FDA Appeals District Court Decision to Issue Injunction Against Regulating Electronic Cigarettes as Drugs/Devices

The Food and Drug Administration (FDA) has appealed a district court decision that I reported here in which Judge Richard J. Leon issued a preliminary injunction blocking the Agency from enforcing its asserted regulatory authority over electronic cigarettes as drugs/devices under the Federal Food, Drug, and Cosmetic Act.

According to an article in the Wall Street Journal: "The Food and Drug Administration is appealing a federal judge's ruling that the agency doesn't have the authority to regulate electronic cigarettes. The FDA on Monday night asked a federal appeals court in Washington to immediately stay an order that prevented the agency from blocking electronic cigarettes from entering the country. The FDA said it does have the authority to regulate some products containing nicotine as though they are drugs and devices, such as nicotine patches and nicotine lollipops. The agency said the judge was 'quite wrong to believe that no injury would result from the use of these harmful and addictive products.'"

The Rest of the Story

Readers should first of all understand that success for the FDA in this particular appeals case would not necessarily mean that the Agency has the authority to regulate electronic cigarettes as drugs/devices. The Appeals Court could overturn the preliminary injunction on two grounds: (1) finding that there is not a high likelihood of success of the legal challenge against FDA regulatory authority over electronic cigarettes under the Food, Drug, and Cosmetic Act; or (2) finding that an injunction against the FDA's ability to take e-cigarettes off the market would cause severe public health injury that outweighs the immediate economic harm that would be suffered by e-cigarette companies.

The issue of whether the FDA has the authority to regulate electronic cigarettes as drugs/devices, given the language of the recently enacted Family Smoking Prevention and Tobacco Control Act - which defines tobacco products as any products "derived from" tobacco - is a complex one and it will be interesting to see how the appeals court rules on that issue. That aspect of the ruling will provide a relatively good sense of how the issue will ultimately be disposed.

The issue of whether taking e-cigarettes off the market is necessary to prevent severe public health harm, however, is not one that is in any way unclear. I strongly disagree with the FDA's assertion that removing e-cigarettes from the market will protect the public's health. To the contrary, I believe that removing e-cigarettes from the market will cause severe and irreparable public health harm.

Why? Because a huge number of e-cigarette users are ex-smokers who have quit smoking successfully using these products. To deprive them of the choice to continue vaping an instead, force them to return to smoking, would severely harm their health. I simply do not see the public health protection resulting from a policy of forcing thousands of vapers to return to cigarette smoking.

While it remains to be seen whether the FDA has a valid legal argument on the first issue, I am sorry to say that on the second issue, the FDA has an invalid scientific argument.