FDA loses in court

A far cry from total victory but one step closer for electronic cigarettes and final freedom from the clutches of Big Tobacco!

A U.S. federal appeals court in a decision Tuesday found that as long as electronic cigarettes aren't marketed as a way to treat or cure a disease, the U.S. Food and Drug Administration has no authority to block the importation of the battery-powered products.read more...

The U.S. Court of Appeals in Washington said today 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. read more...

The U.S. Food and Drug Administration can only regulate "e-cigarettes" as tobacco products and not as drugs, and thus cannot block their import, a U.S. appeals court ruled on Tuesday. read more...

NJOY, the country's most popular electronic cigarette brand, is pleased to announce that the U.S. Court of Appeals for the District of Columbia issued a ruling in the company's favor, rejecting the U.S. Food and Drug Administration's argument that NJOY's electronic cigarettes are drug delivery devices. read more...

A U.S. Court of Appeals today issues a judgment prohibiting the FDA (and thus the police powers of the U.S. government it was employing) from keeping NJOY (and thus others) from importing e-cigarettes into the country as an unapproved medical device/drug. This is good news indeed for public health. read more...

Electronic cigarettes moved a step closer to being regulated just like mainstream tobacco products on Tuesday when a federal appellate court unanimously upheld an injunction against the Food and Drug Administration’s attempt to ban them or regulate them more strictly as drugs. more...

Implications of the Decision

While by no means the final disposition of this issue, the Appeals Court's decision is important, because it gives us a fair indication that the courts are likely to interpret the Tobacco Act and Brown & Williamson decision in exactly the way that I argued in my amicus brief: electronic cigarettes are clearly defined as tobacco products, and absent any therapeutic claims, must be regulated as tobacco products under the Tobacco Act rather than as drug/device combinations under the FDCA.

Ultimately, I believe this would be in the best interests of the public's health. Electronic cigarettes appear to be a much safer product than regular cigarettes and there is strong anecdotal evidence that they are helping many people to successfully quit smoking. Thus, they truly have life-saving potential. While regulation of the marketing claims, access to minors, and other aspects of electronic cigarettes are appropriate and will help assure consumers of their relative safety, allowing these products to remain on the market enables the public to take advantage of this unique innovation. Removing them from the market, as would essentially be required if they were regulated under FDCA, would cause irreparable harm to thousands of ex-smokers who would be forced to return to smoking if the electronic cigarettes they have used to successfully quit smoking were no longer available. the rest of the story