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Attorneys File Appeal In Lawsuit About FDA’s Deeming Rule

Attorneys File Appeal In Lawsuit About FDA’s Deeming Rule

 

Attorneys File Appeal In Lawsuit About FDA’s Deeming Rule

The debate around the Food and Drug Administration’s “Deeming Rule” continues to heat up, and it'll shortly reach American courtrooms. There have been a few lawsuits announced recently challenging the rule, which we've covered in depth on this blog, the latest is an appeal from the original company that challenged the rule: the makers of Halo E-Liquids, Nicopure Labs.


Attorneys representing Nicopure, the Right to be Smoke-Free Coalition (R2BSF) which is comprised of a handful of other local advocacy organizations formally entered an appeal in the U.S. District Court for the District of Columbia for the decision in their lawsuit challenging the FDA’s Deeming Rule.


In the appeal, the plaintiffs take aim at numerous components of the regulation - they argue that the FDA itself has acknowledged the health benefits of vaping as compared to smoking, even as its own rules prevent the vapor industry from sharing this fact with consumers. Further, by preventing those in the vapor industry from helping individuals select or set up a device, and by prohibiting them from sampling devices or flavors to find a fit, the FDA is in effect making it more difficult rather than easier for smokers to quit.


What Is the Deeming Rule?


This is a provision that adds vapor products to the Family Smoking Prevention and Tobacco Control Act. It allows the FDA to regulate and approve any vapor products brought to market after February 15, 2007, even though it didn't take effect until nearly a decade later, leaving virtually every vapor product on the market in a legal gray area, since they were released without FDA approval due to the fact said approval wasn't required at the time.

 

There are some aspects of the rule that the vapor industry isn't arguing. For one, it’s made some common-sense regulatory decisions, such as prohibiting the sale of vape products to anyone under the age of 18 and requiring sensible health warnings to consumers.

This reasonable legislation comes with a price. Inside the rule is language that consistently equates the dangers of smoking combustible cigarettes with vapor products, which has led to widespread misinformation campaigns by anti-vapor advocates that cite the FDA directly.

Background


In May of 2016, Nicopure was the first company to challenge the Deeming Rule after it was passed into law, arguing that the rule could “decimate” the e-cigarette industry.


“Today we turn to the justice system to protect our rights and the rights of our customers because we believe in its fairness”, said Nicopure Labs General Counsel and Chief Compliance Officer, Patricia Kovacevic. “The government’s role is not to regulate for the sake of regulation; regulation must be based on sound science and robust procedure, and it must accomplish certain public health goals.”


In July 2017, a judge had ruled in favor of the FDA, giving the vaping industry its first legal setback against the much-loathed rule. In that ruling, Judge Amy Berman Jackson gave an awkward statement to vapers assuring them that the Deeming Rule was not intended to ban e-cigarettes, but only to regulate them the same as combustible cigarettes.


We'll be following this case as it makes its way through the appeals system.

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