1,860 unconstitutional FDA rules
Will the Food and Drug Administration (FDA) change its rule-making practices when it learns that 98 percent of its regulations since 2001 were unconstitutional? That’s the figure we uncovered in a comprehensive study examining 2,952 Health and Human Services (HHS) regulations issued during a 17-year period.
If a federal agency enforces even one invalid rule against Americans, it breaches the public trust and the rule of law. Enforcing 100 invalid rules would constitute an unprecedented threat to democratic principles from a lawless agency. What we found at FDA dwarfs those figures. From early 2001 to early 2018, FDA issued 1,860 unconstitutional rules.
Though we didn’t know the full scale of the problem, we broke the news of FDA’s unconstitutional rule-making practices a year ago with our lawsuit challenging the FDA’s “deeming rule.” That regulation made vaping product retailers subject to the same requirements as cigarette manufacturers under the Tobacco Control Act. We explained that the deeming rule was not just bad policy, it also was illegal: a career civil-service employee named Leslie Kux signed and issued that rule, even though she had no constitutional authority to do so.
Because Kux was never nominated by the president, confirmed by the Senate, nor hired by the HHS secretary pursuant to a congressional authorization, she could not be an “officer of the United States” as the Constitution defines that term. Career employees such as Kux (who worked at the FDA for 30 years) fill vital staff roles in federal agencies, but they are not democratically accountable for significant policy decisions. Kux’s exercise of rule-making power — the power to issue final regulations that are binding on citizens — was an impermissible end-run around the Constitution’s Appointments Clause, which allows only officers to exercise such coercive governmental power.
The deeming rule litigation is ongoing. Tellingly, the FDA demonstrated its fear that the rule is in jeopardy this month by seeking to cure the constitutional problem with a letter from FDA Commissioner Scott Gottlieb two days before he left office, purporting to “ratify” the rule Kux illegally issued three years ago. The FDA still refuses to acknowledge its past violations of law; Gottlieb denied there was any problem to cure in his litigation-induced letter, but his unusual action speaks louder than his denial. What’s worse, FDA has not altered its unconstitutional practice of career employee rule-making.