| Myth | Dietary supplements are virtually unregulated. |
| Fact | The Dietary Supplement Health and Education Act (DSHEA), enacted in 1994, gives considerable powers to the federal government to assure the safety of dietary supplements as well as the accuracy of their claims and labeling. Under DSHEA, the U.S. Food and Drug Administration has the same powers to regulate dietary supplements as the agency exercises over commonly used foods. This means that like most other foods, it is the manufacturer's responsibility to ensure that the company's products are safe and properly labeled prior to marketing. |
| Myth | The passage of DHSEA has weakened FDA's enforcement powers over the dietary supplement industry. |
| Fact | The passage of DSHEA actually maintained and increased FDA's enforcement powers over dietary supplements by establishing new labeling and potency standards and by making violations of these standards a crime.
Following DSHEA, FDA has the power to:
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| Myth | The FDA has limited authority over the ingredients used in dietary supplements. |
| Fact | Under law, if a manufacturer wants to market a product containing an ingredient that was not used in commerce prior to the passage of the DSHEA, the FDA must be notified in advance and provided with safety data. At any time, FDA may even request a court order to require a recall of a product if the agency believes it presents a health risk. |
| Myth | Dietary supplement makers don't have to follow the same strict good manufacturing practices as do other consumer products. |
| Fact | This is absolutely false. The dietary supplement industry follows the same guidelines that are in effect for the food industry to ensure that controlled, sanitary manufacturing practices are in place and that the resulting products contain what is on the label. Failure to do so is a violation of the law and could even lead to criminal prosecution. While operating under these food GMP regulations, the industry is currently working with FDA to establish GMP regulations specifically for supplements. At the same time, a number of industry groups and trade associations have adopted voluntary programs to ensure that quality are being followed. |
| Myth | There is not enough control over dietary supplement claims. |
| Fact | Under current law, makers of dietary supplements are limited to the types of claims they can make about their products. Statements of nutritional support, commonly referred to as "structure-function" claims, are restricted to explaining how a particular product or ingredient affects the structure or function of the body. As a result, manufacturers are prohibited from making claims that their products are intended to diagnose, treat, cure or prevent a disease. In fact, manufacturers are required to put this disclaimer on the labels of their products whenever making a structure/function claim. Further, manufacturers must have substantiation that the statement is truthful and not misleading and must notify FDA within 30 days after first using the claim in the marketplace. |
| Myth | The advertising of dietary supplements is not adequately regulated at the federal level. |
| Fact | The Federal Trade Commission has enforcement
authority over claims about dietary supplements in
advertising, infomercials, web sites and direct
marketing materials. When the FTC determines that a
claim is unfounded, the agency has the power to:
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| Myth | There is not enough scientific data to support the safety and efficacy of most dietary supplements. |
| Fact | Adding to the large body of scientific evidence
supporting the health benefits of dietary supplements, each year,
numerous studies are published in major medical
journals that document new findings about how dietary
supplements can be used to address specific conditions,
reduce the risk of diseases or to enhance general
nutrition. Such studies can be found in The Journal of
the American Medical Association, New England
Journal of Medicine, American Journal of Cardiology,
American Journal of Clinical Nutrition and the
National Cancer Institute.
Besides newly published research studies on the benefits of dietary supplements from such leading institutions as Johns Hopkins University and the Dietary Supplement Health and Education Act created the Office of Dietary Supplements within the National Institutes of Health to focus specifically on advancing the study of dietary supplements in this country. Since starting operations in November 1995, ODS has held symposia and has sponsored numerous studies to study the effectiveness of commonly used supplements. |
