The Dietary Supplement and Health Education Act (DSHEA) of 1994 was intended to ensure consumer access to safe dietary supplements, e.g., herbs, minerals, and vitamins. It granted the Food and Drug Administration (FDA) considerable enforcement authority to regulate dietary supplement industry. This article discusses relevant components of the DSHEA, explains the division of regulatory responsibilities between the FDA and the Federal Trade Commission (FTC), and refutes the often cited allegation that the herb and dietary supplement industry are unregulated.
Blumenthal, M.1994. Congress passes dietary supplement health and education act of 1994. Herbs to be protected as supplements. Herbal Gram32:18–20.
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Dietary Supplement Health and Education Act of 1994. Public Law 103–417, 103rd Congress. http://www.fda.gov/opacom/laws/dshea.html.
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Federal Trade Commission, Bureau of Consumer Protection Dietary supplements: An advertising guide for the industry (http://www.ftc.gov/bcp/conline/pubs/buspubs/dietsupp.htm).
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FTC-FDA Liaison Agreement. 4 Trade Reg., Rep. (CCH) 9851. 1971. Although the Liaison Agreement does not refer explicitly to dietary supplements, the two agencies follow the same division of roles for dietary supplements as currently used for food products. Under FDA law, dietary supplements are deemed to be foods. 21 U.S.C. 201(ff).
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Marcus, D., and A. Grollman. 2002. Botanical medicines. The need for new regulations. N. Engl. J. Med.347:2073–2076.
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Mc Caleb, R., and M. Blumenthal. 1997. President's commission on dietary supplement labels issues final report. Herbal Gram41:24–26, 57, 64.
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Report of the Commission on Dietary Supplement Labels, November 1997. http://www.health.gov/dietsupp/cover.htm.
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Soller, W.2000. Regulation in the herb market: The myth of the “unregulated industry”. Herbal Gram49:64–67.
