Challenge to the FDA Deeming Rule Fails: Vapes May Still Be Banned This Year

A federal court just dismissed the first legal challenge to the FDA “deeming rule”, the rule that the FDA has used to justify banning any e-cigs manufactured after 2007 that haven’t received approval from the agency.

In Nicopure Labs, LLC v. FDA, vaping retailers and e-cigarette associations launched a sustained attack on the FDA’s deeming rule from multiple angles, all of which failed.

The plaintiffs challenged the deeming rule on First Amendment grounds through two separate claims: one against the prohibition on distributing free product samples and another against the prohibition on “modified risk” claims about e-cigs.

The judge, Amy Berman Jackson, dismissed both First Amendment arguments. While I think that the one about distributing free samples might be a bit of a stretch, her dismissal of the “modified risk” claims about e-cigs is a bit ridiculous. The FDA claims that this is required to protect public health, but anyone who has done a shred of research knows that vaping is significantly safer than smoking. Ironically, by preventing retailers and manufacturers from advertising a reduced risk, the FDA is actually harming public health. Moreover, they are at odds with the other developed countries who have fully accepted the benefits that e-cigs can provide for public health. Even our friends in the UK are able to get free e-cigs from the NHS to help them quit smoking.

Having been defeated with their First Amendment arguments, the plaintiffs also sought to challenge the deeming rule by claiming that it exceeded the FDA’s authority under the Family Smoking Prevention and Tobacco Control Act.

The Tobacco Act gives the FDA the authority to regulate cigarettes and smokeless tobacco products. It also allows the FDA to “deem” other “tobacco products” as subject to regulation.

The plaintiffs argued that so-called “open vaping systems” (aka anything with a tank that you can refill with the liquid of your choice), does not fall under the FDA’s authority because they are not made from tobacco products. Jackson dismissed this claim by arguing that open vaping system regulations are consistent with the Tobacco Act in that they are “components” of regulated products.

While this attempt certainly failed, I’m sure that we will see more vaping companies turn up the heat on the FDA now that the full implementation of the regulations is imminent. This is literally a matter of life and death for the vaping industry and the millions of people who have been able to quit smoking thanks to this amazing technology. It would be a shame if we as a country decide to allow a bunch of douchebags from the FDA, pharmaceutical companies, and Big Tobacco win this fight. If they win in their attempt to ban vaping it’ll be a massive loss for the American public.


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