The U.S. Food and Drug Administration lacks the authority to regulate electronic cigarettes as drugs or devices, an appeals court has ruled, upholding a lower court decision. According to a report from Bloomberg.com, the U.S. Court of Appeals in Washington says the FDA can only regulate e-cigarettes as a tobacco product. The ruling means the government can oversee the marketing of the products, not restrict their sale. E-cigarette maker, Sottera Inc., which does business as Njoy, argued in the case that its products, battery powered devices that generate a nicotine vapor instead of smoke, are tobacco products and not drugs. E-cigarettes are marketed as a tobacco alternative for “smoking pleasure,” rather than for therapeutic uses, the company says. “We’re thrilled,” Craig Weiss, president of Scottsdale, AZ based Njoy, said in an interview with Bloomberg. “Now we can continue to sell e-cigarettes under the regulations of the Tobacco Act.”
Yet in a later development, the FDA filed a petition to ask the entire U.S. Court of Appeals for the District of Columbia Circuit to hold a new hearing and review its appeal, according to The Wall Street Journal. At issue is how the FDA should regulate a nascent industry whose products have caught on with thousands of smokers who are seeking an alternative to their daily habit, said the report. E-cigarettes are battery powered tubes that turn nicotine filled liquid into a vapor mist. The appellate panel ruled that e-cigarettes should be regulated as tobacco products by the FDA, unless marketers make specific claims that the devices help smokers quit or provide other remedies, CSP Daily reports. The agency contends that e-cigarettes are drug or medical devices that require preapproval from the FDA, much like nicotine gums, patches or sprays. The agency began intercepting shipments of e-cigarettes from China two years ago, which triggered a lawsuit by the fledgling industry, the report said.
In its initial ruling, the Appeals Court stated in part, “The FDA’s refusal to admit Njoy’s products into the United States obviously destroyed the firm’s ability in the United States to cover its costs for purchase or production of e-cigarettes. The district court’s finding that this loss would be irreparable, absent an injunction, appears entirely reasonable. Regarding harm to third parties and to the public interest, the district court observed that the FDA had cited no evidence to show that electronic cigarettes harmed anyone. More significantly, the court rightly found that the FDA has authority under the Tobacco Act to regulate electronic cigarettes, enabling it to mitigate or perhaps extinguish any harm to public health. Given the likelihood of Njoy’s success on the merits, the irreparable harm to Njoy’s business, and the FDA’s unquestioned Tobacco Act authority to mitigate any public harm, the district court did not abuse its discretion in granting the preliminary injunction.”