Editing Administrative Law Breyer/Outline
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**“devices” = instrument, apparatus, machine… or other article intended to affect the structure or any function of the body” (21 USC § 321(h) ) | **“devices” = instrument, apparatus, machine… or other article intended to affect the structure or any function of the body” (21 USC § 321(h) ) | ||
*Facts | *Facts | ||
**1996 – FDA concluded it had authority to regulate | **1996 – FDA concluded it had authority to regulate nicotine (a “drug”) and cigarettes/dip (“combination products”) → issued regs intended to reduce tobacco consumption by minors to reduce overall incidence of disease and death | ||
**FDA had previously explicitly/repeatedly disavowed that it had jx<ref>jx = jurisdiction</ref> to regulate tobacco | **FDA had previously explicitly/repeatedly disavowed that it had jx<ref>jx = jurisdiction</ref> to regulate tobacco | ||
*Holding – FDA’s assertion of jx is impermissible and exceeds the bounds of its authority b/c FDCA is not ambiguous (''Chevron'' Step One) | *Holding – FDA’s assertion of jx is impermissible and exceeds the bounds of its authority b/c FDCA is not ambiguous (''Chevron'' Step One) |