The U.S. Food & Drug Administration (FDA) has asked a federal court in Maryland to order that FDA’s substantial equivalence deadline should begin no sooner than 10 months with an additional year for FDA to evaluate the applications. That deadline would be the date by which every cigar sold in the U.S. would be required to have applied for some sort of FDA approval in order to be sold.
Last month, District Court Judge Paul W. Grimm threw out FDA’s August 2021 deadlines for substantial equivalence following a lawsuit brought about by a group of health groups and Maryland pediatricians. They claimed that FDA’s decision to delay the deadline for tobacco companies to apply for FDA approval was a risk to public health and was adding additional burdens on them, as they were now having to do the job of informing the public about the risk of tobacco.
While the FDA disagreed with the plaintiffs, Grimm did not. He ordered both sides to come up with plans regarding how to move forward with the applications for product approvals.
The plaintiffs presented a plan that would call for applications to be due in four months and then FDA to have an additional year to review and rule on the application.
FDA is opposed to that plan—arguing for at least 10 months before the submissions were due and then a year to review—for a variety of reasons. Its two main objections are that the agency believes that four months would produce a flood of applications, many of which would be incomplete or not filed properly, forcing the agency to waste time.
Instead, it’s proposing the 10-month window so that it can finish reevaluating its substantial equivalence approval process. Earlier this week, the agency extended the period for public comment on the new process by a month.
Furthermore, it also argues that the plaintiffs own arguments about the harm no longer make sense given the delays.
“Under their own remedial proposal, Plaintiffs would not receive the additional information they seek here for some 17 months: 4 months for the submission of premarket applications, a year for review, and an additional month for information to be released, see Pls.’ Remedy Br. at 8; 21 U.S.C. § 387j(a)(4)(B), so they provide no reason to think they would be irreparably harmed by not having that information for some hypothetical period of time beyond that point.”
FDA says that it believes that it will receive between 5,424-6,764 applications for premarket products, 2,625 of which will be for cigars.
To learn more about substantial equivalence, click here.