Surveys show that almost 60 percent of Americans take one or more dietary supplements regularly, and two-thirds of them believe the federal government sees to it that their vitamins, minerals, and botanicals are safe and effective. But that’s far from the truth, chairman Tom Davis (R-VA) told a session of the U.S. House Committee on Government Reform called March 9 to hear testimony about the "massive and fast-growing supplement industry."

The fact, Davis pointed out, is that the federal Food and Drug Administration (FDA), which tests and approves most pharmaceuticals, is barred from testing or approving supplements under a law passed by Congress in 1994, the Dietary Supplement Health and Education Act (DSHEA), which specifies that dietary supplement manufacturers do not need FDA approval before manufacturing, labeling, distributing, and marketing their products.

The federal law, which was passed at the urging of Utah Senator Orrin Hatch, in whose state most supplement manufacturers are located, also says manufacturers are not required to alert the FDA to any adverse effects from supplements, and requires the FDA to prove a "significant and unreasonable risk to health" before it can remove a dietary supplement from store shelves.

Given all of those restrictions, Davis asked representatives of three federal agencies to tell the committee what, if any, role the federal government has in dietary supplements.

Speaking for the Center for Food Safety and Applied Nutrition in the Food and Drug Administration, Director Robert Brackett said FDA is pretty much limited to requiring the label to say it’s a dietary supplement, along with the name and address of the manufacturer, packager, or distributor, and nutrition information in the form of a "facts" panel. If the label makes any claim "relating to an effect on the structure or function of the body," it also has to note that the FDA hasn’t evaluated the claim. And the label may not say that the supplement will "diagnose, treat, cure, or prevent any disease."

The FDA works with another federal agency, the Federal Trade Commission (FTC), which has responsibility for enforcing bans on advertising—the FTC can act if supplements advertise that they can treat or cure serious diseases, or if the supplements are deceptively marketed to children and adolescents. And a third agency, the National Institutes of Health (NIH), has a separate division, the National Center for Complementary and Alternative Medicine, that looks into potential benefits or possible risks from dietary supplements, including such widely used supplements as glucosamine and chondroitin sulfate for the relief of pain from arthritis and Gingko biloba for treatment of Alzheimers.

Paul Coates, director of the Office of Dietary Supplements at NIH, pointed to instances in which hopes pinned on dietary supplements for improving health have been realized by modern scientific testing, including use of folic acid to reduce the risk of neural tube defects, iron supplementation during pregnancy to reduce risk of maternal anemia, and the use of vitamin B-12 and D supplements to ensure vitamin and calcium absorption. Coates noted, however, that some ingredients used in dietary supplements have been shown to be harmful to some individuals, including the common ingredient beta-carotene, which has been found to increase the risk of lung cancer in smokers.

A nonprofit organization that has looked extensively into the supplements industry told the committee that the 1994 Dietary Supplement Health and Education Act "opened the floodgates to thousands of untested dietary supplement products." While many dietary supplements, including most vitamins and minerals taken within recommended limits, are safe and can have important health benefits for consumers, a lot of products now on store shelves would never have been allowed on the market if they had been subjected to pre-market safety testing, Consumers Union told the committee.

Among a "dirty dozen" supplements that Consumers Union staff were easily able to purchase in stores and online were aristolochic acid, comfrey, androstenedione, chaparral, germander, kava, bitter orange, organ/glandular extracts, pennyroyal oil, skullcap, and yohimba, several of which are banned as dangerous in other parts of the world.

Another consumer group, ConsumerLab.com, which said it has tested more than a thousand dietary supplements from 300 different brands, found the most common problem a lack of ingredient or substandard ingredient, followed by contamination with lead and other heavy metals and pesticides, tablets that won’t disintegrate to release their ingredients, and products that actually contain more ingredients than listed, with potential for toxicity.

The dietary supplement industry is aware of these and other criticisms, a representative of the National Nutritional Foods Association (NNFA) told the House committee. Calling the Dietary Supplement Health and Education Act "an effective framework for governing supplements," the NNFA, which lists itself as a nonprofit organization dedicated to the natural products industry, called special attention to companies that have marketed drugs or steroids as dietary supplements, saying this practice has wrongly implicated a legitimate industry.

The nonprofit United States Pharmacopeia (USP) testified that its aim is to help consumers select supplements they can trust. To that end, said USP vice president for verification V. Srini Srinivassan, the USP subjects vitamin, mineral, amino acid, and botanical products to rigid tests before they are allowed to display a USP-Verified mark. Its standards are designed to ensure consistency of product, eliminate foreign ingredients, and "provide reasonable certainty that the consumer is getting what he or she paid for," Srinivassan said. The USP maintains that its third-party verification "fills a void in the federal regulation of dietary supplements created by DSHEA" and says it has encouraged supplement manufacturers to take steps to assure that their products are high quality and consistent with their labeling.

Commenting on the fact that people have to resort to a third party to let them know which supplements are safe to take and which are not, committee chairman Davis asked, "What is the average consumer to do? How many of those 29,000 supplements really contain what they claim? How many truly have an exhaustive list of all ingredients on their labels?" He hopes, the congressman said, that his committee will be able to "shed some light on this enormous industry."

See also: FDA Will Prohibit Sale of Dietary Supplements Containing Ephedra at http://www.healthinschools.org/ejournal/2004/jan4.htm