WARNING: This product contains nicotine. Nicotine is an addictive chemical.

Federal court hears opening arguments over Constitutionality of FDA deeming regs

When the U.S. Food and Drug Administration (FDA) issued a policy change in 2015 which reclassified vaping e-liquids as tobacco products, it opened the doors for a constitutional debate.  By placing tobacco-free vape juices into the same legal category as combustible cigarettes, the FDA is essentially implying that the two different industries as  equally as dangerous to public health.

They are not.  For years now, the FDA-equivalent agency in Great Britain – Public Health England – has repeatedly cited documented evidence that clearly indicates that vaping is approximately 95 percent less harmful than smoking. 

Related Article:  HHS Sec. Alex Azar opens legal loophole to challenge FDA deeming regulations on vapes

To muddy the constitutional waters further, the revised deeming regulations were not signed into law by the FDA Commissioner at the time, Dr. Robert Califf, who was appointed in 2016 by President Barack Obama.  Instead, the revised policies were signed by a lower level administrator named Leslie Kux. 

According to federal law, the only government officials who have the constitutional authority to “make laws” are those who are nominated by a U.S. President and confirmed by the Senate.  Kux meets neither of these criteria, which makes her signing of the FDA deeming regulations unconstitutional, opponents say.

The controversial political move of HHS Secretary Alex Azar

Just a few weeks ago on September 15, 2020, Cabinet Secretary of Health and Human Services Alex Azar made a rather astonishing policy change of his own.  In what the New York Times calls a “power grab,” Azar issued a memorandum which forbids all agencies under his jurisdiction to release new rules or regulatory changes to policy without Azar’s formal signature.  The FDA is one of these agencies.  An HHS press release published five days later states the following.

“Before and after this action, no regulation issues from any part of HHS without the approval of the Secretary and the White House. The only change made by this memo is that, instead of the Secretary’s just approving all agency regulations, each regulation now also will be formally signed by him. Any speculation about this memo being motivated by policy considerations is utterly misinformed. This good-government action is only prospective in effect and minimizes litigation risk for the department’s public health actions, prevents potential future abuse of authority, and is consistent with congressional intent. The memo should have no effect on operational work and does not pertain in any way to guidances or any vaccine or drug approval or authorization. This action will not slow any HHS agencies’ work. It is simply the ministerial, administrative act of attaching a signature to a document.”

Related Article:   The unconstitutionality of the FDA deeming regulations: Who is Leslie Kux?

Many political pundits automatically assume that the controversial Azar memo came about because of conflicting coronavirus policies and guidance between the FDA, the CDC, and President Trump himself.  Vaping advocates see Azar’s move as yet another opportunity to overturn the FDA deeming regulations in the federal courts.

Moose Jooce, et al v. Food and Drug Administration

Last week, the Federal District Court of Columbia (Washington, D.C.) heard oral arguments in the lawsuit of Moose Jooce, et al v. Food and Drug Administration. The plaintiffs claim that the FDA deeming regulations violate both the Appointments Clause of the Constitution and the First Amendment. The lawsuit consolidates three former legal complaints by small vape shop owners Moose Jooce, Mountain Vapors, Rustic Vapors, and Dutchman Vapors.  In February, a lower court judge, U.S. District Court Judge Christopher Cooper, ruled in favor of the FDA. 

In his ruling opinion, Judge Cooper claimed that regulations that are not signed by a Senate-confirmed official are okay if a Senate-confirmed judge rules that they are indeed constitutional.  Judge Cooper referred to previous court rulings claiming that the signing of new rules and regulations that would “otherwise be unlawful due to procedural or technical defects . . . can be cured through a subsequent lawful ratification of that action.”

Related Article:   After failing in the Michigan Supreme Court TWICE, Gov. Whitmer tries ban vaping again

Judge Cooper also says that at least two different FDA Commissioners have not rolled back the new policies since their implementation under the Califf Administration.  This reasoning implies that former Senate-confirmed FDA Commissioner Scott Gottlieb and the current Acting Commissioner Ned Sharpless (who is non-confirmed by the Senate) support the new rules’ legality.  Judge Cooper states, “an agency’s ratification of a prior decision or action cures any potential Appointments Clause violation.”

However, the plaintiffs were unexpectedly encouraged last week when arguing their case in front of a three-judge panel in the D.C. Federal Circuit Court when the judges seemingly indicated that Cooper’s prior ruling might be wrong.  When the lead attorney for the Plaintiffs, Jonathan Wood, referred to Judge Cooper’s opinion as a “whack-a-mole approach to the Appointments Clause,” the three-judge panel openly expressed concern.

According to Courthouse News, all three judges questioned the validity of rules signed by officials who are not Senate-confirmed. For example, U.S. Circuit Judge Cornelia Pillard said Judge Cooper’s ruling “feels concerning and somewhat hollow.” Pillard also suggested that if Cooper’s reasoning were correct, then the need for the appointments clause in the constitution is rendered essentially useless. 

Related Article:  There is no ‘epidemiological basis’ for this anti-vaping hysteria, says cardiologist

(Image courtesy of Shutterstock)

Leave a comment

Please note, comments must be approved before they are published