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News: Judge Rules Against Industry Challenge to FDA Cigar Regulations

16 May 2018

Judge Amit P. Mehta of the U.S. District Court for the District of Columbia issued a 70-page decision yesterday in CAA v. FDA, largely ruling against the cigar industry groups that brought the legal challenge to the U.S. Food and Drug Administration’s (FDA) regulation of premium cigars and other tobacco products.

The Cigar Association of America, International Premium Cigar & Pipe Retailers Association, and Cigar Rights of America filed the legal challenge last year claiming the FDA’s move to extend tobacco regulations to cigars and other tobacco products violated the Administrative Procedures Act, as well as the First and Fifth Amendments to the Constitution.

The one win for the industry groups relates to pipe tobacco. The Obama-appointed judge found the FDA was “arbitrary and capricious” when it designated tobacco retailers who blend pipe tobaccos in-store as domestic manufacturers under that Tobacco Control Act. That issue was remanded back to the FDA for further consideration.

The judge rejected claims that the FDA violated the Administrative Procedures Act when enacting the deeming rule, putting cigars under the Tobacco Control Act. He also rejected claims that the large cigar warning labels violate the Constitutional rights of cigar manufacturers who were required by the law to put health warnings on products and advertisements for cigars. (The picture above is of required warning labels in France, which are only slightly larger and more colorful than what is required under the FDA.)

Although the judge noted the “basic unfairness” of enforcing the warning labels and associated costs while the FDA was reconsidering the regulations and may soon change them, he ultimately deferred to the agency’s authority.

Judge Mehta’s decision can (and very likely will) be appealed to the U.S. Court of Appeals for the District of Columbia Circuit. An adverse ruling by a three-judge panel of that court could then be petitioned for review “en banc” by the full court, after which the U.S. Supreme Court could be asked to review that decision.

Analysis

Legal precedent is stacked against those challenging executive agency rules. The “Chevron Doctrine” gives wide deference to executive branch agencies when it comes to interpreting the law. As a result, an agency like the FDA gets the benefit of the doubt in the eyes of federal courts when it comes to interpreting the limits of its authority.

The good news is, in addition to a likely appeal, this isn’t the only legal challenge to the FDA rules. A lawsuit filed by Global Premium Cigars in Florida includes additional claims that the FDA’s actions violate the Regulatory Flexibility Act, designed to protect small businesses from over-burdensome regulations. And an additional lawsuit brought by El Cubano Cigars and the Texas Cigar Merchants Association in Texas challenges the regulations including the warning label requirements.

If any of the various appellate courts split on an issue, it increases the likelihood the U.S. Supreme Court could weigh in on the issue. Although the odds are still long, legal experts believe there is an increasing skepticism on the Supreme Court for the deference afforded executive branch agencies under the Chevron Doctrine.

Ultimately, though, the best hope for stopping FDA regulations of cigars remains outside the courts. Short term, the FDA’s restarted rulemaking process could provide relief for the cigar industry, as the Trump-appointed FDA commissioner has already initiated a new direction for tobacco regulations.

The more fundamental, if difficult, solution is to repeal the FDA’s authority over premium cigars. Once the FDA was granted the power in 2009 to extend its authority over cigars, it was inevitable that eventually the agency would exercise that power.

Back in 2009, some in the cigar industry weren’t particularly worried about the FDA’s new powers over tobacco because the law’s primary target was cigarettes. While it may have been true that cigarettes were the primary target, it was short-sited to think FDA regulation wouldn’t eventually expand to cigars.

Cigar maker Steve Saka provided his reaction to yesterday’s ruling in a Facebook post: “Basically the court is saying that what the FDA is doing is wrong and unjust, but legal… This is a byproduct of an inept Congress that lacks the moral fortitude to fix the colossal mistake they created and bureaucracy run amok. It is beyond frustrating and infuriating.”

In short, if you’re looking for someone to blame for yesterday’s ruling, don’t focus on the judge, but on the Congress that authorized the FDA’s regulation of cigars in the first place. And don’t forget: Today’s Congress still has the power to repeal it.

Patrick S

photo credit: Stogie Guys

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