Opinion by Judge McKEOWN; Dissent by Judge FERNANDEZ.
McKEOWN, Circuit Judge.
Section 303 of the Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 333(a)(2), imposes felony liability for misbranding "with the intent to defraud or mislead." The question presented is whether this provision requires proof of materiality. We hold that materiality must be proven as an element of the offense under either a theory of intent to defraud or a theory of intent...
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