You may use dietary supplements for many reasons, including additional intake of a particular nutrient that is deficient or insufficient in your daily diet. Yet when a manufacturer promotes a dietary supplement to treat or prevent a disease or you use it for these purposes, then supplements can be defined as an illegal drug because the U.S. Food and Drug Administration did not approve it for this purpose. Nonetheless, the FDA can classify certain supplement ingredients as drugs.
Drug Classification
The FDA defines a drug as an "article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease." It approves drugs after reviewing scientific evidence on the safety and efficacy from clinical studies and may decide that the use of medication requires a prescription by a physician or may be sold over the counter without a prescription. The pharmaceutical industry classifies drugs by the source or chemical type of the active substance, the way physicians use the medicine to treat a disease, disorder or medical condition, the potential for users to abuse the drug or by the potential effect of the substance to harm the user.
DSHEA
The Dietary Supplement Health and Education Act of 1994 is a set of government regulations pertaining to dietary supplements. The FDA regulates dietary supplements under DSHEA, which differs from regulations that cover conventional foods and drug products. Under DSHEA, the manufacturer of dietary supplements is responsible for the safety of products before they are marketed to the public and the FDA is responsible for monitoring safety, product labeling and health claims after the product has reached the market. If a manufacturer makes a drug claim on the label or advertising content for the supplement or they contain false or misleading information, the FDA can take legal action against the manufacturer.
Dietary Supplement Claims
DSHEA defines a dietary supplement as "a product taken by mouth that contains a dietary ingredient intended to supplement the diet." These dietary ingredients include vitamins, minerals, herbs or other botanicals, amino acids and enzymes, organ tissues, glandulars, metabolites and other substances, extracts or concentrates that are supplied in tablets, capsules, softgels, powders or liquids. Manufacturers can make three types of claims for dietary supplements that include nutrient content claims, health claims and structure and function claims. DSHEA requires manufacturers who make claims to also include a disclaimer that states "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease."
FDA-Approved Supplements
Physicians prescribe certain nutritional substances to be used as drugs to prevent or treat a medical condition. These products are not sold over the counter. For example, in addition to being sold as a dietary supplement, vitamin B-12 is also sold as a prescription medication administered by intramuscular injection that physicians typically prescribe to treat conditions, such as pernicious anemia or malabsorption, associated with a nutritional deficiency. Consult your doctor about your health and use of dietary supplements.
References
- FDA; Overview of Dietary Supplements; October 2009
- FDA; Sec. 201. [21 U.S.C. 321] Chapter II --- Definitions 1; 2009
- Drugs.com; Drug Classes; 2010
- FDA; Dietary Supplements; December 2010
- FDA; Claims That Can Be Made for Conventional Foods and Dietary Supplements; May 2009
- Office of Dietary Supplements; Vitamin B12; May 2010
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