The FDA “Deeming” Proposal: Some Facts and Thoughts

As you may already know, on April 25, 2014, the Food and Drug Administration (FDA) published a proposal that would deem e-cigarettes as “tobacco products,” potentially subjecting them to similar regulations as analog cigarettes. If successful, this proposal would herald deeply restrictive changes to the vaping industry.

ecigExpress strongly opposes the FDA proposal regarding electronic cigarettes. While FDA oversight of the electronic cigarette industry may very well result in safer electronic cigarette products, the proposal’s overly restrictive and short-sighted requirements would wipe out most electronic cigarette companies, thereby creating a less competitive business environment and severely minimize the number of e-cigarette products available on the market. The FDA proposal, in effect, would only benefit big tobacco companies.

Before describing how the FDA proposal would damage the electronic cigarette industry as we know it, we summarize its most important points below.

1) The proposal classifies nearly every non-pharmaceutical nicotine delivery system as “tobacco products.” All “components and parts of tobacco products, but not their “related accessories” would “meet the statutory definition of tobacco products,” and therefore be subject to FDA regulations.

2) As it relates to electronic cigarette use, the proposal would require that all e-cigarette products, including atomizers, batteries, and e-liquids be approved by the FDA.

3) The purpose of this proposal is to mandate labeling, ingredient disclosure and marketing guidelines. According to the FDA, these measures will restrict youth access, encourage long-term research and ensure product safety.

On the surface, the FDA’s proposals do not seem objectionable. After all, product labeling regulations would deliver important information to consumers, improved safety regulations would protect consumers from poorly-manufactured goods, and promoting further research would help the vaping community make informed decisions about electronic cigarette use.

Contrary to its potential benefits, however, this proposal threatens to destroy the electronic cigarette industry in its current form.

There are three major problems with the FDA proposed regulations: 1) The timeline and restrictions proposed by the FDA are regressive; 2) its procedure for regulations will throttle the market; and 3) the effects of the proposal discourage scientific research on tobacco harm reduction.

Here’s why:

1) The cut-off date for products already on the market to claim that they are “substantially equivalent” to existing products is February 15th, 2007. Any product that came to market after this date must submit a Pre-Market Tobacco Application (PMTA), and companies cannot sell these products until their PMTA has been approved.

This means that the FDA would disregard over a decade of product advancement and development and revert the industry to the state in which it existed in its infancy. Should this proposal succeed, you can forget about trying out the newest clearomizer or MOD. You can also forget about trying the latest and greatest e-liquid recipe; even creating your own e-liquid would be challenging. As a consumer, you would have less choice.

2) The PMTA procedures would put most electronic cigarette companies out of business. On a VP Live podcast on April 28th, during a roundtable discussion about the proposal, Bill Godshall, founder of Smoke Free Pennsylvania, suggested that e-cigarette companies could spend up to $10 million for each application to sell a “new product.”

As far as the FDA is concerned, each and every battery, atomizer, flavor, and e-liquid counts as a “new product”; a company would have to pay up to $10 million for each of them. Such exorbitant costs would put nearly every e-cigarette company out of business, stifling innovation and severely limiting consumer choice. Only the big tobacco companies can afford to get FDA approval, and only on a few products.

3) The PMTA guidelines shift the burden of scientific harm-reduction research onto companies aiming to bring products to market. This move is questionable for two important reasons.

First, the potential for unreliable, distorted findings resulting from corporately funded research is well documented, especially in the tobacco industry. We question the integrity of research funded by big tobacco companies.

Second, much of this research will be redundant, given that every e-liquid flavor and every nicotine strength level would require FDA approval.

In its current form, the FDA proposal treats the lack of scientific research on the effects of e-cigarettes as sufficient evidence for restrictive legislation when it should instead treat it as a good reason to fund further research.

We propose that the FDA fund research on e-cigarette use, requiring scientific rigor and transparency in the research process, in order to produce reliable data. We wonder why the FDA wants to waste taxpayer dollars on paperwork rather than promote public health by encouraging reputable scientists to conduct research on the effects of e-cigarette use.

If the FDA really does care about public health, it should fund scientific research on tobacco harm reduction.

The FDA is currently accepting commentary from the public on this matter, and we encourage you to voice your opinion. You can post your comment here. The deadline to submit comments is July 9th, 2014.

Before posting your comment to the FDA, check the CASAA website. They will soon post a call to action, and we stand by them.

For a lively discussion about the possible effects of the proposal, ECF has an open forum.

We at ecigExpress apologize for this lengthy post, but this is a complicated matter that affects us all. We thank you for your patience, and we will be sure to update you on future developments.

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