Kimberly Manor lost her husband to lung cancer, she was inspired
to make a dramatic career change. Kimberly now owns and operates
Moose Jooce in Lake, Mich., a “vape shop” that sells various
electronic nicotine devices. These products use battery-powered
coils to vaporize liquids, with differing levels of nicotine or
none at all. Thus, vapers may inhale nicotine without the tar or
other harmful chemicals in tobacco smoke, since there is no
tobacco and no combustion. Scientific evidence suggests this is a
much safer alternative to smoking.
Manor estimates that her business has helped more than 500
people quit smoking, most of them longtime smokers in their 50s
or older. Yet the Food and Drug Administration is discouraging
more such enterprises. In a regulation issued in 2016 known as
the “deeming rule,” the agency ordered that vaping products
would be subject to the same regulations developed for the
cigarette industry under the Tobacco Control Act of 2009.
deeming rule has been devastating to businesses like Ms.
Manor’s. To give just one example, vape shop owners frequently
experiment by mixing new flavors for the liquid “juice.” Now,
each separate creation requires its own prohibitively expensive
application for FDA approval, which means that vape shops have
been forced to stop innovating.
are many reasons to criticize the FDA’s action, but its most
fundamental flaw—and the one that our legal foundation raises in
three lawsuits on behalf of Ms. Manor and nine others—is that
the rule was finalized by someone without authority to do so.
The rule was not issued or signed by either the secretary of
health and human services or the FDA commissioner, both
Senate-confirmed officials. Instead, it was issued and signed by
Leslie Kux, a career bureaucrat at FDA.
isn’t the first time the FDA bureaucracy has exceeded its
authority. HHS officials in prior administrations purported to
delegate their rule-making power to the bureaucrats who held the
position Ms. Kux now fills—and she has issued nearly 200 rules.
these rules are invalid. The attempted delegation of rule-making
authority to someone not appointed as an “Officer of the United
States” violates one of the most important separation-of-powers
clauses in the Constitution.
question of who signs off on such decisions isn’t a mere
formality. Suppose a Supreme Court justice said to one of his
law clerks, “You know how I want to rule on the cases this term,
so I authorize you to write the opinions assigned to me—but
issue them in your name so I am not responsible for the final
wording.” Justices certainly do ask clerks to help write their
opinions. But given that the precise wording of an opinion is
crucially important, does anyone think the power to sign and
issue them can be delegated to a law clerk?
accountability matters; that’s why the Framers included the
Appointments Clause in Article II of the U.S. Constitution.
According to that design, certain powers can be exercised only
by principal officers of the U.S. who were confirmed by the
Senate. Thus (with the exception of temporary recess
appointees), only Senate-confirmed judges may issue binding
judicial opinions, and only Senate-confirmed principal officers
in the executive branch may issue regulations that are binding
on the public as a matter of law. This constitutional
requirement preserves democratic accountability for both
judicial decisions and significant executive-branch actions.
progressive vision has been to insulate “impartial” bureaucrats
from supposedly political influences—thereby undermining this
core guarantee of democratic accountability. But as a
constitutional matter, it is well-settled that career
bureaucrats can’t issue regulations. Forty-two years ago, in Buckley
the Supreme Court invalidated the original statute creating the
Federal Election Commission. The high court ruled that the
commission’s powers were reserved to officers of the U.S., and
therefore that it must be reconfigured so that its members would
be appointed as the Constitution requires. The rule-making power
was among the powers that the court explicitly noted were
reserved to officers.
agencies still issue rules the constitutional way. Within HHS,
the Centers for Medicare and Medicaid Services, for example,
issued more than 100 rules since 2010, and all but 12
(correcting typographical errors in previous rules) were signed
by the secretary of health and human services. It isn’t too much
to ask that other Senate-confirmed officers take responsibility
for regulations issued by their agencies.
too often, however, cabinet secretaries and agency heads have
tried to delegate responsibility to low-ranking staff in ways
that are irresponsible and unconstitutional. A career bureaucrat
shouldn’t have the power to disrupt thousands of lives like
Kimberly’s. The lawsuits filed Jan. 30 in Texas, Minnesota and
the District of Columbia are the first step in making that
principle a reality.
Gaziano is director of Pacific Legal Foundation’s Center for
the Separation of Powers. Mr. Berry is an attorney and lead
strategist for PLF’s Constitutional Rules for Rulemaking