THE FDA
DOUBLE STANDARD

An analysis of the FDA’s double standard in which harmless non-drug materials, such as vitamins and food supplements, are burdened with restrictions in excess of those applied to toxic and dangerous drugs.

The FDA’s unrelenting war on vitamins, food supplements, and non-drug medicines is well known. Much of the agency’s time and resources are spent each year warning the public about the dangers that lurk in the nutritional approach to health.

When it comes to drugs, however, there is a more permissive attitude with the implied assurance: “Don’t be overly concerned about harm from drugs. Take whatever we have approved and relax. You’re in safe hands.”

In July of 1971 the FDA issued a “Fact Sheet” on the subject of drug side effects. Under the heading: “Should People Fear Drugs Because of Possible Side Effects?” we find this answer: Drugs should be respected rather than feared. A physician’s decision to use a drug is a considered one. It is his decision that it is better to treat a disease with a certain drug than leave it untreated, and that there is greater danger in not using the drug.[338]

The comment regarding the supremacy of the physician’s decision is a worthy statement of principle but, as any physician who has tried to use Laetrile will tell you, the FDA itself does not follow it. And now, with increasing government regulation of what a doctor may or may not prescribe for individual patients (through such federal agencies as PSRO) it is evident that the government wants physicians to become mere robots who are trained to administer only approved “Federal treatment number 9714–32” in response to “Federal group diagnosis number 7482–91.” But the statement “Drugs should be respected rather than feared” is an accurate reflection of FDA philosophy and, when compared to its paranoia over vitamins, offers a good vantage point from which to observe the operation of its double standard.

Congressman Craig Hosmer, outspoken critic of the FDA’s one-sided attack on the nutrition and vitamin industry, has said:

I have been informed that there never has been an accidental death due to vitamin overdosage, but it is said one person dies every three days from taking lethal doses of aspirin. . . . But, despite the fact that Americans buy twenty-million pounds of aspirin a year, FDA has never publicly considered any kind of regulation or warning on labels. Instead, the agency has spent its time and millions of the taxpayer’s dollars establishing arbitrary daily dosages for harmless vitamins and minerals.

Congressman Hosmer has hit the bull’s eye. The danger to public health does not lie in organic food supplements or vitamins sold in health-food stores. It lies in the vast inventories of toxic man-made drugs. Nothing recommended by a health lecturer ever produced such tragedies as thalidomide babies. Five percent of all hospital admissions are the result of adverse reactions to legally acquired prescription drugs. It has been estimated that no less than one and a-half-million people are sent to the hospital each year as a result of orthodox drugs—which means that these legally acquired materials are injuring hundreds of times more people than all the illegally acquired psychedelic drugs put together. And, after a patient is admitted to the hospital for reasons other than drug reactions, his chances of falling victim of drug sickness more than doubles. Drug sickness in the hospital now strikes well over three and a half-million patients each year.[341]

As long ago as 1960, it was acknowledged that at least forty new diseases or syndromes had been attributed to drugs used in therapy,and the number has grown impressively since then.

The situation with non-prescription, over-the-counter drugs is  almost as bad. Aspirin—which was first produced by Bayer of I.G. Farben—is a classic example. By 1974, Americans had been “sold” on aspirin to the tune of over twenty-million pounds per year. That’s approximately sixteen-billion tablets, or an average of eighty tablets per person, each year!

Although Aspirin is an analogue of a natural substance, it is a man-made drug. It is widely recognized as dangerous if taken in high doses—especially for children. Overdoses can result, not only from a single large ingestion, but also from continuous use which produces accumulative effects. Every year, there are at least ninety deaths in the United States from overdoses of aspirin.

Ninety deaths each year is no small matter. Yet, the FDA does nothing except to require each aspirin label to state the recommended safe dosage plus the admonition: “or as recommended by your physician.” The important point is not that the FDA should do more, but that it applies a glaringly unfair double standard against nutritional supplements. In November of 1973 it stopped the production and distribution of a product known as Aprikern. Aprikern is the trade name given to apricot kernels that have been ground, cold pressed to remove the fatty oils, and encapsulated. The process retains the nitriloside or vitamin B17 content, increases the potency concentration by approximately 20%, reduces the caloric content, and increases the resistance to rancidity. Aprikern, therefore, had become popular among those who were familiar with the vitamin B17 story.

Based upon obscure “studies,” allegedly conducted at the University of Arizona School of Pharmacology, the FDA announced that Aprikern contained “a poison which would kill both adults and children.”

Note that the FDA did not say that Aprikern actually had killed any adults or children—as aspirin does every week—but that it could do so. Note also that, during the court case that resulted from the legal action instituted by the FDA against the manufacturer, the scientists from the University of Arizona who had conducted the toxicity experiments on rats which supposedly proved that Aprikern was dangerous, testified that the results of their tests were inconclusive and that they would not stand behind the interpretation widely publicized by the FDA.

Undaunted, the FDA continued to press its case stating that it was conducting tests of its own and that these surely would “prove” that Aprikern is dangerous.

William Dixon, chief of the Arizona Consumer Protection Division, which worked jointly with the FDA in the initial action against Aprikern, told newsmen:

“We could wait six months for the FDA tests, but if some kid died from eating this stuff, I wouldn’t want our office to be responsible.”

From this, may we conclude that Dixon’s office is responsible for deaths from aspirin overdose? Or are we to suspect that all of this pretended concern for the public welfare is just so much eye wash to conceal an unconscionable double standard whereby agencies of government are being used on behalf of the drug cartel to harass and destroy competition from the non-drug health industry? We may ponder what Mr. Dixon’s concern would be if “some kid,” or some adult, for that matter, dies from not “eating this stuff.”

Leaving no stone unturned, Arizona’s Health Commissioner, Dr. Louis Kassuth, went so far as to issue a public warning that, even though whole apricots would not be affected by the government embargo, their pits should not be cracked open and, above all, the kernels must not be eaten.

Ah, it is comforting to have such wise and beneficent experts watching over us and protecting us from our own folly. How wretched we would be without them. How reassuring it is to pick up a copy of a government publication entitled Requirements of the United States Food, Drug, and Cosmetic Act, and read:

Because of their toxicity, bitter almonds may not be marketed in the United States for unrestricted use. Shipments of sweet almonds [which do not contain vitamin B17] may not contain more than five percent of bitter almonds. Almond paste and pastes made from other kernels should contain less than twenty-five parts per million of hydrocyanic acid (HCN) naturally occurring in the kernels.

Needless to say, there is not a single over-the-counter drug on the market today that could pass toxicity restrictions as severe as these. The law does not protect us. It is a weapon against us.

In a letter to this author dated December 26, 1971, Dr. Ernst T. Krebs, Jr. anticipated the FDA’s action against Aprikern by over two years when he explained:

The full awareness of the significance of vitamin B17 (nitriloside) is now registering in the minds of our bureaucrats and those whom they serve.

The attitude is becoming obvious even to us that these people feel vitamin B17 is too good and too valuable for the Indians. Just as in the past when valuable minerals or oil were discovered on Indian lands,government bureaucracy would move the Indians away to “better land,” so attempts are being made now to move all innovators and pioneers on vitamin B17 away from the development—through the invocation of one legal ruse or another—until it “cools,” and then allow monopoly supporting the involved bureaucracy to preempt the field. . . .

Please keep in mind that the potential or waiting market for Aprikern is at least as great as that for all the other vitamins, including C. Today, bureaucracy can make or break a billion-dollar market within a few days with merely a few pronouncements or edicts. A Surgeon General bought just like fresh beef (but not as intrinsically valuable), can say “yes” or “no” on phosphate or non-phosphate detergents on evening TV. He reads his lines as they are given to him, and the markets move accordingly.

Despite a few twists and turns for window trimming, monopoly is almost always sustained in this game.

The FDA perpetually informs the public that “nutritional quackery” is big business with huge profits. But it remains silent about the really big business and the super profits of the drug industry. FDA spokesmen express great concern over a supposed 3.3-billion dollars spent each year on nutritional supplements. Even if that figure is accurate, it is minuscule compared to the staggering annual expenditure of 55.2-billion dollars spent on prescription drugs plus another 14-billion for drugs sold over the counter. The absence of FDA “concern” over this sector of its responsibility is revealing.

The FDA acknowledges it has received reports of “excessive promotional activity by some representatives of pharmaceutical manufacturers”—meaning that not all field representatives from the drug firms are totally honest in the description of their company’s product. Nevertheless, the agency generally ignores this area of inquiry and devotes a major portion of its resources and manpower to wiretapping, bugging, and following health lecturers in an attempt to catch them making a claim that, even though it may be true, comes into conflict with an FDA ruling. At a time when the FDA is pleading inadequacy of tax funds to properly enforce sanitation standards within the processed food industry, or safety standards within the drug industry, it boasts about expanding its operations against such public enemies as the purveyors of wheat germ, rose hips, honey, and apricot kernels.

Another example of the FDA’s double standard is its attitude toward sodium fluoride, the substance that is added to the water supplies of over four thousand communities in the United States on the supposition that fluoridated water helps to reduce cavities. The original 1939 studies by Dr. H. Trendley Dean that led to this speculation, warned that those communities with low rates of tooth decay had in their natural drinking water, not only unusually high levels of fluoride, but also much more calcium. The report then stated that: “ . . . the possibility that the composition of the water in other respects [than fluoride] may also be a factor should not be overlooked.”

It was overlooked, however, and remains so today. In truth, there is little hard evidence that fluorides actually do what is claimed for them, and much evidence to the contrary. In the original investigation by Dr. Dean, he reported that, in 1938, in Pueblo, Colorado, thirty-seven percent of the people were caries-free with 0.6 parts per million of fluoride in the water.

Yet, in East Moline, Illinois, with 1.5 ppm of fluoride—almost three times as much—only eleven percent of the population were found without cavities. We note, also, that in the city of Washington, D.C., which has had a fluoridated water supply for over twenty years, instead of having fewer cavities than citizens of non-fluoridated communities, Washingtonians have almost a third more!

But that is not really the important point. Even if sodium fluoride did reduce cavities as its promoters claim, the fact is that this chemical is extremely toxic even in small quantities. So much so that drug companies are required to warn consumers that the presence in pills of as little as one milligram of this substance can cause illness in some persons.

Studies in Antigo, Wisconsin, Grand Rapids, Michigan, and Newburgh, New York, all showed that within months of adopting fluoridation of the water supply the death rate from heart disease in these cities nearly doubled and leveled out at about twice the national average. Likewise, in the Philadelphia Zoo there was a sharp increase in animal and bird deaths that coincided with the introduction of fluoridated water.

Dr. Paul H. Phillips, a University of Chicago biochemist who spent twenty-nine years in research on fluoride toxicity, has pointed out that sodium fluoride, even when taken in extremely minute quantities, accumulates and builds up in the skeletal parts of the body. Symptoms of chronic fluoride poisoning may not appear for many years, and when they do, they can be very hard to diagnose. They can manifest themselves in many forms such as vascular calcification, disorders of the kidneys, bowels, skin, stomach, thyroid, and nervous system, and may be responsible for headaches, vomiting, mongolism, mouth ulcers, pains in the joints, and loss of appetite.

Dr. Simon A. Beisler, chief of Urology at New York’s Roosevelt Hospital, has said:

I just don’t feel this thing has been researched the way it should have been. Fluoride in water can reach every organ in the body and there are indications that it can be harmful over a long period of time.

Aluminum companies, as a result of their manufacturing process, produce fluoride compounds as waste products. Much of this goes into the air and eventually finds its way back to earth where it becomes noxious to both man and animal. Breathing the fumes is bad enough but, once it is absorbed into edible plants, it is converted into organic compounds such as fluoracetate or fluorcitrate which are at least five-hundred times more poisonous than the inorganic salt. This means that vegetables and fruits which have been irrigated by fluoridated water supplies could become potential killers.

As a result of this toxic waste, aluminum companies have been the objects of successful damage suits. In 1946 a plant in Troutdale, Oregon, was sued by a local citizen who proved that the health of his family had been damaged by fluoride fumes. In 1950 a Washington plant was ordered by a Tacoma court to pay damages to a rancher whose cattle had been poisoned by eating fluoride contaminated grass. In June, 1958, Blount County, Tennessee farmers were awarded indemnity for fluoride damage to cattle and crops.

Europe also has had its fluoride problems. The “death fogs” of 1930 were finally attributed to acute fluoride intoxication. In a similar 1940 disaster in Donora, Pennsylvania, fluoride concentrations in the blood of victims were found to be twelve to twenty-five times higher than in the blood of unaffected persons.

The November 13, 1972, issue of the Journal of the American Medical Association published the results of a Mayo Clinic investigation into two cases of fluoride poisoning that occurred after drinking water that was fluoridated to the extent of 2.6 parts per million in one case and only 1.7 ppm in the other. These concentrations are significant because many fluoridated water supplies are maintained at one ppm! One can only wonder how many cases of mild fluoride poisoning go unreported or are attributed to some other cause.

“We’re not exactly sure what the problem is,” says the doctor, “but it’s probably some kind of viral infection. Take these pills four times a day for a week and, if they don’t do the job, we’ll try something else. Tricky things, those viruses.”

While one community after another in the United States rushes to fluoridate its water supply, many European countries are moving in the opposite direction. West Germany banned fluoridation on January 4, 1971. Sweden did so on November 18, 1971. And the highest court of the Netherlands declared fluoridation illegal on June 22, 1973. As the National Health Federation asked pointedly: “Do these countries know something we don’t or refuse to accept?”

If fluorides were not used in water supplies of the nation, they probably would be discarded as a waste by-product with little other commercial use except in aerosol sprays, drugs, rat poison, and certain brands of toothpaste. It is significant, therefore, that while the FDA has waged relentless war against harmless vitamins, apricot kernels, and Laetrile, it has endorsed the wide-spread and compulsory consumption of sodium fluoride in every glass of water we drink.

As noted in a previous chapter, the FDA has denied approval for the testing of Laetrile by its promoters because of so-called “deficiencies” in the mountains of paperwork required for IND (Investigation of New Drug). It has stated that Laetrile’s safety has not been sufficiently established to warrant its use on human beings. Aside from the fact that Laetrile’s safety record is well-documented, and that all the currently FDA approved drugs are notoriously unsafe, this action is even more unpalatable when compared to the favorable treatment given to new drugs marketed by some of the large drug companies. In 1970, for example, the Searle Pharmaceutical Company received FDA approval to market an estrogen oral contraceptive within just one week after application. In testimony before the House Subcommittee on Intergovernmental Relations, however, it was revealed that the data submitted was British (it is normal FDA policy to insist on American data), and that the British data itself clearly stated that it concerned effectiveness only, not safety.

When Congressman Fountain asked FDA Commissioner Dr. Charles C. Edwards what was the primary reason behind his agency’s favorable handling of Searle’s application, he replied that it was “public safety.”

When asked to explain how public safety was involved in this decision, Edwards blurted out that it is “not our policy to jeopardize the financial interests of the pharmaceutical companies.”

Sere is another drug that has received FDA favorable treatment. First marketed in 1966 by Unimed, Inc., it was offered to the public for use in treating Meniere’s Syndrome, a complication of the inner ear leading to dizziness and loss of balance. There was substantial evidence that Sere actually made the symptoms of Meniere’s Syndrome worse in many patients. In spite of repeated complaints from the medical profession and even from Congress, the FDA refused to require Unimed to cease marketing the drug even though it admitted that the data submitted on behalf of Sere were “defective,” “inadequate,” and contained “untrue statements of material facts.” Acknowledging that further studies were needed, the FDA defended its decision to allow Sere on the market by saying: “The studies could not be financed unless marketing of the drug was permitted to continue.” In other words, Unimed was given permission to continue to sell a drug already found to be ineffective while consumers were put in the position of financing the research that, hopefully, would prove that it had some value after all. What a contrast to the FDA’s unyielding opposition to Laetrile and the nutritional products of nature.

As Senator William Proxmire phrased it:

The FDA and much, but not all, of the orthodox medical profession are actively hostile against the manufacture, sale and distribution of vitamins and minerals as food or food supplements. They are out to get the health food industry and to drive the health food stores out of business. And they are trying to do this out of active hostility and prejudice.

The subject of psychedelic drugs constitutes perhaps the final madness in the FDA’s insane asylum of double standards. Omar Garrison recalls the story:

Americans reacted with a sense of shock, followed by nationwide cries of indignation, when FDA Commissioner. James L. Goddard told an audience of university students that he would not object to his daughter smoking marijuana any more than if she drank a cocktail. . . .

Even the normally permissive Time magazine clucked with mild disapproval, noting that Goddard’s opinion “was particularly surprising because the FDA director has been so strict in demanding that drug companies show clear proof on the efficacy and safety of their products before he allows them on the market. There is still almost no research, however, into what marijuana does—and does not do—to the human mind and body, and no scientific evidence that proves or disproves that it is better or worse than alcohol.

A short time prior to this, Dr. Goddard had expressed great concern over the extent to which Americans were consuming unneeded vitamin pills, and called for tighter restrictions on the formulation and sale of these harmless commodities. He had supported FDA rulings and penalties calling for up to thirty years in prison for those who advocate the use of harmless herbs and food supplements for the alleviation of metabolic disease. Now he had given his blessings to cannabis sativa which, regardless of all else that might be said about it, is far from harmless.

On May 20, 1974, Dr. Hardin B. Jones, professor of medical physics and physiology at the University of California and Assistant Director of the University Donner Laboratories in Berkeley, appeared before the Senate Internal Security Subcommittee and testified:

As an expert in human radiation effects [it is my observation that damage] . . . even in those who use cannabis “moderately” is roughly the same type and degree of damage as in persons surviving atom bombing with a heavy level of radiation exposure, approximately 150 roentgens. The implications are the same. . . .

Reports of the Department of Health, Education and Welfare are inadequate scientifically, do not touch accurately on the principal matters needing clarification, and, in many instances, are likely to lead the public to believe that science has proven marijuana harmless.

This, then, is the double standard of the FDA. We can buy aspirin and a hundred other drugs of questionable safety by the barrel. We can buy alcoholic beverages by the case and tobacco products by the carload. In over four-thousand communities we are forced to drink sodium fluoride in the water supply. But when it comes to food supplements and vitamins, the FDA swoops down like the avenging angel and becomes the super guardian of the nation’s health.

When a woman takes the life of her unborn child on the theory that she may do what she wishes with her own body, she receives the approval of the Supreme Court. But if she purchases Laetrile in an attempt to save a life—either her child’s or her own—she has participated in a criminal act.

How much longer will people tolerate this outrageous double standard?