For Long Life, Swallow Anything: Part II
In the last Newsletter, I reviewed the basic changes imposed on the FDA by the Dietary Supplement Act 1994 wherein the initial responsibility for regulating dietary supplements was removed from the FDA and handed over to the manufacturer. This was a breath-taking excision from the landmark Food and Drug Act of 1938 which gave the FDA responsibility for regulation of cosmetics, "conventional" foods, and drug products before they were marketed. The 1994 legislation simply relegated to the FDA responsibility for the safety of dietary supplements after they were marketed. No longer would the FDA even regulate advertising claims, which became the purview of the Federal Trade Commission (FTC). As long as these products did not claim to treat or prevent disease, manufacturers could claim their diet supplements enhanced performance, "energized," controlled appetite, accelerated fat loss, relieved pain, "detoxified," in short use their imagination to make virtually any fanciful claim.
Public Misconceptions about Diet
Our national preoccupation with health translates, into wildly mistaken beliefs about what constitutes a "good" diet. The endlessly entangled relationships between culture, nutrition, diet, health, disease, and human longevity, continue to edge into a sort of theological quagmire, given the universal failure of even the Science gods to provide convincingly consistent answers to the unanswerable. If in fact, an estimated 20% of Americans consume too many calories, leading to an epidemic of obesity-now becoming a world-wide problem, very few indeed ingest a diet deficient in essential nutrients. Despite the almost universal belief in the health benefits of extra vitamins, minerals, amino acids, hormones — and now plant derivatives, herbs, essential oils and an unlimited list of exotic compounds, doctors almost never encounter true deficiency diseases among the normal population. Absent the shocking increase in anorexic eating disorders, the extreme rarity of clinical nutritional deficiencies is as true today as it was 50 years ago.
How Safe are Supplements?
Dietary supplements are used by more than one-half of the adult US population. The market for these products, extrapolating from earlier FDA figures, exceeds $13 billion yearly in the U.S. alone, with the industry targeting especially high school and college students. Dietary supplements may be sold in the United States with little regulation other than listing of ingredients. But this is no guarantee of what is actually contained in the bottle, its strength, purity, safety, effectiveness, and composition of, particularly, herbals and botanicals. Among these products, melatonin and homeopathic products, prepared from minuscule amounts of substances as diverse as salt and snake venom had the most reports of reactions in 2005. Indeed, how safe are products with such names as Cat's Claw, Dandelion, and Blessed Thistle (see this drug information page)? Dr. Alain Joffe, Director of the Student Health & Wellness Center, quotes a study done in Los Angeles to see how 12 brands of nutritional supplements lived up to their labels. This study found that only one brand out of 12 was accurately labeled. Of the other 11 brands, the list of ingredients was inaccurate and/or the amount of each ingredient was listed incorrectly. "Buyer beware" warns Dr. Joffe.
As pointed out in the American Journal of Clinical Nutrition, herbal products in Germany are carefully regulated by the same standards as drugs, and efforts are under way to standardize their regulation in the entire European Union. But the "nutraceutical" manufacturers continue to fight back, and The European Union continues to come under pressure.
Most patients taking herbal and dietary supplement do not inform their physicians they are taking these products, most likely because they do not regard them as drugs. To make matters worse, most physicians do not inquire. It is increasingly apparent that many products contain potentially toxic substances or have dangerous interactions with regulated drugs. Hence, it is essential that practicing physicians develop a working knowledge of herbals — specifically, about claims for their usage and potential for harm. The Anesthesia Department of the University of Wisconsin currently recommends that patients discontinue herbals 1 to 2 weeks before anesthesia and surgery, and goes on to list 16 popular botanical products with potential for serious complications. Among these are: Echinacea (liver damage), Garlic and Ginko (enhanced effect on anticoagulants), Ginseng (tachycardia, hypertension, bleeding, etc.), Kava-kava (potentiates sedatives), and Saw Palmetto (hormone therapy interaction).
More Regulatory Problems
College students are among supplement enthusiasts obsessed with taking care of their bodies. A previous National Collegiate Athletic Association (NCAA) drug survey of student-athletes revealed enthusiasm and widespread acceptance of nutritional supplement use. The survey results were based on responses from 21,000 student athletes at NCAA-member institutions. 42% of students surveyed said they had used nutritional supplements other than a multivitamin during the previous year. Of this group, half used supplements to improve their physical appearance and half wanted to improve their athletic performance. In a more recent NCAA survey 29% of college athletes reported having taken nutritional supplements in the twelve months prior to the study. The survey revealed that 26% of the students added creatine to their diets, 10% add amino acids, and 4% add androstenedione, chromium, and ephedra (before it was banned in 2004). Because the nutritional supplement manufacturers do not have to provide the FDA with the results of in-house studies (if there are any), knowledge of the long-term effects of the majority of supplements is, for the most part, unknown. For a long list of "alternative medicines and herbal supplements" and some examples of present illegal advertising claims appearing boldly on the Web, such as "Parkinson's Success Story," "Diabetes Herbal Cure," "Cure for Crohns Disease," "Natural Depression Cure," "New Psoriasis Treatment," "Natural Cure for Acne," etc. see here.
Some Supplements Are Vital — Sometimes
No one disputes the critical importance of dietary supplements used to treat or prevent disease, e.g. calcium and Vitamin D for osteoporosis, folate supplements in pregnancy, iron supplements for benign anemias due to chronic blood loss (excess menstruation), etc. Yet for the vast majority of people, proteins, amino acids, vitamins, minerals, antioxidants, and other compounds occur naturally in the variety of foods we eat. Why seek man-made versions of these products when you have only to eat a healthy meal? A growing concern is the virtual absence of large scale scientific studies on the benefits and risks of nutritional supplements. From the little information available we have no way of knowing how supplements, taken by perhaps 150 million Americans will affect them over the years to come.
As Dr. Joffe observed, "When you go to the drug store to pick up a prescription of penicillin, you know what you are getting. But when you buy nutritional supplements, you walk alone."
Martin F. Sturman, MD, FACP
Copyright 2006, Mathemedics, Inc.
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