Court gives FDA greater latitude in declaring dietary supplements "unapproved drugs".(Brief Article)

Food & Drug Packaging | June 1, 2001| | Copyright

The U.S. Court of Appeals for the 10th Circuit has ruled that the Food and Drug Administration (FDA) has the authority to declare a dietary supplement to be an unapproved drug when the active ingredient in the supplement is the same as one used in an approved drug product.

Under the Dietary Supplement Health and Education Act, Congress included a provision to exclude from the term, dietary supplement, "an article that is approved as a new drug." Congress included this provision to prevent a product that is the equivalent of a new drug from being sold as a dietary ...

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