FDA Stands By Rules for Nicotine-Free E-Cigarettes

WASHINGTON, D.C. — Some e-liquids may not contain nicotine, but according to the Food and Drug Administration (FDA), the newly enacted deeming rule still applies.

Answering a legal challenge from Nicopure Labs LLC, the FDA said all e-cigarette products "present significant risks to the public health," even when nicotine-free liquids are consumed, the Winston-Salem Journal reported.

Within days of the agency released the final deeming rule, Tampa, Fla.-based Nicopure Labs filed a lawsuit alleging the deeming rule would subject electronic cigarettes and other vaping products to more onerous restrictions than combustible cigarettes under the 2009 Family Smoking Prevention and Tobacco Control Act.

In its court filing, Nicopure Labs, who is not affiliated with any tobacco company, said the FDA's rulemaking process violated the Administrative Procedure Act, and that the deeming rule violates the First Amendment to the United States Constitution, the company said.

According to the news report, the question at hand is whether e-cigs and vaporizers, when used with nicotine-free liquids, are tobacco products, as claimed by the FDA.

Nicopure Labs began operations in 2009, nearly two years after the Feb. 15, 2007 grandfather date spelled out in the deeming rule.

Nicopure contends the FDA's rulemaking process violates the Administrative Procedure Act, and that the deeming rule violates the First Amendment of the U.S. Constitution.

In July, a federal court judge in Washington, D.C., ordered a complaint filed by the Right to be Smoke-Free Coalition and nine other groups against the FDA, FDA Commissioner of Food and Drugs Robert Califf and Secretary of Health and Human Services Sylvia Burwell to be consolidated with Nicopure Lab's lawsuit, as CSNews Online previously reported.

Judge Amy Berman Jackson set an Aug. 16 deadline for the FDA to respond to the lawsuits and scheduled a hearing for Oct. 19.

"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," the FDA said in its response filed last week.

"Nicopure does not disclose its actual ingredients for its e-liquids, so what consumers are really inhaling is largely unknown," the agency added.

According to the Winston-Salem Journal, the FDA claims that because most e-liquids are used in refillable devices, even if the original liquid used contained no nicotine, there is no guarantee that subsequent e-liquid use will be nicotine free.

The FDA claimed Nicopure has shown no proof of being harmed by the new regulations because it did not assert that its nicotine-free e-liquids are intended to be mixed with liquid nicotine.

"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 agency said.

In addition, the FDA said the regulations' free sample ban "regulates conduct, not speech," and its deeming regulations "are modeled after the premarket review of therapeutic drugs under the Federal Food, Drug and Cosmetic Act."