Myths & Facts

Myths & Facts About Dietary Supplements

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 DSHEA 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:

		Refer for criminal action any company that sells a dietary supplement that is toxic or unsanitary
		Seize dietary supplements that pose "an unreasonable or significant risk of illness or injury"
		Stop a new dietary ingredient from being marketed if the FDA does not receive enough safety data in advance
		Stop the sale of an entire class of dietary supplements if they pose an imminent public health hazard
		Require manufacturers to certify and substantiate their claims
		Require dietary supplements to meet strict manufacturing guidelines including potency, cleanliness and stability

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 standards 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:

		Challenge and stop advertising that is not adequately substantiated
		Investigate complaints or questionable trade practices. Here, the agency has the power to require a company to produce documents, give testimony, and provide answers to written questions
		Negotiate a consent order or work through the courts to obtain an order from an administrative or federal court requiring a company to cease and desist making unsubstantiated claims. These orders can be very broad in scope
		Seek preliminary or permanent injunctions to stop false advertisements or other marketing practices
		Seek civil penalties from violators

To further ensure that manufacturers stay within the confines of the law when marketing their products, the FTC published advertising guidelines for the dietary supplement industry in 1998.

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 Journal of 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 American Heart Association, 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.

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