Just wondering about this.....

[btngchck]

Do you think the FDA is trying to re-classify devices to regulate the e-cig? I came across this at work today and it made me think about it.

Stakeholders Tell FDA to Revise or Pull Draft Guidance on Classifying Drugs, Devices | BNA

 

[JustJulie]

Good question . . . of course, I can't read the FDA's mind, but my gut reaction is that what you've cited to doesn't have any direct impact on e-cigarettes. The FDA has already indicated its intent to regulate e-cigarettes as tobacco. What you've cited to is a discussion of the dividing line between drugs and devices. So long as an e-cigarette manufacturer/vendor doesn't make therapeutic claims, they should fall under the tobacco regulations, not the pharmaceutical regulations.

If someone else has a different interpretation, I hope they'll share it.

I think it's great that you're watching and paying attention. We can't afford to let our guard down.

 

[Allan.GH]

That's the exact reason that I've been (as some would see it) nit-picky about referring to eCigs/vaping as smoking cessation aids. If this aspect of vaping is over emphasized, we could find ourselves at the bottom of a slippery slope in claiming that these products are a recreational alternative to tobacco smoking. I uniformly refer to the cessation of tobacco use as a beneficial, yet unintended, side effect.

 

[Stubby]

That's the exact reason that I've been (as some would see it) nit-picky about referring to eCigs/vaping as smoking cessation aids. If this aspect of vaping is over emphasized, we could find ourselves at the bottom of a slippery slope in claiming that these products are a recreational alternative to tobacco smoking. I uniformly refer to the cessation of tobacco use as a beneficial, yet unintended, side effect.

As an individuals it doesn't matter what we say about e-cigs. We can say whatever we want. It's the manufactures and sellers that can't make claims that it is a smoking cessation device.

Same goes for something like smokeless tobacco. The manufacturers can't make the claim that smokeless is less harmful then smoking, but I can say it all I want. The manufacturers are not liable for what I say. Even CASAA can make the claim as they are not connected to the manufacturers.

 

[Allan.GH]

Just my casual thinking about this issue....

The manufacturers may or may not make claims; however, the Ruyan Patent does happen to expressly state that "...an objective of the present invention is to provide an electronic atomization cigarette that may function as a substitute for smoking cessation products...". This is sufficient for the domestic authorities to consider the device to be a smoking cessation product, subject to clinical trials--as they previously asserted in court.

The active marketing dialogue so far, in the United States, has been that the "electronic cigarette" or vaping, is a recreational alternative to tobacco consumption. It isn't a theory, it has been the actions, via active marketing campaigns, that has placed vaping in the category that it currently occupies, and a federal judge agreed with that line of reasoning in setting-forth a judgment that the FDA shall regulate vaping products in the same way that tobacco products are regulated.

Many people are currently forming businesses with the central aim of distributing eCigs, mods, and niquid; and, many of those people come from the vaping community. When those individuals engage in marketing of these products, they will use the language, and follow the reasoning they have acquired as a result of their participation in the vaping community (there will be exceptions).

We, as a community need to realize that, should enough vendors of these products advance their marketing strategies by making the claim that the eCig, or vaping in general, is a form of smoking cessation; the FDA will have another day in court with hardcopies of just such advertising claims--and it would not be undue for an FDA lawyer to submit evidence regarding howe the devices are pervceived by the public, including communities like ECF--asking to regulate these devices as a drug delivery system. Under such circumstances, they stand a good chance of having the decision of 25 April reversed in their favor.

Will they actually do that? Who knows? Should we participate in handing them a loaded gun? No.

We can reduce the probability of that scenario arising, by monitoring and regulating our own expressions about eCigs and vaping. In short, ours should be an effort of forming good habits in this respect within our own community, and calling-out vendors when they market their wares as smoking cessation aids (and I have seen quite a few such claims made in writing and advanced verbally).

In short, it all starts with us.

Anyway, that's just my take on it.