Posted on Leave a comment

Nicopure and R2B Smoke-Free to appeal FDA defeat

As predicted by some, Nicopure Labs and the Right to be Smoke-Free Coalition, who lost a lawsuit to the FDA taking on the FDA’s deeming regulation, are to appeal U.S. District Court Judge Amy Berman Jackson’s decision.

The verdict came on July 21, shortly before new FDA commissioner Scott Gottlieb postponed the much-feared deeming regulation date of August 8, 2018, a deadline that poses a huge threat to vaping, with manufacturers set to be forced to submit their products in an expensive, unpredictable premarket tobacco application (PMTA) to continue selling their products.

Unfortunately, despite the deadline being pushed back to August 8, 2022, it still exists and the predicate date remains in place. Furthermore, a marketing order from the FDA is needed to sell products made after August 8, 2016, and the only way you can get one of those is by submitting a PMTA. So there’s a lot riding on this appeal, even if it’s not the only avenue vapers are trying.

It’s high stakes now: fail in the U.S. Circuit Court of Appeals and the only option left for Nicopure and R2B Smoke-Free would be the Supreme Court. But the Notice of Appeal has been filed and we eagerly wait to see what transpires.

Nicopure CEO Jeff Stamler accused the FDA of “doing a massive disservice to public health” with their deeming regulations, and said that he was on the side of millions trying to quit smoking through vaping. Stamler added that Nicopure will continue to battle for the vape industry and carry on helping those attempting to end tobacco addiction and live a cleaner life.

The Department of Justice (DOJ) could theoretically give up fighting for the rule in the courts, although we aren’t sure whether the Trump Administration will act differently to the Obama Administration. Precedent says that the DOJ will defend the deeming regulations.

But let’s suppose that the Trump Administration’s DOJ and FDA do let the rule side – that still may not be the end. In principle, a federal court could hand responsibility to another party, in this case likely an anti-nicotine coalition headed up by the usual suspects. Indeed, the Campaign for Tobacco-Free Kids will be eyeing up getting involved if they can, having done that in the past with lawsuits versus the FDA.

All that considered, it’s hard to see how a vaper in the United States can feel free at the moment.

Leave a Reply

Your email address will not be published. Required fields are marked *