A Lawsuit to Make Rulemakers Follow the Rules

Ilya Shapiro

Last week, the indispensable Pacific Legal Foundation added the Food and Drug Administration to the long list of alphabet-soup federal agencies it has taken on in court. In three separate lawsuits filed in three districts, PLF is challenging the “Deeming Rule,” a 2016 regulation issued under the Obama FDA that made vaping devices subject to the Tobacco Control Act. (Full disclosure: the lawsuits are spearheaded by former Cato legal associate Tommy Berry and former Cato legal intern Jonathan Wood.)

The Deeming Rule, to begin with, is terrible policy. It takes an industry that is saving lives by helping people to quit smoking and imposes heavy-handed regulations designed for the much different cigarette industry. Vape shops are typically mom-and-pop operations, not billion-dollar corporations, and submitting every new e-juice creation for costly and time-consuming FDA approval just isn’t feasible.

But the problem spotted by PLF is much more fundamental, and the precedent the organization could set with this case goes beyond vaping and to the heart of separation of powers. It turns out that the FDA has for many years been delegating its rulemaking authority to its “associate commissioner for policy,” a career civil-service position two rungs below FDA Commissioner in the bureaucratic depth chart. For eight years, the Associate Commissioner for Policy has been a woman by the name of Leslie Kux. It was Kux, not then-Secretary Sylvia Burwell or then-Commissioner Robert Califf, who signed and issued the Deeming Rule.

Why is this a problem? Because the Constitution draws a distinction between “Officers of the United States” and mere employees of the federal government. Only officers can exercise “significant authority” under federal law. But in exchange for that greater power, officers must go through a constitutionally prescribed procedure, typically nomination by the president and confirmation by the Senate (with a few exceptions applicable only to inferior officers). This ensures that anyone appointed to a policymaking role &nmdash; one whose duties go beyond the ministerial and advisory &nmdash; will first have their character and judgment vetted by the politically accountable Senate (who shares in the blame when an appointment goes wrong).

The power to issue a final rule is indisputably a “significant authority” reserved only to officers. The Supreme Court made this clear in 1976 in the foundational campaign-finance case Buckley v. Valeo, when it struck down the original version of the Federal Election Commission because most of its members were installed in ways that did not comport with the Appointments Clause. The court stated explicitly that the rulemaking power held by the FEC was a “significant authority.” That’s why today all FEC commissioners are Senate-confirmed presidential appointees.

But Leslie Kux has never been nominated by any president or confirmed by the Senate. Indeed, she has not even gone through any of the procedures acceptable for inferior officers. Instead, Kux was hired through the civil service as a career federal employee, just like millions of others.

Why, then, has Kux been issuing the FDA’s rules? Because the FDA commissioner has purported to delegate to her all of his rulemaking powers.

But this is a delegation that the Constitution simply does not allow.

Officers can’t take the powers that the Senate has entrusted to them and pass those powers along to someone the Senate has never reviewed. Sub-delegation of rulemaking power to a non-Senate-confirmed federal employee allows the executive branch to covertly accomplish precisely what the Supreme Court struck down in Buckley: granting rulemaking power to those not duly appointed or confirmed as officers of the U.S.

But the FDA has been getting away with it for quite a while. The delegation was tucked away in a staff manual guide buried deep in its website. It’s only now, finally, that the FDA is being held to account for its attempt to make an end-run around advice and consent.

If successful, this suit could be a victory for both the separation of powers and tobacco harm reduction. Not only will it establish a precedent that rulemaking authority can’t be sub-delegated ad-infinitum, it will also quite literally save the livelihoods of PLF’s clients and thousands of other vaping entrepreneurs across the country who are passionate about saving lives.

The courts should vaporize the ill-considered and unconstitutional Deeming Rule &nmdash; and set a cautionary example for other agencies with similar unconstitutional delegations.

Ilya Shapiro is a contributor to the Washington Examiner’s Beltway Confidential blog.