Stringent Laws and Regulations for Dietary Supplements
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Stringent Laws and Regulations for Dietary Supplements
Too Jioag Advanced Biotechnology Studies, Johns Hopkins University, Baltimore. Maryland
Shr Zhoag Georgetown University Medical Center. Washington, DC
Key Words Dietary supplement: DSHEA; FDA: Public Law 109-462: Final rule
Correspondence Address Shu Zhang, Georgetown University Medical Center. 2115 Wisconsin Ave. NW, Suite 603, Washington. DC 20007 (email: [email protected]).
On December 22, 2006, the US Congress passed Public Law 109-462, Dietary Supplement and Nonprescription Drug Consumer Protection Act. On June 25, 2007 FDA published its long-anticipated final rule establishing regulations governing current good manufacturing practices for dietary supplements. This article considers whether or not such expanded support of rigorous, unbiased scientific research can be used effectively in dietary supplements.
Dietary supplements are just that, supplements to a healthful diet and regular exercise. They are, by legal definition, designed to supplement the diet, not replace components of the diet. We must deal with the fact that the dietary supplements industry is not always adequately regulated. The US Food and Drug Administration's (FDA's)interactions with the dietary supplement industry are a saga. On October 7, 1994, after several years of intense grassroots pressure, lobbying, and negotiation, Congress passed s. 784, the Dietary Supplement Health and Education Act (DSHEA) of 1994. The bill's chief sponsor in the US Senate, Senator Orrin Hatch (R-UT),noted on the day the legislation passed that the bill was a "tremendous victory for consumers who want to lead healthy lifestyles" (1). The term dietary supplement, defined under Section 201(ff)(3) of DSHEA, 21 USC Section 321(ff)(3),uses several criteria in its formal definit ion: Is a product (other than tobacco) that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical. an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite. constituent, extract, or combinations of these ingredients. Is intended for ingestion in pill. capsule, tablet, or liquid form.
The authors conducted a review of selected dietary supplements to see if there is an effective system to ensure that dietary supplements are not marketed prior to safdy and eficaq being established asfor drugs and medical devices. We believe that this new act and the final rule are a step toward treating dietary supplements more like pharmaceuticals and not like food. Therefore we believe that we need these stringent laws and regulations for dietary supplements.
Includes products such as an approved new drug, certified antibiotic, or licensed biologic that was marketed as a dietary supplement or food before approval,certification. or license (unless the Secretary of US Health and Human Services waives this provision). (2)
DSHEA expanded dietary supplements
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