PURPOSE: To discuss the regulatory history of dietary supplements, define the term dietary supplement, clarify ingredient and nutrition information labeling, and discuss safety issues and implications for practice. DATA SOURCES: Review of primary and secondary sources, including both Internet sites and journal articles. CONCLUSIONS: In the United States, 6 out of every 10 people use dietary supplements. For decades, the Food and Drug Administration (FDA) protected the public from mislabeled and unsafe products by regulating as foods those dietary supplements that included only essential nutrients. The Nutrition Labeling and Education Act of 1990 included herbs as dietary supplements. When the Dietary Supplement and Health and Education Act (DSHEA) of 1994 was passed, the FDA lost its regulatory power. The DSHEA expanded the definition of dietary supplements beyond essential nutrients. Dietary supplements are no longer considered food additives, which makes them exempt from prescreening or any safety and efficacy studies before they are released to the public. Under the DSHEA, the FDA may take action if a product poses a direct health threat and only after adverse health effects have already occurred. IMPLICATIONS FOR PRACTICE: A good understanding of the regulatory procedures for dietary supplements will aid nurse practitioners (NPs) in patient education regarding these products. Patients should be advised to choose supplements that are made by nationally known food and drug manufacturers that belong to trade groups. NPs and patients can contact the manufacturer directly and can access government Internet sites for more product information.
PURPOSE: To discuss the regulatory history of dietary supplements, define the term dietary supplement, clarify ingredient and nutrition information labeling, and discuss safety issues and implications for practice. DATA SOURCES: Review of primary and secondary sources, including both Internet sites and journal articles. CONCLUSIONS: In the United States, 6 out of every 10 people use dietary supplements. For decades, the Food and Drug Administration (FDA) protected the public from mislabeled and unsafe products by regulating as foods those dietary supplements that included only essential nutrients. The Nutrition Labeling and Education Act of 1990 included herbs as dietary supplements. When the Dietary Supplement and Health and Education Act (DSHEA) of 1994 was passed, the FDA lost its regulatory power. The DSHEA expanded the definition of dietary supplements beyond essential nutrients. Dietary supplements are no longer considered food additives, which makes them exempt from prescreening or any safety and efficacy studies before they are released to the public. Under the DSHEA, the FDA may take action if a product poses a direct health threat and only after adverse health effects have already occurred. IMPLICATIONS FOR PRACTICE: A good understanding of the regulatory procedures for dietary supplements will aid nurse practitioners (NPs) in patient education regarding these products. Patients should be advised to choose supplements that are made by nationally known food and drug manufacturers that belong to trade groups. NPs and patients can contact the manufacturer directly and can access government Internet sites for more product information.
Authors: Scott Burris; Alexander C Wagenaar; Jeffrey Swanson; Jennifer K Ibrahim; Jennifer Wood; Michelle M Mello Journal: Milbank Q Date: 2010-06 Impact factor: 4.911