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.

Therapeutic Claims

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.”

Conclusion

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.

Our Conclusion

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.

The new Marlboro Brand Protection Act as some are calling it, was signed into law by president Obama on June 22nd, 2009. The actual bill is called H.R.1256, The Family Smoking Prevention and Tobacco Control Act and essentially gives the FDA regulatory control over tobacco products. Many argue that the Bill simply maintains the current market share by Philip Morris, who helped “kraft” the Bill H.R.1256 has the potential to put very tight restrictions on smoking alternatives that could have otherwise had a net positive effect on public health.

Whether or not it is a good bill or a bad bill, that seems to be in the hands of the FDA who will create the procedures and regulations to govern this age old industry. It is clear the FDA will have a lot of power in determining who makes money from selling tobacco and tobacco products. What is not so clear is how this “Big Tobacco meets FDA Bill” will effect the electronic cigarette. Below is the definition of a tobacco product according to the Bill:

SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT.

(a) Definition of Tobacco Products- Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the following:

`(rr)(1) The term `tobacco product’ means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).

`(2) The term `tobacco product’ does not mean an article that is a drug under subsection (g)(1), a device under subsection (h), or a combination product described in section 503(g).

`(3) The products described in paragraph (2) shall be subject to chapter V of this Act.

`(4) A tobacco product shall not be marketed in combination with any other article or product regulated under this Act (including a drug, biologic, food, cosmetic, medical device, or a dietary supplement).’.

The Electronic Cigarette as a Tobacco Product

I believe we can make a couple assumptions. First, the e-cigarette with zero nicotine would certainly NOT fall into the definition of a tobacco product. In this case, there is no nicotine, no tobacco, no drug…..just propylene glycol or vegetable glycerin, water, and flavoring. Second, the actual electronic cigarette device (battery, atomizer, mouthpiece/cartridge) could not be considered a tobacco product. So, the only thing that could be classified as a tobacco product would be the eliquid. But eliquid can be made with synthetic nicotine or with a compound similar to nicotine or with nicotine from another source other than tobacco. And if it is, then there would be no part of it derived from tobacco. The other argument is that nicotine extracted from a tobacco plant and purified is so far removed from the original plant that it ceases to be a tobacco product. This falls in line with the FDA’s current assertion that the electronic cigarette is a new drug and therefore needs approval.

The Electronic Cigarette as a New Drug

First off, it is a stretch to claim nicotine is a “new drug”, when in fact it is one of the oldest drugs used by man. Second, if the definition of a drug must include “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” then the electronic cigarette does not fall into this category. Using the e-cigarette is smoking, it doesn’t cure it (if smoking is even a disease to begin with). Some call it vaping, but it is still the habit of hand to mouth. Drug addiction is considered a disease by the CDC. So does the electronic cigarette diagnose, cure, mitigate, treat, or prevent drug addiction? Since e-smokers continue to get the nicotine, then NO. Users could use the zero nicotine eliquid, but there is no evidence that they will or even if they do, that they will stick with it and not go back to nicotine. If electronic cigarettes treat nicotine addiction then cola treats caffeine addiction.

So What is the Electronic Cigarette?

As many of us in this industry have stated from the beginning, the electronic cigarette is unique. It is a technology that will continue to create ripples well into the future. This doesn’t mean it should be given a free pass and it doesn’t mean it should be pulled off the market. It means we need to have rational and intelligent discussions with regulatory bodies to ensure the industry follows standards and consumers are protected. Instead of these discussions, the e-cigarette industry has been attacked by politicians with local agenda’s, by public health organizations with money ties to the pharmaceutical industry, and the FDA who seems to take orders from the pharmaceutical companies. Considering the size and scope of smoking cessation sales in the US and worldwide, it is not hard to contemplate the drive to protect the market.

The e-cigarette industry has begun the process of legitimizing the industry through the formation of the Electronic Cigarette Association. Although a very young organization with much yet needed to be done, the ECA strives to implement standards and bring trust to this new industry. The ideal situation would be for the FDA to work with the ECA to create standards while using industry money to regulate, rather than tax payer dollars. Prohibition didn’t work. The “quit or die” philosophy doesn’t work. And banning products that have the potential of the electronic cigarette can not possibly be in the best interest of public health.

Bill S.982 also known as the Family Smoking Prevention and Tobacco Control Act is now available online. This “Tobacco Bill” was under the name Waxman and now appears to be associated with Kennedy. The Bill is meant to give the FDA regulatory authority over tobacco products. It may or may not have the actual effect of limiting market access to potentially safer tobacco products and maintain the existing tobacco cigarette market. Philip Morris supports the Family Smoking Prevention and Tobacco Control Act.

I encourage you to read this bill and let me know your thoughts. All the implications of this bill are unclear, especially with regard to the electronic cigarette. I do hope Congress has the good sense to create a fair marketplace where smaller companies can compete with established Tobacco companies by offering alternatives to a known killer.