Dietary supplements are governed by various federal laws and regulations that limit manufacturers in their production and sale of these products. The Food and Drug Administration's Vasilios Frankos, Ph.D., director of the agency's Division of Dietary Supplement Programs, advises consumers to be savvy when considering using these products, as they do not require any prior regulatory approval before a manufacturer sells them.
Dietary Supplements
In 1994, Congress passed the Dietary Supplement Health and Education Act, or DSHEA. This law established that a dietary supplement is any product composed of a dietary ingredient that the manufacturer intends for human use and is to be taken orally, according to the Food and Drug Administration. Dietary supplements cannot contain drugs or controlled substances, but can contain dietary ingredients such as plant extracts, or botanicals; vitamins, minerals, enzymes and herbs.
Safety Requirements
The FDA reports that a dietary supplement manufacturer has the duty to ensure that any product it releases or sells must be safe. The manufacturer does not have to submit the product to the FDA or any other federal agency for approval before it decides to sell it, nor does it have to register the specific product. However, the FDA states that the Bioterrorism Act requires dietary supplement manufacturers to register themselves with the FDA before selling or producing any products.
Lables
Dietary supplements are also subject to labeling regulations that dictate what a manufacturer has to reveal on the product. The FDA reports that the labels have to include such information as the name and location of the manufacturer, a description that the product is a dietary supplement, a complete list of the ingredients and the net contents of the product. The product package also has to have a nutritional label that reveals each dietary ingredient contained in the supplement.
Advertising
The Federal Trade Commission, or FTC, regulates all advertising and marketing that food supplement manufacturers use. In general, supplement advertisements must be truthful, must not mislead the consumer and must be supported by adequate substantiation. It is the responsibility of each individual manufacturer to ensure that its advertising meets the regulatory requirements, though the FTC and the FDA have the power to restrict or limit advertising it finds unfair or deceptive.
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