Document ID: ./input/supremecourt_opinions/opinions/21pdf/20-1410_1an2.pdf
Page Number: 11.0

Cite as:  597 U. S. ____ (2022) 

7 

Opinion of the Court 

at 6); see also X-Citement Video, 513 U. S., at 72–73. 

In addition, the regulatory language defining an author-
ized prescription is, we have said, “ambiguous,” written in
“generalit[ies],  susceptible  to  more  precise  definition  and 
open  to  varying  constructions.”    Gonzales  v.  Oregon,  546 
U. S. 243, 258 (2006); see id., at 257 (regulation “gives little 
or  no  instruction  on”  major  questions);  see  also  21  CFR 
§1306.04(a) (regulation defining “effective” prescription as 
one “issued for a legitimate medical purpose by an individ-
ual  practitioner  acting  in  the  usual  course  of  his  profes-
sional practice”).  The conduct prohibited by such language
(issuing invalid prescriptions) is thus “often difficult to dis-
tinguish from the gray zone of socially acceptable . . . con-
duct” (issuing valid prescriptions).  United States Gypsum, 
438 U. S., at 441.  A strong scienter requirement helps to
diminish  the  risk  of  “overdeterrence,”  i.e.,  punishing  ac-
ceptable and beneficial conduct that lies close to, but on the 
permissible side of, the criminal line.  Ibid. 

The  statutory  provisions  at  issue  here  are  also  not  the 
kind  that  we  have  held  fall  outside  the  scope  of  ordinary 
scienter requirements.  Section 841 does not define a regu-
latory or public welfare offense that carries only minor pen-
alties.  Cf. Rehaif, 588 U. S., at ___ (slip op., at 6); Staples, 
511  U. S.,  at  606.    Rather,  §841  imposes  severe  penalties 
upon those who violate it, including life imprisonment and
fines  up  to  $1  million.  See  §841(b)(1)(C);  see  generally
§841(b).  Such severe penalties counsel in favor of a strong 
scienter  requirement.  See  Staples,  511  U. S.,  at  618–619 
(noting that “a severe penalty is a further factor tending to
suggest  that  .  .  .  the  usual  presumption  that  a  defendant 
must know the facts that make his conduct illegal should
apply”); United States Gypsum, 438 U. S., at 442, n. 18. 

Nor is the “except as authorized” clause a jurisdictional
provision, to which the presumption of scienter would not 
apply.  Cf. Rehaif, 588 U. S., at ___ (slip op., at 4); United