Thursday, April 24, 2014

FDA Gives Huge Gift to Combustible Tobacco, and to Cancer

With the release of its deeming regulations, the FDA is poised to give a huge gift to combustible tobacco and to the diseases and death caused by cigarettes. If promulgated as is, the regulations will be devastating to the public's health by protecting the combustible cigarette market at the expense of the introduction and promotion of much safer alternative products that would otherwise have the potential to substantially reduce lung disease, heart disease, stroke, and cancer.

There are two major aspects of the deeming regulations that deal a devastating blow to the public's health:

1. Electronic cigarette companies cannot inform consumers that these products are safer than cigarettes, and they cannot even tell the public that they are free of tobacco.

2. The regulations put a huge, if not insurmountable, obstacle in the way of new and innovative electronic cigarette products.

The Rest of the Story

I will address each of these two provisions of the deeming regulations, showing why they represent a devastating blow to the public's health and a huge gift for combustible cigarettes and in turn, for cigarette-related disease and death.

1. Electronic cigarette companies cannot inform consumers that these products are safer than cigarettes, and they cannot even tell the public that they are free of tobacco.

The deeming regulations subject electronic cigarettes to section 911 of the Family Smoking Prevention and Tobacco Control Act, which prohibit the marketing of tobacco products as modified risk products without the approval of the FDA. Specifically, what this means is that electronic cigarette companies cannot tell consumers the simple truth: that their products are safer than tobacco cigarettes. They cannot even tell consumers that the intended purpose of these products is to provide a safer alternative to smoking.

This means that 99% of the electronic cigarette companies currently on the market are going to have to change the way they market their products. They are going to be forced to implicitly lie about their products by pretending that providing a safer alternative to smoking has nothing to do with why they are marketing these innovative devices.

According to the deeming regulations, electronic cigarettes cannot inform consumers that the electronic cigarette "presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products" (which includes cigarettes). In other words, the marketing of electronic cigarettes will need to be based on the false pretense that e-cigarettes are not intended as a safer alternative to smoking.

This is a disaster not only because it hides from consumers knowledge that these products are safer than cigarettes, but because it forces electronic cigarette companies to rely on other advertising pitches, such as portraying the use of these products as being sexy or attractive, boasting about how these products can be used in places where smoking is not allowed, or portraying these products as fancier types of cigarettes. This is going to make it more difficult to deter young people from picking up these products because it becomes more difficult for them to understand the true purpose and meaning of electronic cigarettes.

I cannot think of a regulatory provision that would be more favorable to combustible cigarettes than to ban any potential competitor products that are not made from tobacco and do not involve combustion from informing consumers that these products are safer alternatives to smoking. This is literally a huge gift to the combustible cigarette market and therefore, it is devastating to the public's health. It is going to increase disease and death. This is absolutely the opposite of what the FDA should be doing in these regulations.

To highlight the absurdity of this aspect of the deeming regulations, it means that electronic cigarette companies will not be allowed to even claim that their product is free of tobacco. The law states that a tobacco product manufacturer cannot claim that "the tobacco product or its smoke does not contain or is free of a substance." In other words, an electronic cigarette company cannot claim that its electronic cigaretes do not contain, or are free of, tobacco.

If a company were to make such a claim, it would constitute a reduced exposure claim, which is prohibited under section 911. To make matters worse, such a claim can only be approved by the FDA if the company shows that if consumers hear that the product is free of tobacco, they will not be led to believe that the product is safer. In other words, to simply make the truthful and uncontroversial claim that your electronic cigarettes are free of tobacco, you would have to first demonstrate that consumers will not interpret the absence of tobacco as indicating that the product is any safer. But we know for a fact that consumers will interpret (and should interpret) the absence of tobacco as an indication that vaping is safer than smoking. Therefore, the deeming regulations place a de facto, permanent ban on electronic cigarette companies making the simple claim that their products do not contain tobacco.

While it is theoretically possible that an electronic cigarette company could some day get a full reduced risk claim approved, the regulatory burden is extreme. Not only would the company have to show that the product is safer than smoking, but the company would also have to demonstrate that the product will not deter smokers from quitting and will not introduce youth to the use of nicotine. The studies required would be substantial. For most companies, the costs would be prohibitive. It would take many years before any company could even have a reasonable chance of getting such an application approved and by then it will be too late for the market to continue to expand.

Moreover, what scientific evidence is the FDA looking for in order to approve a simple claim that electronic cigarettes are safer than tobacco cigarettes? If the overwhelming current evidence is not sufficient, then no evidence will ever be sufficient because there is no further research that is necessary in order to draw this conclusion. It doesn't take a rocket scientist to figure out that a product which burns tobacco and produces tobacco smoke with more than 10,000 chemicals including more than 60 carcinogens and causes more than 400,000 deaths per year is more harmful than a product which merely heats and aerosolizes nicotine from a solution of propylene glycol.

The rest of the story is that by applying section 911 to electronic cigarettes, the FDA is forcing electronic cigarette companies to implictly lie to its consumers by hiding from them the undeniable truth that electronic cigarettes are much safer than tobacco cigarettes. This removes the most critical element of potential marketing competition from combustible cigarettes.

For the combustible cigarette market, this is a dream come true. In fact, it seems too good to be true because it is a supposedly public health protection agency that is issuing this immense market protection.

2. The regulations put a huge, if not insurmountable, obstacle in the way of new and innovative electronic cigarette products.

In order to introduce a new electronic cigarette product to the market, the manufacturer will have to demonstrate that the product is beneficial to the public's health. This does not simply mean that one must demonstrate that the product is safer than cigarettes. The applicant also needs to show that the introduction of the product into the market will not deter smokers from quitting or encourage youth to start using the product. At the present time, there is a substantial body of opinion among tobacco control experts that electronic cigarettes do not reduce population risk. Therefore, how can we expect that a manufacturer could demonstrate, at the level of proof required, something which most tobacco control experts do not even agree with?

In other words, the deeming regulations place an insurmountable obstacle in the way of new and innovative products. This is disastrous because it is new products which are essential to continue to drive the market forward. It is the new products which will be safer and more effective. It is the new products that are critical to allowing electronic cigarettes to some day seriously challenge or overtake the combustible market.

However, the deeming regulations take away both the prospect of innovation and the incentive to introduce new products. Essentially, these regulations freeze the current market of electronic cigarettes, or at least of those electronic cigarettes which were most like the products already on the market in 2007.

1 comment:

Blogger said...

Vaporfi is the highest quality electronic cigarettes provider on the market.