NJOY Joins Fight Against FDA Rules

Asks Court to reverse ruling citing the First Amendment.

NJOY LLC, a company that develops, imports and distributes electronic nicotine delivery products, has asked a court to reverse a lower court’s decision that blocks e-cigarette companies from truthfully describing their products to consumers, on the grounds that it violates the First Amendment of the U.S. Constitution and prevents the public from obtaining important health information.

Separately, Iowa Attorney General Thomas Miller filed his own brief, calling on the court to allow manufacturers to provide information to help consumers make informed decisions about their health.

Both NJOY and the Iowa Attorney General filed amicus briefs Tuesday with the U.S. Court of Appeals for the District of Columbia. The briefs were filed in support of an appeal filed by another e-cigarette manufacturer, Nicopure, which previously sued the U.S. Food and Drug Administration (FDA) in 2016 and is appealing decisions made in that case.

At issue, is the FDA’s implementation of the Family Smoking Prevention and Tobacco Control Act’s Modified Risk Tobacco Product (MRTP) rule that subjects e-cigarettes to many of the same marketing restrictions as tobacco cigarettes. Under the rule, e-cigarette manufacturers can’t disclose truthful information that vaping products are less harmful than combustible cigarettes without pre-clearance from the FDA.

“There is compelling evidence in this case that the FDA’s misguided paternalism is not merely constitutionally unjustified, but could also have grave public-health consequences,” NJOY said in the brief. “The emerging scientific consensus is that e-cigarettes are vastly less likely to cause cancer, heart disease and other serious ailments than combustible cigarettes.”

“The FDA’s ban on truthful, non-misleading statements about the relative health risks of e-cigarettes and the substances contained in e-cigarette vapor will inevitably keep millions of smokers from hearing facts that could persuade them to switch to e‑cigarettes—a decision that could ultimately save their lives,” according to NJOY’s brief.

NJOY CEO Douglas Teitelbaum said the Company believed it was critical to file this brief to raise the public’s awareness that e-cigarettes have been shown in studies to be a safer alternative to smoking and that they should be used by smokers who cannot, or will not, quit with an FDA-approved cessation aid.

“This is first and foremost a public safety issue. At NJOY, we want to use our platform and resources to counter a misinformation epidemic where over 61% of the smokers in this country believe there is no material difference between e-cigarettes and tobacco cigarettes,” Teitelbaum said. “This has to change.”

In his filing, Attorney General Miller said the current rules place “a roadblock in public health advocates’ path and frustrates harm-reduction objectives by requiring pre-market review of truthful, non-misleading claims that compare the health risks of using combustible tobacco products to the reduced health risks of using” electronic nicotine delivery systems (ENDS) or e-cigarettes.

“The FDA accepts the overwhelming consensus among researchers: that ENDS are less harmful than combustible tobacco. Iowa wants smokers to hear that message from ENDS manufacturers at the point of sale (and everywhere else) until it changes their behavior—because when it does, it will have saved their lives,” according to the Attorney General’s brief.


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