Judge Lays Smackdown On FDA Over E-Cigarette

Very recently, e-cigarette users and retailers gained important legal victory. On January 14, 2010, a federal district court judge ruled that the FDA can not ban the importation of the e-cigarette. Judge Richard Leon ruled that the FDA may not regulate the e-cigarette as a "drug device".

The parties to the suit were Smoking Everywhere, Njoy, and the FDA. Both Smoking Everywhere and Njoy are retailers of the e-cigarette in the United States. Neither Smoking Everywhere nor Njoy manufacture e-cigarettes. Instead, they both import e-cigarettes from foreign manufacturers and sell those imported e-cigarettes in the United States.

The events leading to the litigation began back in the fall of 2008 when the FDA decided to ban shipments of e-cigarettes that were destined to arrive at both Smoking Everywhere's and Njoy's e-cigarette retail businesses. The FDA claimed that the e-cigarettes were "drug devices", and accordingly, that they had the power to impose the ban. As a response to the ban, Smoking Everywhere sued the FDA. Later, Njoy entered the suit as a co-plaintiff.

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. In making his decision, Judge Leon made the following points:

1) Under FDA vs. Brown & Williamson Tobacco Corp., a United States Supreme Court Case, the FDA has no authority to regulate tobacco products as "drug devices."

4) The recent Family Smoking Prevention and Tobacco Control Act, which does give the FDA authority over "tobacco products", broadly defines the the term "tobacco products" and the e-cigarette fits within that definition.

2) Congress has a clear intent to not outright ban tobacco products.

3) The e-cigarette is a "tobacco product", so long as no claims are made about its ability to cure nicotine addiction.

4) The FDA may regulate tobacco products, but it cannot outright ban them.

A more through discussion of the case can be found