FDA Vitamin Regulations; Struggle over Vitamin and Mineral Pills; Butterfat in Cooking
Contents in in this issue:
- “FDA Moves Back Date on Vitamin Regulations,”
- “The Coming Struggle over Vitamin and Mineral Pills,”
- “Observations of Advantages of Butterfat in Cooking,” by G.W. Coombs.
The following is a transcription of the January 1967 issue of Dr. Royal Lee’s Applied Trophology newsletter, originally published by Standard Process Laboratories.
FDA Moves Back Date on Vitamin Regulations
Washington – The Food and Drug Administration has postponed indefinitely the effective date of regulations proposed in June to regulate composition and labeling of vitamin-mineral dietary food supplements and fortified foods. They were to have become effective December 15.
FDA also announced some changes in the June proposal, including revision of the controversial “crepe” label for vitamin-mineral supplements and fortified foods, and allowed 30 days for filing objections to the changes. It said objections previously filed need not be restated.
The entire proposal will be held in abeyance, pending a public hearing to be called sometime next year. The proposal was published in the December 14 Federal Register. Among other things, the proposal revises the previously published tables of recommended dietary allowances, showing maximum and minimum quantities of permitted and optional vitamins and minerals in supplements. It also provides limitations by age groups and for pregnant and lactating women.
The age groups are infants, children aged one through eight, children aged nine through 17, and adults.
The new language of the “crepe” label reads: “Vitamins and minerals are supplied in abundant amounts by commonly available foods. Except for persons with special medical needs, there is no scientific basis for recommending routine use of dietary supplements.”
This statement would not be required for foods represented solely for use by infants, children aged one through eight, or pregnant or lactating women. However, it would have to be used on other products, and any statement inconsistent with it would result in misbranding.
FDA did not say when the public hearing will be held. The date probably will be determined by the availability of a hearing examiner. William E. Brennan, FDA’s only examiner, is wrestling with the aftermath of the long hearings on whether meprobamate should be covered under the Drug Abuse Control Act. He is apt to be tied up for some time.
Among the issues listed by FDA that will be considered at the hearing are whether the regulations should be limited to vitamins and minerals listed in the proposal; whether the recommended dietary allowances should be adopted; what label designations should be carried (such as “multivitamin supplement”); whether the proposed “crepe” label should be required; whether labels of dietary supplements should carry the name and amount of each vitamin or mineral they supply; whether labels should name the ingredients used to provide the vitamins and minerals and the source of these ingredients.
—As reported in Drug Trade News, December 19, 1966.
In this article several references have been made to the “crepe” label (a nickname assigned to the disclaimer label as listed). It is presumed by some of the vitamin and dietary supplement manufacturers that this required bottle label will sound the death knell for dietary supplements as presently known.
However, as the following article concludes, the proposed hearings may tend to summarize present nutritional knowledge, as many scientists have been alerted and are protesting most of the proposed changes in the new regulations. No doubt, a pro and con discussion by qualified scientists is necessary to awaken a greater professional interest in the art of whole nutrition or the science of physiological chemistry. This science has recently become known as biochemistry and is now taught in a few medical schools. It is regrettable that dietetics, a fractional part of the science of biochemistry, having to do with the regulation or restriction of food for therapeutic purposes, is more generally taught and often is mistaken, by lay people, as the last word in nutrition. The failure of dietetics, in some instances, is well known by the biochemist, as it is impossible to make a part serve as the whole. Diets are designed to usually serve until a complete nutritional program can be adopted.
Scientists in many of the older countries are now following Hippocrates’ advice, “Let food be your medicine and medicine be your food.” Hippocrates is known as the father of medicine and was one of the earliest scientists. A keen student of organic physical chemistry, many of his scientific deductions are still true. In fact, modern science has only recently recognized that the human body is applied biochemistry.
The science of human biochemistry has now become a vital part of the healing arts in many European countries, especially in preventive medicine. Apparently, we have been dragging our feet in this country as it is only recently that the true state of health has become a subject for serious scientific investigation. This, no doubt, has been accelerated by the poor general health of our young male draftees. When we consider the draft statistics as an indication of our national health, the results are appalling. Surely preventive measures must be taken to preserve our national health.
Congress recently granted the FDA a budgetary request for funds to make stricter tests to determine the toxicity of chemical food additives and the side effects of drugs now being used. These toxicological tests are long overdue, as was stated by Congressman Delaney back in 1951: “Our food supply is being doctored by hundreds of new chemicals whose safety has not yet been established.” He was trying to remove the legal loophole that the FDA could not act until after the food product had been put on the market.
Under the circumstances all those affected by the new regulation must assume a “wait and see” attitude as to what will transpire at the FDA hearings. It is generally presumed that consumer rights will demand due respect. For, among other problems, the Mile’s committee report found “a need to elevate the level of scientific competence of the FDA.” And as FDA commissioner Dr. Goddard recently stated, “We must maintain responsible vigilance not only over industry, but over government, including the Food and Drug Administration as well.”
The Coming Struggle over Vitamin and Mineral Pills
The year 1967 is almost certain to see the start of public hearings on the Food and Drug Administration’s proposed deregulations to limit drastically the potency and distribution of vitamin and mineral food supplements. It is highly unlikely, however, that the dispute—or even the hearings themselves—will end during 1967. The whole matter is likely to drag on for years, while scientific witnesses contribute testimony to build a record pro or con on the 23 separate and distinct issues that FDA has indicated will be decided by the hearings.
Far simpler questions have consumed frightening amounts of hearing time. In late 1965 and early 1966, a hardy group of lawyers, reporters, and consumer representatives spent about six months in the cramped, smoke-filled FDA hearing room arguing over a recipe for peanut butter. The food standard for white bread, which was hammered out a couple of decades ago, took years of hearings. The dietary food hearings threaten to be the biggest ever, however. millions of dollars’ worth of annual business is at stake for large and small organizations alike, and momentous nutritional questions will be debated. No one with a serious interest in the outcome can afford to use shortcut methods in presenting evidence or testimony.
Each of the 23 questions to be decided is important. The most publicized issue is whether there should be a label on containers of vitamins and minerals telling people they aren’t really necessary and that you can get all the nutrients you need from food. But many of the other points are also vital. Should more than the 17 vitamins and minerals on the FDA list be allowed to be mentioned on food supplement labels? Are the potency limits set by FDA for those vitamins and minerals in the public interest? Should sellers of dietary foods be prohibited from saying that Americans may be suffering from dietary deficiency, or that storage, processing, transportation, or cooking of food can cause nutrient losses? Those are just a sampling of the issues. The others are no less vital.
Looming even larger than the specific issues in the minds of many people, however, is the troubling question of whether the whole dietary food “trial” will end up being a meaningless pageant. They suspect that it will be just a holding action against the inevitable day when Commissioner Goddard simply decides to do what he originally proposed.
It may be pointless to argue whether such a thing could or could not happen in this freedom-loving, enlightened country. For there is a great likelihood that what will emerge from this in-depth examination of the nutrition of citizens will not be a clear verdict for either side, but a hung jury. The best and most respected experts have already gone on record to the effect that we simply don’t know enough about what people are eating and what that food is doing for them to create a rigid, nationwide pattern of diet control.
That will no doubt be the position of the Food and Nutrition Board of the National Academy of Sciences-National Research Council, which has already repelled FDA’s effort to tie it to the diet control plan. The Food and Nutrition Board has said that its decisions are meant only to be used as guides and recommendations—not inflexible rules. Individual experts have also continually called attention to the dark areas of nutritional knowledge. “It is my firm opinion that we are presently recognizing and correcting only a small fraction of the mineral imbalance problems currently plaguing animals and man,” said W.G. Hoekstra of the University of Wisconsin Department of Biochemistry in Federation Proceedings, September/October 1964. Vitamin nutrition is likewise far from a settled issue.
Predicting the future is a frustrating and usually futile game. But it does appear that the dietary food and food supplement hearings could have the long-term effect of giving the science of nutrition the public attention and professional understanding that it has lacked for so long. From the reams of testimony may emerge a truly valuable summary of what is known about human vitamin and mineral nutrition—and perhaps an even lengthier compendium of what is not known.
—As reported in Rodale’s Health Bulletin, December 24, 1966.
Observations of Advantages of Butterfat in Cooking
By G.W. Coombs
In recent years considerable attention has been focused on the nutritional effect of heated oils and fats on laboratory animals. Depending on the type of lipid, the heat treatment, and the amount taken in diet, pathological disorders observed have ranged from loss of weight to death after a few days. This subject has recently been reviewed by Kaunitz (1962), by Kummerow (1962), and by Matsuo (1962).
Early workers in this field used fats oxidized far beyond the stage ordinarily reached in cooking. However, Johnson, Sakuragi, and Kummerow (1956) fed corn oil, margarine base stock, and butterfat heated at 200°C for 24 hours to weanling rats. With corn oil the rats suffered severe diarrhea and a decrease in food intake, and were characterized by rough fur. Under similar conditions margarine base stock gave slight growth depression. With butterfat no adverse effect was observed. The extent to which the oils were heated in these experiments was well within the limits of the heat treatment to which re-used household cooking fats and oils are subjected.
If this heat-induced toxicity resulting from the ingestion by animals of fats other than butterfat applied also to humans, it would be of considerable importance in human nutrition.
Bhalerao, Johnson, and Kummerow (1959) stated butterfat contains triglycerides that are acetone-insoluble and are able to counteract the effect of toxic products or prevent the formation of toxic products during the thermal polymerization of a fat.
There are obvious difficulties in studying toxic effects of fat in human diet, and this is no doubt partly responsible for the limited amount of work that has been done in this field. To evaluate the relative effects of different fats after heating would demand extensive clinical observations on many patients under rigid dietary control.
Evidence of one such test has been reported by Horwitt (1962), who stated that “nine out of 23 (human) subjects that had been on a diet in which fat had been oxidized to a peroxide number of 50…had evidence of active duodenal craters.”
In the investigations reported here, however, it was possible, by working with patients already suffering from gastrointestinal disturbances of various types, to make observations on the effect of altering the type and amount of fat in the diet, and to define the maximum temperature to which the fat was heated.
Remove all visible fat. For frying use a minimum amount of butterfat for one operation only, varying from, say 6 g for a thin steak to 30 g for crumbed fish cutlets, pancakes, etc., and adjusting the amount so that the cooking vessel is free of fat when cooking is complete. For oven-baking use a rack and brush on butterfat at intervals during cooking, or baste with a mixture of equal parts of butterfat and flour.
Steam in saucepan with 3 g of butterfat and a quarter-inch of water (cabbage is first shredded and no water added). For oven roast, treat as for meat. For frying, sear and crisp at 400°F and then reduce to 350°F.
This regimen excludes the intake of all fats other than butterfat in every type of food in the diet.
Of 22 patients suffering from duodenal and gastric ulcers, with an age range of 28–76 years and a duration of illness from one to 45 years, with an average mean of 13 years, 17 improved to the point of not suffering pain after eating baked or fried meals. Of 16 patients suffering from flatulent dyspepsia, heartburn, nausea, distension, vomiting and water brash, whose ages ranged from 40–72 years and with a duration of illness from one to 47 years, with a mean of between 13–17 years, 15 of these patients were improved to the point of not suffering from these symptoms after eating baked or fried meals.
In this test, wherein the patients concerned were not aware that tests were being made with the fats used in the preparation of their foods, the four patients reacted in a similar manner to those in Experiment 1.
Two cases of chronic diarrhea and hemorrhage, with a duration of illness of 19 years, improved after three months to the point that hemorrhaging no longer existed and diarrhea occurred only under stress. One of these patients had been diagnosed by an Army doctor as suffering from chronic ulcerative colitis.
This experiment supported the view that, whereas ordinary cooking fats produced in the patients the gastrointestinal symptoms normally experienced, butterfat was without ill effects. These results are, moreover, consistent with the observations of Johnson et al. (1956) already mentioned, indicating that while some heated fats when fed to rats produce adverse effects, heated butterfat was found to be harmless.
In the work carried out by Coombs, Kaye and Parodi, 38 chronic long-term sufferers (22 from digestive disorders and 16 from duodenal and gastric ulcers) were put on a regimen that substituted butterfat for other cooking fats. The condition of 32 of these patients improved to the extent that they were able to eat meals baked or fried in prescribed amounts of butterfat without suffering pain. In another similar experiment involving four cases, subjective experimental errors were excluded because the patients were unaware that they were being tested. In another study the effect of the butterfat regimen on two chronic sufferers from diarrhea was examined. The results thus obtained strongly supported the advantage of cooking (as prescribed in the regimen) with butterfat by comparison with other commonly used cooking fats.
—Reprinted from Internationales Journal