Chapter 47 – Administrative Law
consumers from being misled were clearly substantial and would be advanced by the
regulation under which health claims could not be made on container labels unless the
“significant scientific agreement standard” was met. The D.C. Circuit concludes,
however, that the FDA’s refusal to allow the making of the health claims with appropriate
disclaimers made the speech restriction more extensive than necessary (i.e., it prohibited
far too much speech and thus did not reflect a reasonable fit with the underlying
government interest). Appropriate disclaimers would go a long way toward preventing
consumers from being misled about possible or probable health effects, while still
allowing the speech set forth in the health claims to be made. Hence, there was a First
Amendment violation. Ask the class whether the court’s application of the relevant test
gives the government enough regulatory latitude, given that commercial speech receives
only intermediate–rather than “full”–First Amendment protection.
In this case, it appears that there was credible evidence to support the health claims at
issue even though the “significant scientific agreement” standard could not be met. Ask
your students whether the D.C. Circuit’s analysis seems to contemplate that the FDA
should be expected to allow health claims with appropriate disclaimers even if there is
virtually no scientific evidence to support the claims? How would/should the D.C. Circuit
view and evaluate such a case?
Briefly note the court’s holding and supporting reasoning on the Administrative
Procedure Act (and possibly Fifth Amendment due process) issue: that the FDA must
more clearly define the term “significant scientific agreement.” Is the term really as
unclear and vague as the D.C. Circuit says it is? How might the FDA more clearly define
the term or clarify its meaning and scope?
Additional Examples: For an example of an agency action challenged on First
Amendment grounds, see Problem Case #1. For an example of an agency action
challenged on due process grounds, see Problem Case #4.
3. Discuss the principle of separation of powers and the limits it places on the ability of
Congress to delegate its legislative power to an agency. Any new agency is likely to face
a challenge to the constitutionality of its enabling legislation early in its existence.
a. Note the general tendency of modern courts to approve quite broad grants of power
to agencies. Courts see a constitutional problem in a broad grant of power only
when–and such instances are exceedingly rare today–the grant is so sweeping and
without limitation that it effectively amounts to a congressional abdication of its
lawmaking responsibilities. Even very broad grants of power thus are not regarded
by courts as beyond the pale. You may wish to point out that courts faced with a
separation of powers argument may avoid striking down an agency’s enabling
legislation by narrowly construing the powers granted to the agency under the
statute. For a classic New Deal case in which a delegation was struck down as
overly broad, see Schecter Poultry Corp. v. United States, 295 U.S. 495 (1935). For
another classic decision, one upholding wartime price controls, see Yakus v. United
States, 321 U.S. 414 (1944) (delegation upheld unless statute so lacking in standards
that it would be impossible for court to ascertain whether will of Congress has been
obeyed). The consistency with which courts have upheld broad grants of power
during the preceding 60 years made it very surprising that in its 1999 American
Trucking Associations decision, the D.C. Circuit Court of Appeals held that the
Clean Air Act contained an unconstitutional delegation of power to the
Environmental Protection Agency. In a 2001 decision that appears as a text case and
is discussed below, the Supreme Court reversed the D.C. Circuit’s decision and
upheld the statute’s grant of power to the EPA.
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