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CRA repeal of FDA deeming regulations: Legal experts uncover possible legal loopholes

Posted by Matt Rowland on

There is a long-standing argument within the vaping community as to whether the FDA deeming regulations are eligible for quick repeal via the Congressional Review Act of 1996 (CRA).  And the Wall Street Journal is now indirectly entering the debate.

The CRA is an obscure law that allows Congress to revoke certain governmental actions implemented within the last sixty legislative days of the previous administration.  The technical cutoff date for 2017 is June 13, but the FDA deeming regulations were published over a month prior on May 10.  So, this makes them completely ineligible, right?

Not necessarily.

Many in the vaping community are automatically assuming that the FDA deeming regulations are not eligible for CRV repeal based solely on this May 10 publication date.  Some have even claimed to receive confirmation of their assumptions directly from politicians on Capitol Hill (or the people who work for them).  But according to the Wall Street Journal (WSJ), the technical cutoff date is only a small portion of the qualifying criteria.

“Here’s how it works: It turns out that the first line of the CRA requires any federal agency promulgating a rule to submit a ‘report’ on it to the House and Senate. The 60-day clock starts either when the rule is published or when Congress receives the report—whichever comes later.”

The WSJ’s interpretation of the Congressional Review Act is also substantiated by more than a few legal analysts, including members of the National Law Review  and a senior fellow in constitutional law at the Pacific Legal Foundation named Mr. Todd Gaziano.

Gaziano helped write the Congressional Review Act of 1996

Much like many advocates within the vaping community, the accepted wisdom in Washington, D.C. has been that the CRA only applies to legislative actions by the executive branch that were “published” within the last sixty days of the preceding congressional administration.  However, Gaziano told GOP leaders on Wednesday that their congressional authority to implement the CRA can reach back as far as 1996 when certain political stars align in just the right order.

(Related Article: TRUMP PROMISES ‘FDA REFORM;’ BIG PHARMA & VAPING INDUSTRIES TAKE NOTICE)

And Gaziano would know, because he actually helped write the Congressional Review Act back in 1996 when he was legal counsel to Republican Congressman David McIntosh.

“There was always intended to be consequences if agencies didn’t deliver these reports…And while some Obama agencies may have been better at sending reports, others, through incompetence or spite, likely didn’t…Bottom line: There are rules for which there are no reports. And if the Trump administration were now to submit those reports—for rules implemented long ago—Congress would be free to vote the regulations down.”
-Gaziano by way of the WSJ

Furthermore, the CRA seems to have a very different definition of what qualifies as a “rule” as compared to the definitions of even our most vape-friendly Congresspersons and Senators.  And the definition has very little to do with the date that the rule was published on the Federal Register.

The CRA also seems to apply to “guidance” reports issued to Congress by related agencies, which in this case, is the FDA.  The question now becomes, “Did the FDA issue guidance reports regarding their controversial deeming regulations?”

FDA website seemingly invalidates May 10 ‘publication date' claim.

Thanks to the Freedom of Information Act, even the typical vaper can now go online to determine “if” and “when” these guidance reports were issued to Congress.   According to the Tobacco Products webpage on the FDA website, the last time that a report of any kind was issued by the FDA to Congress was way back in 2013. 

If Gaziano is correct, then the issue of the May 10 publication date of the FDA deeming regulations on the Federal Register means absolutely nothing because the FDA did not provide the necessary “guidelines” for implementation to Congress. 

Paul Larkin is a senior legal research fellow at the Heritage Foundation, and he also agrees with Gaziano’s assessment. According to Larkin, if federal agencies did not submit required guideline materials to congress, then governmental rules as far back as 1996 can qualify for CRA repeal.

“If they haven’t reported it to Congress, it can now be challenged,” states Paul Larkin.

Perhaps this is why the FDA deeming regulations appear on the GOP wish list of targeted regulations for quick repeal by the Trump Administration.  The document entitled First 100 Days:  Rules, Regulations, and Executive Orders to Examine, Revoke, and Issue is compiled by the House Freedom Caucus and can be located online.

(Related Article:  RON JOHNSON TO OBAMA ADMINISTRATION: OVERTURN FDA DEEMING REGS BEFORE TRUMP REPEALS THEM)

And, yes.  Several of the included rules and regulations on the list date back years before the assumed June 2013 cutoff date for the Congressional Review Act, which seemingly supports Gaziano’s interpretation of the statute.

All of this is pure speculation at this point.  No one in the vaping community knows for certain whether the FDA deeming regulations are eligible for CRA repeal.  In fact, even our elected officials in Congress are still scratching their collective heads over issue, if the Wall Street Journal article is to be believed.

The vaping community should not give up hope for CRA repeal based solely on a May 10 publication date.  As the National Review article states, “enthusiasm should be taken seriously by all potentially affected stakeholders.” 

(Related Article:  HOUSE PASSES MIDNIGHT RULES RELIEF ACT TO REVOKE FDA DEEMING REGULATIONS FOR VAPING)


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The opinions expressed in this article are those of the author's and do not necessarily represent the viewpoints, policy or company position of Vapes.com, the rest of our staff, and/or any/all contributors to this site.



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