Dietary supplements and the DSHEA of 1994
Rycyk, Matthew Thomas
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The Dietary Supplement Health and Education Act of 1994 provides for a much different set of regulations than those that cover pharmaceuticals and conventional food products. Under this law, the dietary supplement manufacturers are responsible for ensuring that the supplement is safe before it is marketed. However, no efficacy claims can be made because clinical trials are not required. Manufacturers do not register their products and do not have to receive approval before marketing. It is the responsibility of the FDA to monitor safety in the post-market environment. In the years since the passing of the DSHEA, there have been instances where supplements have not been safe for use. Through a critical change analysis of the issues and gathered expert opinions this research addresses two questions: Are dietary supplements safe for use or is there need for reformed DSHEA legislation to ensure safety?