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Seek Comments On Saccharin Ban The Food and Drug ad­ ministration is now accepting public comments on proposals to ban saccharin as a general purpose food additive but permit its continued use as a drug, provided manufacturers can demonstrate medical ef­ fectiveness. There is continued public interest in the subject of sac­ charin, as evidenced by the thousands of letters that con­ tinue to pour into FDA offices. Based on those letters, there is also some public confusion about the scientific and legal bases for these proposals. This story will be around for some time. Therefore, ' to irovide the community with background, a copy of a recent article which appeared in the "FDA Consumer" magazine follows. The article explains the background of saccharin, up to the recent proposals. The Saccharin Ban The Food and Drug ad­ ministration's proposal to ban saccharin as an ingredient in food, beverages, and cosmetics, but to permit its continued sale as a drug if its medical effectiveness can be demonstrated, has touched off a public reaction seldom ex­ perienced even by an agency used to being in the midst of controversy. The public reaction has ranged from letters from diabetics who feel their health would be imparied if diet sodas are banned, to questions about the reliability of the evidence that saccharin causes cancer. These criticisms have elicited defenses by the scientific community of the validity of experiments in which large doses of chemicals are fed to test animals. The debate has extended to public policy questions about the law that prohibits FDA approval of any food additive shown to cause cancer in man or animal. The public reaction was evidenced by some 40,000 letters FDA received within a month after it first an­ nounced--on March 9--its position on the use of saccharin in food and beverages, but before it had addressed the question of saccharin's use as a drug. These letters came not only from diabetics, but also from people on weight-control diets, people who questioned why the government is taking saccharin off the market while not taking similar action against cigarettes, and people who challenge the govern­ ment's authority to prohibit the use of certain products rather than giving the public the freedom to use any substances it wants, so long as the label carries appropriate warnings. FDA set forth its detailed plan for saccharin on April 15. Commissioner of Food and Drugs Donald Kennedy said the proposal to ban most uses of saccharin but to consider its use for medical purposes would reduce consumption of the artificial sweetener by as much as 90 percent. "This approach would eliminate the risk to children and to the general public from unnecessary uses of saccharin while preserving its benefit for people with health problems," Kennedy said. "Furthermore," said Ken­ nedy, "if saccharin is available only as a single-ingredient drug with a warning label then people would have to make a personal and conscious decision to use it. But if it were to continue to be used as just another ingredient in diet sodas or foods or lipstick or mouth­ wash, consumers likely would be exposed to it without full knowledge or consent." Buy now and beat the heal o & Then sit back and re­ lax in cool comfort when hot weather arrives. Prompt service, too. when you buy before the busy season. Let us show you the Whirlpool air condi­ tioning'system right for your home. Call today for a FREE ESTIMATE. \Wurij>oql VIKING HEATING SERVICE 385-3772 FDA'S proposed actions by no means represents a final position. The agency permitted sixty days for public comment and scheduled a public hearing so consumers, manufactures, scientists, and others with an interest in the use of saccharin can express their views. FDA's formal proposal was published in the April 15 "Federal Register" and anyone wishing to comment on it may do so by writing to the FDA Hearing Clerk, Room 4-65, 5600 Fishers lane, Rockville, Md. 20857. Final regulations are ex­ pected sometime this summer. If they are issued exactly as FDA has proposed, this is what would happen: Food and beverages: Sac­ charin no longer could be added to any food or beverage by manufacturers. This would mean an end to saccharin in diet sodas, the largest single current use of the artificial sweetener. Foods and beverages containing sac­ charin and made before the final regulation goes into effect could be sold. There would be no recall. Cosmetics: Thirty days after the final regulation is published, saccharin no longer could be added to any cosmetic likely to be ingested. Examples are lipstick, mouthwash, and toothpaste. Cosmetics to which saccharin already had been added could be sold until the supply is depleted. Drugs: Saccharin would be banned as a nonmedical ingredient in prescription and nonprescription drugs, where it is used in small amounts to make some products taste better. The ban would be im­ posed gradually over a period of months. FDA would consider requests to permit the con­ tinued use of saccharin as an ingredient in combination-of- ingredient drugs specially formulated for diabetics, but only if the manufacturer submits data demonstrating the medical need for such use. Single-ingredient drug: If the final regulation is published as proposed by FDA, saccharin would be sold as a single- ingredient drug available without a prescription. All such products--whether powder, tablet, or liquid would have to carry a cancer warning on the label. This warning would say: "Saccharin causes bladder cancer in animals. Use of saccharin may increase your risk of cancer." The label warning would be required within 120 days after the final regulation. Manufacturers who want to sell saccharin as a single- ingredient drug would have 180 days after the regulation is issued to submit to FDA proof of its medical effectiveness. Manufacturers who submit such data would be permitted to continue to sell saccharin while FDA is evaluating the information. Manufacturers who submit such data would be permitted to continue to sell saccharin while FDA is evaluating the information. Manufacturers who do not submit data would be prohibited from selling sac­ charin. In explaining FDA's proposal to consider saccharin as an over-the-counter drug, Com­ missioner Kennedy made clear that he recognized this is a novel approach. "I know of no other drug whose only purpose is to change the taste of food," he said. "I know of no other drug which is to be taken not for what it can accomplish in itself, but because the only alternative-- in" this case sugar--must be avoided. But for those individuals who must limit their sugar intake the benefits of saccharin may well outweigh any potential risks that we can now project. It is on this basis that we will consider the continued marketing of saccharin for those individuals with a medical need for a nonnutritive sweetener." FDA made clear, however, that the permanent approval of saccharin as a nonprescription drug is not automatic. The risks of saccharin are such that a manufacturer must demon­ strate that there are offsetting medical benefits, such as for use by diabetics. If no such evidence can be provided, saccharin would be banned for all purposes, including drug use. FDA's proposed action on saccharin is the latest in a long series of events surrounding the artificial sweetener. Sac­ charin's use dates back almost 100 years. Although it was suspected of causing "digestive disturbances" as long ago as the 1800's, saccharin's safety was not seriously questioned until about a decade ago. A successive series of evaluations by leading scientists, working through the National Academy of Sciences, resulted in a recommendation that sac­ charin should continued to be used but should be tested further. The testing began in earnest in" 1970 after FDA banned cyclamate, another artificial sweetener. That ban made saccharin the only artificial sweetener on the market and resulted in dramatic growth in its use in diet sodas and ar­ tificially sweetened foods. During the past year Americans used about 5 million pounds of saccharin. The first clear signal that saccharin could cause cancer came in 1971 in a study con­ ducted by the Wisconsin Alumni Research foundation. In that study, seven of fifteen male rats fed saccharin at the rate of 5 percent of their diets for two years developed bladder tumors. On the basis of that study, plus doubts raised about sac­ charin's safety by other studies, FDA in 1972 put limits on its use. These limits were intended to discourage the upward spiral of consumer use of saccharin until the questions about its safety were resolved. A study completed by FDA in 1973 again indicated that large amounts of saccharin in the diets of test rats could cause cancer. Of twenty-three male rats fed a diet of which 7.5 percent was saccharin, seven developed bladder tumors. Of thirty-one female rats, two developed cancer. On the basis of these studies, FDA asked the National Academy of Sciences' National Research council to review again the possible cancer- causing potential of saccarin. In December 1974, the scien­ tists said that the data then available had not established conclusively whether saccarin itself caused cancer or whether an impurity found in com­ mercial saccharin could have induced the tumors. This im­ purity is called or- thotoluensulfonamide, or OTS. This impurity is called or- thotoluensulfonamide, or OTS. In February® 1974, the Canadian government began what was intended to be the definitive test on saccharin. The test involved the feeding of pure saccharin--with the OTS removed--to rats. Another group of rats was fed OTS. FDA received the results of the Canadian test March 7, 1977. The tests demonstrated beyond serious question that saccharin causes bladder tumors in test animals. In the study, 100 male and female rats were fed saccharin throughout their lives at a rate of 5 percent of their total diet. Seven males developed bladder tumors. In addition, 100 off­ spring of these rats were fed saccharin. Of the offspring, two females and twelve males developed bladder tumors. Thus, of a total of 200 animals, twenty-one developed bladder tumors. In contrast, of 100 "control animals" not fed saccharin, only one developed a tumor. And none of the animals fed OTS developed tumors. The findings of the Canadian study are particularly significant because two generations of rats were studied. The second generation--the offspring of the first--had been exposed to saccharin "in utero" or from the time of conception. These rats developed more malignant tumors than their parents, raising important questions about the possible effect of saccharin on humans during the fetal stage and in childhood. Many of the consumers who have written FDA have worried that the Canadian rat study involved such high doses of saccharin that the results were unrealistic. Many argued that almost any substance fed in such high doses would cause cancer. Neither of these views is correct. The exposure of test animals to high doses is the most valid way science today knows tp predict whether a chemical may cause cancer in people. Such tests are both realistic and reliable. They are, in fact, essential to predict rare oc­ currences--for example, to seek out and identify a sub­ stance that can cause cancer in only one out of every 20,000 Americans. That may be a rare occurrence statiscally but it represents more than 10,000 people in our total population. The most important reason test animals are fed doses far larger than humans are ever likely to receive is simply practicality. No one could breed, raise, sacrifice, and examine test animals fast enough to find one case of cancer out of 20,000 animals. There aren't enough breeders, examiners, time, or money. Instead, fewer animals are used and, to compensate, they are given high doses.' This system works. Tests similar to those used for saccharin have shown that all but one of the thirty or so chemcials known to cause cancer in people also cause cancer in animals. Thus, when a chemical tested in high doses on a limited number of animals causes cancer, scientists are concerned. This concern stems from the knowledge that if a high dose of something causes cancer in a significant number of test animals, a low dose probably will cause cancer in some people. It simply is not true, however, that extremely high doses of almost any substance SUCTION 2 will cause cancer in test animals. In fact, in 1969 the National Cancer institute reported that of 120 pesticides and industrial compounds given to mice, only eleven were found definitely to induce tumors. And these chemicals were not randomly selected. Most were picked because there already was reason to suspect that they might cause cancer. Even so, the great majority of more than 100 suspicious chemicals did not cause cancer in animals even when tested at very high dose levels. The experiment on saccharin conducted by the Canadian government conformed to the requirements of good animal testing and good science. The study showed beyond reasonable doubt that sac­ charin is , among the com­ paratively small number of substances that do cause cancer in test animals and, therefore, may be hazardous to humans. There is no way to determine from checking animals exposed to high doses of a cancer- causing chemical precisely how many huipans might get cancer from a lower dose. But there are reliable methods for estimating the maximum number of people who might be so affected. Using these methods, FDA scientists calculate that even moderate use of saccharin, the amount present in one large diet soft drink, if ingested over a lifetime by every American, might lead to 1,200 additional cases of bladder cancer per year. Commissioner Kennedy summarized FDA's view of this hazard at a press conference announcing FDA's proposed course of action on saccharin: "With a thousand Americans a day already dying from cancer, with another 1,600 new cases being detected daily, and with the knowledge that we don't know what causes most of these cancers, then I think that we as a nation cannot ignore the kind of evidence that we now have against saccharin." FDA's decision to ban sac­ charin from food and beverages has touched off a related controversy over a section of the Food, Drug, and Cosmetic act known as the Delaney clause. This clause says: "No additive shall be deemed to be safe ... if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal." When FDA first annoucned on March 9 its inteniton to ban saccharin from food and beverages, it said it was doing PLAINDKALER - WEDNESDAY. JUNE 15, 1977 so on the basis of the Delaney clause. As a result, many people concluded that P DA was acting only because it was required to under a strict, in­ flexible provision in the law That is not the case. FDA made clear at the time that provisions of the Food. Drug, and Cosmetic act other than the Delaney clause require that food additives be safe. FDA's judgment, based on the ac­ cumulated scientific evidence, is that the artificial sweetener is not safe for continued use as a general purpose food ad­ ditive. The agency would have moved to ban saccharin from general use even without the Delaney clause. Public debate on the Delaney clause, however, should be beneficial. This law is almost 20-years-old. As scientists improve their capability to detect hazards, new suspicions will be raised about many familiar ingredients in food. Decisions similar to the one on saccharin are likely to confront the public and FDA in the years ahead, so reexamination of the laws that govern FDA's efforts to assure the safety of the food supply is welcome. Many of the people writing to FDA about the proposed sac­ charin actions have asked why the federal government has not acted to remove cigarettes from the market since they too have been shown to cause cancer. Cigarettes do not come under the provisions of the Food. Drug, and Cosmetic act. Congress has determined by law that cigarettes are not to be regulated from a health standpoint except for a warning label. That decision apparently reflects the wishes of the American people Those who advocate a change in the laws on cigarettes should address their concerns to Congress Another question raised often concerns the prospects for FDA approval of other artificial sweetners. There have been press reports of a number of potential replacements for saccharin, but none of these substances has thus far been tested sufficiently to demon­ strate its safety. FDA does not foresee early approval "of another artificial sweetener Although the great number of questions and comments generated by the saccharin issue has taxed FDA's resources, the agency views this public interest and concern as a healthy and vital part of the regulatory process. Public involvement in the saccharin decision is essential, FDA Commissioner Kennedy em­ phasized in announcing FDA's proposals.The proposals, he said, are "in accord with FDA's basic responsibilities for protecting the public--not in some authoritarian "we know best' way but with the full knowledge and open par­ ticipation of the public in the process." Flood Hazard Boundary Maps Made Available McHenry county has received new flood hazard boundary maps from the Federal Insurance ad­ ministration says Richard O. Klemm, chairman of the County board. The purpose of the maps is to identify those areas of the community which have shown to be subject to special flood hazards. Klemm said, "Since many of the residents living in a flood hazard area may apply for flood insurance, many people in our county may be interested in knowing the official designation in order for them to apply for flood insurance. Also, future consideration may also be affected by the flood designation areas, and I would hope those concerned in development activities would be aware of the flood hazard locations in our county." The maps have been distributed to the various county offices in the courthouse and may be viewed by the public at the Planning Department office, Room 105, in the courthouse, between the hours of 8:30 a.m. and 5 p.m. five days a week. 1 4-H NEWS | 4 CLOVERS Our recreation for the evening was a game called Detective. The meeting was called to order at 8:25 p.m There were twelve members in attendance. We named our club and voted to have dues starting Sept. 1. Lisa Kuglin had an interesting talk about ceramics. Tom Barry, reporter French Menu On a French menu, anything identified as "provencale" or "a la portugaise" is a dish made with tomatoes Pewter Stains Certain chemicals and acids present in many foods may cause stains and pitting if in long con­ tact with pewter. Common cul­ prits include party dips. eggs, salad dressings, oils, vinegar, salt and fruit juices 24 EXCITING CATEGORIES @ OUR RICH HERITAGE SUNDAYS AT HOME OUR FAMOUS RESTAURANTS SATURDAY NIGHT PARTIES THE SOUTHWEST NEW ENGLAND CREOLE COUNTRY BUDGET STRETCHERS THE FRENCH TOUCH LOW-CALORIE DISHES CHILDREN'S FAVORITES * . PARTY CASSEROLES jfcft OUR ITALIAN HERITAGE THE OLD SOUTH THE MIDWEST CONTEMPORARY COOKING DO-AHEAD DISHES COUNTY FAIRS 0 A WORLDWIDE MEDLEY THE PACIFIC COAST HOLIDAYS COOKING WITH WINE ^ COOKING WITH HERBS ^ MEMORABLE SUMMER MEALS BUYA SET AWEEK! 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