Myths & facts.

• Position: Dietary Supplements - Dietary Supplement Health and Education Act 1994, United States - Brief Article

With mounting evidence that consumers want greater access to information about vitamins, minerals, herbs, and specialty supplements, the dietary supplement industry has launched a far-reaching public education campaign to focus on the health benefits, safety, and regulation of these products. The Dietary Supplement Information Board offers the following myths and facts about them:

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 the FDA's enforcement powers over the dietary supplement industry.

Fact: Its passage actually maintained and increased the FDA's enforcement powers by establishing new labeling and potency standards and by making violations of these standards a crime. Following DSHEA, the FDA has the power to:

* Refer for criminal action any company which 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 utilized in commerce prior to the passage of DSHEA, the FDA must be notified in advance and provided with safety data. At any time, the agency may 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 that other consumer products...