Today the US Appeals Court issued their ruling about whether the FDA could continue to block shipments of electronic cigarettes based on their assertion that the product is a New Drug. The ruling was clear; provided no therapeutic claims are made, the electronic cigarette should be regulated under the Tobacco Act rather than the FDCA (which would made the electronic cigarette a New Drug). The Judges of the U.S. Appeals Court include Barland, Kavanaugh, and Senior Circuit Judge Williams.
This decision is part of the larger case involving one e-cigarette company, Sottera, and the FDA regarding the classification of the electronic cigarette. The Judge presiding over this case, Judge Leon, has already made his opinion clear that the FDA is trying to overstep it’s regulatory jurisdiction.
Now that one Federal Judge and the U.S. Appeals Court has ruled against the FDA, it is unclear how the FDA will proceed. Bloomberg reported earlier today on the story and quoted Jeffrey Ventura, a spokesman for the FDA, as saying “We are studying the opinion and considering next steps”.
We hope the FDA realizes the potential of the electronic cigarette and works with the industry to create reasonable regulations that protect consumers and the many small businesses that currently make up the market.
To read the full decisions, download The U.S. Appeals Court Tells The FDA Electronic Cigarettes Are Not New Drugs