Herbal Supplements and Their Regulation From the Food and Drug Administration
Herbal Supplements and Their Regulation From the Food and Drug Administration
In the United States, the government and its agencies do not maintain the same regulation of herbal remedies in the same way that they ensure the safety of other foods and medicines. Furthermore, while these products were once the mainstay of only such minute groups as vegetarians and other counterculture types, they have now become widely popular among the general public as the widespread assumptions about their safety and naturalness has permeated contemporary society. However, on the other hand, many professionals within the medical community conversely claim that the dietary supplement industry is selling modern day snake oil that has no proven safety or efficiency. In the end, both factions are correct, and in spite of the natural base of herbs and dietary supplements that can make these products appealing even when traditional medicines are not appropriate, these items are also powerful medicinal agents. Therefore, due to the public’s lack of ability to make informed decisions surrounding these products, the Food and Drug Administration must be granted the same sovereignty over herbal remedies and vitamins that it maintains over other foods and medicines.
One reason that these products are becoming so popular is because there is a growing fascination with alternative medicine. Both doctors and consumers are realizing that there is more than one way to treat health problems. For example, pain can be relieved with conventional analgesic medications or acupuncture. Additionally, alternative remedies are increasingly gaining credibility in the medical community: Favorable scientific reports are emerging about everything from massage to hypnosis, and recent studies published in trusted medical journals have shown that gingko biloba may stabilize and improve memory for up to a year in Alzheimer's patients; garlic supplements may slow the hardening of the arteries that occurs as people age; and St. John's wort may ease symptoms of mild to moderate depression. Nearly forty medical schools now offer courses in unconventional medicine (Fontanarosa 10) and insurance companies are even beginning to cover alternative therapies. However, there is another reason for the popularity of these items: Consumers have come to realize that Western medicine is not a cure-all; indeed, it is not very effective at combating chronic ills such as stress, colds and migraine headaches.
Still, one reason that some people believe that it is not necessary for the government to become involved in this industry is indeed largely because of the mistaken belief that these agents are safe merely because they are natural. In fact, according to one 1997 poll, more than half of consumers who use natural remedies are convinced that they are equally as safe and effective as traditional treatments like aspirin ( Greenberger 1077). However, since 1994 there have been reports of at least 34 deaths and nearly 900 adverse reactions--including heart-rhythm disturbances, heart attacks and strokes associated with supplements that contain one herbal stimulant that is often taken to boost energy and to lose weight (Josefson 1440).
This confidence in the naturalness of these substances also prompts a trust that can ultimately cause consumers to disregard side effects. This means that they often experiment with these agents without the benefit of knowing about possible side effects. In fact, manufacturers sometimes do not include any warnings on the label, and some even overtly proclaim to have “no side effects.” However, Sanford Miller, Ph.D., dean of the graduate school of biomedical sciences at The University of Texas Health Sciences Center at San Antonio says that a the claim that there is no reason to be concerned about dosages should prompt consumer to be especially careful, since “(e)verything has a toxic level" (Greenberger 1080). He also advises that consumers should never take several types of supplements at the same time or mix them with conventional medications since this could reactions ranging from dizziness to death.
In addition to the lack of safety that exists as the result of the lack of regulation, many people indeed believe that these medicines are regulated. According to the former Food and Drug Administration Commissioner, Dr. David Kessler, who is now the dean of Yale University School of Medicine in New Haven, Connecticut, when consumers go into the drug or health food store, they assume that “somebody is looking out to make sure the claims have some validity” (Wingert 53). However, he continues, while society has “developed methods to assure the safety and efficacy of everything else that comes into contact with the body…this…industry…has basically escaped regulation. It's truly Buyer beware” (Ibid.). Therefore, while these products often look promising, some are merely a waste of money, while others may actually hurt users.
Additionally, few high-quality long-term studies have been done surrounding these products. Moreover, much of the research has been conducted in Germany where a government-appointed agency known as Commission E (which is similar to the FDA) has approved about 201 herbal medicines as reasonably effective and safe. However, while these studies are generally reliable in terms of safety, they are less stringent than American research in terms of effectiveness. For instance, they are sometimes based on anecdotal reports that are made by doctors who may have a financial interest in supplement manufacturers. Therefore, Dr. Kessler says that not only scientific evidence is needed, but society must also seek more closely monitored and more widespread studies, especially because of the placebo effect, which Dr. Kessler says will cause approximately one third of people to feel better after taking a medication, whether it works or not (Wingert 54).
Ultimately, the combination of these frightening issues certainly leads to the question of why the FDA has not become more involved in protecting consumers. The reason is that the agency simply does not have the authority to review scientific evidence-supporting claims that herbal supplements are safe and effective like it does for drugs and food because a specific law, The Dietary Supplement Health and Education Act of 1994, sharply curtailed the FDA's regulatory power over the supplement industry. This law was enacted after a fierce battle between the FDA and the dietary-supplement industry during which consumers and politicians responded to their conviction that vitamins were endangered. The FDA lost and deregulation ensued.
Nevertheless, prior to the passage of this law, the FDA regulated dietary supplements similarly to the way that foods were regulated. The safety of all new ingredients were reviewed before a manufacturer was allowed to market a product, and the agency ensured that the health claims were truthful. However, the industry now polices itself and the law insists that the FDA must prove that a product is dangerous or unreasonably risky before it can remove a product from the market.
While supplement manufacturers cannot say that their products prevents, mitigates, treats or cures a specific disease, which would create the consideration that the product was a drug, the manufacturers are free to say that their products affect the “function or structure” of the body as long as their supplement labels carry a disclaimer that states that the actual statement has not been evaluated by the Food and Drug Administration and that the product is not intended to diagnose treat cure or prevent any disease. Thus, manufacturers cannot claim that a supplement could specifically cure a yeast infection but they can say that it “stimulates the immune system.” As a result, consumer confusion abounds over misleading gibberish on product labels.
Clearly, the public’s health is at risk, and supplement manufacturers should make available to consumers evidence for and against the claims behind their products. Product claims should also be substantiated by scientifically valid research, and the FDA should establish a panel of experts to review preventive and therapeutic benefits of herbal products, and allow manufacturers of well-studied botanical to apply for over-the-counter drug status. Finally, manufacturers should provide warnings about potential side effects, and the FDA should move swiftly to address safety issues. However, while each of these recommendations are seemingly based in common sense, none are legally binding.
Therefore, hopefully, competition in this burgeoning industry will help raise manufacturing and research standards, and as individuals, the consumer must be careful to make smart choices about supplements. Before taking any product, users should research it as much as possible; look for books and newsletters, and talk to their doctors. They should also report any side effects, like stomach upset or irregular heartbeat, and most importantly, they must use common sense: If a product doesn't help, they should simply stop taking it.
In conclusion, although herbal remedies and supplements were once the mainstay of only groups like vegetarians, they have become more common throughout contemporary American society. However, despite their increasing popularity, these items remain largely unregulated, especially by the Food and Drug Administration. As a result, they can be merely a waste of money, or can be actually harmful or fatal. Therefore, while much of the public expects that these products are safe and mistakenly believes that they are indeed regulated, society should be taking active steps to ensure that they are eventually monitored in the same fashion as other foods and drugs, and will therefore ultimately be able to expect the same degree of safety from supplements and vitamins that they do from products that are currently regulated.
Fontanarosa, Phil B. and George D. Lundberg. “Complementary, Alternative, Unconventional, and Integrative Medicine.” Archives of Internal Medicine. January 12, 1998: 9-11.
Greenberger, Phyliss. “Herbal Medicines: Are Supplements Safe?” Journal of Women’s Health. November 1998: 1077-1980.
Josefson, Deb. “Herbal Stimulant Causes U.S. Deaths.” British Medical Journal. June 8, 1996: 1440.
Wingert, Pat. “An Industry Unmonitored.” Newsweek. June 7, 1993: 52-54.