Why are so many health care professionals critical of herbal remedies and dietary supplements?

Prescription drugs and drugs you can purchase over-the-counter (so-called "OTC drugs") are required to meet a set of very strict standards for purity and consistency. To be sold in the United States, prescription drugs and over-the-counter drugs must be proven to be safe and effective. These drugs are regulated by the Federal Food and Drug Administration (FDA).

Dietary Supplements and herbal remedies are not subject to the same requirements. In 1994, Congress passed the Dietary Supplement and Health Education Act (DSHEA) which excludes products sold as herbal remedies and dietary supplements from FDA drug regulations. There are no regulations requiring a company to prove that a supplement actually works. Producers can make health claims but cannot claim to cure or treat disease but they have no obligation to prove that their product works.

The production of herbal remedies and dietary supplements is also not as tightly regulated. Because we cannot determine if many actually work and cannot guarantee their purity, we do not recommend the use of herbals and dietary supplements.

Aren’t herbal remedies and dietary supplements safe because they are natural?

Unfortunately, the answer is no. Just because they are natural doesn’t mean they are safe. Many herbal remedies and dietary supplements are, in fact, very toxic if you take too much. The best example is an herbal called Ma Huang or ephedra. It is commonly sold in "natural diet pills or herbal Fen-Phen". Ma Huang contains a drug known as ephedrine, a potent stimulant of the central nervous system. The FDA has received over 800 reports of serious toxicity, including deaths, with the use of products containing Ma Huang.

Several years ago, a nutritional called L-Tryptophan was sold as a dietary supplement to "obtain relief from sleeping difficulties, premenstrual syndrome, obsessive/compulsive behavior, stress," among other symptoms. Unfortunately, consumption of L-Tryptophan led to 1500 cases of a toxicity called Eosinophilia Myalgia Syndrome and 38 deaths because of an impurity in the supplies.

Even herbal teas can be dangerous. Chamomile tea is consumed for its relaxing effect. But chamomile can cause severe allergic reactions in people who are allergic to ragweed, asters and chrysanthemums.

Aren’t herbal remedies and dietary supplements used in countries elsewhere in the world?

Yes. In fact, herbal remedies are prescribed by physicians in many countries just like prescription drugs are here. The difference is government regulation. In Germany, for example, herbal remedies must meet the requirements of the Commission E before they can be sold. The Commission requires that there be proof of effect and makes demands on the manufacturers to insure purity. Congress chose to prevent the FDA from doing just that in passing the DHSEA. At least one bill before Congress seeks to further weaken FDA oversight of these products.

But there are so many people taking herbal remedies and dietary supplements, isn’t there some evidence that they work?

Unfortunately a simple answer can’t be given. For some herbal remedies such as St. John’s Wort, there is some evidence in scientifically valid studies to suggest a modest effect. This is not true for many herbal remedies and nutritional supplements. Most do not have scientific evidence to suggest that they work in the way that the producers say they do.

And when they do work, it is frequently only a part of the plant, such as a leaf or root and not the entire plant. You can’t be guaranteed that the manufacturer is using the correct part of the plant.

So, if I am reading this right, the FDA has almost no regulatory authority, there are few scientific studies to back up the manufacturers’ claims and it is difficult to make certain that I am getting the right product in the right amount. Is that true?

Unfortunately, yes. The responsibility is now on you, the consumer, to be educated. If you think that herbal remedies or nutritional supplements are right for you, be an informed consumer. Try to read as much as you can about the product you intend to use and as much as you can about the producer. To be safe, you need to be educated. Unlike prescription and over-the-counter drugs, you don’t have the FDA looking after your interests when you take herbal remedies and dietary supplements. The FDA (http://vm.cfsan.fda.gov/~dms/supplmnt.html) maintains information on dietary supplements and herbal remedies. If you routinely consume these products, you should visit this website.