Friday, August 26, 2005

Should the FDA Regulate Dietary Supplements?

In an arena dominated by powerful drug companies, the debate rages on as to how much regulation should be required for dietary supplements, also known as alternative medicine. Currently, the FDA (Food and Drug Administration) exercises limited control over herbal supplements. According to Judy Foulke, FDA spokeswoman, “It is the manufacturer's responsibility to produce a product that will not cause harm.” (Herb) The Journal of Athletic Training wrote, “Under the current legislation, supplement makers do not have to prove a product is safe; the FDA has the burden of proving a product is unsafe. The FDA can only take action if a product is found to present a significant or unreasonable risk of illness or injury” (Winterstein and Storrs). While manufacturers must provide adequate labeling, the FDA can ban any substance they feel is harmful to the public. Herbal advocates accuse the FDA and big drug companies of suppressing dietary supplements, while the FDA and drug companies claim that dietary supplements should be subject to regulation. There are several reasons why FDA regulation is not the answer to this problem. Regulation of a substance by the FDA does not guarantee its safety. Regulation of dietary supplements by the FDA is ineffective. Regulation by the FDA gives drug companies a monopoly on medicine.

Despite their extensive research requirements, the FDA cannot assess all the perils of a product. Some products have long term consequences that cannot be discovered in a study confined to the limits of time. The Herb Research Foundation writes that, “Over half of approved drugs are discovered to have "serious post-approval side-effects" requiring them to be removed from sale or restricted from use” (Herb). In addition, some drugs, although useful in dire circumstances, are seriously injurious to human health. Yet, these dangerous drugs are FDA approved. For example, the pain killer methadone received FDA approval in 1947, yet overdoses last year killed 264 Floridians (Greene). The FDA stamp of approval is no promise that the substance taken cannot have serious side effects.

Inconsistency and inaccuracy do not secure confidence that the FDA can both protect the public and improve the quality of available medicine. If someone is to believe that FDA regulation is imperative, they must also believe that the FDA already fulfills its duties. Sources indicate otherwise. “In fact, dietary supplements are subject to a safety definition stricter than that required for conventional foods and far stronger than for all classes of drugs. A supplement is considered unsafe if it "presents a significant or unreasonable risk of illness or injury. . .drugs are allowed to present significant risks, as long as these risks are outweighed by benefits” (Herb). Last year’s FDA ban on ephedra demonstrates the same inconsistency—the drug was banned based on the deaths of 5 people, and yet 106,000 deaths attributed to prescription drugs don’t have the same effect (Wong). It does not appear that the FDA seeks to increase the availability of safe medicine when their standards are inconsistent, and they ban herbal substances at will on insufficient grounds. Consequently, no one should expect that regulation of dietary supplements by the FDA will necessarily assure a safe product.

The last link in the argument leads to the drug company monopolizing the market. With free license to ban products, the FDA controls the dietary supplement market. Their regulation only gives drug companies a bigger hold on the availability of medicine. One source states that FDA bureaucrats want to regulate all nutritional supplements, and force, “citizens to depend entirely on prescription drugs that are controlled by a monopolistic industry” (News Target). Drug and pharmaceutical companies have every incentive to oppose and encourage opposition of alternative medicine, which, in some cases, can provide the same results at lower costs and fewer side effects.

The original question is: should the FDA regulate herbal supplements? FDA regulation is not the answer. Based on various sources, the FDA cannot reliably, effectively and consistently determine safety of a given product. The FDA’s bias and incentive towards selling expensive drugs prevents the public from receiving potentially useful, affordable, and comparatively safer medicine. Alexander Tabarrok said, “The FDA can make two kinds of mistakes. It can permit a bad drug, and it can fail to permit a good drug” (Tabarrok). Finally, despite the claim that dietary supplements endanger the public, their track record is incomparable to the dangers and deaths associated with conventional drugs.

Contact author for works cited and bibliography.

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