An important legal victory was recently won by both sellers and users of electronic cigarettes. On January 14, 2010, federal district court judge Richard Leon ruled that e-cigarettes can not be regulated as a ‘drug device’ by the FDA. As a result, the FDA can not ban the importation of electronic cigarettes.

The Facts of the FDA’s Case Against Electronic Cigarettes

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.

The FDA’s Reasoning

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’s Decision In Favor Of Electronic 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.

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

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

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

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

Can Electronic Cigarette Smokers Breathe Easier?

There’s no doubt that this is an important victory for the electronic cigarette industry. However, I would be surprised if the FDA doesn’t try another tack in its effort to halt sales of e-cigs.

Big Tobacco companies won’t be happy with this ruling, and they will surely use their influence to keep pressure on the FDA to curb the sale of electronic cigarettes. But Judge Leon’s ruling, along with mounting pressure from users and medical professionals, will make it difficult for them to win in the end.