Dietary Supplements: Political Pressure Cooker

In recent years, the political and bureaucratic pressures surrounding dietary supplements have exploded with new attempts by the United States Food and Drug Administration (FDA) to restrict the flow of information about them. Through a misguided fear of “snake-oil salesmen” and a mission to promote the development and safety of new drugs, the FDA has been on a vendetta against the dietary supplement industry since early in its history. They apparently see dietary supplements as a threat to patented pharmaceutical agents.
This situation in the United States has implications for other countries, since many of them take their regulatory cues from the actions of the FDA. In Norway, for example, doses of supplements beyond the RDA were at first banned, and then the government opened a chain of stores that became the only ones allowed to sell high-dose supplements. In 1994, I had an opportunity to testify at meetings in Great Britain concerning European Economic Community regulations of dietary supplement doses. The issue has not yet been resolved there. This is an ongoing struggle in many countries and seems to threaten the status quo wherever anyone wants to take charge of their own health care.

Protecting You from Information

The FDA’s regulatory efforts are purportedly aimed at protecting the public from misinformation that the marketers of dietary supplements might use to sell their products. It is true that this has happened in the past and is happening, although to a lesser extent, today. However, the issue has come to the fore because in their zeal the FDA is “protecting” the public from accurate information that will do them a world of good.

The truth is, there has been an explosion of new research data showing the value of dietary supplements in almost every sphere of health care. From cancer to heart disease to AIDS to headaches, dietary supplements are being shown to be of value. They are helping people stay off drugs and they are reducing the costs of health care, in terms of both money and undesired side effects.

In spite of official opposition to supplements (from both government agencies and much of mainstream medicine), the public demand for them is growing. In response to this, the FDA has used rule making and legal maneuvering to subvert the intent of the laws that Congress passed designed to increase the flow of nutrition information to the public.

In 1992 and 1993, Congress considered bills that would restrict the ability of the FDA to skirt around the intent of the laws. During the hearings held by the Senate Labor and Human Resources Committee in 1993, the commissioner of the FDA, David Kessler, made some erroneous statements about supplements. He also put on a show of some bottles of dietary supplements that he claimed were “misbranded” because they made health claims.

Any health claims for dietary supplements were against the regulations of the FDA if they were made by supplement manufacturers or distributors, even if they were truthful and not misleading and even if they were the same health claims that other agencies of the US government were making. For example, if the US Public Health Service suggested folic acid supplements for pregnant women, it was illegal for a company marketing folic acid to quote that agency in its promotional literature.

The bill then being considered, the Dietary Supplement and Health Education Act, eventually passed despite the opposition of some vehement protectors of the FDA. However, many of the most important sections of the Senate version of the bill, which would allow the easiest public access to supplement information, were deleted before the bill was passed by the House of Representatives. This was the result of compromises with powerful committee chairpersons.

As of this writing, in 1995, efforts are underway to correct some of the omissions of the final version of the bill as passed into law. Other committees are considering stricter oversight of the FDA, in order to prevent them from making laws through “regulations” and interpretation.

I testified at those 1993 Senate hearings and had to depart from my prepared testimony in order to address some of the misinformation presented by the director of the FDA. I then submitted to the committee some written follow-up testimony which included most of the statements that I felt compelled to present ad lib. Although I have seen it many times, I am always surprised when scientific information is misrepresented for political purposes. Here is the original version of my testimony, and the follow-up testimony.

Senate Testimony

My name is Michael Janson. I am a physician in Massachusetts with an office in Barnstable, on Cape Cod. I received my MD from Boston University 23 years ago in 1970, and then did a 4-year residency in pathology. I developed an interest in nutrition, preventive medicine and vitamin therapy after graduation, and proceeded to found the Cambridge Center for Holistic Health in 1976 and more recently, the Center for Preventive Medicine, in Barnstable, Massachusetts, on Cape Cod.

I am a charter member of the American Holistic Medical Association. I am a Fellow and member of the Board of Directors of the American College for Advancement in Medicine, and the Chairman of their Scientific Advisory Committee. I am a Fellow of the International Academy of Nutrition and Preventive Medicine. I have a weekly Boston area call-in radio show reporting the latest in nutrition and preventive medicine. I am also the Vice President of the
American Preventive Medical Association.

I want to thank Senator Kennedy and the members of this committee for the opportunity to clarify some of the important issues regarding dietary supplements and the FDA. I am particularly eager to relay the concerns of many of my patients and radio listeners in and around Massachusetts about their continued ability to purchase all forms of dietary supplements and to have information about their use. Many ideas relating to this form of medical care and self-care are coming out of Massachusetts. You are no doubt familiar with the reports on alternative health care by Harvard physician Dr. David Eisenberg, from the recent PBS series with Bill Moyers.

One-third of all Americans are choosing to visit alternative health care practitioners and one-half take dietary supplements because they are willing to take personal responsibility for their own health. This costs the government nothing, and it can be clearly demonstrated that it will potentially save the government billions of dollars while enhancing the health of most Americans, with no significant risks.

The FDA has a long and clear history of bias against dietary supplements, recently evidenced by their attempted removal from the market of black currant oil capsules, claiming that it was an unsafe food additive and that the food to which it was being added was the gelatin capsule in which it was packaged. This was thrown out of court by three judges who said that the FDA was using “Alice-in-Wonderland reasoning in an effort to make an end-run around the law.” FDA’s own scientists and toxicologists testified that they were unaware of any safety problems with this oil. Following FDA’s lead, the Texas Department of Health removed coenzyme Q10 from health food stores. Coenzyme Q10 is a remarkable, harmless substance that helps so many patients that I could hardly practice conscientiously without it. I have no doubt that it would be unavailable without passage of S. 784.

The FDA has disregarded or rejected competent scientific evidence that Serenoa repens, a standardized extract of the saw palmetto berry, can help shrink an enlarged prostate in middle-aged men. Meanwhile, another more expensive, more toxic, and less effective drug, for the same purpose, has been approved by the FDA. They knew that the published evidence showed the superiority of the Serenoa, but their action exposed 10 million men to unnecessary risks.

CSPI [Center for Science in the Public Interest] has referred to this bill as the “snake-oil promotion act.” This is offensive to me and thousands of my colleagues who have clinically used supplements safely and effectively for many years. In fact, I started using them because of the vast medical literature substantiating their benefits. I have seen these benefits in 17 years of clinical practice. I have seen almost no side effects from these products in all these years and no serious side effects. FDA-approved prescription drugs, when used as directed, continue to kill and injure many people annually. Dietary supplements are remarkably safe. I have been taking large amounts of them myself for many years. FDA’s stated concerns about the safety of such products is not justified. Supplements are probably safer than the water that you drink to take them.

The case of l-tryptophan is important, because the FDA continues to use it as an example. It was published in both the New England Journal of Medicine and in the Journal of the AMA, in 1990, that the eosinophilia myalgia syndrome was due to a contaminant in a particular company’s product. In fact, l-tryptophan has not been removed from the market, but only from the health food stores. It is still used in intravenous feeding and in infant formulas. The FDA has adequate safety data to permit it as an ingredient in these products.

No one wants to be the victim of fraud, and labels must be accurate. S. 784 vigorously addresses fraudulent labeling. However, misleading labels are not as serious or dangerous a problem as the potential loss of health-enhancing dietary supplements. But FDA’s proposed regulations, which essentially ban all health claims for dietary supplements, violate the intent of the NLEA [Nutrition Labeling and Education Act]. A textbook about supplements, or scientific studies, cannot be provided by a health food store, according to FDA. Last year the New York Times published an article supportive of the value of dietary supplements, but a manufacturer cannot send that article, nor any supportive scientific article, to its customers without concern for potential FDA regulatory action.

FDA’s spokesmen mislead by carefully selecting their words when testifying before Congress in order to avoid saying what they really intend, as evidenced by their position papers. They say the debate is not about vitamins and minerals when sold in what they call reasonable potencies. What they call reasonable is far too low to be used as a guideline for optimum health. FDA considers as a drug any higher potencies of vitamins or minerals, or dietary supplements that have no essential requirement in human nutrition, or products consumed for health enhancement or therapy. Again, the real public health danger is from restricting access to dietary supplements, not their potential side effects.

Specific Points

1. Without the passage of S. 784, the FDA will increase its inappropriate enforcement of misinterpreted regulations to remove a number of safe and beneficial dietary supplements from the marketplace, thus decreasing the available health choices of Americans and raising health care costs.

2. The Dietary Supplement Health and Education Act would allow these products to remain on the market with substantiated health claims based on scientific data. FDA and CSPI do not speak for or protect the public on this issue, and their comments are usually unsubstantiated opinion.

3. I couldn’t practice medicine responsibly without many of the substances that the FDA has already tried and will continue to try to remove from the market. I base this on what I have read from their own position papers.

4. The vast majority of the population do not want the FDA to restrict dietary supplements. To call this bill simply an industry attempt to avoid regulation belittles the enormous grass roots movement in its favor and the intelligence of the many constituents who take and depend on dietary supplements for their continued good health.

5. The FDA blatantly misrepresents the dangers of supplements when it reports to Congress that there have been deaths from vitamin A or toxicity from essential oils, which is contrary to fact.

6. It would be ridiculous in America to have restrictions on dietary supplements but ready access to
alcohol, tobacco, and “Big Macs,” with all their known problems.

If I could spend a half-hour with each of you, I am convinced that you would want to take at least two or three dietary supplements that the FDA has either already tried to restrict, or will without passage of S. 784. Serenoa for the prostate and coenzyme Q10 for the heart are good examples.

In my medical practice in Massachusetts over the past 17 years, I have seen over 10,000 patients. It is clear that many people are willing and competent to make their own choices regarding health care, including dietary supplements. They are not being duped, but they know what is at stake, and they are willing to spend their own money, not federal or state money, for the right to improve their health and prevent disease. They will not be able to continue to do this without the passage of this bill, which I strongly support.

Some of my colleagues and various researchers have also expressed similar sentiments, and I would like to report some of these to you. For example, Gladys Block, PhD, has made the following points:

1. The evidence of a beneficial role for [antioxidant] nutrients is extraordinarily extensive.

2. Many Americans are not consuming even minimal, let alone excessive, amounts of nutrients.

3. There is no evidence that supplement users neglect their diet or other health care-quite the contrary.

4. The evidence of benefit is increasing explosively, and conclusions formed a decade ago are insufficient to inform us.

5. FDA’s role in protecting public health would be much more valuable if focused on ensuring quality of supplements and providing consumers with information.

In the reviews of the Serenoa repens extract studies published by the FDA in New Developments, of March 5, 1990, they gave their reasoning for not allowing claims for prostate improvement. Although they admitted that there was “statistically significant” improvement, they considered it not to be “clinically significant,” even though it was better in all parameters than the drug that they did approve. The drug is potentially dangerous, and women who may get pregnant who are partners of men taking the drug are cautioned to avoid exposure to this partner’s semen and to avoid handling the crushed tablets of the drug. It also has other side effects (impotence, decreased libido, ejaculation dysfunction). There are no known side effects from the herbal product.

The FDA does not consider only the value and safety of dietary supplements in deciding what to approve. It has other motives, including “…what steps are necessary to ensure that the existence of dietary supplements on the market does not act as a disincentive for drug development.” Also, Deputy Commissioner for Policy David Adams said that the establishment of a separate regulatory category for supplements “…could undercut the exclusivity rights enjoyed by the holders of approved drug applications.”

In a letter to the New York Times, September 8, 1992, Dr. Bernard Rimland said “…Dr. Kessler tells us that the FDA doesn’t want to block the sale of vitamins. All we have to do is convince him and his fellow bureaucrats that they have been wrong for many decades in saying that vitamins are useless. Just provide the FDA with the evidence that will make them change their minds and they will let us buy all the vitamins we want. Fat chance! The FDA’s stonewalling of any and all evidence favoring the use of vitamins is legendary. We could more easily convince a shark to become a vegetarian.”

The evidence does not support the FDA claims that nutrients, including amino acids, are in any way a significant risk. These baseless claims mislead Congress and the public and make it dangerous to give such regulatory power to the FDA.

In case there is doubt about the regulatory intentions of the FDA, let me include some quotes from FDA officials pinpointing their position:

From the Task Force Report on Dietary Supplements:

“…the task force recommends that the agency adopt a ‘Dietary Supplement Limit’ which would be the maximum daily intake of a given vitamin or mineral that the agency deems safe” – e.g., “the highest RDA levels listed by the National Academy of Sciences.” “The Agency should take regulatory action against those supplements that exceed the above guidelines as ‘unsafe food additives’….”

“Amino acids should be regulated as drugs.”

“If a potency is listed on the label for any non-essential substance (a dietary supplement for which there is no RDA) action would be taken against those products.”

One has to question the rationale behind the FDA’s proposal to redefine amino acids as “drugs.” Using such an approach should suggest that sugar (sucrose) refined from beets or sugar cane, a food extraction product, should be regulated as a “drug.” In fact, sugar in the American diet poses far more risks than amino acids.

Follow-up Testimony

Here is the text of what I wrote to the committee after the hearings were over, for inclusion in the official Congressional record of the hearings:

During the testimony at this hearing of Dr. David Kessler, Commissioner of the Food and Drug Administration, he made a number of misleading and false statements and a number of confusing points. I addressed some of those points in my testimony, but due to a lack of time I did not address all of them, nor did I respond adequately to reflect my concerns.

First of all on the issue of the safety of nutrients. The FDA has asked that dietary supplements meet the same standards of safety as OTC [over-the-counter] drugs. Using their own data and according to all the records of the American Association of Poison Control Centers, dietary supplements are 2550 times safer than OTC drugs.

Dr. Kessler said that there was potential toxicity from chromium, folic acid, gamma-linolenic acid (GLA) and
l-tryptophan. I am sure that he feels there is a problem with other nutrients in spite of their long record of safety based on animal and human studies and traditional use. If Dr. Kessler feels there is a risk, he can avoid taking these products, but only if he can reasonably prove a risk should the FDA be allowed to remove these from the market.

I would like to state categorically that there is no known risk from the ingestion of any of the above products at anywhere near the amounts that are typically used. In fact, you would probably have to take enough GLA-containing oil to get obese from the calories before it would do any other harm. No one is recommending such high doses.

Folic acid does not cause any side effects. What Dr. Kessler calls a side effect, the masking of the anemia that is an early sign of a B12 deficiency, is actually a therapeutic benefit. However, I recognize that a B12 deficiency, if prolonged, may lead to peripheral neuropathy, but this is not a side effect of the folic acid. There are now easy ways to measure B12 in the blood, so a physician would not have any difficulty in recognizing a deficiency. You might argue that you need to see a physician to determine this even if people are taking folic acid on their own. However, that is moot, because a person would need a physician to recognize the anemia also. Although the dispute revolves around the dose of 400 to 1000 micrograms (mcg), folic acid is safe at doses measured in milligrams (mg). I have seen no side effects in patients taking up to 100 mg (100,000 mcg). This dose has been used to treat gout, because, as a xanthine oxidase inhibitor, folate works like the drug allopurinol. Inhibition of xanthine oxidase may also reduce the risk of heart disease.

Chromium is a perfectly safe nutrient that can lower cholesterol and help to regulate insulin, thus improving sugar control in diabetics and hypoglycemics. Doses that I have recommended, again with no clinical or laboratory signs of toxicity, range up to 1000 micrograms. It is safer than the drugs that are approved to lower cholesterol (e.g., lovastatin), and they have side effects such that their effect on mortality is neutral or negative.

Lovastatin actually inhibits the production of another substance, coenzyme Q10, which is very important for a healthy heart, immune function and energy production. Since coenzyme Q10 protects against heart disease, there is theoretical evidence, and also clinical studies, showing that this is a risk of taking the drug. And, as an aside, coenzyme Q10 is a substance that the Texas Department of Health, following FDA’s lead, tried to remove from the health food stores in Texas.

The case of l-tryptophan deserves more comment. Dr. Kessler repeated in his testimony the claim that “they” were not sure that the eosinophilia myalgia syndrome (EMS) was due only to a contaminant. As I stated in my testimony, the New England Journal of Medicine and the Journal of the AMA both concluded that it was from a contaminant back in 1990. In the past month there have been two reports, one from the CDC by Robert Hill published in the Journal of Contaminants and Environmental Toxicology and one from Dr. Cluew, a professor at George Washington University, reported at a rheumatology meeting. They both concluded that the EMS was the result of a contaminant and not
l-tryptophan itself.

If the FDA and Dr. Kessler do not know the older literature on the subject and they do not know the more recent literature on the subject, they are the wrong agency or the wrong personnel to be involved with the enforcement of dietary supplement regulations. There are many other reasons that I have come to this conclusion. Either we change the agency, change the personnel or specifically limit their power with strict Congressional guidelines such as mandated in S. 784.

Dr. Kessler also revealed his true intentions inadvertently when he stated that FDA was within the law to regulate dietary supplement products that were mixtures as food additives. There is no scientific rationale for removing two safe products from the market if they happen to be mixed together, just because you have the legal authority to do so. Some products are better when they are mixed, such as GLA and vitamin E. The product lasts longer on the shelf without oxidizing because of the presence of the vitamin E. Sometimes mixtures are cheaper and sometimes they are more effective. The FDA attitude is to blow up Mount McKinley because it’s there! There is no reason to expect that the FDA, with its current personnel make-up and level of authority, will suddenly start to treat dietary supplements more equitably than they have for decades.

Dr. Kessler left the impression that all the bottles of products that he displayed, in his grandstanding gesture, were labeled with false claims. He presented only one that had a false claim on the label. (No one at the hearing actually examined the label, but I have no doubt that there are occasional false claims, which generally are not a great risk to the public health.) Most of those products were properly labeled, but FDA agents were able to cajole someone at a health food store to suggest to them that the product would be useful for a specific health problem. The manufacturers or distributors are inapppropriately being held liable for the actions of retail clerks. If a clerk in a market said to take prunes for constipation, that would be an unsubstantiated health claim according to the FDA, and they could have put a box of prunes on the table with all those bottles.

When confronted with the toxicity of FDA-approved drugs, which kill so many people annually, Dr. Kessler replied with his “canned” comment that “half of our drugs are derived from plants.” This is a clear misrepresentation and designed to mislead. Many pharmaceuticals are plant extracts that have been significantly altered so that they can be patented, and this alteration usually increases their toxicity. Also, many of them are synthetic analogs of plant products, not the plants themselves. You might as well say that they are made from carbon, nitrogen and oxygen, which we encounter every day! Further, many of the most widely used and most expensive drugs are totally synthetic and have nothing to do with plants. Anti-ulcer drugs, anti-inflammatory drugs, anti-anxiety drugs, newer cardiac drugs and antihyper-tensives are not plant products. They cost many Americans lots of money and have numerous side effects. They are necessary for many patients but are widely overused. This is partly because physicians have no access, in the normal course of their work, to the information about dietary supplements that should be disseminated widely. This would lessen the need for drugs and enhance the health of all Americans, while reducing the medical care crisis that we are now facing.

Dr. Kessler decried the variety of health claims being made for evening primrose oil. He is perhaps unaware of the hundreds of studies in the literature supporting most of those uses. It is not surprising that a physician would be skeptical of something that seems to help so many illnesses. But it is a mistake to be blinded by skepticism from seeing the scientific evidence. Because GLA [from evening primrose and other oils] is a precursor to regulatory substances known as “prostaglandins,” it has wide-ranging metabolic effects. It does help to lower blood pressure, reduce or cure atopic dermatitis, relieve PMS, reduce cholesterol and inflammation and help asthmatics and allergic patients. These are the many effects of the prostaglandins that are made from this important fatty acid. It is therefore not “incredible” to someone who bothers to look up the scientific documentation and who understands the metabolic rationale.

I want to reaffirm that these claims were not on the labels of these products, but they are in the medical literature. Also, I have observed in my practice the above-stated clinical effects, and have reviewed many of the studies substantiating some of the claims that the FDA agents heard from health food store clerks. The FDA should be doing everything in its power to disseminate this information and encouraging manufacturers to disseminate it also, as long as it is in the medical literature and not misleading. Instead, they are an obstacle to information exchange and are themselves misleading. This can only be changed if the FDA stops confusing its role of regulating real danger and fraud with the role of being the arbiter and promoter of truth as they see it. Passage of S. 784 will ensure a more sane approach to regulation, availability of dietary supplements and truthful health claims.

When Dr. Kessler says that they “plan to take no products off the market,” that is a dramatic shift from what they have proposed in all their written material until now. With such waffling, confusion and misleading testimony, the FDA cannot be expected to take an honest and human approach to regulating such an important component of our health care.

I have read Dr. Linus Pauling’s letter addressed to the committee supporting the Dietary Supplements Act. I hope it is included in the record because it is an eloquent statement that combines common sense, science, reason and compassion.

Linus Pauling’s Testimony

Linus Pauling, the only person ever to have won two unshared Nobel prizes, died in 1994 at the age of 93. He pursued his research and directed the Linus Pauling Institute of Science and Medicine until shortly before his death from prostate cancer. He partially credited his long life (his parents had both died quite young) to his large doses of vitamin C (18 g per day) and other dietary supplements.

Here is the text of Linus Pauling’s letter to the Senate committee, reprinted with permission of his family:

I am deeply concerned with the current state of affairs revolving around the issue of dietary supplements and related substances. The overwhelming body of evidence in the official medical and scientific indices regarding the efficacy and safety of vitamins, minerals, enzymes, amino acids, herbs, and other nutritionally related substances is obviously being ignored or, at best, misinterpreted to suit the special interests of a medical and political contingency. The volumes of respected historical data and conclusive current research in regard to these substances and their value in healthcare far outweigh single isolated instances of contamination, not to mention clinically and statistically unsubstantiated claims of toxicity. The manipulation of empirical credibility by political or economic egos is not to be tolerated or exonerated.

As a scientist, chemist, physicist, crystallographer, molecular biologist, and medical researcher, I have spent a lifetime in pursuit of expert knowledge. This issue involving the definition, regulation, and censorship of dietary supplements and associated information goes far beyond this hearing. It touches upon the very fiber of our human and constitutional rights. It mandates monopolization of the healthcare industry by creating an economic premise that will eventually eliminate those unable to meet its unrealistic requirements. These demands would require millions of dollars in research and excessive time constraints to prove the safety of substances already historically and statistically within considerable safety margins.

In the scientific and medical comunities, among those of reputable and significant knowledge, the votes have already been cast in favor of nontoxic therapies that are effective and affordable. This issue of agency determination of definitions and regulations overrides the individual’s freedom of choice in healthcare, and inhibits free access to vitamin information that better enables a person to make an informed intelligent decision regarding services that could be of significant value in the prevention and treatment of disease, making it mandatory that they be made available only as “drugs,” and under the jurisdiction therefore of the medical community. This ultimately enslaves a population to becoming chemically, psychologically, and economically dependent, rather than being actively responsible for its own well being. Billions of dollars and millions of lives are at risk of being jeopardized in this ruthless campaign to subjugate the health industry to being puppets of a legislated system of lobbying efforts.

It is imperative to maintain the highest quality of purity, safety, and performance in regard to consumer products and services. However, the subversive actions of raids at gunpoint, confiscation of patients’ records and personal property, and warrantless censorship and banning of information and substances that are statistically proven to be of benefit are blatant violations of human and constitutional rights. As a scientist, I am appalled at the audacity of those challenging these rights; as a citizen, I am compelled to voice my indignation at being considered incapable of being in charge of my own health. The medical community needs to become a partner, not a dictator, in the healthcare system.

Over a quarter of a century ago, I became interested in nutrient compounds and their effects on human health. The old professors of nutrition who helped to develop the science of nutrition seemed complacent with their accomplishments and ignored the new discoveries that were being made in medicine, biochemistry, and molecular biology. They continued to teach their students the old ideas, many of them incomplete or incorrect, resulting in principles and practices that have denied the public proper access to new concepts and therapies.

Physicians themselves, though dedicated and intelligent, are virtually untrained in the area of nutritional science and metabolic therapy, other than conventional drug modalities and allopathic procedures. If there is to be a concerted effort to regulate and eliminate toxic substances, it would serve the issue far better to address the abuse of drugs and treatment procedures that are the cause of hundreds of thousands of medical catastrophies and deaths per year, which could possibly be avoided by improving medical education of the physicians and the public as to nutritional alternatives in healthcare maintenance.

At this hearing, I urge you to consider seriously the ramifications of crippling the full disclosure of information to the public regarding health research, and the unnecessary regulations and improper definitions of dietary supplements as drugs. This implies a direct infringemement of medical freedom of choice and the First Amendment, freedom of speech, allowing for a dangerous precedent of censorship that could generate epidemic problems not only in human health but human values. The Constitution of the World Health Organization, as mandated in conformity with the Charter of the United Nations, of which the United States is a signatory, states:

“Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity. The enjoyment of the highest standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition. The health of all peoples is fundamental to the attainment of peace and security and is dependent upon the fullest cooperation of individuals and states. The extension to all peoples of the benefits of medical, psychological and related knowledge is essential to the fullest attainment of health. Informed opinion and active cooperation on the part of the public are of the utmost importance in the improvement of the health of the people.” (Geneva, 1976)

This hearing is paramount to the determination of the Dietary Supplements Act, S-784. I submit to you the history-making moment that we are facing. As representatives of the people, consider not only the medical and scientific implications, but the humanity of your decisions. We are on the threshold of a new paradigm. The future of our self-determination as humankind depends upon our right to life and to live in freedom. Herophiles in 300 BC stated: “When Health is absent, Wisdom cannot reveal itself, Art cannot become manifest, Strength cannot be exerted, Wealth is useless, and Reason is powerless.”

I trust that your reason will surpass the rhetoric, and that your wisdom will reveal the truth in support of the Dietary Supplements Act.


Linus Pauling

Unfortunately, in spite of the ultimate passage of a watered down version of the Dietary Supplement Health and Education Act, there are still political, behind-the-scenes maneuverings that make it unclear what will happen with regulation and oversight of dietary supplements by the FDA. The FDA officials and lawyers have been working tirelessly to “interpret” the language of the bill to try to maintain their inappropriate restriction on availability of supplements and on access to information about them.

If you want to help ensure the continued availability of dietary supplements and your access to information about them, you can contact your representatives in Washington and let them know you want their support for this. You can also support several organizations that, as of 1995, are working toward passage of a revision of the dietary supplement bill. This will surely still be an issue for the next few years. One of these organizations is the American Preventive Medical Association (see Appendix 2, “Resources”), which is working toward more health freedom in many ways.

Health Endangered In Canada

North of the border, dietary supplement consumers face similar problems to those in the US. And their regulations may be even worse. In 1995, the Canadian parliament has been considering a bill (C-7) which would make it difficult to find any over-the-counter dietary supplements. Because they have an effect on states of health, it is being proposed that access to supplements and information about them be restricted.

The Bill C-7 would technically criminalize anyone who sold any herbal remedy or natural supplement with stimulant or relaxant properties. Tryptophan is already a prescription drug in Canada, and its price has risen dramatically since losing its over-the-counter status. (At least it is available, unlike in the US.)

Other substances that are harmful to health are being specifically exempted from coverage by this bill. Thus, Canadians may be in the ridiculous position of being able to buy nicotine, alcohol and caffeine freely but not large doses of vitamin C or vitamin E. It can hardly be argued that the main goal of this bill is to protect public health. There is also an exemption for prescription drugs, which are at least 2500 times more dangerous than dietary supplements. There are Canadian associations that are working against this bill.

Avatar Written by Michael Janson MD

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