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The regulation of dietary supplements
Larissa L Larsen1, Judith A Berry
1Brigham Young University's College of Nursing, Provo, Utah, USA.
Journal of the American Academy of Nurse Practitioners
|October 17, 2003
Summary
Dietary supplement regulation in the U.S. has shifted, with the Dietary Supplement and Health and Education Act (DSHEA) of 1994 reducing the Food and Drug Administration's (FDA) oversight. This impacts product safety and necessitates informed consumer choices.
Area of Science:
- Nutritional Science
- Regulatory Affairs
- Public Health
Background:
- Dietary supplements are widely used in the United States, with 60% of individuals consuming them.
- Historically, the FDA regulated dietary supplements as foods, ensuring safety and proper labeling.
- The regulatory landscape changed significantly with legislative acts impacting oversight.
Purpose of the Study:
- To examine the regulatory history of dietary supplements.
- To define the scope of dietary supplements.
- To clarify labeling requirements and discuss safety concerns.
Main Methods:
- A comprehensive review of primary and secondary sources was conducted.
- Internet resources and peer-reviewed journal articles were utilized for data collection.
Main Results:
- The Nutrition Labeling and Education Act of 1990 expanded the definition to include herbs.
- The Dietary Supplement and Health and Education Act (DSHEA) of 1994 reclassified supplements, removing FDA pre-market approval.
- Under DSHEA, the FDA can only intervene after adverse events occur.
Conclusions:
- Understanding DSHEA is crucial for healthcare providers, particularly nurse practitioners (NPs), in educating patients.
- Patients should be guided to select reputable brands and verify information through manufacturers and government resources.
- Informed patient counseling can mitigate risks associated with supplement use.