In Process: US. Federal District court judge makes serious error regarding the import of e-cigarettes..

January 15, 2010 - Judge Richard Leon for the U.S. District Court for Washington DC on Thursday, January 14th granted a preliminary injunction barring the Obama administration from trying to regulate electronic cigarettes and prevent them from being imported into the United States.

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA: SMOKING EVERYWHERE, INC., Plaintiff and SOTTERA, INC., d/b/a NJOY, Intervenor-Plaintiff v. U.S. FOOD AND DRUG ADMINISTRATION, et aI., Defendants. Civil Case No. 09-771 (RJL) MEMORANDUM OPINION (January H, 2014) [# 2 and 24]

At issue in the case was whether e-cigarettes were ''drug devices" as claimed by the FDA or whether they were "tobacco products" as claimed by Smoking Everywhere and Njoy. If e-cigarettes were "drug devices", the FDA would have the authority to ban them. If, however, e-cigarettes were "tobacco products" then the FDA would not have the authority to ban the importation of e-cigarettes.

Judge Leon decided that e-cigarettes, under the facts of the case before him, were "tobacco products" under the current law. Accordingly, the FDA had no right to outright ban them.

U.S. District Judge Richard Leon of the District of Columbia found that the agency had overstepped its bounds by trying to regulate so called e-cigarettes as “drug-device combinations” instead of as a tobacco product under the recently passed Smoking Prevention and Tobacco Control Act.

Judge Leon’s ruling included a court order instructing the FDA to release detained shipments of electronic cigarettes and to halt further detainments of the devices pending the completion of a full trial.

A set back for public health

a Federal District Judge today ordered the FDA to cease detaining shipments, preventing them from entering the United States, and that the products may not be regulated as drug delivery devices.

..
Matthew L. Myers, president of the antismoking advocacy group Campaign for Tobacco-Free Kids, said the ruling opened “a gaping loophole” in the F.D.A.’s ability to regulate non-tobacco products containing nicotine.
"This is a misguided and mind-boggling decision by the court," said National Research Center for Women & Families President Diana Zuckerman. "Nicotine is an addictive drug, and therefore e-cigarettes are a drug delivery system."


References: Judge OKs imports of e-cigarettes, blasts FDA, Jeremy Pelofsky and Susan Heavey, Reuters, 1/14/2010; District Court Rules That FDA Cannot Regulate E-Cigarettes as Drug-Device Combination Products; FDA Detention Decisions Are Reviewable by Courts, by Peter M. Jaensch, FDA Law Blog, 1/14/2010; Federal Court Deals Blow to Public Health in Ruling FDA Cannot Regulate E-Cigarettes as Drugs or Medical Devices, Matthew L. Myers, President, Campaign for Tobacco-Free Kids, 1/14/2010.