FDA and supplement warnings misleading, exaggerated or unproven
Article by Dr. Zoltan P. Rona MD MSc

Move over, HPB. The Fuddy Duddy Association (FDA) has just taken your place as the world¹s foremost publisher of exaggerated claims and warnings about vitamins, minerals and herbs. On Feb. 22, 1998 the FDA, after malabsorbing information on the safety of food supplements, regurgitated three heavily slanted anti-vitamin, anti-herb press releases over the AP Wire. It is thought that this barrage of negativity is in preparation for an upcoming press conference regarding new rules for nutritional supplements stemming from the "Commission on Dietary Supplement Labels Final Report".

Dr. Elizabeth Yetley, chief of the FDA section on special nutritional products, says that such products do not raise safety concerns. Despite this fact, the FDA now has listed 16 supplements as risky. The FDA can only legally intercede if it can prove that a supplement poses an unreasonable risk or is marketed as a drug.

To better understand the toxicity issue, one must have a firm grasp of the politics of health care and be able to use common sense. Statistics aside, any substance, including water and oxygen, can become toxic if the dosage is high enough. For example, although extremely rare, cases of water poisoning have been reported in psychotic patients who drank gallon after gallon of water until they drowned. Similarly, excessive oxygen can cause tissue damage so severe as to lead to organ destruction (e.g. blindness due to oxidative damage to the retina). It¹s simply a question of amount. Since most mentally balanced people even at the HPB and FDA do not guzzle 80 gallons of water in one sitting, it is reasonable to assume that water is a safe nutrient supplement. The same can be said for most vitamins, minerals and herbs. When taken in the traditionally recommended dosages, none of the list of 16 vitamin, mineral and herb supplements is dangerous. When used as directed, they all have potent health-enhancing effects which have been well-documented for centuries. So, let¹s analyze the toxicity claims and see where the deception really lies.

"Ephedra: Also called ma huang, epitonin and sida cordifolia, it contains stimulants known chemically as ephedrine. The Food and Drug Administration has 900 reports of side effects, including heart palpitations and psychosis, heart attacks and strokes. Several states have banned ephedrine-containing supplements. Federal limitations are pending."

As with any nutrient, including water and oxygen, herbs can produce side effects if taken in excess or at the wrong times. I do not dispute that. Critics of Ephedra, however, focus only on the isolated chemical components and fail to see the whole picture. In the hands of an experienced herbalist, nutritionist, naturopath or doctor, the side effects with the proper use of Ephedra are rare. Drinking coffee or tea is far more likely to cause insomnia, dizziness, increased blood pressure and death than any whole Ephedra product. The same can be said for cigarettes and nicotine-containing chewing gum, both sold without prescription despite being proven to be lethal substances.

Yes, if you isolate ephedrine or pseudoephedrine from the whole herb, side effects are much more pronounced or even dangerous. It must be remembered that herbs were never meant to be used in this fashion. Only pharmaceutical manufacturers use herbs in this way and, as a result, get toxic effects - over 1000 deaths occurring each year as a direct result of over-the-counter cough and cold remedies.

Pseudoephedrine is the chemical responsible for the side effects frequently whined about by the critics of herbal medicine. It does not have the same properties as ma huang. Any claim to the contrary is false and is being used as a smokescreen to remove Ephedra, a perceived competitor to drug company pseudoephedrine products, from the market. Drug companies are guilty of doing just that in over 30 prescription and over-the-counter drugs that contain pseudoephedrine (e.g. Actifed®, Novahistex®, Sudafed®, etc.). Many over-the-counter drugs for colds, allergies, asthma and obesity contain these herbal extract mimics and are big business for the multinational drug companies. Their effects, however, are clinically much different from those of the whole herb. Alarming people about their dangers without taking these facts into consideration is a grave disservice to the public.

It is said that people with high blood pressure, heart problems and prostate problems should not take ma huang. Nonsense. Coffee and tea are more likely to cause such people problems than ma huang. For those with heart or blood pressure problems, ma huang should be taken starting with low doses and gradually increased as tolerated. For those with prostate problems, ma huang can be combined with saw palmetto or seronoa repens extract (from saw palmetto) and flower pollen. This will prevent problems with the urinary flow and help shrink a swollen or enlarged prostate. In large doses, ma huang can prevent weight gain and, for this reason, it is not recommended during pregnancy. Weight loss is not what one wants for a healthy baby. Once the baby is weaned, the mother can go back to using ma huang to help lose the weight accumulated during pregnancy.

"Chaparral: Sold as teas and pills to fight cancer and "purify blood," it has been linked to serious liver damage. FDA has recorded two deaths and 10 cases of hepatitis or other liver abnormalities in users."

Chaparral has been used for centuries without incident by Native American Indians as well as by millions of cancer victims. In fact, it is estimated that over 200 tons (500 million capsules) has been sold in the U.S. in the last two decades alone. Dr. Norman Farnsworth¹s extensive studies on chaparral in the 1970s and 1980s were unable to find any hepatotoxic properties.

The FDA claim for chaparral liver toxicity is, at best, questionable. What the FDA and the multinationals are really upset about is the fact that growing numbers of cancer patients are using chaparral and other herbs either in conjunction with or instead of highly toxic, highly expensive and highly ineffective conventional cancer chemotherapy. The real risk is to the financial interests of the pharmaceutical multinationals, not to the health of the public.

The so-called evidence for chaparral liver toxicity is anecdotal. It is not the result of any double blind studies nor clinical trials. One of the "typical" cases used by the FDA as an example of chaparral toxicity can be found in the Journal of the American Medical Association (273(6):489) where a 60-year-old woman was taking one to two capsules of chaparral with a pinch of garlic in a tea made from nettle and chickweed. When jaundice and liver failure occurred, the authors immediately assumed it was the chaparral that caused it. The patient in question was also taking diltiazem hydrochloride, atenolol, enteric coated aspirin, a nitroglycerin patch, and acetominophen - all drugs with profound toxicity potentials. Diltiazem and acetominophen have both been documented to cause liver toxicity. The authors of the paper, however, conveniently ignored this fact and also failed to consider the large combination or interaction of drugs as a causative or contributory factor in the liver toxicity.

"Comfrey: Banned in Canada and severely restricted in Germany, comfrey root originated as a poultice to reduce swelling but later was used internally. It contains alkaloids toxic to the liver, and animal studies suggest it is carcinogenic, said Varro Tyler, an emeritus professor at Purdue University and author of ``The Honest Herbal.'' FDA knows of one death."

Comment:

Like chaparral, comfrey has been used externally and internally by millions of people throughout the world without evidence of significant dangers. Most herbalists feel that short-term, common sense use of comfrey where indicated is perfectly safe. Nonetheless, it is true that comfrey has been linked to four cases of veno-occlusive disease in the world throughout the last 20 years. It should be noted, however, that these cases involved long-term, abusive doses of comfrey tea (e.g., 10 cups of comfrey tea plus handfuls of comfrey-pepsin tablets every day for years).

Also, please note that the type of comfrey that should be used is symphytum officinale (medicinal comfrey), not Russian comfrey (symphytum xuplandium) which is typically used for composting and should never be taken internally.

"DHEA: A hormone that turns into estrogen and testosterone inside the body. The National Institutes of Health says there is no evidence that DHEA fights aging as it claims, and warns that it could increase cancer risk and may lead to liver damage even when taken briefly. FDA records show 31 reports of possible DHEA side effects, from fainting to hepatitis."

This is just more science fiction and entirely based on rat studies using massive, non-therapeutic doses of DHEA. In the rat study they gave the rats 650 mg/day of DHEA. Rats normally produce negligible amounts of DHEA while, in humans, DHEA is the most ubiquitous hormone produced in the body. For a human to take a corresponding dose to what caused liver damage in rats, a man or woman would have to take about 7,000,000 mg. a day, a dose which has never even been contemplated in human medicine. Humans using DHEA as a cancer treatment have consumed 2000 mg/day for extended periods with no documented ill effects, a fact which is most likely unpalatable for multinational chemotherapy manufacturers.

Many published studies on humans indicate that DHEA is both safe and effective. For example, a twelve year study by Dr. Elizabeth Barrett-Connor at the University of California published in the New England Journal of Medicine in 1986 reported that of the 242 men aged 50-79 studied: "A 100 microgram per deciliter increase in DHEA sulfate concentration corresponded with a 48% reduction in mortality due to cardiovascular disease and a 36% reduction in mortality for any reason. The natural level of DHEA sulfate was measured and those individuals with higher DHEA sulfate levels lived longer and had much lower risk of heart disease."

Further, a 1990 study by Roberts indicated that M.S. victims had low DHEA levels which were improved by DHEA administration. It was also noted that the majority of these patients had discernible improvement in their daily quality of life including increased energy levels, better dexterity, greater limb strength, decreased sensations of numbness, more power in the lower limbs and even an increase in libido. Another 1990 study by Calabrese concluded that DHEA helped to improve the fatigue so often associated with M.S.

The negative view of DHEA by FDA officials avoids mentioning some very important facts. While it is true that the long term effects of daily DHEA supplementation are not fully known, the same can be said for many of the prescription and non-prescription drugs given quick approval without long term safety and efficacy studies. According to Office of Technology Assessment reports, about 80% of all currently available medications on the market have never been subjected to clinical trials.

Studies show that commonly eaten foods (especially red meats and processed foods) are far more likely to cause prostate cancer than DHEA. The relationship between prostate cancer and DHEA is anecdotal, speculative and unproven. There is no clinical study verifying such a cause and effect relationship. The Associated Press articles also neglect to say that the public, with full FDA approval, can self-medicate with unproven over-the-counter antibiotic creams, anti-yeast drugs, eye drops, cortisone creams and inhalers, stimulants, antihistamines, anti-fungal treatments, sleeping aids and many other potentially harmful chemicals. A long list of readily available synthetic steroids, birth control pills and fertility drugs have been linked to higher rates of cancer. The long term use of non-steroidal anti-inflammatory drugs (NSAIDS) has been associated with as many as 25,000 cases of gastrointestinal hemorrhage each year. So, let¹s put the toxicity issue into perspective.

Some of the short term side effects of FDA approved, freely available drugs include yeast infections and resistant bacterial strains (antibiotic overuse), gastrointestinal hemorrhage (NSAIDS), breast cancer, thromboembolism and stroke (birth control pills) and heart attacks (antihistamines combined with antibiotics or antifungal drugs). None of the short term side effects of DHEA come even remotely close to this. In one study, a daily dose of 1600 mgs. of DHEA given for 28 days to healthy subjects resulted in some insulin resistance but no other noticeable side effects. DHEA studies in lupus cases where 200 mgs. daily was taken for over 3 months concluded that it was well tolerated except for mild to moderate acne and occasional mild hirsuitism (abnormal hair growth); symptom relief in autoimmune diseases, however, has also been documented with DHEA doses in the range of 5 - 15 mgs. daily without any side effects for several years. There is no evidence that DHEA is any more harmful than the birth control pill (a steroid) or over the counter cortisone (steroid) creams, lotions, eye or ear drops.

The truth is that, compared to the majority of over-the-counter drugs, hormones and food supplements, DHEA administration is relatively safe. Until more is known about its long term effects, DHEA should be used with caution, a fact which can easily be displayed on the bottle label similar to that seen warning of gastric bleeding from aspirin, liver failure from acetominophen, bone marrow suppression from chemotherapy drugs, prostate problems from pseudoephedrine containing sinus remedies, kidney failure from certain antibiotics or cancer from cigarette smoking.

Recognizing the potential of DHEA, a company called Research Corporations Technologies in Tucson, Arizona issued a press release on January 14, 1997 on Phase 1 clinical trials of a synthetic, patentable version of DHEA called "Fluasterone" which they are attempting to show to be effective in preventing breast cancer, systemic lupus erythematosus, Type II diabetes, rheumatoid arthritis, cancer, and obesity. Are you seeing a developing pattern in all of this?

Œ'Dieter's teas:'' Herbal blends containing such ingredients as senna -- also known as cassia angustifolia -- aloe, rhubarb root, buckthorn, cascara and castor oil. They act as laxatives that, when consumed in excessive amounts, can disrupt potassium levels to endanger the heart. The teas are linked to diarrhea, vomiting, chronic constipation and fainting, and the FDA knows of four young women who died after excessive consumption. Spurred by California law, some manufacturers are adopting warning labels."

It should be noted that the herbs in "Dieter¹s teas" are found in a long list of combination products marketed by a growing number of large pharmaceutical firms. The side effects and potential toxicity can and will occur with the pharmaceutical grades of these herbs unless the products are used as directed and with a pinch or two of common sense. Oxygen and water ingestion can kill if abused every bit as much as laxative abuse. This FDA attack on laxatives appears to target only the ones manufactured by firms committed to natural products. Is this an FDA oversight or just a put down of drug company competitors?

"Pennyroyal: A member of the mint family, it induces abortion. The FDA knows of one woman who died of cardiac arrest in 1994 while attempting a pennyroyal abortion."

Once again, the FDA is misleading the public by painting an incomplete picture of a very useful herb. Pennyroyal, a member of the mint family, is only toxic if its oil is ingested in large amounts. Pennyroyal tea has been used frequently for ages without any hint of a problem. Its major use is as a carminative - it breaks up gas and prevents nausea, constipation and flatulence. It can can also be used as a stimulant on a hot day to cool down the body because it increases perspiration. Native Americans have used it to suppress menstruation, and, in massive quantities, it will induce abortion, a fact which contraindicates its use in pregnancy and is easily put on a warning label.

"Sassafras: Once a flavouring for root beer, the oil is banned as a U.S. food additive. But sassafras still is sold as a supplement to make Œtonics'¹ and teas. ŒIt's never been proven to be good for anything,'¹ Tyler said, but has been shown to cause liver cancer in animals."

Sassafras is best used as a topical remedy to relieve the symptoms of stings and insect bites, rheumatism, gout, sprains and swellings. Safrole, the main ingredient, is comparable to anti-inflammatory activity and pain relief to indomethacin, a very potent NSAID used in severe gouty arthritis. Unlike indomethacin, sassafras does not cause gastrointestinal bleeding - another fact which was ignored by the FDA. If massive dosages can cause liver cancer in animals this does not necessarily mean that the same will occur in humans. The cancer connection has never been documented.

"Other supplements may interact dangerously with medicines: Eating lots of licorice root, a popular herb also found in some licorice candies, speeds potentially serious potassium loss when used with laxatives. Flax seed can delay absorption of medicines."

Once again, these effects are dose dependent and rare to non-existent when the herbs are used as directed. The benefits of licorice root for infections and blood glucose imbalances and flax seed for cancer prevention are so overwhelmingly positive that only abusive dosages are capable of any deleterious effects. Diets supplemented with ground flax seed can reduce high cholesterol levels and lower the risk for atherosclerosis. Use common sense and ignore the warnings of fuddy duddies.

"Kava kava can increase the effects of alcohol and certain psychological drugs."

More nonsense. Kava kava has been used for hundreds of years without incidence. The real issue for the FDA and its drug company masters is the fact that this herb is a safe and effective competitor to prescription tranquilizers and anti-depressants. The latter are more likely to be abused and ingested with alcohol in successful suicide attempts. In the history of the planet there has not been a single documented case of a death reported with the use of kava kava while thousands of deaths occur yearly with "safe and effective" prescription sedatives, tranquilizers and anti-depressants.

"High doses of Vitamin E cause bleeding in people taking blood thinners. So can bromelain, a pineapple enzyme used as a digestive aid."

The commonest prescription anticoagulant (blood thinner) is a rat poison derivative (coumadin) which causes side effects too numerous to list. Since many natural remedies can effectively replace rat poison, complementary medical doctors and naturopaths are often consulted to help patients with alternatives like garlic, fish oils, vitamin E and bromelain. Although it is true that vitamin E and bromelain can enhance the anticoagulant effects of coumadin, it is also true that they prevent heart attack and help reverse atherosclerosis. Vitamin E is a well documented antioxidant that prevents the oxidation of polyunsaturated fatty acids (the rancidification of fats) found in cell membranes. Bromelain is a digestive enzyme that breaks down arteriosclerotic plaques and prevents blood clots. The preventive benefit of using bromelain, vitamin E and other products far outweigh any minor risks. The real problem is the rat poison, not the natural blood thinners.

"High doses of vitamins and minerals sold in some supplements also can cause serious side effects:

Vitamin A: High doses during pregnancy can cause birth defects. Also, doses of 25,000 International Units a day can cause severe liver injury, headaches and joint pain.

Vitamin D: Consuming for several months doses 10 times the daily recommended allotment of 10 micrograms can cause dangerously high calcium levels and lead to kidney damage. Early symptoms are vomiting and increased thirst.

Vitamin C: Doses higher than 1,000 milligrams a day can cause diarrhea and kidney stones."

There has never been a study demonstrating a clear cause and effect relationship between women using massive doses of vitamin A during pregnancy and the appearance of birth defects. Certainly, the amount of vitamin A in multivitamins or cod/halibut liver oil (10,000 I.U. or less) has no effect on the fetus. One recent study by Johnson et al proved that such doses do not even raise blood levels of vitamin A, let alone cause abnormalities in liver function tests or birth defects. The same cannot be claimed for synthetic (adulterated) forms of vitamin A used in the treatment of acne (i.e. isotretinoin). Synthetic, prescription forms of isotretinoin do indeed cause birth defects at even low doses. Let us, however, not confuse these drugs with naturally occurring vitamin A in multivitamins or fish oil capsules.

Further, a recent study by Bendich, Mallick and Leader in the May, 1997 issue of the Western Journal of Medicine, concluded that the ingestion of a daily multiple vitamin and mineral supplement (including vitamins A, C, D, E and folic acid) by all women of childbearing age could cut the annual hospital charges for birth defects, low birth weight premature births and coronary heart disease by 40, 60, and 38% respectively.

Vitamin toxicity is rare and only theoretically possible. The commonest vitamin toxicity reported in scientific journals is Hypervitaminosis A. The dose required to produce toxicity is highly variable. One study claims that 1 million I.U. daily taken for 5 years did not lead to toxicity in a series of patients. Others claim toxicity with daily intakes of 25,000 - 50,000 I.U. daily for several months. These discrepancies can be reconciled by understanding that low doses are more likely to produce toxicity in persons where liver function is compromised by drugs, viral hepatitis, alcohol abuse or protein-calorie malnutrition. In those with normal liver function, even massive doses fail to have a toxic effect.

If a pregnant woman has normal liver function, there is absolutely no evidence that taking a multivitamin containing vitamin A could do any harm. On the contrary, she is helping to prevent birth defects, blindness, infections and a large number of other afflictions all too often seen in newborns whose mothers are ignorant about sound nutritional practices.

If vitamin A was such a dangerous nutrient, with the huge numbers of people now taking vitamin A either in a multivitamin or in fish oil capsules, one would expect epidemic numbers to develop vitamin A toxicity. The actual worldwide incidence of vitamin A toxicity is very small. It is estimated to be 200 cases annually. Even this is reversible on discontinuing the supplement This is many times less than the incidence of toxicity with over-the-counter drugs often recommended by doctors for pregnant women (e.g. acetominophen, ASA, anti-nausea drugs, antibiotics, etc.).

What are some of the signs of vitamin A toxicity? According to published reports in many journals, signs of chronic vitamin A toxicity include fatigue, malaise, lethargy, headaches, abdominal pain, constipation, insomnia, restlessness, night sweats, hair loss, alopecia, abnormal bone growth in children, brittle nails, irregular menses, emotional lability, mouth fissures, dry, scaly, rough, yellowish skin, superficial retinal hemorrhages, exophthalmos, gout attacks, peripheral edema and increased intracranial pressure with headaches, nausea and vomiting. In the majority of cases, however, most of these symptoms are relieved within a few days to a week of discontinuing vitamin A. Full recovery usually follows within weeks or months. Cirrhosis and bone growth abnormalities caused by vitamin A toxicity are irreversible. Since nausea is likely to occur long before any significant liver damage sets in, most people will see this as an obvious reason to stop or decrease their intake of vitamin A supplements. This built-in safety mechanism is not 100% foolproof so periodic lab tests to assess liver function are a good idea, especially in those who take higher than 25,000 I.U. doses daily for any extended periods of time.

Vitamin C can indeed cause diarrhea but the dose at which this happens varies considerably from individual to individual and is reversible by lowering the dose. What the vitamin C critics fail to mention is that, in order to achieve the full therapeutic effects of vitamin C in treating viruses, allergies, inflammation, cancer and heart disease, the dose must initially be pushed to bowel tolerance levels (i.e. the diarrhea dose) before tapering off to maintenance levels. Also, if one takes vitamin C with bioflavonoids, this buffers the acid and prevents the irritative effects that produce diarrhea in some individuals even at very low doses.

The statement that vitamin C causes kidney stones is, at best, a myth. At least a dozen clinical studies have proven that vitamin C does not cause kidney stones. The most recent of these studies by Curhan et al. published in a 1996 Journal of Urology actually showed that there is a reduced incidence of kidney stones in people who supplement with 1500 mg/day or more of vitamin C.

"Iron: One of the most frequent causes of fatal poisonings in children who take supplements meant for adults. High doses in adults also are linked to heart disease."

The majority of iron supplements are manufactured by pharmaceutical firms and prescribed by conventional medical doctors who are unaware of basic nutritional concepts like the connection between heart disease and high iron levels. If patients do not follow prescription advice nor are monitored to assess either efficacy or toxicity with regular follow up lab tests, problems are potentially possible. The solution is better doctor and patient education, not restrictive new rules limiting access.

"Selenium: Supplements of 5 to 50 milligrams a day can cause nausea, loss of hair and nails and nerve damage."

A dose of 5-50 mg of selenium corresponds to 100-1000 times the dose found in standard capsules or tablets and this astronomically high dosage would have to be taken every day for several months in order to produce the adverse effects claimed by selenium critics. The FDA may have found one or two cases of such irresponsible behaviour, but the example is so irrelevant as to be meaningless to all but a few crackpots. By the way, a growing body of evidence favours the use of high doses of selenium (1 - 3 mgs.) as an effective anticancer treatment. Perhaps preliminary reports of cancer reversals using high dose selenium supplements has made the chemotherapy pushers nervous about lost revenues to an inexpensive and unpatentable trace mineral.

Further, while issuing these misleading statements about natural health care products, the FDA is saying and doing nothing about the highly documented toxicity caused by mercury amalgam dental fillings, a practice which has been banned in Sweden and other countries and which is the subject of several class action lawsuits in Canada and around the world.

The FDA and its masters appear to be on a campaign aimed at discrediting the natural health care industry. Although many of the products attacked in this most recent AP Wire blitz are marketed by drug companies, the ultimate aim is to create a monopoly of legitimate or "sanitized" natural products for the multinational pharmaceutical firms. In Canada, as in the United States, this is to be accomplished by the creation of rules and regulations (The Third Categoy for nutritional supplements in Canada) which enforce all manufacturers to submit their companies to rigourous and expensive procedures currently in use by drug companies. Unfortunately, these "good manufacturing practices" (GMP), while plausible and useful for drugs, are unnecessary and potentially detrimental to the fields of herbal and homeopathic medicine.

GMP is A SMOKESCREEN FOR LARGER COMPANIES TO MAKE MONEY AT THE EXPENSE OF SMALLER FIRMS WHO COULD NOT AFFORD THE extra taxes, staff, equipment and testing facilities. There is no proof that GMP increases or enhances the safety or efficacy of herbal remedies. A very good example of how this is true is the case of Traditional Chinese Medicine (TCM). For centuries, when clients visited a practitioner of TCM, the herbs were sold in dried, powdered bits, pieces or teas. For the most part this is the way in which TCM is practised to this day. The success and growth of TCM has continued to be high with no documented deaths, epidemics, absence of "active ingredients" and all the other overblown benefits of GMP. No one can or should apply GMP to TCM or to herbal medicine in any other of its many forms. Anyone who says otherwise is just a drug company lobbyist intent upon subjugating all natural health care products under the pharmaceutical industry umbrella, eliminating the small manufacturing firms, raising prices to consumers and reaping high profits in the process.

GMP is reductionistic. It assumes that the right thing to do is to reduce a food or herb to its "active ingredients" and ignore or neglect the rest. In other words, you extract the indoles from broccoli, encapsulate them and sell them as standardized broccoli supplements to prevent breast cancer. This is not natural medicine. This is the pharmaceutical business pretending to promote natural therapeutics while patenting and GMPing natural remedies.

Adopting GMP for natural remedies like herbs and food extracts is a perversion of the basic principles of holistic medicine, TCM and other whole food therapies. It is an unproven set of arbitrary rules suitable only for the drug business. If you manufacture drugs, GMP is desirable. It does not necessarily follow that GMP applies equally to herbs, whole foods and homeopathic remedies. The large "nutraceutical" manufacturers would like to think that GMP should apply to all natural product manufacturers because GMP gives them a financial advantage. GMP, however, does not give them a quality advantage. In fact, it perverts their products into pseudo-drugs. Look closely and you will find a pharmaceutical manufacturer behind every individual and firm that pushes for GMP, more government intervention, a "third category" for nutritional supplements and other forms of hidden taxation, exploitation and monopolization.

Associated Press, FDA: Diet Drugs Pose Health Risks; Feb. 23, 1998

Associated Press, Govt. List of Risky Supplements; Feb. 22, 1998

Associated Press, Tips on Supplement Safety. Feb. 22, 1998.

Barret-Connor E, et al. A prospective study of dehydroepiandrosterone sulfate, mortality and cardiovascular disease. New England Journal of Medicine, 1986;315:1519-1524.

Berdanier CD; Parente JA Jr; McIntosh MK; Is dehydroepiandrosterone an antiobesity agent? FASEB J 1993 Mar;7(5):414-9:

Bendich, A., Mallick, R., Leader S. Potential health economic benefits of vitamin supplementation. West J. Med. 1997 May; 166:306-312.

Calabrese, V.P. et al. DHEA in multiple sclerosis: positive effects on the fatigue syndrome in a non-randomized study. In The Biologic Role of DHEA by Kalimi, M. and Regelson, W., Editors. New York: Walter De Gruyter, 1990, pp. 95-100.

Charron, Jean-Marc. Regional Bulletin on DHEA (dehydroepiandrosterone). Health Canada HPB, Dec. 19, 1996.

Curhan, G.C. , et al. A prospective study of the intake of vitamins C and B6, and the risk of kidney stones in men. J. Urol. 1996; 155:1847-1851.

DerMarderosian, Editoe. The Review of Natural Products. St. Louis: Facts and Comparisons. 1997.

Ebeling P; Koivisto VA. Physiological importance of dehydroepiandrosterone. Lancet 1994 Jun 11;343(8911):1479-81.

Fayerman, Pamela Sun Health Issues Reporter, New study hints decongestants, cold medicines can cause stroke; The Vancouver Sun, April 16, 1997.

Gaby, Alan R. Dehydroepiandrosterone: Biological Effects and Clinical Significance. Alternative Medicine Review; Volume 1, number 2, July 1996; pp.60-69.

Mowrey, Daniel B. Herbal Tonic Therapies. New Canaan, CT:Keats Publishing. 1993.

Murray, Michael T. Natural Alternatives to Over-the-Counter and Prescription Drugs. New York:William Morrow and Company, Inc., 1994.

Murray, Michael T. Encyclopedia of Nutritional Supplements. Rocklin, CA:Prima Publishing, 1996.

Regelson W; Loria R; Kalimi M. Hormonal intervention: "buffer hormones" or "state dependency". The role of dehydroepiandrosterone (DHEA), thyroid hormone, estrogen and hypophysectomy in aging. Ann N Y Acad Sci 1988;521:260-73.

Roberts, E. and Fauble, T.J. Oral DHEA in multiple sclerosis: results of a phase one, open study. In The Biologic Role of DHEA by Kalimi, M. and Regelson, W., Editors. New York: Walter De Gruyter, 1990, pp. 81-93.

Rona, Zoltan P. and Martin, Jeanne Marie. Return to the Joy of Health, Vancouver: Alive Books, 1995.

Rona, Zoltan P. Childhood Illness and The Allergy Connection. Rocklin, California:Prima Books, 1996.

Schwartz AG; Whitcomb JM; Nyce JW; Lewbart ML; Pashko LL. Dehydroepiandrosterone and structural analogs: a new class of cancer chemopreventive agents. Adv Cancer Res 1988;51:391-424.

Schwartz AG; Pashko LL. Cancer chemoprevention with the adrenocortical steroid dehydroepiandrosterone and structural analogs. J Cell Biochem Suppl 1993;17G:73-9.

Whitcomb JM. Inhibition of tumor development by dehydroepiandrosterone and related steroids.Toxicol Pathol 1986;14(3):357-62:

Zumoff B. Hormonal abnormalities in obesity. Acta Med Scand Suppl 1988;723:153-60.