What Does The FDA Tobacco Bill Mean For Electronic Cigarettes?

The new 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.