Understanding the Dietary Supplement Industry

Whenever you read about supplement regulation, you will see references to DSHEA. Congress passed the Dietary Supplement Health and Education Act (DSHEA) in 1994. This act allows manufacturers to market products as "dietary supplements" rather than as drugs. To qualify as a "dietary supplement," the product must contain one or more of the following substances: "a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands), or a concentrate, metabolite, constituent or extract" of the above. ²

The DSHEA advises that manufacturers of dietary supplements be sure their products are safe before they are sold. However, supplements do not need approval before being sold, nor do manufacturers need to submit any studies to the FDA before marketing a new product. The FDA does not need to look at a product unless it receives enough complaints about it. When a questionable product comes to the FDA's attention, it must show that the dietary supplement is unsafe before it can remove the product from the market. You may have read about the FDA ban on dietary supplements containing ephedrine. This action was recently overturned by a federal court ruling, which stated that the FDA did not have sufficient evidence to prohibit these products.

The DSHEA does not mandate that dietary supplements be effective. If a product is shown to be ineffective, the FDA need not require that the product be removed. However, if many complaints are received, action may be taken by the Federal Trade Commission (FTC), which may investigate fraudulent advertising.

Both foods and supplements are subject to the labeling requirements of the Nutrition Labeling Education Act of 1990 (NLEA). The NLEA prohibits labels from claiming that a product or its ingredients help to treat or prevent disease, except for certain health claims allowed by the FDA. Since sports performance is not a disease, statements claiming to improve sport performance are allowable without proof that the claim is true.