Tuesday, May 20, 2014

Tobacco Control Legal Consortium Supports Deeming Regulation Changes that Would Take Almost All Electronic Cigarettes Off the Market

The Tobacco Control Legal Consortium (TCLC) is urging the public to write to the FDA and encourage the agency to strengthen the proposed deeming regulations on electronic cigarettes. In a set of talking points provided by the TCLC, the Consortium attacks the 24-month grace period for the submission of substantial equivalence or new product applications by electronic cigarette products, calling for the removal of this grace period:

"The FDA proposal would significantly delay the implementation of premarket review for newly covered products. Most egregiously, the proposal creates a twenty-four month provisional period for the submission of tobacco product marketing applications. Applications received during the provisional period enable the continued marketing of the product until the FDA acts on the application which may be well beyond the twenty-four month period. A similar loophole was established during the passage of the Act to apply to cigarettes and smokeless products. The FDA received 3,517 applications but three years later has only issued an order removing four products from the market. After the withdrawal of 117 applications, the tobacco companies are still able to market the unapproved products represented by the 3,396 outstanding applications."

The Rest of the Story

As a public health advocate, the position of the Tobacco Control Legal Consortium is perplexing to me. The Consortium appears to be calling for the removal of the 24-month grace period for submission of substantial equivalence or new product applications by electronic cigarette products. If this advice were to be implemented, then the only electronic cigarettes that could remain on the market are those which were actually marketed as of February 15, 2007. This means that 99.9% of the electronic cigarettes currently on the market would have to be taken off the market.

In other words, the TCLC is calling for a virtual ban on electronic cigarettes. The upheaval created by this ban would destroy all but the largest of the electronic cigarette companies, and would essentially deliver the industry to the tobacco companies. However, even the tobacco companies would have to remove their electronic cigarettes from the market until their applications were approved, a process that would likely take many years.

The effects of such a regulation would be to force thousands of ex-smokers back to cigarette smoking. It would also result in thousands of dual users who have substantially cut down on their smoking to return to their pre-vaping cigarette consumption levels. Of course, the net effect of such a policy would be to substantially harm the public's health.

It's not clear to me whether the TCLC has simply not considered the impact of its recommendations or whether the Consortium actually wants to see a de facto e-cigarette ban. Either way, if the FDA adopts these recommendations, it would be a total disaster for the public's health and a great victory for the cigarette market.

1 comment:

Blogger said...

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