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100 years of FDA.

This year has represented a little-remarked-upon major milestone in American medicine: the 100th anniversary of active Federal regulation of food and drugs. The Pure Food and Drug Act came into effect on January 1st, 1907--the first step toward the creation of the modern Food and Drug Administration (FDA), and a step forward from the dangerous anarchy of the patent medicine era.

For the first time, drug manufacturers were required by law to disclose the dosage and purity of their products (including, for the first time, disclosing whether they contained poison, alcohol, or narcotics such as heroin or cocaine). They were also required to refrain from deliberately lying about their products, and from fraudulently substituting a claimed ingredient for some other ingredient. Bizarrely, such laws were needed.

Today, herbal concoctions and other supplements are cooked up and marketed with wild abandon, with all the unrestrained, unverified boasting of the patent medicine era still on display. We are told (coyly, skirting the few rules for labeling) that herbs and proprietary blends can cure more-or-less anything. Have we really made so little progress against health fraud?

In fact, we've come a long way. Most medicines are now carefully regulated, and consumers can be reasonably assured of the basics: that effectiveness, side effects and interactions are known to some degree; that the bottle contains what the label says; that we are not unknowingly buying bottles of heroin, and so on. We all know that regulation comes with its own cost (drugs take a long time to get to market, for example) but we're much, much better off than drug consumers in the early decades of the last century.

However, current regulations allow for unregulated herbal "supplements" to flood the market. The Dietary Supplement Health and Education Act of 1994 (DSHEA), which seized back control of patent medicines from the FDA, was passed after strenuous lobbying from supplement manufacturers, and this legislation removed all herbs, vitamins, and minerals from FDA oversight--despite the fact that herbs are drugs, exhibiting a full range of effectiveness (or ineffectiveness), dangerous side effects, and interactions with other drugs. Not only are the producers of herbal drugs and other supplements no longer required to prove that their products work--or even whether they are safe--but the burden of proof regarding safety is explicitly shifted to the FDA.

If a supplement proves dangerous enough to get the FDA's attention, and if the staff of the FDA can find the time and budget, they can then attempt to prove in court that the supplement is unsafe. This costly and lengthy procedure is attempted only rarely, and in only the most severe cases, such as that of ephedra. The supplement was suspected in hundreds of deaths, yet the ban was challenged in court and overturned on the basis that the DSHEA forbids FDA action even in such an extreme case. Luckily, the ruling against the ephedra ban was itself overturned on appeal. After more than two years of legal battles, ephedra supplements are today illegal.

The supplement industry has exploded and now takes in tens of billions of dollars a year. Requiring no expensive safety testing or FDA approval, these products are produced with an enviable profit margin, which has of course drawn large pharmaceutical corporations enthusiastically into the supplement industry. People buying "alternative" herbal products need to recognize how likely it is that they are feeding their dollars into the exact same Big Pharma system they are attempting to circumvent. The chilling difference is that the corporation has been excused from the responsibility of ensuring the safety or effectiveness of the drugs.

There are several useful watchdog websites that can help you make intelligent choices about herbal supplements. For information on a particular herbal remedy or supplement, search for it at one or more of the following sites:

Herbal Watch

Natural Medicines Comprehensive Database

National Institutes of Health--Office of Dietary Supplements

National Center for Complementary and Alternative Medicine

Consumer Lab

Nutrition in Complementary Care, a practice group of the American Dietetic Association

Botanical Society of America
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Publication:Running & FitNews
Date:Nov 1, 2007
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