Tuesday, May 06, 2014

Deeming Regulations: New Product Applications Make No Sense for Electronic Cigarettes

I have already discussed what I believe is the most disastrous aspect of the proposed FDA deeming regulations for electronic cigarettes: the subjection of electronic cigarettes to section 911 of the Family Smoking Prevention and Tobacco Control Act, which will prohibit e-cigarette companies from truthfully marketing their products as a safer alternative to smoking.

Today, I discuss what I see as the second most disastrous aspect of the deeming regulations: the requirement for new product applications for most electronic cigarettes.

The Rest of the Story

The proposed deeming regulations require all electronic cigarette products that are not substantially equivalent to those on the market as of February 15, 2007, and all new products, to submit new product applications. Electronic cigarette products currently on the market have 24 months to submit these applications and can remain on the market until a decision is made on their applications. New e-cigarette products must have their applications approved before they can enter the market.

There are two important issues to consider. First, what products on the market are substantially equivalent to those that were on the market in February 2007? Second, what will be necessary to have new product applications approved?

The answer to the first question depends on exactly how FDA interprets substantial equivalence. However, if it is anything like the way the FDA is defining substantial equivalence for cigarettes, then most of the thousands of electronic cigarette products currently on the market will not meet the definition of substantial equivalence and will have to submit new product applications, rather than substantial equivalence applications.

Substantial equivalence requires that the product raise no new or different issues of public health compared to the predicate product. Since in February 2007, the predicate products were drastically different from most of what is on the market today, it is unlikely that the FDA would find most of today's products to be substantially equivalent to those early products. Remember that e-cigarettes only entered the U.S. market in 2006, so the products on the market as of February 15, 2007 were antiquated by today's standards.

Moreover, even if a brand were nearly identical to a predicate product, if there is any difference in the e-liquids or heating mechanisms, it is most likely going to present different issues of public health. Moreover, without any testing of the chemicals in the vapor of the predicate products available, it will be impossible for most companies to demonstrate that their products fail to present different issues of public health from the predicate product.

In other words, if the FDA stays true to the clear statutory meaning of substantial equivalence, there will be only a few products that can meet this standard.

Therefore, for the bulk of the products on the market, it will come down to a new product application.

New product applications require that the company demonstrate that the product is appropriate for the public's health. This means not only that the product must be shown to be safer than cigarettes for smokers who switch to the product, but also that the product benefits the public's health, taking into account nonusers of the product. Thus, in order to meet FDA approval, you would have to prove that the product improves health, both on an individual and a population level.

While I believe it would be quite straightforward to demonstrate the individual health benefits of electronic cigarettes over real ones, it is not so trivial to have to demonstrate the overall population-level benefits. To do this, one would have to estimate the proportion of smokers who would switch to electronic cigarettes and the proportion of nonsmokers who would start using the product. One would also have to know the percentage of nonsmokers who would progress to smoking.

The studies required to obtain this information are substantial, and it is doubtful that most smaller companies have the resources to conduct these studies. It is not initially clear to me that any company would be able to meet this regulatory burden. However, if any companies are equipped to do so, it is the tobacco companies and perhaps the largest of the electronic cigarette companies.

The end result of this provision would likely be to contract the market, making fewer choices available to consumers.

But taking a step back, what sense does it make to require new product applications in the first place?

With cigarettes, I can see how new product applications make sense. The tobacco companies had a history of introducing products to the market that appeared safer, but were not. They also had a history of making product changes in order to make cigarettes more addictive. Therefore, it might make some sense to require new product applications for cigarettes.

However, for electronic cigarettes, it makes absolutely no sense. To be sure, the newer products are the safest and the most effective. It is the older products - the antiquated ones - that were much less effective and generally not as safe. With time, product quality has improved, more manufacturing standards have been put in place, better methods have been developed, and safer products have been produced.

For example, early products - such as the ones on the market in 2007 - were found to contain diethylene glycol, an ingredient in anti-freeze. Since that time, I am aware of no testing of any new product which has detected diethylene glycol.

The rest of the story is that the FDA has this all wrong. They are doing the exact opposite of what they should be doing. Instead of requiring new product applications for all the new and improved electronic cigarettes to stay on the market or to enter the market, the FDA should be requiring the older products to demonstrate why they should be allowed to remain on the market. In other words, those old products with diethylene glycol - they should be the ones with some sort of regulatory burden, not the newer products that don't deliver diethylene glycol.

Moreover, this provision will stifle innovation in the e-cigarette market. But innovation is what is going to gradually create safer and more effective products. And innovation is what is going to stimulate demand, thus resulting in an expansion of the market and a continuing decline in combustible cigarette consumption.

The deeming regulations - if adopted as is - would greatly inhibit innovation and constrict the e-cigarette market, reducing the beneficial impact of electronic cigarettes in reducing combustible cigarette consumption.

In this way, the deeming regulations will harm the public's health rather than protect it. Or stated another way, these deeming regulations will result in more deaths than lives saved.

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