Many in the electronic cigarette industry believe that Judge Leon’s ruling against the FDA is the final word in the battle over the future of electronic cigarettes. That is not the case. It was, however, a legal opinion about the potential outcome of a trial regarding the classification of the electronic cigarette. Judge Leon gave opinions on the 3 arguments that the FDA was making to show electronic cigarettes are a drug delivery device and that they have a legal right to stop the importation.
Structure Or Function Claims
The FDA argues that electronic cigarettes contain nicotine, a drug, and it effects the way the body works so it is a new drug.
Judge Leon answered this argument by stating, “Because plaintiffs sell their electronic cigarette products for customary recreational use, those products (just like traditional cigarettes) are properly excluded from the meaning of drug or device under the FDCA.”
The argument that the FDA is making here is the same one they made when they tried to classify tobacco cigarettes as a new drug. That didn’t work either.
The FDA argued that the sellers were making therapeutic claims, thereby making the electronic cigarette a new drug.
By definition, a new drug must be “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.”
Judge Leon’s opinion was, “there is no basis for FDA to treat electronic cigarettes, as they are marketed by the plaintiffs in this case, as a drug-device combination when all they purport to do is offer consumers the same recreational effects as a regular cigarette.”
He also stated, “Nor does the fact that plaintiffs advertise their products as a healthier alternative to traditional smoking mean that electronic cigarettes quality as a drug-device combination under the FDCA.”
So, making health claims does not make a product a new drug. However, he did mention that making quit smoking claims or nicotine treatment claims DOES make the electronic cigarette a new drug. In this case, there was no evidence either company was making such claims.
Harm To Third Parties And The Public Interest
Lastly, the FDA argued that stopping the importation of electronic cigarettes was for public health. A sad argument at best considering that electronic cigarettes are the alternative to a product that kills over 400,000 Americans each year.
Judge Leon found that “Together, both Smoking Everywhere and NJOY have already sold hundreds of thousands of electronic cigarettes, yet FDA cites no evidence that those electronic cigarettes have endangered anyone. Nor has FDA cited any evidence that electronic cigarettes are any more an immediate threat to public health and safety than traditional cigarettes, which are readily available to the public.”
Judge Leon found that this was “yet another example of FDA’s aggressive efforts to regulate recreational tobacco products as drugs or devices under the FDCA”.
So what does this mean?
It means that the FDA can not legally stop the importation of electronic cigarettes by Smoking Everywhere or NJoy. It means Judge Leon believes that if this goes to trial, the e-cigarette suppliers will win. It means that Judge Leon believes the electronic cigarette is a reduced harm tobacco product, as outlined in the Tobacco Bill.
The FDA can continue to stop other companies shipments, but leave themselves open to future lawsuits. Without specific therapeutic claims (i.e. quit smoking and treating nicotine withdrawal claims), they have no basis to stop the products until such time as they do prove it is indeed a new drug or the electronic cigarette is legally classified as a tobacco product as Judge Leon suggests. What is interesting is that Judge Leon made no mention of the distinction between the zero nicotine e-liquid and that which contains nicotine. Without nicotine, the e-liquid contains no part of tobacco. And the batteries, chargers, atomizers, and cartridges contain no part of tobacco. So it appears that the only thing that could possibly be included in the definition of a “tobacco product” is e-liquid that contains nicotine. And this has not been settled either.