Judge Throws Out FDA Regulation Cigars Industry Beats FDA In Court

Premium cigars win in long-awaited ruling

It’s a good day for lovers of good cigars. Last Thursday, August 10th 2023, Judge Amit P. Mehta of the U.S. District Court for the District of Columbia dealt a decisive blow against the over-regulation of premium cigars. In 2014, despite fervent objections, the FDA put in place rules that classified and regulated premium cigars with the same guidelines as lower quality “mass-produced machine rolled cigars  typically available at convenience stores”, as opposed to the “handmade or hand rolled” varietals available here. Specifically, the FDA defined premium cigars as having all eight of the following characteristics:

(1) are wrapped in whole tobacco leaf

2) containing a 100 percent leaf tobacco binder

3) contain at least 50 percent (of the filler by weight) long filler tobacco

4) are handmade or hand rolled

5) have no filter, nontobacco tip, or nontobacco mouthpiece

6) do not have a characterizing flavor other than tobacco

7) contain only tobacco, water, and vegetable gum with no other ingredients or additives

8) weigh more than 6 pounds per 1,000 units.

Problems with the original rule

The problems with this 2014 rule have been obvious for quite some time. Last July, Judge Mehta pronounced the deeming rule that the premium cigar industry was held under to be “arbitrary and capricious”. In supporting his claim, Judge Mehta relied primarily on two basic issues with the FDA’s filing. Despite FDA’s reliance on the health claims of cigar smoking in substantiating the need for this regulation, Judge Mehta noted that only 3.3% of cigar smokers smoke daily; this low level of consumption significantly limits any health effects of cigars. He also noted the negligible youth use of premium cigars, especially in comparison to machine rolled cigars.

After these glaring issues came to light, Judge Mehta was left with two options:

  • Remanding without Vacatur – Had he chose this option, Judge Mehta would have simply instructed the FDA to restructure its regulation to address the issues in its previous filing. This would have been a lengthy process, during which the current regulations would not apply to premium cigars, but it would have given the FDA a straightforward path to new regulation.
  • Vacating the Rule – With this option, Judge Mehta would have simply vacated the current regulation in its entirety. In recognition of the glaring issues in the FDA’s filing and attempted regulatory process, Judge Mehta would force the FDA to restart the process entirely, if it wished to restart the process at all.

Last Thursday’s decision

On this past Thursday, Judge Mehta made clear that “the [FDA] failed to consider data before it concerning the use of premium cigars and the health effects of such use”. Specifically, Judge Mehta noted that “The [FDA] then ignored relevant data in the record that commentors had highlighted and inexplicably made a ‘no data’ finding” in conflating premium cigars with machine rolled cigars.

By lumping premium cigars in with other, cheaper, lower-quality brands, Judge Mehta’s order ruled that the FDA’s regulation had simply failed to take into account any relevant differences between the two, and had, in effect, regulated the premium cigar industry by the standards of a different product. In recognition of this lack of discernment in distinguishing premium cigars from their low-quality counterparts, Judge Mehta simply vacated the FDA’s rule: exempting the premium cigar industry from *all regulation*.

What does this mean for the future

This is an important win for the cigar industry. It will mean the ends of significant burdens placed on cigar makers that distract from their focus on the quality of their final product. As the President of the Cigar Association of America (one of the plaintiffs in this case), David Ozgo said in a statement released soon after the ruling “This is a big victory for cigar enthusiasts across America. The evidence clearly showed the public would receive little benefit resulting from FDA regulation of premium cigars. Moreover, regulation would add burdensome costs to all premium cigar manufacturers which cannot be justified.”

Despite the sweeping breadth and depth of the victory, Thursday’s success may not last forever. Judge Mehta’s ruling does not bar the FDA from beginning this process anew. Future regulation from the FDA may come, although the extensive process of regulation likely means that any regulation on premium cigars is years down the line. The “public comment” period on any fresh regulation must legally last for at least 60 days.

Even in the future where such regulation is pursued (premium cigars currently sit at the lowest enforcement priority level among tobacco products at the FDA), such regulation will almost certainly be tied to the actual effects of premium cigars, instead of forcing the premium cigar industry to account for the negative effects of another. No matter what else happens, this victory is no small thing.

A full link to Judge Mehta’s order can be found here.

Please view the video below to see what Rocky Patel on KMA Talk Radio had to say this past Saturday on the ruling:

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