The Food and Drug Administration is enforcing regulations to ensure the safety of nutritional supplements. Within the next 1-2 years, supplement manufacturers will need to satisfy these requirements or go out of business. The cost of buying these supplements will substantially increase.

What has caused this change? Are vitamins and minerals dangerous? Are people at risk of illness or death from taking supplements? Should supplements be regulated as if they were drugs because they are used like drugs, as has been suggested by an editor of the New England Journal of Medicine?

A visitor from another planet, observing our current healthcare situation, would probably think we were crazy. The United States spends 2.1 trillion dollars on healthcare, more than $7000 for every man, woman and child, or one out of every seven dollars we earn. More than 200 billion dollars a year go for pharmaceutical therapies. Despite this incredible expense, the United States ranks no higher than fifteenth in the world in health-care outcomes.

If vitamins were as dangerous as drugs, there would be no argument about the need for intensive regulation. Of course, they are not as dangerous. The use of prescription and over the counter medications is responsible for more than 100,000 deaths every year, and more than 2,000,000 serious adverse reactions. If this were true of supplements, we would have no supplements. If we did have them, no one would risk taking them.

The conventional medical paradigm treats illness with drugs, and prevents illness with drugs. Children are recommended to have more than 20 vaccinations, sometimes 4 or 5 at the same time, beginning at the age of one day. Vaccinations are implicated as a cause of neurological disease, including autism, yet in some states it is illegal to send children to school without them. Parents have told me they were turned away from pediatric practices when they refused to have their children vaccinated.

Non-steroidal anti-inflammatory drugs are taken by millions of people for the relief of pain and inflammation. They are effective, but also cause gastrointestinal ulcers and bleeding, fluid retention, edema, high blood pressure and heart failure, liver and kidney disease. They are one of the major causes of hospitalization for congestive heart failure, and are considered responsible for about 10,000 deaths a year. Most of them are available over the counter. So much for the safety of non-prescription drugs.

Every year 4 or 5 well-known drugs are withdrawn by pharmaceutical company decisions or after FDA recommendations, when previously unrecognized toxicity is discovered. Rezulin, the first of a new class of antidiabetic drugs, was withdrawn several years ago, after about 40 people died of liver failure. Remarkably, this drug was approved for use in the United States even after it had been removed in England because of excessive liver toxicity. Are livers any different in England than they are in the United States? Last month a related diabetic drug, Avandia, was withdrawn after excessive cardiac failure and death were identified. Vioxx, a non-steroidal pain reliever, was interred in the drug cemetery because it caused heart attacks and death, after it had been prescribed to millions, for years.

Drugs are approved for use by the FDA after only brief studies have demonstrated statistical benefit. There are NEVER any long term studies performed prior to drug approval, because costs are prohibitive. Thus many drug complications are discovered long after the drug is released for patient consumption. It is only years later, after many patients have suffered unanticipated complications, or died, that adverse drug effects lead to termination.

Sometimes medications are approved because they benefit a clinical marker, with no proof that they prevent or cure disease. After several years of proliferating prescriptions and billions in profits, a cholesterol lowering drug was found to actually increase arterial degeneration. Apparently the sponsoring pharmaceutical company withheld the damaging results of research for two years, until forced to release them by congressional pressure.

The adverse effects of drugs are under-reported and deliberately or unintentionally underestimated. One type of anti-hypertensive drug was said to cause an irritating cough in 1-2% of patients, while the true incidence was more like 20%. The statin drugs, considered a panacea par excellence for heart disease, are claimed to cause muscle pain and weakness in a very small percent of patients. I have seen this complication in many patients, however, and it has often been unrecognized or disregarded by their primary physicians. Some patients have been told to continue taking the drug no matter how bad they felt, or else die of heart disease. Statin drugs provide little or no benefit for people without pre-existing heart disease, yet they are prescribed promiscuously, even for eighty year old women with cholesterol levels only 10 points above normal. This type of practice is preposterous, and it is dangerous.

It is common for 60 and 70 year olds to be taking five and six drugs at the same time. A couple of weeks ago I encountered a patient taking 13 prescriptions at once. I quickly helped him get off seven of them, and he felt much better. As is often the case, several of his drugs were prescribed to handle the side effects caused by other drugs. A vicious cycle of effect/counter-effect develops, with the patient the unknowing recipient of multiple complications.

My mother developed intestinal problems several years ago, with cramps, diarrhea and bloating. After going to several medical institutions and an array of physicians, she was prescribed a drug that made her drowsy and resulted in an accident when she dozed off while driving on the freeway. I told her to stop the drug, and initiated a combination of nutritional therapies that she continues to take. To this day, she has no symptoms.

It is usual for many physicians to repudiate the value of nutritional supplements, or to claim they are dangerous and counteract the benefits of conventional drug therapies. I have many patients who decline to tell their other physicians that they are taking supplements, afraid that they will be ridiculed or turned out of the practice. This is especially true in the realm of cancer therapy, where oncologists and radiation therapists assert that vitamin and mineral supplements will impair the effectiveness of their treatments. I have many patients who silently take recommended supplements, and experience remarkable recoveries from cancer, with minimal side effects from their therapies.

Into this scenario enters an array of vitamins, minerals, herbs, and amino acids. What is the truth about them? What precautions should be taken? Are they innocent pawns in a conflict between conventional and alternative medicine? How much do they interfere, and how much do they help?

It is important to know that most supplements are safe. There is vast latitude in the doses that may be taken without concern for complications. About the worst that can come from vitamin C is diarrhea, except in cases of kidney disease, or a rare enzyme deficiency. Most B vitamins have no toxicity at any dose, although folic acid should only be taken when vitamin B12 has been repleted. Vitamin D has been maligned as a dangerous item, yet it turns out that most Americans are deficient in vitamin D and should take supplements to prevent osteoporosis, diabetes and multiple sclerosis.

I have prescribed nutritional supplements along with lifestyle changes for many years in the treatment and prevention of disease. Diabetes mellitus is preventable or reversible in 70-90% of patients, without medications. So, often, is hypertension, and hyperlipidemia, and osteoporosis. Patients come who want to get off medications, or be treated without medications, and without surgery. They have already suffered complications of these therapies, or have seen their family members suffer.

Certain precautions should be followed in choosing supplements. Several companies do not follow good manufacturing practices. The ingredients in their preparations are lower than stated on the container, or of poor quality, or contain contaminants. Some large companies sell supplements at prices so low as to defy any possibility of value. It is unlikely that a quality product will be produced at extremely low cost.

Some preparations contain colorings, additives and preservatives that should be avoided. Read the labels.

Some products may not be bioavailable. Tablets may not dissolve. High heat and pressure used in making tablets may destroy certain ingredients, such as B vitamins and vitamin C.

Some formulations are better than others. Minerals are better absorbed when offered as chelates. For instance, calcium and magnesium chelates are better absorbed than carbonate or oxide formulations.

Therefore, choose products produced by reputable companies. If you are unsure about which products are preferable, ask a health care practitioner who has experience in dealing with these products. It is not generally useful to inquire of a conventional physician, since he is not likely to be trained in this area.

Supplements should be labeled with an expiration date and stored properly. Beyond this date, they begin to lose potency, and may spoil. This is particularly true of fish oils containing omega 3 fatty acids and other oil-based nutrients, which may become rancid. Storage in light or high temperatures should also be avoided and some supplements must be kept in the refrigerator.

Care should be exercised in choosing herbs, as certain herbs are known to be toxic. Aristolochia, for instance, has caused renal failure and urologic malignancies, primarily in Asia. Comfrey has caused liver disease. In general, such herbs are not available in health food stores in the United States. There are also reports of herbs imported from the Orient containing toxic heavy metals such as lead and mercury. Certain companies are highly reputed for their herbal formulations, and their products should be chosen preferentially.

Several deaths occurred recently as a consequence of consumers taking excessive doses of weight loss preparations containing ephedra, a relative of epinephrine. I do not recommend using any formulation containing ephedra, mainly because most reputable nutrient companies, the ones whose products can be trusted, no longer offer ephedrine-containing preparations.

All supplements are not equal, and it is unwise to assume that they are. Two dollars spent on a cheaper fish oil supplement may be two dollars spent for nothing. Sometimes, unfortunately, individuals working in health food stores may not be knowledgeable about their products. Spend some time talking, studying, and looking around, the way you would when looking for a new car or a new home.

The field of nutritional supplementation is diverse and complicated. New discoveries and new formulations are frequent. If you are not an expert yourself, it is best to be in communication with an expert who can help guide you make the best choices for your particular situation. All patients are not the same, and nutrients should be chosen with proper attention to individual requirements. Nutrient levels of vitamins, minerals, fatty acids and amino acids can be measured in blood. In patients with gastrointestinal conditions, stool studies can be performed to evaluate the need for beneficial bacteria and gastrointestinal nutrients such as glutamine or zinc.

Some medications are interfered with by certain nutrients. In general it is better to separate nutritional supplements from drugs. Thyroid hormone, in particular, should be taken by itself.

-Allan Sosin, MD

(*The information contained in this article is provided for educational purposes only and is not intended to diagnose, treat or cure any illness or condition. These recommendations have not been reviewed by the U.S. Food and Drug Administration (FDA). No content contained in this article is a substitute for professional medical advice, diagnosis or treatment. Never increase, reduce or discontinue any medication or treatment without first consulting your doctor. If you are seeking the advice of a medical professional and wish to make an appointment with one of our doctors, please call our office at (949) 600-5100. Unsolicited e-mail may not be answered and is not a substitute for obtaining medical advice in person from a qualified health professional. If you have a medical emergency, contact your personal physician or local medical emergency service immediately.)

Author's Bio: 

Allan Sosin is the founder and medical director of the Institute for Progressive Medicine. He received his medical degree from Northwestern University Medical School and is board-certified in both Internal Medicine and Nephrology, the study of kidney disease.

For thirteen years Dr. Sosin ran a private internal medicine practice in Philadelphia. During that time he became increasingly interested in alternative approaches to medical problems including nutrition, vitamin and mineral therapies, chelation therapy, acupuncture, natural hormone replacement therapy, exercise and stress management. He also held the position of Assistant Medical Director at The Institutes for the Achievement of Human Potential, a world-renowned facility for the treatment of brain injured children.

Dr. Sosin is an expert in the use of natural approaches to replace drugs and surgery. He has over 40 years of clinical experience in treating patients with traditional therapies and 15 years experience using alternative methods in combination with conventional medicine. He is a member of the American College for the Advancement of Medicine (ACAM) and is a certified Defeat Autism Now!® physician. Dr. Sosin has also worked extensively with IV therapy, acupuncture and natural hormone replacement therapy. He has successfully treated thousands of patients with serious medical conditions. Dr. Sosin is the author of two books, Alpha Lipoic Acid: Nature's Ultimate Antioxidant, and The Doctor's Guide to Diabetes and Your Child, and has appeared on both radio and television.