Electric Cigarettes Industry Wins Victory in Court
A recent United States appeals court ruling has said that the government, specifically the Food and Drug Administration (FDA), cannot halt the sale or import of electric cigarettes under existing laws. A three-judge appellate panel upheld a lower court ruling stating that the FDA has no authority to block the sales of battery-powered nicotine devices. The FDA had appealed a January 2010 decision by Federal Judge Leon.
Because they are not marketed for therapeutic or smoking cessation purposes, the court ruled that electronic cigarettes should be regulated like tobacco products rather than like smoking cessation aids like nicotine gum or patches. The ruling means that the electric cigarette industry will not need to conduct expensive clinical trials to prove that their products are safe and effective to help smokers stop smoking.
Instead, the devices are to be regulated the same way as tobacco products, which have less stringent requirements than drugs or therapeutic devices. The FDA has statutory authority under the Tobacco Act of 2009 to regulate the marketing of traditional cigarettes and tobacco products. However, it is not authorized to restrict the sale of these products.
The case began in April 2009 when the FDA halted the import of electronic cigarettes; the agency labeled them as “unapproved drug-device combinations.” Electric cig companies sued and won a preliminary order that bars the FDA from enforcing its ban. The appeals court said that the electric cigarette industry was “likely to succeed” in a final court ruling in the case. The FDA sought to halt imports while the case was litigated, but the appeals court found that the ban would do “irreparable harm” to some companies.
“Although electronic cigs don’t contain the nearly 4,000 chemicals found in traditional cigarettes, we don’t see them as health or therapeutic devices,” explained Nick Evans of Red Dragon, the makers of mini ecigs, ecig battery replacements, and ecig cartridge replacements. “We applaud the courts for recognizing the true nature of our product and upholding the principle that the FDA overstepped its authority in its 2009 action.”
The electronic cigarette industry is careful not to market its products to minors and does not encourage nicotine use by non-smokers. They see their target market as current smokers who would like a smoking experience with fewer dangerous chemicals and would like to enjoy smoking in public locations.
Following the decision, the FDA told the press they are evaluating their future legal steps.
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