Stephen Goldner We see this as 100% happening.

E-cigarettes are already considered therapeutic goods in Australia ... so long as they are intended (or "likely to be taken") to help people quit smoking or reduce their dependence on nicotine.
The nicotine cartridges themselves would be 'medicines', but the e-cigarette hardware would likely be a Class IIb medical device if supplied separately, as it is active and intended to deliver a potentially hazardous substance (nicotine).
More info on the TGA website here:
https://www.tga.gov.au/community-qa/electronic-cigarettes

Paula Rutledge Interesting discussion topic Ian. Didn't see this one coming 10 years ago

David Gomez I'm not a smoker, but when someone finally decides to create medications that handle the vaporizing process, you know little things like COPD drugs or inhaled corticosteroids or asthma meducations, ONLY THEN should you earn the right to be regulated. Or how about rescue drugs of different varieties? (And yes we do have concepts for these delivery systems). Unfortunately for now its just a power play because the tobacco industry was castrated by a fringe element they did not see coming and are now crying foul and mobilizing lobbyist. Does the FDA regulate cigarettes? No, the fed justs taxes them to help subsdize health costs. Are there inherent risks, sure there are, but there are many many non pharmacy supplements pedaled everyday with all kinds of claims. If the govt was really keen on safety they would usurp the supplement industry. Caveat emptor is what I say. It's really about education and personal choices. Regulation is rarely about keeping people safe, it's about destroying competition.

Nice topic to discuss. E-cigarettes are already classfied as medical devices in Undersecretariat of Turkey Customs due to it is nicotin replacement theraphy.

I have seen the vaping devices (e cigarettes) being sold in pharmacy stores in Malaysia....hence, probably qualifies as medical device already

Medical ? Any benefit to health ?

This is quite an interesting question. Looking at our data from Delve Health, we already see this happening. Since 2013, a little over 100 clinical trials have been initiated using eCigs for drugs, therapeutic use and some are devices as well across multiple disease conditions (i.e. lung cancer and lung disorders) as a substitute for cigs.

E-cigarettes could never be classified as a medical device since they would have to be labeled, promoted or used in a manner that meets the following definition in section 201(h) of the Federal Food Drug & Cosmetic Act in order to be regulated by the Food and Drug Administration as a medical device.

One of the definitions of a medical device is "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals".

However FDA's new regulations for e-cigarettes, cigars, and all other tobacco products which became effective August 8, 2016 has similar complex pre-marketing and post-marketing regulatory controls and requirements in place that are found with medical device registrations and listings.

In Brazil ecigs are not approved by ANVISA, due lack of long term evidences. Devices or liquids It cannot be commercialized

I have been monitoring the growth of e-cigarette over a year ago. I can't be sure enough to consider it as MD but it still has some advantages over traditional smoking, I didn't get any evidence based, mature clinical studies with significant follow up..... my personal opinion it's not considered as a MD

where is medical purpose of ecigarette?

Julie Omohundro I don't think e-cigarettes meet any part of the definition of a medical device under section 201(h) of the FD&C Act:

"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

- intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

Very interesting question, and even better responses.

It's a device.
But it cannot be classified as a medical device unless it has medical application.

When Trump takes office, direction will be subject to change. Pharma companies could easily lobby for ecigs as a regulated method to deliver nicotine. However from a risk standpoint, nicotine delivery products are about as risky as they come.

Jean Bigoney, RAC, CQE I can see how e-cigarettes could fit the definition of a drug which treats an addiction in analogy to Probuphine to treat opiod addiction. What I don't think would allow e-cigarettes to be classified as a medical device is that at best, they achieve their primary intended purposes by delivering a substance which is metabolized.

But, why are we having this discussion? E-cigarettes are regulated as tobacco products, so they already have a designated branch at FDA which is responsible.

Stephen Goldner I disagree with those who say e-cigs could never be regulated as medical devices. The basis for these products is that they mitigate the use of cigarettes, which are well know to cause multiple disease conditions. Therefore the labeling is :e-cigs are used to mitigate or prevent asthma, lung cancer or other medical outcomes from cigarette smoking. Is this not suitable for medical device classification?

Beluh Mabasa Ginting Currently in my country (Indonesia) e cigarettes are not classed as medical devices yet so that not to be registrated.

Julie Omohundro Harold, I would describe nicotine delivery products as relatively low risk. Health risks posed by medical products come from two sources.

The first is failure to perform as intended. It is hard to see how the failure to deliver any or lower-than-intended levels of nicotine might present health risks. Delivery of a higher dose than intended could indeed pose health risks, but this risk does not distinguish e-cigarettes from any other drug delivery system.

The second source is unwanted side effects that are seen when the product performs as intended. The data seem to indicate that an otherwise healthy person has to smoke the equivalent of a pack a day of regular cigarettes for several decades before being at any more risk of most "smoking related" diseases than a non-smoker. The data also suggest that it is the carbon monoxide in regular cigarettes that is associated with a higher rate of these diseases, not the nicotine.

Julie Omohundro Jean, yes, as of this past August, FDA has been regulating e-cigarettes as tobacco products. FDA’s regulatory authority was extended to include e-cigarettes, all cigars, waterpipe and pipe tobacco, nicotine gels, and dissolvables that did not previously fall under the FDA’s authority.

FDA regulates all tobacco none of these products fit the FD&C Act's definitions of either a drug or medical device, and Congress wasn't up for revising either of those definitions, presumably because this would have necessitated revisiting too many drug or medical device regulations that were based on those definitions.

Julie Omohundro Stephen, are there data available to support these claims?

Great responses! I can see how e-cigs are used as medical device to mitigate the use of cigarettes, but they themselves are actually an extremely unhealthy alternative. Would nicotine gum then be labeled as a medical device?

I believe the FDA will have to also do more research on the impacts of ecigs on human health before ever considering it a medical device.

If they could, in turn, develop ecigs that help cigarette addiction without all the terrible side effects to the users health, then it could be considered a medical device. The reason why I'm siding it as a medical device is because inhalers are also considered medical devices, which helps the affect of asthma. Thus, ecigs would help the affect of tobacco addiction.

Great question, and I'll continue to follow this tread 🙂

Katie Bates This is such an interesting discussion! Classifying e-cigarettes as medical devices could really set a precedent for all kinds of devices being deemed "medical". It's an interesting question that brings up so many more questions!

NO...nicotine is not medicinal

Whether the FDA regulates e-cigarettes as a tobacco product or as a medical device will depend on product inhaled and for what reason. If it is a tobacco product inhaled without the intent to treat, mitigate, cure, prevent, or diagnose a disease, then it will remain regulated as a tobacco product under the 2009 tobacco regs. If the product inhaled is tobacco (or essentially anything else) but intended to treat, mitigate, etc a disease using the e-cigarette as the delivery mechanism, my assumption would be the medical device regulations will be triggered. Relevant to another question in this thread, the e-cigarettes would be regulated as a medical device, but nicotine gum (or even the product inside the e-cigarette) would be regulated as a drug as the mechanisms of action are mechanical versus chemical, respectively - think a nebulizer vs albuterol.

The current regulation and law underpinning it define an e-cigarette as a electronic nicotine delivery system ENDS. The center for tobacco product has jurisdiction. Believe me, none of the other centers want this product. CTP doesn't do safety/efficacy. They do- do no worse.

Glyn Braithwaite I know at least one person in the UK was prescribed a nicotine inhaler (successfully )- as smoking cessation device. The mechanism I suspect differs from vape systems (cold versus heated), but of interest.

Julie Omohundro Steven, I agree the new Rule ends the debate on how e-cigs as currently marketed will be regulated by FDA. However, if someone were to start marketing these products for use in the "diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease" in the future, this question would probably be revisited at that time.