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FDA tobacco regulation

Executive Summary

Supreme Court rules March 21 that the Food Drug & Cosmetic Act does not authorize FDA to regulate tobacco products. The FDCA allows FDA to regulate products that are unsafe for obtaining therapeutic benefit; but if tobacco products cannot be used safely for any therapeutic purpose, they fall outside of FDCA's regulatory scheme, the court concluded. Subsequent legislation from Congress has also not given FDA authority to regulate tobacco products. In the 5 - 4 decision, the court found that Congress demonstrated an intent to regulate tobacco through means other than FDA by enacting separate limits on tobacco advertising and other restrictions

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