Changes rules on drugs added to dietary supplements

Sets new conditions for when a drug or biologic ingredient may be added to food or dietary supplements, and lets sellers challenge FDA warnings in court right away.

• Allows the ingredient if the drug was sold in the U.S. before October 15, 1994
• Allows it if drug trials were inactive or withdrawn for at least seven years
• Tells the FDA to weigh differences in dose, route, and concentration
• Makes FDA warning letters immediately reviewable, with the government carrying the burden of proof

In committee

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