Document ID: ./input/supremecourt_opinions/opinions/21pdf/20-1410_1an2.pdf
Page Number: 3.0

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

3 

Syllabus 

ments are convincing.  First, the Government and the concurrence cor-
rectly  note  that  the  statutory  clauses  in  the  cases  just  described  set 
forth elements of an offense.  Here, the Government and the concur-
rence say, §841’s “[e]xcept as authorized” clause does not set forth an 
element of the offense.  In support, they point to a separate statutory 
provision—§885.  Section 885 says that the Government need not “neg-
ative any exemption or exception . . . in any complaint, information, 
indictment, or other pleading or in any trial,” and that “the burden of 
going forward with the evidence with respect to any such exemption or 
exception shall be upon the person claiming its benefit,” not upon the 
prosecution.  But even assuming that lack of authorization is unlike 
an  element  in  these  two  ways,  §885  has  little  or  nothing  to  do  with 
scienter requirements.  Section 885 simply absolves the Government 
of having to allege, in an indictment, the inapplicability of every stat-
utory exception in each Controlled Substances Act prosecution.  Sec-
tion 885 also shifts the burden of production—but not the burden of 
persuasion—regarding statutory exceptions to the defendant, thereby
relieving the Government of having to disprove, at the outset of every 
prosecution, the inapplicability of all exceptions.   

Section 885 thus does not provide a basis for inferring that Congress 
intended to do away with, or weaken, ordinary and longstanding sci-
enter requirements.  At the same time, the factors discussed above— 
the  language  of  §841;  the  crucial  role  authorization  plays  in  distin-
guishing  morally  blameworthy  conduct  from  socially  necessary  con-
duct; the serious nature of the crime and its penalties; and the vague, 
highly general regulatory language defining the scope of prescribing 
authority—all support applying normal scienter principles to the “ex-
cept as authorized” clause.  And the Government does not deny that, 
once a defendant satisfies his burden of production under §885 by in-
voking the authorization exception, the Government must then prove 
lack of authorization by satisfying the ordinary criminal law burden of 
proof—beyond a reasonable doubt. 

The Government also offers a substitute mens rea standard.  Instead 
of applying the statute’s “knowingly or intentionally” language to the 
authorization clause, the Government instead asserts that the statute 
implicitly contains an “objectively reasonable good-faith effort” or “ob-
jective  honest-effort  standard.”    Brief  for  United  States  16–17.  But 
§841 uses the words “knowingly or intentionally,” not “good faith,” “ob-
jectively,”  “reasonable,”  or  “honest  effort.”    And  the  Government’s 
standard  would  turn  a  defendant’s  criminal  liability  on  the  mental 
state of a hypothetical “reasonable” doctor, rather than on the mental
state of the defendant himself or herself.  The Court has rejected anal-
ogous  suggestions  in  other  criminal  contexts.    See  Elonis  v.  United 
States, 575 U. S. 723.  And the Government is wrong to assert that the