Monday, January 14, 2013

Top 5 Reasons Why an FDA Deeming Regulation for Electronic Cigarettes Could Be a Public Health Disaster

Under the Family Smoking Prevention and Tobacco Control Act of 2009, the Food and Drug Administration (FDA) has the authority to issue a regulation deeming "other" tobacco products (beyond cigarettes and smokeless tobacco) to be subject to FDA jurisdiction. The FDA has announced that it is preparing such deeming regulations for electronic cigarettes.

As I see it, the FDA has two options. First, it can issue a deeming regulation that simply makes electronic cigarettes subject to all the provisions of chapter IX of the Tobacco Control Act, including the new product provisions, modified risk provisions, etc.

Second, the FDA could carve out a special regulatory framework for electronic cigarettes, different from that mandated by Congress for cigarettes and traditional smokeless tobacco products.

I have argued that the FDA should choose the second option and regulate electronic cigarettes under a separate and specific framework that is different from that used for products that contain tobacco. It is essential that products which do not contain tobacco be regulated differently than products which actually contain tobacco, even if the former products meet the definition of "tobacco products" under the Act.

Here, I outline the top 5 reasons why a deeming regulation that makes electronic cigarettes - which contain no tobacco - subject to the same rules that govern cigarettes and smokeless tobacco products would be a public health disaster.

The Rest of the Story

1. Requiring Approval of New Products Under the Act Would Prevent Safer and More Effective Products from Entering the Market

Electronic cigarettes are relatively new products and even within the past year or two, substantial advances have been made that have improved the safety and effectiveness of these products. For example, most of the electronic cigarette juice used to be manufactured overseas; now, there are U.S. companies which manufacture the juice under very tightly controlled conditions. Advances have also been made in terms of making electronic cigarettes more similar to active smoking, and therefore more effective for smoking cessation.

If electronic cigarettes are made subject to the new products provision of the Tobacco Act, there will no longer be an opportunity for further advancement. Such a move by the FDA would freeze the current market and would ensure that the least effective products remain the only ones on the market. It would preclude the development of better and more effective electronic cigarettes and e-liquids, thus hindering the ability of these products to play an increasingly important role in getting people off of cigarettes. In my view, this would be a public health disaster because these products are the single most promising intervention that could potentially save millions of lives by successfully capturing a substantial portion of the existing and future tobacco cigarette market.

2. Adopting the Substantial Equivalent Requirements for Electronic Cigarettes Could Result in the Removal of Many Products from the Market

Strictly speaking, a deeming regulation could potentially make electronic cigarettes introduced into the market after 2007 subject to a requirement that they apply for a substantial equivalence determination, something that might be impossible under the current framework that the FDA has established for such determinations as they apply to tobacco cigarettes. This would be a disaster because it would remove many brands of electronic cigarettes from the market and could result in a large number of vapers returning to cigarette smoking.

3. Adopting the Substantial Equivalent Requirements for Electronic Cigarettes Would Cause Massive Confusion and Could Create a Black Market

A deeming regulation that made electronic cigarettes introduced into the market after a certain date subject to a requirement that they apply for a substantial equivalence determination would create massive confusion. It is not clear, for example, what constitutes the "product." Is it the tube? Is it the battery? Is it the charger? Is it the e-liquid? Is it the cartridge? Is it all of the above? What if a cartridge contains no nicotine? Would such a deeming regulation mean that all e-liquid introduced in the U.S. after a certain date would have to be taken off the market? Would the e-cigarette device itself have to be taken off the market? This is an incredibly complex set of issues and could cause massive confusion.

In addition, as explained in #1 above, there have been many advancements in electronic cigarette devices and liquids. Taking off the market many of the newer products and juices would force vapers to revert back to the less effective products. This would almost certainly result in many vapers deciding to return to cigarette smoking.

Furthermore, if FDA chooses this approach, it could result in a black market for certain products, especially the e-liquid cartridges. Already, many vapers are stocking up on e-liquids so that they will be able to continue vaping should this occur. I can easily see the development of a black market for these products.

4. Adopting the Modified Risk Product Provisions for Electronic Cigarettes Would Force Companies to Hide the Truth from Consumers

Although there is abundant scientific evidence that using electronic cigarettes is much safer than smoking, companies could not inform their customers of the truth. Doing so would make their products a modified risk product, and therefore they cannot make such claims without approval (a process that may be impossible, given the way the modified risk rules have been written). Even telling consumers that electronic cigarettes do not contain tobacco and therefore eliminate most of the thousands of chemicals present in tobacco cigarettes would constitute a modified risk claim, and could not be made if they suggest to consumers that vaping is safer than smoking (which of course is exactly what this fact would and should suggest).

Ironically, the modified risk provisions of the Tobacco Act - if applied to electronic cigarettes - would accomplish exactly the opposite of their intended purpose. They are intended to prevent companies from deceiving consumers about the risks of tobacco products. If applied to electronic cigarettes, they would ensure that consumers are deceived about those risks.

5. A Deeming Regulation that Makes Electronic Cigarettes Subject to Chapter IX Would Force Companies to Hide from Consumers the Truth about the Potential Usefulness of These Products in Smoking Cessation and Reduction

A regulation that simply deems electronic cigarettes subject to chapter IX provisions could potentially preclude electronic cigarette marketers from mentioning that these products may be useful for smoking cessation, because such a claim might be interpreted as a drug claim and therefore put the product under the realm of the Food, Drug, and Cosmetic Act. What is needed is a guidance from the agency which makes it clear that a simple statement of the truth - that these products may be helpful to smokers in quitting or cutting down on the amount they smoke - will not be interpreted as a drug claim.


The bottom line is that a deeming regulation that makes electronic cigarettes subject to chapter IX of the Family Smoking Prevention and Tobacco Control Act, rather than carving out a specific and separate regulatory framework for this product that contains no tobacco, would constitute a public health disaster. It would hinder the development of safer and more effective products, force many vapers to return to cigarette smoking, cause massive confusion, create a black market, and force companies to deceive their customers about the health risks and usefulness of these products.

There is no justification for regulating a product that contains no tobacco in a way that is identical to products that actually contain tobacco. If the FDA has any ability to see the big picture with regards to the public's health, it will avoid this disastrous pitfall.

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