent years for just two diseases - cancer and diabetes.
In addition, there is no evidence that saccharin controls weight. On the contrary, as Dr. Wolfe noted in his testimony: "Animal studies show weight gain caused by saccharin fed at doses comparable to human intake. The mechanism of this increased hunger with saccharin may well be its demonstrated ability to abnormally lower blood sugar which can induce hunger."
The American Diabetes Association has condemned the ban, but Dr. Jesse Roth, cheif of diabetes at the National Institutes of Health, says: "Artificial sweetener has no special place in a diabetic's regime. The saccharin ban is of no consequence."
Dr. Lawrence Power, a professor at Wayne State University in Detroit whose speciality is treatment of diabetes, hasn't had his "diabetics using saccharin for the last 10 or 15 years. The notion that the poor diabetic is going to be badly abused (by the ban) is a terrible distortion," Power said. "The best thing a diabetic can do is lose his sweet tooth and saccharin doesn't help him do this." Power said that "over a period of six months or a year," a diabetic can learn to live without sweets.
Whether or not one agrees with the ban, FDA cannot be accused of acting precipitously as some have suggested. For at least the last six years the agency has been warning about the possible hazards of saccharin. It was concerned enough with an accumulation of findings to remove the sweetener from a list of safe additives in 1979 and place it in a special "interim" category, while further tests were conducted. There are several other saccharin studies with rats which indicate an increased incidence of tumors, including one study in which the artificial sweetener caused cancer when the equivalent of 1.6 cans of soda a day was fed to the rats.
Saccharin was not always considered safe. From 1911 to 1938 it was sold only as a drug because of concerns about its safety based on curde human feeding studies conducted in 1906. As Turner wrote, the use of saccharin as a drug "preserved its legitimate functions and discouraged exploitation of a phony weight-loss market."
Turner suggests that once the controvery dies down legitimate uses of saccharin "could be preserved by subjecting it to the drug portion of the Food and Drug Act." Nelson said he "would have no trouble with that solution."
But he said: "The Delaney Amendment should not be modified until the scientists can agree on what a safelevel of a carcinogen is."