July 12, 2019 Charlie Minato FDA/Deeming Regulations,  News

Federal Judge Says Substantial Equivalence Applications are Due May 12, 2020

A federal judge in Maryland has ruled that cigarmakers have until May 12, 2020, to submit applications for substantial equivalence, about 450 days earlier than cigarmakers have expected.

Judge Paul W. Grimm made the decision as part of a lawsuit brought by health groups and pediatricians against the U.S. Food & Drug Administration (FDA).

In May, Grimm threw out FDA’s August 2021 deadlines for substantial equivalence. The plaintiffs 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.

Grimm ruled in favor of those claims, with his findings nearly exclusively mentioning e-cigarettes and vaping products and the youth use of those products. Cigars were not mentioned by Grimm in today’s ruling.

After the May decision, Grimm asked for both sides to present plans for what the new substantial equivalence process should look like. The plaintiffs asked for a plan that would require applications to be due in four months, FDA asked for a plan that would start in 10 months.

It’s unclear whether the May 2020 date will stick. The cigar industry—through six separate plaintiffs—has asked a federal judge in Washington, D.C. to throw out Grimm’s ruling. They argue that the Maryland-based pediatricians and health groups were already denied standing in the matter by the D.C.-based court that is handling the cigar industry lawsuit.

American Academy of Pediatrics American Academy of Pediatrics — Maryland American Cancer Society Cancer Action Network American Heart Association American Lung Association Campaign for Tobacco-Free Kids Cynthia Fishman David Myles Deeming Regulations FDA Leah Brasch Linda Goldstein Public Health Intervenors Steven Hirsch Truth Initiative U.S. Food & Drug Administration
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Charlie Minato

I am an editor and co-founder of halfwheel.com/Rueda Media, LLC. I previously co-founded and published TheCigarFeed, one of the two predecessors of halfwheel. I have written about the cigar industry for more than a decade, covering everything from product launches to regulation to M&A. In addition, I handle a lot of the behind-the-scenes stuff here at halfwheel. I enjoy playing tennis, watching boxing, falling asleep to the Le Mans 24, wearing sweatshirts year-round and eating gyros. echte liebe.

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