Nicopure and R2B Smoke-Free will appeal loss to FDA

The case goes to the federal Circuit Court of Appeals - last stop before the Supreme Court

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Nicopure Labs and the Right to be Smoke-Free Coalition will appeal the decision against them in their consolidated lawsuits challenging the FDA’s deeming regulations. The original ruling came last month from U.S. District Court Judge Amy Berman Jackson.

Judge Jackson delivered her decision on July 21, just one week before FDA commissioner Scott Gottlieb announced that the final deadline of the agency’s deeming regulations — the August 8, 2018 deadline to submit premarket tobacco applications (PMTA), or exit the market — would be postponed for four years, giving vape manufacturers a reprieve.

However, the four-year delay by the FDA doesn’t change the deeming rule’s predicate date. Products made after February 15, 2007 still face extinction after August 8, 2022. And there is still no way for manufacturers to introduce products made after August 8, 2016 without first receiving a marketing order from the agency. A marketing order requires submission of a PMTA, which could cost millions of dollars, and in no way guarantees approval.

Typically the DOJ defends executive actions by previous administrations, even ones the new administration disagrees with.

Now the plaintiffs have filed a Notice of Appeal in the U.S. Circuit Court of Appeals in Washington. If they lose at this level, they would only have the Supreme Court to appeal to.

“We believe in helping millions of adult smokers battle tobacco addiction through vaping products,” Nicopure CEO Jeff Stamler said in a press release. “We believe the FDA is doing a massive disservice to public health and we will keep fighting for the vaping industry to ensure these products will continue to help a growing number of people quit tobacco and start a new, smoke-free life.”

It is possible that the Trump Administration Department of Justice (DOJ) will decline to further defend the rule in court, which would result in a default win for the plaintiffs. That is unlikely though. Typically the DOJ defends executive actions by previous administrations, even ones the new administration disagrees with.

If the DOJ and FDA decline to defend the rule, there is the weird possibility of a federal court stepping in and allowing a group of anti-nicotine organizations to take on defense of the deeming regulations. The Campaign for Tobacco-Free Kids and several associated groups have asked to do just that in two related lawsuits against the FDA.

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Jim McDonald
I spend most of my time studying the regulatory, legislative and scientific challenges to vaping, advocating for our right to exist, and talking with others who do the same. Consider me a source for information, and feel free to agree or disagree with anything I say. I love good coffee and sweet Michigan cherries. My childhood hero was Gordie Howe.