What if you bought a 50-pound bag of rice, then realized you don't like it. What would you do with it all?
Well, one thing you could do is buy a bunch of empty gelatin capsules, fill them up with rice grains, add a few drops of vitamin E, bottle and sell them. You could label them "Balinese plant energy capsules" and could claim that they were a "concentrated energy source" and that a dose of three capsules a day "maintains healthy bodily functions and may promote long life." If you marketed your product as a dietary supplement, you could sell it in health food stores, supermarket chains and over the Internet. You could become a millionaire.
Does this sound crazy to you? Well, it could happen. It's even legal, since the Dietary Supplement Health and Education Act (DSHEA) was passed by Congress in 1994. Since then, manufacturers of "dietary supplements" do not need the approval of the Food and Drug Administration (FDA) before making and distributing a new product.
The DSHEA was sponsored by Sen. Orrin Hatch, R-Utah. Utah is the home of many of the nation's dietary supplement makers, where it is a $3 billion industry.
Initially, this law was welcomed because it removed barriers to the manufacture of dietary supplements, such as vitamins, minerals and herbs, which were thought to be safe. The FDA was directed to put these supplements in the "food" category, instead of the "drug" category. "Drugs" must be proven safe and effective before they can be marketed. "Foods" do not.
Since 1994, it's been up to the manufacturers of dietary supplements to regulate themselves. There is no law that says they have to disclose to the FDA or to consumers any information they have about the effectiveness or safety of their product.
The makers and sellers of dietary supplements insist that the FDA does indeed regulate their industry. This is true, but only if you really stretch the definition of "regulate."
The FDA requires certain information to appear on the labels of dietary supplements: the name of the product, name and address of the maker or distributor, and a "Supplement Facts" panel listing each dietary ingredient in the product.
The FDA does not test products to make sure that the ingredients and quantities listed are correct and that the product was free of contamination. Consumers have to trust the manufacturers to label their products accurately. (There is a new proposal to have the FDA establish standards for the safety of supplements, but this is not yet in effect.)
The FDA has the power to restrict or remove a dietary supplement from the market only if they can prove it is unsafe. Unfortunately, people who have a negative experience with a dietary supplement rarely report it to the FDA. Only when many well-publicized serious reactions occur (as in the recent ephedra-related death of Baltimore Orioles pitcher Steve Bechler) can the FDA take action.
Unfortunately, some manufacturers of dietary supplements have taken advantage of this lack of regulation. Advertising can be misleading. Consumers mistakenly believe that "natural" means "safe."
So, how are you to know if a dietary supplement is safe? Your health care provider may have some knowledge about supplements, but naturopathic physicians (NDs) are probably your best source of information on the topic. You can find plenty of general information on the Internet. Keep in mind, though, that most Web sites about vitamins, herbs and other supplements are selling them and so they emphasize the benefits of their product and are unlikely to mention potential side effects.
Tips for the Savvy Supplement User: Making Informed Decisions and Evaluating Information at www.cfsan.fda.gov/~dms/ds-savvy.html is an excellent source of information. Also, the National Center for Complementary and Alternative Medicine has a section called "Alerts and Advisories" at www.nccam.nih.gov/health.
Just because a dietary supplement has worked for someone else, don't assume it's right for you. Do some research, talk to a health care provider and know the possible side effects. If something sounds too good to be true, it probably is.
Kathryn B. Brown is a family nurse practitioner with a master's degree in nursing from OHSU. Is there a health topic you would like to read about? Send your idea to firstname.lastname@example.org.