Our write up in the WSJ
Ms. 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.
The 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.
There 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.
This 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.
All 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.
The 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?
Political 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.
The 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 v. Valeo , 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.
Many 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.
All 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.
Mr. 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 Litigation Campaign.