Tag: substantial equivalence

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

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

    Photo: Tobacco Reporter archive

    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.

  • SE approval for S&M’s Riverside

    S&M Brands has received substantial equivalent orders from the U.S. Food and Drug Administration on its redesigned Riverside cigarette brand. S&M Brands is one of the few companies, behind Lorillard, that has navigated the Tobacco Control Act to obtain approval of a new cigarette tobacco product, and the first to obtain approval of a full line of king and 100s in regular and menthol.

    “We are treating this as a milestone in the industry, for our company and the industry as a whole,” says Steven Bailey, president, S&M Brands.

    “Introducing a new tobacco product under FDA regulation is an arduous, technical and scientific process that takes substantial time and resources. We felt, however, that improving our Riverside product was paramount for our adult customers, so our excellent in-house team, together with our outside consultants, worked tirelessly with the FDA to navigate the substantial equivalent process.

    “We believe this achievement demonstrates that our company is staffed up for regulatory compliance to be around for our distributor and retail partners and customers for the long haul.”

    The redesigned Riverside brand will be distributed to retailers and available to consumers by Oct. 15, 2014.