Company files first lawsuit against the FDA's e-cigarette rule

A company has filed the first legal challenge to the Food and Drug Administration's (FDA) move to regulate e-cigarettes and cigars like traditional tobacco products.

Nicopure Labs LLC, a leading manufacturer of American made e-liquids, announced Tuesday that it has filed a lawsuit in the federal district court in Washington, D.C., challenging the “deeming” rule.

The rule finalized last Thursday allows the FDA, for the first time, to regulate cigars, e-cigarettes, hookahs, personal vaporizers and electronic pipes under the 2009 Family Smoking Prevention and Tobacco Control Act.

Nicopure Labs argues in its filing that FDA’s rulemaking process violated the Administrative Procedure Act and that the regulation violates the First Amendment.

“FDA’s rule does not protect the consumer from low quality products; instead, it places a disproportionate and unjustified regulatory burden on compliant companies such as ourselves, who are determined to drive the industry to the highest standards of quality and innovation,” Jason del Giudice, the company’s cheif technology officer and co-founder, said in a statement.

FDA's rule forces manufactures to put health warnings on product packaging and on advertisements, and prohibits sales to anyone under the age of 18, but it’s the provision requiring any product that hit store shelves after February 2007 to go through a costly approval process that has companies most distressed.

Industry leaders claim that provision alone will wipe them out of business since most of their products came out in 2009.

“Today we turn to the justice system to protect our rights and the rights of our customers because we believe in its fairness” Nicopure’s General Counsel and Chief Compliance Officer Patricia Kovacevic said in a statement. “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.”

Other companies are reviewing what options they have to fight back against a rule they say will stifle product innovation even if the 2007 predicate date is changed.

When asked if Fortem Ventures, which makes the e-cigarette brand blu, would also challenge the rule in court, the company's senior vice president Marc Michelsen said "we're not going to rule anything out."

“We have to look at what our options are,” he said.
Resource: http://thehill.com/regulation/court-battles/279413-company-files-lawsuit-challenging-fdas-new-tobacco-rule