Nicopure is an independent company with no ties to Big Tobacco, their action states: “Such regulation will severely burden Nicopure and its operations, costing millions of dollars.”
“The Deeming Rule violates those provisions because, inter alia, its definition of ‘tobacco product’ and attendant proposed reach of its provisions is unambiguously foreclosed by, and is an unreasonable construction of, the text of the Act.”
Nicopure’s press release accompanying the suit filing states: “The FDA's Deeming Rule fails to consider the scientific evidence readily available to the agency regarding the safety and the public health benefits of e-cigarettes. The Deeming Rule is improper under the APA not merely because it fails any manner of scientific analysis, and is therefore arbitrary and capricious, but also because it is in direct conflict with Congress's intent to prevent smoking and aid cessation through the [Family Smoking Prevention and Tobacco Control] Act.”
The FDA’s Mitch Zeller, and former pharma employee, is at pains to point out research that claims to demonstrate many 0mg juices actually contain nicotine. It is this aspect of ‘may’ contain tobacco products that they are hiding behind in order to carry out the far-reaching clampdown.
In response to Nicopure’s case being filed, the FDA commented: “Although the FDA recognized that completely switching to e-cigarettes may reduce the risk of tobacco-related disease for individuals currently smoking conventional cigarettes, it found that e-cigarettes still pose a number of significant health and safety risks. Nicopure does not disclose its actual ingredients for its e-liquids, so what consumers are really inhaling is largely unknown.”
It continues: “The only nicotine-free e-liquids that the rule brings under the FDA’s regulatory authority are those that are made or derived from a tobacco product, or that otherwise meet the definition of a ‘component’ or ‘part’.”
The trouble with this is that Nicopure can’t know which of its products will fall under the deeming regs, as the FDA will not tell them.
American Vaping Association’s Gregory Conley expressed the feeling: “At the same time that England and France are making great strides in distributing truthful information about vaping to the public, the FDA is ramping up the rhetoric and relying on easily debunked junk science.”
Speaking about Zeller, Conley added: “[He] recognizes that unless you decimate nicotine-free e-liquids and open vapor system devices, there is no possible way for the agency to truly kill the industry.”