Thursday, December 9, 2010

Era of the Electronic Cigarette Officially Begins.

Court blocks FDA from prohibiting e-cigarettes.

It’s official: The e-cigarette is here. The right of a distributor of Chinese electronic cigarettes to market the product in the U.S. was solidly affirmed last week by a three-judge ruling in the U.S. Court of Appeals for the District of Columbia. The Food and Drug Administration’s refusal last year to allow importation of e-cigarettes by Sottera Inc. had been the basis for a lower court decision in Sottera’s favor. The earlier court ruled that e-cigarettes did not require FDA approval because they were neither new drugs nor new drug delivery devices. (The FDA is prohibited by an act of Congress from barring the sale of tobacco products outright.)

Last month, under a consent judgement worked out with California state Attorney General Jerry Brown in a related case, Florida-based Smoking Everywhere Co., another distributor of Chinese electronic cigarettes, had agreed not to target minors in its advertising, or to make claims that its products are safe alternatives to tobacco. The move came shortly after the FDA announced plans to regulated battery-powered e-cigarettes as new drug delivery devices, culminating in the Sottera lawsuit.

The legal argument before the appeals court hinged largely on semantics. The court found that electronic cigarettes are “battery-powered products that allow users to inhale nicotine vapor without fire, smoke, ash or carbon monoxide. The liquid nicotine is derived from natural tobacco plants.”

Here is the catch: “The FDA may only approve a product for marketing under the Federal Food, Drug and Cosmetic Act (FDCA) if it is safe and effective for its intended use,” the Appeals Court Justices ruled.  However, the FDA has “exhaustively documented” that tobacco products are unsafe for pharmacological use of any kind. The earlier court had concluded, stealing a page from “Alice in Wonderland”: “If they cannot be used safely for any therapeutic purpose, and yet they cannot be banned, they simply do not fit” within any conceivable regulatory scheme.

Hence the difficulties in the FDA’s attempt to regulate by agency fiat. E-cigarette manufacturers and distributors, having sensed an opening, are now ready to drive a convoy of semis right through it. This wasn’t a completely straightforward march, as the e-cigarette forces, in the appeals presentation, were required to thread the needle on such conundrums as: Does it matter that e-cigarettes do not, strictly speaking, contain “tobacco products?” Nicotine is a component of, not a product of, tobacco.

You see the problem. The relevant statutes have not been written with pure nicotine delivery devices in mind. In fact, having nicotine--but not the evil substance tobacco--in your product turned out to be a definitional advantage for the e-cigarette marketers: The court pointed out that, unlike products containing tobacco, which the FDA has found to be associated with “cancer, respiratory illnesses, and heart disease,” the FDA has manifestly NOT found that nicotine or tobacco-free products that deliver nicotine are inherently unsafe. And second, the “tobacco-specific legislation” invoked in earlier court cases “simply does not address products that deliver nicotine but contain no tobacco.”

Matthew Myers, president of the Campaign for Tobacco-Free Kids, said in a prepared statement: "This decision will allow any manufacturer to put any level of nicotine in any product and sell it to anybody, including children, with no government regulation or oversight at the present time. We urge the government to appeal this ruling."

Among the many  questions the ruling leaves open is the status of e-cigarettes under existing no-smoking regulations. That litigation has not even gotten underway.

See my earlier post on the e-cigarette question HERE.

For the full court decision, click HERE.

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