Why doesn't the FDA regulate herbal supplements?

By: Josh Clark

A Chinese man measures medicinal herbs in 1992, a time of renewed interest in TCM. Check out our staying healthy pictures.
Francois Perri/Liaison

Around 2800 B.C., Chinese healers added a new medicinal herb to their repertoires. This herb, a short, evergreen shrub, was dubbed Ma Huang ("bitter yellow"), after the plant's color and horrible taste [source: Berkley]. When brewed into a tea, it's a powerhouse against respiratory problems like colds. Ma Huang became a worthy tool in Traditional Chinese Medicine (TCM).

In 1887, a Japanese chemist isolated the active ingredient in the plant, an alkaloid he called ephedrine or ephedra [source: Ebadi]. In short order, ephedrine appeared in medicines around the world. It stimulates the sympathetic nervous system (which is responsible for the fight-or-flight response), in turn dilating the bronchial tubes. Ephedra became particularly useful for alleviating symptoms in asthma sufferers.


During the 1990s, TCM and other types of alternative medicines (essentially any type of medicine outside modern Western medicine) experienced a surge in popularity. Ma Huang had millennia of proven effectiveness behind it, and it was part of this newly discovered spectrum. In the image-conscious United States, however, the stimulant was largely touted for its ability to stimulate weight loss and enhance energy in products with names like Metabolift and Herbal Ecstasy [source: Jacobs and Hirsch]. Soon after, reports of deaths linked to ephedra surfaced.

Between 1993 and 1997, at least 34 deaths and 800 medical cases were directly linked to use of ephedra [source: Jacobs and Hirsch]. By 2003, 69 percent of all reported health problems from herbal remedy use were linked to ephedra. As many as 16,000 reports of health problems, including stroke and psychosis, were submitted to the federal government from the 1990s to 2003 [source: University of Washington].

What happened? The Chinese had successfully employed Ma Huang for 5,000 years; in the United States, it was proving fatal. Perhaps the best explanation is a lack of respect and understanding of herbs in the West: What Westerners consider herbs, the Chinese consider drugs. And unlike what Americans consider drugs, herbs aren't overseen by the U.S. Food and Drug Administration (FDA) -- they're freely marketed and sold. On the next page, read about potential problems from this lack of regulation.


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.


The DSHEA: Why the FDA Doesn't Regulate Herbs

POV Magazine publisher Troy Masters receives the first AIDS vaccine to make it to clinical trials in December 1998.
POV Magazine publisher Troy Masters receives the first AIDS vaccine to make it to clinical trials in December 1998.
Frances M. Roberts/Getty Images

So why doesn't the Food and Drug Administration (FDA) regulate herbs? The most obtuse (but accurate) answer is that the herbal ingredients found in supplements on the market simply haven't been classified as drugs -- they're considered dietary supplements. Some naturally occurring plants, like marijuana and psilocybin mushrooms, are classified as drugs. These, however, are considered illicit drugs rather than medicinal ones and are enforced under the purview of the Drug Enforcement Agency instead of the FDA.

Herbs' classification as dietary supplements comes from the Dietary Supplement Health and Education Act of 1994 (DSHEA). The act essentially ties the regulatory hands of the FDA. Producers of pharmaceutical and over-the-counter (OTC) drugs alike must first demonstrate that their products are effective and safe. After an average of 8.5 years' worth of tests, conducted first in labs and then in clinical trials at universities, drug producers file an appeal for FDA approval. The FDA then reviews the claims and either approves the drug, classifying it as an OTC or prescription drug. If the FDA doesn't approve the drug, it cannot be sold in the United States. Only about 0.1 percent of the compounds first tested in labs ever receive FDA approval [source: FDA].


There is no similar process for herbs. Under the DSHEA, the burden of proof to demonstrate an herbal supplement or its ingredients are unsafe is transferred from the producer to the FDA [source: Doogan]. Essentially, anyone who can package, market and distribute supplements with herbal ingredients can do so with no oversight by the FDA. As such, herbal supplement manufacturers can make wide claims concerning the benefits their products provide people who pop them. Only after a drug has been proven an "unreasonable" health risk or "imminent hazard to public safety" can the FDA compile a complaint, file it and hope for the best [source: Doogan].

The DSHEA gives a lot of leeway in making claims for herbal supplements. So long as the producer doesn't say the product can "treat, mitigate or cure a disease," it's in the clear [source: FDA]. This leaves a fairly wide loophole through which supplement producers can market their products. For example, rather than saying their product containing hoodia (a cactus found in the Kalahari region of Africa thought to suppress appetite) cures obesity, the producer can simply say its product leads to quick weight loss. Other producers claim herbs like Echinacea and St. John's Wort boost the immune system and provide a sense of well-being, respectively, rather than prevent illness and treat depression.

In addition to the potential health risks, the lack of FDA oversight has also led to a measure of hucksterism in the herbal supplement industry. In March 2008, the makers of Airborne, a natural cold prevention supplement settled a $23.3 million class action lawsuit after it was revealed their product couldn't hold up to the claims it made. The settlement was further helped along after it was revealed the clinical trials on which the company based its claims were conducted by a two-person company created just for the Airborne trials [source: Nizza].

None of this is to say that herbs don't provide benefits to human health. There are certainly plenty of reputable companies that take alternative medicine seriously. As long as the FDA operates under the DSHEA, though, it's buyer beware for consumers traversing the herbal supplement industry.

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