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FDA's Deeming Rule Deemed Unconstitutional!!!

May 21, 2019

Do you know who Leslie Kux is? Neither did we. It turns out she's the gal who signed on the dotted line to create the FDA's Deeming Rule that subjects vaping products to the same regulations as cigarettes and other tobacco products under the Tobacco Control Act. The problem is, according to a recent news item, she had no Constitutional authority to do so which would make the Deeming Rule threatening to decimate the entire vaping industry null and void.

FDA Rubber Stamp

The Hill, a D.C. based news site that is considered the rag to read if you're in politics, featured the shocking article on April 29, 2019. The authors state that the FDA has been involved in a decades long, massive, unconstitutional rule making rampage. According to the authors, a full 98% of the FDA's regulations enacted since 2001 are unconstitutional amounting to 1,860 separate rules and regulations from 2001 through early 2018.

The thing is, not just anybody who happens to work in government can create regulations and sign off on them. To have that power, an individual must be considered an "officer of the United States." At the FDA, that means they must be either:

  • Nominated by the President of the United States
  • Confirmed by the Senate
  • Hired by the Health and Human Services secretary pursuant to a congressional authorization

Leslie Kux meets none of these requirements yet, it is ink from her pen that created the Deeming Rule now hanging over the heads of American vapers. The reason for these requirements is that anyone given law or rule making authority has to be democratically accountable. The American people must, to whatever extent we have it, retain control over the people making the rules and that means we have to be able to vote them out of office or, at least, vote the person who nominated or confirmed them out of office. Because she was just a career employee, Leslie Kux is beyond the reach of the voters and therefore she in turn cannot bind us with rules and regulations.

Regulations Must Be Constitutionally Passed

The authors of the article in The Hill are lawyers for the Pacific Legal Foundation. The organization just released a study entitled, "But Who Rules the Rulemakers? A Study of Illegally Issued Regulations at HHS." The study looked at nearly three thousand rules set by the United States Department of Health and Human Services (AKA the Health Department) over the last 17 years and found that:

  • Nearly 75% of these rules are unconstitutional due to the fact that they were issued by low level employees who had no authority to issue them
  • 2,094 of the 2,952 HHS rules examined fall into this category yet many of them had significant impact on the lives of Americans
  • The FDA was the worst offender with a full 98% of regulations being issued unconstitutionally
  • A mere 2% of the unconstitutional HHS rules were issued by agencies OTHER THAN the FDA
  • There were 25 unconstitutional rules issued by the FDA that each had an impact of 25 million dollars or more (that's a 625 million dollar impact on the economy, individual Americans and/or small businesses)

Illegally Issued Regulations at FDAThe 44 page study outlined "an impermissible end-run around the Constitution’s Appointments Clause, which allows only officers to exercise such coercive governmental power."

Indeed, any law that is unconstitutional is null and void. This was established by the Supreme Court case Marbury v. Madison in 1803. In this landmark case, Chief Justice John Marshall wrote that, “No provision of the Constitution is designed to be without effect. Anything that is in conflict is null and void of law.” The case established what is known as the principal of judicial review which essentially says that the courts have the power to strike down laws, statutes, regulations and some government actions if they're not in line with the U.S. Constitution.

U.S. Constitution

So, might the fact that the FDA's Deeming Rule was issued unconstitutionally bring a halt to it going into effect? Yes. In a legal precedent set last year that bears a lot of similarities, the Supreme Court ruled in Lucia v. S.E.C. that the Securities and Exchange Commission had been guilty of the same thing, violating the appointments clause, in this case in relation to the selection of administrative law judges.

 Also, tellingly, in his second to last day before stepping down, Scott Gottlieb, the FDA Commissioner who resigned in early April, wrote a letter attempting to retroactively "ratify" the unconstitutionally issued Deeming Rule signed by Leslie Kux three years ago. He was clearly aware that, with lawyers already challenging it in court, the Deeming Rule could well be struck down on constitutional grounds.

Previous FDA Commissioner Scott Gottlieb

How did the FDA end up letting lower level staff members create and sign off on the rules? The authors of the article in The Hill conclude that it was a simple case of laziness that got out of hand once it was sucked into the bureaucratic machine of the FDA. A previous FDA Commissioner decided in 1991 to delegate the boring, tedious or simply too time consuming task of creating rules to unappointed underlings. Once set on this path, the tidal wave of bureaucratic repetition swept this practice all the way down stream until the Deeming Rule landed on Leslie Kux's desk with a loud "thunk."

"Compliance with the Constitution clearly is not too much to ask, and it does not bring the process of issuing important regulations to a halt. Instead, it ensures that Senate-confirmed officers are accountable for — and make the final decision regarding — rules that bind the public, as the people who ratified the Constitution insisted," the authors of the article in The Hill conclude.

Could bureaucracy end up saving the day for vapers?

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