View Full Version : 1973 Article: FDA and the War on Vitamins, by Gary Allen

01-29-2012, 02:27 PM
The Food and Drug Administration is waging war on vitamins. It has published new regulations which would limit the potencies and combinations of such food supplements to an extremely narrow range which will, according to the F.D.A.'s own estimate, outlaw 80 percent of the food supplement products now marketed. Among the features of this harassment are: Prohibition of any implication that a diet of ordinary foods cannot supply adequate nutrients; prohibition of all claims that inadequate or insufficient diet is due to the soil in which the food is grown; prohibition of all claims that transportation, storage, or cooking of foods may result in inadequate or deficient diet; prohibition of all claims that vitamins and/or minerals derived from natural sources are in any way superior to those derived from synthetic sources.

Vitamins: Federal Bureaucrats want to take yours! (http://www.scribd.com/doc/78360827/Vitamins)

American Opinion | Gary Allen
September 1973

If the federal Food and Drug Administration has its way, Americans concerned about sound nutrition will soon be paying up to three times as much for vitamin and mineral supplements. One anticipates a clandestine organic underground in which pink-cheeked mothers meet shady characters in alleys. The ladies stealthily approach Vita-Pusher as their bright but shifty eyes peer furtively into the shadows for signs of the feds.

"How are you fixed for E?" the health-conscious mothers ask.

"They busted my E contact," grumbles Vita-Pusher, "but I can get you a fix of B-Complex or enough wheat germ to last your kids for a week."

All of this seems hyperbolic, of course, but the fact is that the faceless bureaucrats who run the Food and Drug Administration are about to make it a reality - even though the raging controversy over government restrictions on vitamin and mineral supplements has in the past four months produced nearly a million letters to Congressional offices. Consumers and retailers of health foods are discovering for themselves, as F.D.A. critic Omar Garrison observed in The Dictocrats, that: "When bureaucrats go on the rampage, they destroy everything in their path. They destroy human values, reputations, bank accounts, privacy, freedom of thought, freedom of speech, and freedom of belief." Though there has long been grave concern about the excesses of the Food and Drug Administration, it took F.D.A. publication in the Federal Register of an outrageous set of proposed regulations on vitamins and food supplements to trigger the avalanche of mail. Consumers had discovered that the publication of the new regulations in the Register of January 17, 1973, was tantamount to adoption. And those proposed regulations will become administrative law unless a bill proposed by Representative Craig Hosmer is passed by the Congress to stop it. Briefly, the new regulations drastically limit the potencies and combinations of food supplements to a narrow range which will, according to F.D.A.'s own estimates, outlaw approximately eighty percent of food supplements now being marketed. These restrictions would outlaw such products as a B-Complex formula, the combination of calcium and Vitamin D, the combination of Vitamins A and C, etc. Further, manufacturers would have to eliminate any and all explanations of the healthful value of their products, and they would have to publish some sort of disclaimer on their labels. They may not state on their packages that the nutrients are of any use whatsoever. It is not even permissible to say that the nutrients can prevent or cure a deficiency state of those very nutrients.

The edict would also require that amounts of vitamins and minerals in other foods, for which nutritional claims are made, be listed on labels according to a method known as the Recommended Daily Allowance (R.D.A.). This would replace a previous labeling requirement known as the Minimum Daily Requirement (M.D.R.), and the change would further confuse consumers about the value of such over-the-counter products. Operating on Washington's usual dictum that the public doesn't know what is best for itself, the moguls of F.D.A. don't claim that vitamins or health foods are toxic or otherwise harmful. You see, they just don't want you to waste your money. Of course the government is now the Number One waster of your money, and if Big Brother can force you to stop wasting your cash on "frivolous" vitamins and nutrition he will have established a precedent for deciding how you will spend the rest of your income which survives his tax collectors.

Nonetheless, the new administrative regulations will become operative next year, unless Representative Craig Hosmer's H.R. 643 is passed to stop the F.D.A. in its tracks. If the regulations are put into effect, millions of people who now take high-potency vitamins will be up a nutritional creek without a dietary paddle. Their only recourse will be to go to their doctors for prescriptions allowing healthful dosages larger than the paltry allowances under the ruling.

The new regulations, for example, outlaw production of capsules (or tablets) with over forty-five I.V.s of Vitamin E per capsule, and unless you want to gulp down one hundred pills or so to make up for the reduction in potency, your daily ration of Vitamin C will be limited by Big Brother to a miscroscopic ninety mg. Many top experts on nutrition, of course, recommend a daily intake of ten to twenty times the amount being promoted by the F .D.A. as desirable.

Under this arbitrary ruling, stores would be permitted to carry, for general purchase, only those supplements for which the daily intake is represented at or below the following:

Vitamin A, 5,000 I.U.
Vitamin D, 400 I.U.
Vitamin E, 45 I.U.
Vitamin C, 90 mg.
Thiamin, 2.25 mg.
Iron, 27 mg.
Riboflavin, 2.6 mg.
Niacin, 30 mg.
Calcium, 1.5 grams
Phosphorus, 1.5 grams
Iodine, 225 mg.

The new F.D.A. ruling would remove Vitamin K, sulphur, sodium, potassium, and manganese from the non-prescription list entirely.

As Jonathan Spivak observes in the Wall Street Journal: "The regulations are bound to have a major impact on manufacturers, which are selling an estimated $322 million of vitamin and mineral pills a year, according to recent estimates. The minimum and maximum limitations and requirements that pills contain specified vitamins and minerals could force many companies to reformulate products. One FDA specialist predicts that 75% to 80% of the products involved may have to be reformulated."

If the F.D.A. bosses have their way under the new restrictions, sound nutrition will be officially discouraged in America. No seller of food supplements will be able to state or even imply that the nutritional adequacy of our foods can be so much as affected by heating, storing, chemically processing, or adulterating. This is as sinister as it is ludicrous. While unwilling to admit the general deterioration of ordinary foodstuffs, the F.D.A. admits in the very same Federal Register proposal that: "Some vitamins are susceptible to partial destruction through the effects of heat, light, oxidation and other physical and chemical reactions." As Congressman Craig Hosmer observes: "This obvious contradiction is an affront to the intelligence of any man."

The Food and Drug Administration also claims that foods grown in America's soils are just as nutritious as they were in grandmother's day, and that the need for vitamin and mineral supplements is therefore minimal at best. The F.D.A. bureaucrats haven't been listening to the scientists employed by the United States Department of Agriculture, who noted in a special report in 1971:

The protein in feed wheat in Kansas from 1940 to 1969 declined by 44.7 percent. Recent tests per 100 grams weight showed a variation in produce grown in those two years to be as follows: Asparagus, 68 to 49 for phosphorus in California, 91 to 41 in New Jersey; snap beans for magnesium, 32 to 19 in Maryland, 39 to 22 in New York; carrots for iron, 65 to 31 in Arizona, 88 to 31 in Texas; celery for calcium, 56 to 13 in California, 74 to 41 in Michigan; sweet corn for copper, 15 to .03 in Florida, 13 to .05 in North Carolina; lettuce for sodium, 10 to 5.5 in Arizona, 1.8 to .58 in New Jersey; onions for potassium, 211 to 163 in Michigan, 188 to 144 in New York; tomatoes for phosphorus, 41 to 18 in Maryland and 39 to 16 in Texas.

And this same Department of Agriculture report goes on to observe: "We took 4,000 samples of corn from 1 0 Midwest states. The old-fashioned, open pollinated corn contained, on the average, 82 percent more crude protein, 37 percent more copper, 197 percent more iron and 113 percent more manganese, as compared to the new hybrid corn. That means, the farmer must feed three times as much corn to his animals so they will get the same amount of body building protein." These experts pointed out that there had been the same sort of deterioration in the content of calcium, sodium, zinc, and magnesium.

Scientists at Rutgers verified the U.S.D.A. findings in the important Firman-Bear Report, which revealed that over a twenty-year period: "Cabbage varied in its sodium content from 94 ppm to 20 ppm. Tomatoes varied in iron from 1,928 ppm to 1 ppm. Spinach varied in its content of magnesium from 203 ppm to zero ppm." In all cases, the depreciation was highly significant, and the figures reflected a persistent downward spiral of nutrients.

Both the U.S.D.A. report and the Firman-Bear Report verify that there has been a drastic decline in all of the minor soil elements. And the Department of Agriculture concluded: "Due to the sterile condition of the soils, we are heading towards a nationwide nutritional famine." Yet the new F.D.A. regulations would prohibit any nutritional claims for supplementary rutin, other bioflavonoids, para-amino-benzoic acid, inositol, and similar substances. And it would prevent combining them with other dietary supplements in any way. To add dietary insult to nutritional injury, the F.D.A.'s ruling would also prohibit anyone from claiming that natural vitamins are nutri* tionally superior to synthetic ones.

Such madness would be laughable if it were not for the fact that it can only produce severe harm to American nutrition in the name of extending the authority of Big Brother over the quality of our lives. Nonetheless, the vast, arbitrary power of the F.D.A. bothered relatively few Americans until very recently. In fact, many of those who are now most vociferous in their denunciation of the outrageous rulings on vitamins and minerals were either silent or cheering the F.D.A. on to greater excess when that agency was running roughshod over other segments of the food and drug industry. Though there have been a number of well-fought campaigns against the dictatorial policies and programs of the Food and Drug Administration over the past two decades, in almost every case the people leading them fully supported the F.D.A.'s harassment of everyone else.

For example, not long ago the F.D.A. proposed new regulations on the "unapproved uses of approved prescription drugs." The American Medical Association, in a strongly worded rebuke, denounced these F.D.A. regulations as unwarranted interference with the practice of medicine. Under the terms of those regulations, "unapproved use" means any use not indicated on the label. It does not even refer to an officially disapproved use. A use might not be approved on the label simply because the F.D.A. hasn't gotten around to it. The discrepancy might involve such matters as the physician's judgment about the dosage or regimen best for his patient. And it might reflect new procedures recommended by the most careful medical research.

What particularly angered the A.M.A. was another section of the F.D.A. ruling which declared that all labels for prescription drugs must declare that the prescription may not be refilled. The American Medical Association pointed out that the F.D.A. has no blanket statutory authority to prohibit refills, and that the Controlled Substances Act limits prescriptions for even Schedule III and IV substances to five refills without a fresh prescription from a physician.

Another section of the ruling that upset the A.M.A. required the distribution of drugs to specified channels, and limited prescribing, dispensing, or administration to physicians with specified qualifications. The American Medical Association noted that the F.D.A. was again overextending itself and that the agency had no legal authority to direct channels of distribution for previously approved drugs. "The physician is the proper person to impart needed information to patients, on an individual basis, about drugs that he provides," the A.M.A. said.

The organized proponents of health foods were silent in this controversy. Just as silent as the American Medical Association has been on the new vitamin-mineral regulations.

Few complained, and many cheered, when the F.D.A. announced on June 19, 1973, that forty thousand prescription drugs would be put to its bureaucratic test of "effectiveness." According to the Associated Press, as many as eight thousand drugs, many marketed and used successfully for as long as thirty-five years, could get the ax and be classed as worthless by the bureaucrats. Busy doctors, who had been using many of these drugs effectively for years, expressed outrage and concern. But their objections were lost in the general clamor for more and more control over just about anything and everything.

One physician who voiced indignation at the F.D.A. power-grab was Dr. William Center of San Antonio, Texas. He complained in the American Medical News:

The FDA is literally tearing to shreds the private practice of medicine in this country. The destructive process has been taking place before our very eyes and with the sympathy and votes of the people we sent to Congress. When you shake it all out, the patient ends up paying the greatest penalty. There isn't one doctor in a thousand in this country who knows and understands the modus operandi of the FDA to render us all robots. I offer the doctors of this country as the most eligible to receive the blue ribbon for being the biggest collective ostrich in this land.

Even economist Milton Friedman declared in Newsweek for January 8, 1973, that the F.D.A.'s controls on drugs have "done more harm than good." He cited the tragic economic losses suffered by manufacturers and retailers, not to mention distributors, when the F.D.A. decides to clamp down on a drug that has been used for a generation, or when it arbitrarily orders the change of one word on five million labels.

Dr. Francis A. Davis notes in Private Practice that the F.D.A. has caused the development of new life-saving drugs to become an "expensive, time-consuming and risky venture by imposing undue restrictions and standards." He observes that there were sixty-three important new drugs marketed in this country in 1959; but that, with the massive escalation of F.D.A. controls, only four new drugs were made available in 1969. In human terms, he notes, the effect of introduction of the drugs that conquered tuberculosis provides a dramatic illustration of what this means. Postponing the introduction of those drugs for just two years, Dr. Davis explains, would have meant an additional 45,000 deaths and 90,000 more cases of TB. The implication, put bluntly, is that harassment of the pharmaceutical industry by the Food and Drug Administration is resulting in the needless deaths of scores of thousands.

Still, most Americans were unaware and unconcerned about the effect of such bureaucratic harassment until that day in January of 1973 when the F.D.A. moved to choke off their vitamins and food supplements. That brought the issue home to the kitchen table. Virtually a million people wrote letters to their representatives in Washington. Enough was enough!

Much to the surprise of Representative Craig Hosmer, who had been fighting the excesses of the F .D.A. practically alone for five years, 160 Congressmen, knowing a sure vote getter when they saw one, stood in line to add their names as co-sponsors to his H.R. 643. Since he has had plenty of experience writing such bills, Hosmer's legislation is a masterpiece of simplicity. It would simply require the F.D.A. to define vitamins and minerals as foods rather than drugs. This is an important point, since it would prevent minerals and vitamins from being put into the prescription category no matter how potent. It would also prohibit the bureaucrats of F.D.A. from "their continued efforts to ban the sales of truthfully labeled vitamin and mineral food supplements for reasons other than fraud and safety."

The Hosmer bill is far from perfect, but by limiting the F.D.A.'s power in the area of food supplements it would serve notice on the bureaucracy that the Congress has had enough dictatorship by administrative ukase.

Such diverse ideological bedfellows as "Liberals" Bella Abzug and Benjamin Rosenthal joined with "Conservative" types like California's Clair Burgener and Philip Crane of Illinois in co-sponsoring Representative Hosmer's H.R. 643. It was a veritable love feast - until the New York Times got wind of what was happening.

On May fourteenth, the Times carried a hatchet job, disguised as a news feature, which blasted Hosmer and his "kooky" supporters and ridiculed "Liberals" who were co-sponsoring his bill. The Times reporter boasted in his story of telephoning Washington and convincing several of the terrorized "Liberals" to drop their support of the measure. Representative Morris Udall, the Arizona "Liberal," wailed that he had been "conned" into supporting H.R. 643 by "associations lobbying for the Hosmer bill who were made up of four-eyed groups." No doubt Moe, as Morris is called by his friends, prefers not to catch passes from those who wear glasses.

Also jumping backwards in the fray, an aide for Representative Howard Robinson (R.-New York), pleaded with the Times that the Congressman's co-sponsoring of the Hosmer bill "is all a mistake." Robinson was so frightened by the Times attack that he not only called Hosmer's office to complain that he had been "deceived," but went so far as to write a letter to the Chairman of the Congressional Committee considering H.R. 643 in order to recant. Of course, Robinson knew very well that once his name was on a bill as a co-sponsor it could not be removed. It was a grandstand play by an intimidated Congressman to impress the Times.

The Times reporter demanded of Bella Abzug why she would support "such quackery legislation." Always among the first to shout her defiance in the face of opposition from the Right, Bella was so intimidated by the New York Times that all she could think of to say was that she had become a co-sponsor only "because Ben Rosenthal is on the bill."

As for Ben Rosenthal, he managed to be out of the country when the Times came calling. One of his aides, according to the Times reporter, turned to another and said, "Maybe you can talk your way out of this!" At which point the second aide told the Times: "We had an outside source telling us it was ok. I think we may look it over again."

David Ajay, an official for the National Nutritional Foods Association, is convinced that the Food anq Drug Administration was responsible for the attack by the New York Times. He says that the objective was to "allay the fears of the public ... in order to cause a letup in the storm of protest that has been generated in Congress."

Congressman Hosmer answered the Times in the House on May 24, 1973. After explaining what his bill would and would not do, Hosmer suggested that as usual big business was trying to use government to drive out the competition. He explained that the big drug lobbies are delighted to have the F.D.A. restrict high-potency vitamins to prescription, as such a move "will line their pockets as it drives the small vitamin and food supplement stores [and producers] out of business." He added that "the people who support HR 643 are not intellectual basket cases. They just do not believe the FDA ought to be allowed to spend taxpayers' money to take something away from people which they want and which cannot hurt them."

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