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Article: Court gives FDA greater latitude in declaring dietary supplements "unapproved drugs".(Brief Article)
- Article from:
- Food & Drug Packaging
- Article date:
- June 1, 2001
- Author:
CopyrightCOPYRIGHT 2001 BNP Media. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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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 supplement. However, the provision is ambiguous: Does the term "article" refer to a finished drug ...