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

On September 15, Secretary Alex Azar of the U.S. Department of Health and Humans Services (HHS issued a memorandum barring the 27 agencies under his control from implementing new rules within his expressed signature.  In most administrations, the task of signing these legislative actions typically falls to the chief officer of the related department or perhaps an appointed officer in the highest points of the agency’s management hierarchy. 

This new announcement means that the current chief of the U.S. Food and Drug Administration, Ned Sharpless, no longer has the authority to randomly implement new or harsher anti-vaping regulations without Secretary Azar’s written consent.  For vaping advocates and their attorneys, this change of protocol may be opening a new legal loophole with which to fight the constitutionality of the FDFA deeming regulations of 2016.

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

According to federal law, the only federal employees who have the constitutional authority to make new laws (or sign off on them) is an “officer of the United States.”  And that “officer” is very clearly defined to include the following three criteria.

  • The officer must be nominated by the President of the United States.
  • The officer must be approved by the Senate.
  • And in the specific case of the FDA deeming regulations, the officer must be “hired by the Department of Health and Human Resources Secretary pursuant to congressional authority.”

In 2016 under the Obama Administration, Dr. Robert Califf was the FDA commissioner responsible for reclassifying vaping devices and e-liquids as tobacco products, even though they are 100 percent tobacco-free.  This apparent contradiction in terms has always been a sticking point with the vaping community.

The controversy surrounding Leslie Kux, signatory of the FDA deeming regulations

To make the situation appear even more sketchy, Califf was not the one who signed the FDA deeming regulations into law in 2016.  That historic honor fell to a woman named Leslie Kux – a woman who was not appointed by President Obama and not confirmed by the Senate.  Technically speaking, Kux does not meet the three criteria outlined in the U.SD. Constitution.  For these reasons, Secretary Azar’s recent memo is especially interesting.

When the EVALI scandal of late 2019 first appeared in the mainstream media, The First Lady Melanie Trump was understandably concerned.  After all, she and her husband, President Trump, have a teenage son, Baron.  During a White House press conference on September 11 in which both The First Lady and Secretary Azar was also present, the president said that he was considering a federal vaping ban as a result of all the bad press.

Related Article:   WH Presser: Trump plans to ban flavored vapes; no mention of THC or smoking

But he never went through with it.  After conducting his own investigation, President Trump decided a federal vaping ban would be too risky.  His chief concern, according to a broadcast of ABC News Live, was the likely rise in black market vapes and e-liquids that would be certain to follow any such ban. 

 “The one thing I see though, you watch prohibition, you look at, with the alcohol, you look at cigarettes, if you don’t give it to them, it’s going to come here illegally. Okay.  They’re going to make it.  But instead of Reynolds or Juul or legitimate companies, good companies, making something that’s safe, they’re going to be selling stuff on the street corner that could be horrible.   That’s the one problem I can’t seem to forget.  I’ve seen it.  You just have to look at the history of it. And now, instead of having a flavor that’s at least safe, they’re going to be having a flavor that’s poison.  That’s a big problem.”

Related Article: Still unconvinced of vape bans. Trump says Black Market ‘poison’ is chief concern

As more and more states and municipalities install vape ban legislation throughout the nation, the U.S. Congress is beginning to show an interest in consolidating their power over the vapor industry by imposing a all-encompassing federal ban of their own.  But congress is not the only one taking notice.  So is, apparently, Mr. Trump and, by extension, Secretary Azar.

As of this writing, a bill is sitting on the desk of House Speaker Nancy Pelosi which has already been approved in a bipartisan manner in the Senate.  Bill S-183 aims to criminalize the delivering of all vaping products through the U.S. Post Office. If passed by the House, Bill S-183 will be heading to the desk of President Trump for either his signature or a veto.  And Alex Azar’s latest memo might just give him the credibility Trump needs to overrule the congress’s decision while simultaneously landing a political blow on his arch nemesis, Ms. Pelosi.

Related Article:   Call to action: Congress set to vote on bill to ban vapes-by-mail

 (Images courtesy of Shutterstock)


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