Are Vitamins Regulated?Blaming a rarely unanimous Congress for restraining the Food & Drug Administration (FDA), many "health experts" are cited as claiming that the 1994 Dietary Supplement Health & Education Act (DSHEA) exempts dietary supplements from FDA control and permits poorly supported claims on natural products. This is absolutely false!
Dietary supplements are regulated as a special class of food products, rather than regulating them just like dangerous pharmaceutical drugs. This is reasonable and proper. All appropriate safety and labeling laws apply to these products, and were in fact enhanced by DSHEA. DSHEA instructed the FDA to regulate "structure-and-function" claims, which relate only to normal nutrient-body relationships, but not to nutritional influences on disease.
Disease claims for nutrients and plants are forbidden unless the FDA approves a drug claim. Even if the disease claims are true and backed by good science, FDA regulations prevent them from being made except for approved drug products. The FDA specifically has the power to deny any label claims if not based on scientific consensus, and has frequently had battles in federal courts over their overzealous denials of legitimate claims.
They've often lost these cases by going beyond the intent of Congress and preventing truthful, non-misleading statements from appearing on product labels. Or by attempting to label natural products as "unapproved food additives" to prevent their sale in the U.S. Fortunately, recent FDA commissioners have become more reasonable in their policies.
I strongly support DSHEA and the current regulation of herbs, vitamins and other dietary supplements as a special category of food. The safety level of these products is so very much greater than for drugs that over-regulating them is not appropriate. On the other hand, outrageous and unscientific claims give the natural health business a bad name, and should not be supported. Responsible businesses do not engage in this kind of hype, nor deserve to be associated with those who do.
How harmful are supplements? A recent yearly report from the American Association of Poison Control Centers' shows zero deaths in the U.S. from taking dietary supplements, with the exception of two deaths from overdosing on iron (considered suicides), and ten deaths from all plants (mostly poisonous mushrooms).
Compare that safety record with the 340 reported deaths from taking analgesics (aspirin, acetaminophen, etc.), 153 from antidepressant drugs, 127 from cardiovascular drugs, 127 from cold and cough formulas, 121 from street drugs, 110 from sedatives, and 4 from lipsticks/lip balms. A medical journal estimates the real death rate from FDA-regulated drugs as being well over 100,000 a year!
While there are a few small companies who seek unfair advantage by making illegal or unethical claims, it is equally ridiculous to deny all of the science behind dietary supplements and to also try to blame those companies who responsibly "toe the line". There are industry organizations that provide self-policing of the dietary supplement industry. They provide independent "third party" certification of Good Manufacturing Practices and random testing of nutritional products to assure that they match their label claims.
That has been necessary because the FDA claims that they don't have adequate money or personnel to implement current regulations. But there have been dozens and dozens of enforcement actions taken against dietary supplements every year, so it's neither fair nor correct when "experts" declare that DSHEA has prevented the FDA from protecting us from mislabeled or harmful products.
The FDA admits on their own Web site that they have full regulatory authority over the manufacture, safety and label claims of dietary supplements. DSHEA, passed unanimously by Congress, actually authorized new regulation of manufacturing practices by the FDA, which has still not been accomplished due to its low priority at FDA. They have also set up legal structures for reporting adverse reactions to supplements, as needed. Again this has not really been implemented fully.
Other regulations have been passed which regulate the labeling of products, so that the lack of consistency between different manufacturers' product labels would be eliminated. This all benefits the consumer, or will whenever it becomes a reality. But the law is not preventing the FDA from acting, just lack of money and manpower. Anyway, they do have more important things to do, like regulating drugs and chemicals.
One example used to attack DSHEA is the controversy over the herb Ephedra Sinesis (ma huang), a source of the alkaloid ephedrine. Ephedra has been repeatedly attacked over the years; but when the FDA has convened scientific panels to review this herb, they simply wouldn't prohibit its use because of the wealth of data that it is safer than many drugs, and rarely responsible for causing deaths or serious injuries when used according to labeling guidelines. Recent speculations that this herb played a role in athlete deaths have typically not been sustained by comprehensive medical evidence. In fact, many asthmatics find that using ephedra makes breathing easier, so it may actually save many more lives than it "endangers".
With its enviable safety record for an estimated 3 billion doses per year, ephedra is a useful substance to have available. Of course, it's not safe for everyone; but neither are corn, soy, eggs, milk, peanuts and other normally safe items that most of us eat; which may be harmful or even deadly to others.
Two recent published studies on ephedra-and-caffeine combinations show that they are safe and effective if the users have been carefully screened according to standard recommended label cautions. But members of Congress and some medical experts are demanding that Ephedra be banned, complaining that DSHEA is preventing the FDA from banning it until the danger is scientifically proven. Meanwhile, scared insurance companies have jacked up insurance rates for manufacturers of products that contain Ephedra, causing most companies to drop Ephedra as an ingredient anyway.
Please remember that dieters often have access to other kinds of products that are already proven to be very dangerous. Obesity is an epidemic in this country, and the side effects of that problem include many chronic diseases and deaths-many more than may be caused by Ephedra or other dietary supplements. Strict labeling and strong warnings would protect the general public more than a ban based on allegations which have not been scientifically proven, despite the unsuccessful efforts of so many scientists to find a "smoking gun".
It is unfortunate that supplements are often judged as interfering with drugs. In a more perfect world safer, natural remedies would be the first choice of intervention. This would include trying diet, exercise and nutritional supplements before being condemned to a lifetime of being hooked on dangerous prescription drug cocktails. Mixing drugs creates their own unique interactions that are themselves little studied. And while the natural substances are more forgiving of potency variations and biochemical variations between people, drug doses and mixtures really need to be carefully calibrated to the individual.
This is not often done, except by gross trial and error. Blaming vitamins, foods and spices for interfering with drugs should be viewed as backwards. Better that the drugs should be carefully screened against the individual's diet and supplementation for proper dosing at the lowest possible level. Failure to do this results in what one medical journal estimates as the real death rate from FDA-regulated drugs: over 100,000 deaths a year. Hospital errors administering drugs additionally cause hundreds more deaths every week.I question the ability of many medical authorities to understand non-medical treatments such as herbs and vitamins. There is often a defensiveness about their own lack of training on the subject, combined with an understandable bias toward treating these natural products as if they were drugs. If a food or herb interacts with a drug, many doctors' gut reaction is to badmouth those natural products and demand restrictions on their use. But since drugs are already restricted, it's only reasonable that drug companies and medical authorities should be focusing on learning these interactions and adjusting prescriptions to match the patients' unique habits and biochemistry.
Why do the self-described "quackbusters" take on these safer products which compete with their own extremely imperfect practice of medicine, which causes so many deaths? They are trying to divert attention from the real quacks: the tiny minority of physicians who defraud insurance companies, the government, and their patients. Modern medicine treats medical procedures as usual-and-acceptable even before there are any peer-reviewed, placebo-controlled published studies done on them, while condemning natural products safely used for centuries as "unproven" even after there are hundreds of research papers published about them.
Even the standard body temperature of 98.6 degrees was recently found to be derived from one doctor's pronouncement from his clinical records, and was never established or proven by peer-reviewed science. Heart bypass surgery was practiced for years without studies analyzing the costs versus benefits, or examining long-term changes in prognosis of the underlying heart disease. Perhaps that's why we call it "practicing medicine". Standard treatments are constantly changing and are often not rigorously tested before being accepted as orthodox medical practice.
Medical texts from the first half of the 20th Century used herbs and other natural products with some efficacy and were considered scientific. No one is deficient in penicillin or in cholesterol-lowering drugs. But sick people may be deficient in plant nutrients that reduce inflammations or protect tissues from sun or chemical damage. The Hippocratic Oath demands that doctors first try to do no harm. That's what the dietary supplement advocates are saying too.
With the rise of Complementary or Integrative Medicine, physicians can supervise treatments using natural products, diet, exercise and mind-body techniques while reserving the dangerous drug and surgical techniques for those with more acute health crises. That is a more responsible practice of medicine, and I applaud those health professionals with the courage to seek this new, scientific method of improving health instead of fighting simply "disease". Sooner or later the insurance companies will figure out how this new model of health care will shrink their expenses, and that will shift the whole of medicine to this model of personalized, minimalist medicine.
Health Disclaimer. Content provided by NOW Foods. Copyright ©2004-2014. Published with permission. Neil E. Levin CCCN, DANLA is a certified clinical nutritionist and is a professional member of the International & American Associations of Clinical Nutritionists. Neil is the Nutrition Educator Manager for NOW Foods. He also serves as a Product Formulator and Truth Advocate. Neil Levin is not affiliated with avivahealth.com.