Why doesn't the FDA regulate herbal supplements?

The Problems with Herbs

A Ugandi traditional healer prepares a healing compound. While a far cry from the lab, healers like this work with potent chemical compounds.
A Ugandi traditional healer prepares a healing compound. While a far cry from the lab, healers like this work with potent chemical compounds.
Alexander Joe/AFP/Getty Images

One major problem with a lack of federal oversight on herbal supplements is the public perception of herbs. Pharmaceuticals, especially prescription drugs, tend to be perceived as potent chemicals. Regard for the potential danger prescription drugs can pose is more pronounced. In other words, the more regulated a substance is, the more dangerous it is perceived to be. Likewise, a substance that almost completely lacks any regulation might appear harmless. What's more, because they're naturally occurring, the chemicals found in herbs may be perceived by the public as less harmful than a drug produced by chemists in labs [source: Johnston].

This perception can prove dangerous. Although they're not synthetic, herbs contain powerful chemical compounds as well. Monkshood, for example, can stop the heart or lungs, killing a human within a couple hours of even handling it [source: University of Pennsylvania]. When eaten, the leafy herb jimsonweed causes strong hallucinations -- a detachment of soldiers in the Jamestown colony "turned natural fools upon it for several days" after they ate the weed in a salad in 1676 [source: Beverly]. In more extreme cases, the herb can cause death by lowering pulse and body temperature.

Heavily regulated prescription drugs locked away in pharmacies have much in common with many herbs available in stores. The sedative diazepam -- sold most popularly under the trade name Valium and a Schedule III drug under Drug Enforcement Agency classification -- is a synthesized, nearly identical version of valerian. Anyone can purchase this root in limitless quantity at most herb stores. And aspirin (once a trade name itself) was originally synthesized from white willow [source: Stein].

There's also a risk when herbal supplements and the modern medical establishment collide. A study published in 2003 found that 70 percent of patients who used herbs and visited a physician didn't tell their doctors they use herbs, largely because the patients feared being told to discontinue their use [source: Johnston]. This can prove problematic, as herbs can negatively interact with drugs. Garlic and aspirin combined can cause nausea; mixing the sedative kava kava and prescription sedatives can produce tremors like those found in Parkinson's disease patients [source: Johnston].

The reticence to disclose herb use to physicians reveals one facet of the distrust by some for the modern medical establishment. Western healthcare is perceived by many Americans as "cold [and] impersonal" [source: Robinson]. Even worse, physicians are viewed by some people as merely shills for large pharmaceutical companies, a conflict of interest in which the patient's interests can suffer [source: Horton].

This distrust arguably helped fuel the popularity of herbs in the West. Many people took responsibility for their health into their own hands, essentially self-medicating. As a result, the medical establishment sought at the beginning of the 21st century to integrate herbs into their practices, creating a hybrid of modern and traditional medicine, called Complementary and Alternative Medicine (CAM) [source: White House]. This practice is still predicated upon the safety and efficacy of the herbs themselves. And without FDA regulation, physicians are just as uncertain as anyone else interested in practicing CAM how safe or effective an herbal supplement may be. Under the threat of lawsuit for malpractice, it's tough to fault doctors who reject recommending untested and unregulated herbs to their patients.

With all of these potential pitfalls and even proven deaths, why doesn't the FDA regulate herbs? The answer is that under federal law, they can't. Find out why on the next page.