Over the past couple decades millions of Americans have started taking some form of dietary supplement to improve their health and well-being. As defined by the Food and Drug Administration (FDA), dietary supplements not only include the vitamins and minerals that many people are familiar with, but herbs, amino acids, extracts and concentrates, metabolites, and even enzymes that are taken by mouth.
The reasons that people take dietary supplements are as vast and diverse as the supplements themselves. A pregnant mother may take a supplement to aid in the developmental health of her future child while another individual may take supplements to improve or maintain his cardiac health.
Dietary supplements themselves come in a variety of forms such as liquids, powders, tablets, and capsules and can be contained within drinks, health bars, and many other consumable products. Although the main claim or purpose of many of these supplements may be to improve health, the FDA does not classify dietary supplements as “drugs,” and instead categorizes them under “foods.” In general, manufacturers are not required to register their products with the FDA or get FDA approval before making or selling dietary supplements.
The Dietary Supplement Health and Education Act (DSHEA) of 1994 controls not only the definition of dietary supplements, but how dietary supplements must be labeled for consumers and a variety of other regulatory activities enforced by the FDA. Under DSHEA, the dietary supplement manufacturer is responsible for making sure that their product is safe before it reaches the consumer market. It also stipulates that a dietary supplement must be labeled clearly and truthfully so that it includes the amount and type of ingredients listed on the label.
Once the product is in the market, the FDA can take action against any unsafe dietary supplements. The FDA also monitors the labels and claims of manufactures and distributors of dietary supplements. Meanwhile, the Federal Trade Commission works closely with the FDA to regulate the advertising of dietary supplements.
In order for the FDA to remove a dietary supplement from the market, it must first show that the product is unsafe. Although the burden of proof rests with the FDA, manufacturers and distributors of dietary supplements are required by law to record, investigate, and inform the FDA about serious adverse reactions from their products. While the FDA must be kept informed about the post-market safety of a dietary supplement, there is no FDA requirement that a company disclose this information to the public.
In cases when a “new dietary ingredient” is used, the manufacturer is required to notify the FDA. Following the terms of the Federal Food, Drug, and Cosmetic Act, a “new dietary ingredient” is defined as a dietary ingredient that was not marketed in the United States in a dietary supplement before October 15, 1994. In most cases the manufacturer’s notification must simply state that the product containing the new dietary ingredient has been found to be safe under its recommended usages.
In addition to abiding by the rules and regulations set forth in DSHEA and the Federal Food, Drug, and Cosmetic Act mentioned above, manufactures of dietary supplements must register themselves under the Bioterrorism Act and abide by the comprehensive regulations for Current Good Manufacturing Practices published by the FDA in June 2007.
For more detailed information on rules and regulations governing dietary supplements, visit www.fda.gov.