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Sack Saccharin—Defend Delaney
by Bob Park
The Food and Drug Administration (FDA) decision to ban saccharin generated a predictable reaction from the food and beverage industries, but also aroused the many consumers of this product (current U.S. consumption is 5 million pounds per year). Following hasty Congressional hearings, more than 100 senators and representatives were supporting legislation to reverse the decision. While the beleaguered FDA appears to be defending the public good (the FDA estimates that 1200 cases of bladder cancer per year could be expected from saccharin), there is a less flattering interpretation of the agency’s position.
The ban was required by the Delaney Amendment, which excludes from food any chemical shown to cause cancer in animals. It is one of the few laws which do not equivocate on cancer· and is soundly based on current, limited understanding of how chemicals cause cancer. A general relationship has not been established between dose levels of chemical agent~ and the resulting rates of cancer. Therefore, it cannot be assumed that the relation is not proportional at lower doses; in fact, in some plausible models of how cancer is caused, the probability of cancer is proportional to the dose level or concentration of the chemical. What this means is that you would get about the same number of cancers in a small population with a high dose of a chemical as you would in a population one thousand times larger with one-thousandth of the high dose. Furthermore, there is some evidence that the relation between dose and risk of cancer from saccharin is proportional over a wide range of doses (testimony of the Health Research Group before Subcommittee on Health. House Commerce Committee. March 21. 1977).
The FDA’s position is based on the recent Canadian rat study, which used saccharin at high doses said to be equivalent to a human consumption of 800 cans of diet soda per day. Based on the above reasoning, the results of the study predict 1200 cancer cases per year in humans in the U.S., at current use levels. This is a meaningful, conservative estimate of the hazard. The industry of course manifests no interest in such a precautionary approach.
Since its passage in 1958. the Delaney Amendment has not only haunted the food industry but has made the FDA’s job more awkward: there is little room left for administrative “flexibility” on decisions which might damage powerful industrial or political interests. In fact, the FDA has been trying for years to produce scientific justification for removing the Delaney Amendment. According to them FDA Commissioner Charles Edwards. speaking about a new research center before the House Agriculture Subcommittee in 1971. “the Pine Bluff (Arkansas) testing facility will provide the scientific basis on which the Delaney anti-clause may be changed … the agency is locked into an ‘all-or-nothing’ box.” According to Dr. Samuel Epstein of the University of Illinois, who has fought carcinogenic pesticides with some success, the FDA has continued this intention in recent years (SftP, July 1976, p. 4).
In response to public awareness of the hazards of food aditives, the FDA announced plans in January 1997 for a toxicity review of over 2000 additives. This would be the first such review for many of these substances. This was the first step toward a showdown on the Delaney clause. Following earlier reaction to bans on cyclamates and Red Dye No.2, the FDA clearly knew that the saccharin decision would blow the lid off the Delaney debate; the agency has already recommended that the law itself be changed, rather than legislating a specific exception for saccharin. Whether or not getting rid of the Delaney clause was a major motivation for the FDA decision on saccharin, that would certainly be the major consequence of the decision. In place of the Delaney clause, the FDA seeks to establish “safe” levels for known carcinogens, taking into account the benefits and the risks, including economic factors (i.e., profits). The handling of the saccharin decision has thus become a major threat to the public health. Rather than being extended to require thorough testing before commercial use, the law will possibly be gutted.
For the many people who depend on saccharin, there will probably be alternatives available soon. But we should all ask, “how did we get hooked on sugar to begin with?” Over the past 500 years, the western diet has come to include massive amounts of sugar, to the benefit of no one but the food industry, and with mildly disastrous effects on people’s health. People are locked into lifestyles in conflict with their best health, faced with a “choice” of heavy sugar consumption in a normal diet or avoidance of sugar with the use of hazardous substitutes. For people who aspire to a “science for the people,” the saccharin ban is a challenge: to reveal the true hazards to the people. to justify the Delaney clause and even stronger measures, and to place it all in the broader context. The FDA is a mediator of disputes between institutions which serve largely ruling class interests and has nothing to offer the people in this conflict except what we force it to offer.