Court Won’t Throw Out ‘SE’ for Premium Cigars

The U.S. District Court for the District of Columbia on Feb. 4 refused a request to throw out the U.S. Food and Drug Administration’s substantial equivalence requirements for premium cigars, reports Halfwheel.

Three cigar trade groups had asked the court to “clarify” an August ruling that delayed those requirements until after the U.S. Food & Drug Administration completes a review of whether it should create a new, streamlined process for “premium cigars.”

As the court pointed out, that “clarification” was in fact a request to have the substantial equivalence requirements thrown out.

Judge Amit P. Mehta concluded that the court had no authority to vacate the substantial requirements under that argument. By giving the FDA the authority to regulate cigars under the Tobacco Control Act, Congress also gave FDA the authority to require premarket review for cigars, the court reasoned.

The next phase of the lawsuit will likely focus on the question of whether FDA acted properly when deciding to regulate “premium cigars” the same way as other tobacco products.

The plaintiffs will argue that FDA neither went through the proper steps nor had sufficient evidence to regulate “premium cigars” the same way FDA has chosen to regulate e-cigarettes, little cigars or hookah tobacco.

The FDA will not enforce its substantial equivalence requirements until it completes the review mandated in August. There is no established timeline for when that review might be completed.