FDA preemption is the legal theory in the United States that products licensed or otherwise approved for use by the Food and Drug Administration (FDA) are exempt from various state efforts to preclude their use.
[1] The doctrine hinges on the assertion of Congressional intent to designate FDA as the national clearinghouse for determinations of the safety of pharmaceutical products, and the Supremacy Clause of the Constitution of the United States placing federal law over state law.
[clarification needed] The doctrine has also been raised in connection with the growing efforts of some states to ban or severely restrict the use of the abortion drug mifepristone, in a manner contrary to the regimen set forth by FDA.
[5] FDA preemption has also been raised against direct efforts by states to ban disfavored FDA-licensed pharmaceutical products, as with the failed effort by the state of Massachusetts to ban opioid analgesic Zohydro.
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