As I noted in this space a year and a half ago, the Food and Drug Administration’s restrictions on vaping (e-cigarette) products — which questionably apply the Tobacco Control Act to products that contain no tobacco — “will drastically restrict and maybe even ban a popular option for smokers seeking to quit the cigarette habit. It’s not just an assault on individual choice and commercial freedom — it could wind up killing people.” Along the way, the agency would dent consumer choice in the cigar market.

Now the Pacific Legal Foundation has filed a challenge to the FDA rules, with separate legal actions in three courts. PLF’s central objection is that the regulation was issued by a career FDA civil servant without proper legal authority to do so. Ilya Shapiro, Washington Examiner:

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 — one whose duties go beyond the ministerial and advisory — 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.

While FDA commissioners have purported to delegate rule issuance authority to the permanent employee, PLF argues that the Constitution does not permit them to evade its prescription by such means.

Beyond that, the rules’ restrictions on marketing — which forbid companies to promote vaping as a method of harm reduction that could benefit existing smokers, even if that statement is plainly true — run into the First Amendment and the protections it affords to much truthful commercial speech. PLF:

The vaping edict flouts the First Amendment by forcing businesses to run a daunting regulatory gauntlet in order to advertise truthful information. The government can’t require pre-approval for truthful speech, and it especially can’t shift the burden of proof to the speaker to prove the benefits of his speech will outweigh any harms the government perceives may result.

Beyond violating the Constitution, the vaping rule is horrible public policy: it threatens to shut down thousands of small businesses that provide potentially life-saving products and creates a public safety hazard by making it very difficult to improve and repair products.

Filed under: FDA, tobacco