In this report
Overview
12 supplements to avoid
Supplement labels
What you can do
May 2004
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What you can do

Sen. Richard Durbin, Democrat of Illinois, and Rep. Susan Davis, Democrat of California, have each introduced legislation that for the first time would require supplement manufacturers to disclose reports they receive of “serious” adverse events. Durbin's bill also sets up a separate category for stimulants, which would have to receive FDA safety approval before being marketed, and reclassifies androstenedione and similar “steroid precursors” as controlled drugs. The Davis bill also strengthens the FDA's powers to investigate emerging supplement safety problems. Davis's bill exempts vitamins and minerals from its provisions. (Consumers Union, publisher of Consumer Reports, supports both bills.)

Though the bills are still in committee, the supplement industry has mobilized in opposition. On its Web site and in flyers handed out at supplement stores, the National Nutritional Foods Association, a supplement retailers’ trade group, says the legislation “would significantly undermine many of the freedoms that American consumers of dietary supplements like you hold dear.”

The industry is supporting a more limited bill introduced by Sen. Orrin Hatch, Republican of Utah, and Sen. Tom Harkin, Democrat of Iowa, that would give the FDA an extra $20 million this year, and more in subsequent years, to enforce DSHEA and would reclassify androstenedione and other steroid precursors as controlled drugs. Unlike the Durbin bill, however, this measure would exempt the steroid dehydroepiandrosterone, or DHEA, allowing it to continue to be marketed as an anti-aging product. Some $47 million worth was sold in 2002, according to the Nutrition Business Journal.

Until the law is substantially changed and the FDA is adequately funded, you cannot rely on the federal government to ensure that dietary supplements are safe and effective. Here are some steps you can take to minimize your risk from any supplements you decide to take:

Stay away from the dirty dozen. All carry risks that in our view are unacceptable (see 12 supplements to avoid). In combination products, you need to read the detailed ingredient list in the tiny print on the back. Who could otherwise guess, for instance, that Gaia Herbs’ PMS Day 14-28 capsules contain kava? (To the company's credit, the label includes a warning about liver toxicity.)

Do not take daily doses of vitamins and minerals that exceed the safe upper limits. While vitamins and minerals are by far the safest and best-studied of supplements, it's possible to overdose on some of them. For more information, see our October 2003 report on fortified foods (available to subscribers). Recommended allowances and safe upper limits can be found online at www.ific.org/publications/other/driupdateom.cfm.

Limit your intake of other supplements. Over the years, our medical and nutritional consultants have identified and tested a few products, other than standard multivitamins, with possible benefits and sufficiently low risks to recommend for general use: saw palmetto for benign enlarged prostate in men, glucosamine and chondroitin for arthritis, and fish-oil capsules (omega-3 fatty acids) for heart disease. (We plan to test additional supplements with potential benefits, such as probiotics.)

Tell your doctor about your supplements. “The Achilles’ heel of unregulated supplements is the risk created by herb-prescription drug interactions,” said Grollman, the pharmacologist at the State University of New York. “St. John’s wort, used to treat depression, for instance, may reduce the effectiveness of prescription drugs used by millions of Americans for hypertension, AIDS, heart failure, asthma, and other chronic diseases.”

Stay away from supplements for weight control. These products frequently contain several stimulants that have never been adequately tested separately, let alone in combinations. “I'd just as soon experiment with rats first rather than using the U.S. population as guinea pigs,” said Bill Gurley, Ph.D., professor of pharmaceutical sciences at the University of Arkansas.

Do your own research. Health-food-store clerks and marketers, alternative-medicine practitioners, herbal company Web sites, and even physicians are not necessarily knowledgeable about the scientific evidence regarding dietary supplements. These two Web sites contain reliable information: the National Institutes of Health site at ods.od.nih.gov/databases/ibids.html and Memorial Sloan-Kettering Cancer Center's site at www.mskcc.org/mskcc/html/11570.cfm.

Watch for adverse events. Let your doctor know if you experience anything worrisome after starting a supplement. If your doctor concludes that the side effect may be related to the supplement, be sure to report it to the FDA, by calling 800-332-1088 or by visiting www.fda.gov/medwatch.

 
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