News: Regulatory ‘Game Changer’ Creates New Opening to Repeal FDA Cigar Rules

Almost certainly, the timing of the FDA’s long-awaited deeming rule regulating cigars was influenced by a law passed two decades earlier called the Congressional Review Act. That legislation has long been interpreted to allow Congress to overturn agency rules and regulations within 60 legislative days of their enactment.

The Review Act works like this: If simple majorities of both the House and Senate vote in favor of a resolution to overturn an agency regulation, it then goes to the president’s desk. Unless the president vetoes the resolution, the regulation is not only overturned, but the agency is barred from enacting a similar rule again unless Congress specifically authorizes it to do so.

Because of the way the Congressional legislative calendar works, when the Food and Drug Administration (FDA) published the rule on May 10, 2016, the 60 legislative days were then guaranteed to pass in a way where even if Congress used the Congressional Review Act to attempt to overturn the regulation, such an action would land on President Obama’s desk. Given that the Obama Administration had initiated the new rule and that Obama had signed the Tobacco Control Act into law that authorized the cigar rules, a veto was guaranteed.

Had the FDA waited until later (June 13 turned out to be the cutoff, although the exact date wasn’t known until later), the Congressional Review Act action might have ended up on the next president’s desk. Thus, by getting the cigar deeming rule published in early May 2016, it appeared it was insulated from being overturned by the Congressional Review Act by a waiting Obama veto threat.

However, as detailed in a Wall Street Journal article published last week, one of the original drafters of the Congressional Review Act says that’s not how the 60-day clock was intended to work and, in fact, numerous regulations going back years could still be overturned using the Congressional Review Act:

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.

“There was always intended to be consequences if agencies didn’t deliver these reports,” Mr. Gaziano [who was involved in drafting and passing the law] tells me. “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.

There’s more. It turns out the CRA has a expansive definition of what counts as a “rule”—and it isn’t limited to those published in the Federal Register. The CRA also applies to “guidance” that agencies issue.

If this interpretation of the Congressional Review Act is correct, could it be used to repeal the FDA’s cigar rules? Opponents of the regualtuons say they are looking into the possibility. Inquiries to the FDA’s media office were directed to the agency’s Freedom of Information Act contact, but the FDA’s Tobacco Products’ page listing reports to Congress shows no reports on implementation of the Tobacco Control Act since 2013. (Even if a timely report was submitted, guidance documents necessary for enforcing the FDA cigar rules could still be challenged under Gaziano’s interpretation.)

For opponents of the FDA’s cigar regulations, the benefits of this line of attack are two-fold. First, it would eliminate the Senate filibuster as a means of stopping Congress from sending the repeal to President Trump. And second, unlike new agency rule-making to undo the regulation, using the Congressional Review Act would bar the FDA from reissuing the rule (or something similar under a different administration).

Of course, it’s hardly a given that the Republicans in Congress will try this strategy, which even its proponents admit is “aggressive” and would require significant “intestinal fortitude.” Still, an alternative pathway to permanent repeal of the FDA cigar rules has presented itself, if those who say they oppose out-of-control regulation are willing to back up their words with actions.

–Patrick S

photo credits: Stogie Guys