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Discussion Topic: e-cigarettes

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 Josh
(@orleron)
Posts: 95
Trusted Member Admin
Topic starter
 

This is always a fun module for discussion topics because there's always some modern technology out there that challenges the current regulatory framework.

Today... e-cigarettes. If you don't know what one is, google it. Does the FDA currently regulate e-cigarettes?

Here we have a situation where there is an electronic device that vaporizes water containing other organic compounds, so you can breathe in that vapor and deliver it to your lungs. Do you think that is different from a normal cigarette in terms of regulation?

Why doesn't the FDA regulate normal cigarettes?

Do you think an e-cigarette should be a drug delivery device and therefore a Class III medical device that will require a full clinical trial for EACH MODEL released by EVERY company?

Find some articles on the web about this. They are fun to read.

Spiral Medical Development
www.spiralmeddev.com

 
Posted : 29/10/2016 6:27 am
(@thuytienlecao)
Posts: 72
Trusted Member
 

As of now, the FDA has finalized a rule that extends its regulatory authority to all tobacco products, including e-cigarettes, cigars, and hookah and pipe tobacco. So yes, they do (including cigarettes effective August 8, 2016 (fda.gov).

In terms of regulation, I think vape e-cigarettes and regular cigarettes are different because vaping involves using electronic devices so in this case, it's considered as a combination product while regular cigarettes only contain the bio-compound. (Ex: the delivery/administration part of the electronic cigarette supplied separately from the nicotine-containing product--> medical device).

I think e-cig should be a drug delivery device and require regulations as a medicinal product. Even though the pros outweigh the cons as of now for e-cigs, a lot of people are using it and this number is dramatically increasing, especially in teens: 900% from 2011 to 20115 (cnn.com). Therefore, the potential damage if not taken into consideration carefully can be tremendous.Furthermore, consumers and health professionals also need to be secure in the knowledge that what they are buying contains what it says it contains and meets acceptable standards of safety, quality, and consistency (bmj.com).

References:
http://www.cnn.com/2016/12/08/health/surgeon-general-report-on-e-cigarettes/index.html
https://www.health.harvard.edu/blog/electronic-cigarettes-good-news-bad-news-2016072510010
http://www.bmj.com/bmj/section-pdf/187647?path=/bmj/345/7876/Feature.full.pdf
https://www.fda.gov/tobaccoproducts/labeling/rulesregulationsguidance/ucm394909.htm

 
Posted : 25/09/2017 8:32 am
(@amandaally1029)
Posts: 40
Trusted Member
 

The FDA does in fact regulate electronic nicotine delivery systems, such as e-cigarettes, hookah pens, and vapes [1]. I think that e-cigarettes are different from normal cigarettes in terms of regulation because, with e-cigarettes its tobacco-less, and it contains just some of the chemicals as normal cigarettes [2]. With normal cigarettes, it contains tobacco along with a numerous amount of chemicals that can be harmful [2]. Based on this, normal cigarettes seem to be more debatable in terms of how it should be regulated. I do think that its possible for e-cigarettes to be used as a drug delivery system, but only for drugs that can be delivered successfully in that way. This would definitely require some clinical testing to make sure that the drugs are successfully delivered to its target area. Even though the e-cigarette is already a known product, I do think that it would be considered a class 3 device since it would be used for drug delivery, which is different from its initial purpose.

[1] https://www.fda.gov/TobaccoProducts/Labeling/ProductsIngredientsComponents/ucm456610.htm

[2] http://www.stopcancerfund.org/uncategorized/are-e-cigarettes-safer-than-regular-cigarettes/

 
Posted : 25/09/2017 12:41 pm
(@alexandrabuga)
Posts: 149
Estimable Member
 

As @thuytienlaco and @amandaally1029 stated, e-cigarettes are regulated by the FDA. In Aug 2016 the FDA finalized the rule extending CTP's regulatory authority to cover all tobacco products, including electronic nicotine delivery systems (ENDS) that meet the definition of a tobacco product.

As per 21 CFR Parts 201, 801, and 1100
Tobacco product is defined as" any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)"

There was in interesting article in the NY Times about developing a comprehensive plan for tobacco and nicotine regulation. The FDA will encourage companies to reduce nicotine levels so that they are not addictive. However, the addictive aspect is how big tobacco makes their profits and business model. I'm not sure how tobacco will take to that encouragement. https://www.nytimes.com/2017/07/28/health/electronic-cigarette-tobacco-nicotine-fda.html?mcubz=3

I agree that an e-cigarette would be considered a class III medical device since it is releasing a drug. The primary mode of action is to release nicotine.

The FDA expects that most ENDS products that companies submit for market authorization will go down the Premarket Tobacco PMTA pathway, which does not require a comparison to a predicate product and will determine when it is necessary to have a clinical trial and when it is not necessary.

Reading up on this topic I found it really interesting that FDA considers EACH ENDS product with a differing flavoring variant or nicotine strength to be a different product. So the blueberry, cupcake, cherry, etc would all be considered different products and submitted as such. The FDA does say you can submit one premarket application but it does need to be broken down by product (each flavor). The more flavors, the more paperwork.

In regards to normal cigarettes, the Tobacco Control Act requires all new cigarettes to receive explicit approval from the FDA before being allowed on the market if they are a new product introduced after March 2011.

 
Posted : 25/09/2017 4:56 pm
(@mark-abdelshahed)
Posts: 80
Trusted Member
 

FDA considers e-cigarette just like a regular cigarette. FDA now regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of ENDS, including components and parts of ENDS but excluding accessories. However, the FDA’s Center for Drug Evaluation and Research maintains its authority to regulate electronic smoking devices as drugs or devices if the devices are marketed for therapeutic purposes. Even though the FDA now regulates electronic smoking devices, local and state governments may still adopt laws regulating electronic smoking devices, including restrictions on their sale or use.
I think that e-cigarettes should be treated differently by the FDA; FDA should allow more of the e-cigarettes, so that people go toward e-cigarettes rather than regular cigarettes. Since e-cigarettes have much less tobacco than a regular cigarettes then using them would reduce the use of tobacco, which is the goal of the FDA.
Yes, e-cigarettes are a drug delivery device and yes they have nicotine, however, they should be classified as medical devices since they are electronic devices which makes them a combination device.

 
Posted : 25/09/2017 8:09 pm
(@dag56)
Posts: 79
Trusted Member
 

As thuytienlecao mentioned above, the FDA currently regulates the electronic cigarette due to it containing tobacco products (nicotine) which is a controlled substance. This electronic device is also very different when compared to normal cigarettes due to its lack of some ingredients and over concentration of others. E-cigarettes do lack a lot of the harmful ingredients conventional cigarettes have such as tar, however, some also have a much higher nicotine concentration making them debatably more dangerous due to growing cultural trends. Therefore, I believe that they should definitely have different regulations from their ‘organic’ counterparts.

Lastly, an electronic cigarette is simply a device that delivers a drug (nicotine) to the body and therefore should be in consideration for class III combination device. In addition, I believe that each company SHOULD require a full clinical trial for each model released due to each model possibly having a different mechanism of action. This is because different variations of the device could deliver different amounts of the drug into the body in addition to each flavor on the market reacting differently with the body/ device. In my opinion, overregulation of inherent non-medicinal products can’t hurt, under-regulation can.

https://www.whitecloudelectroniccigarettes.com/how-it-works/ecig-strengths/
https://www.nicvape.com/About-Nicotine-Strengths

 
Posted : 26/09/2017 6:24 am
(@asimbana)
Posts: 61
Trusted Member
 

The FDA regulates the e-cigarette as stated earlier in the previous posts, this is because its a device that uses chemicals that is heated into a vapor and delivers to the human body via the lungs. This respiratory delivery system is a known drug delivery pathway such as for example using Albuterol as a steroid for patients that have Asthma. This e-cigarette is closely compared to a Nebulizer which heats up saline into a mist form and is combined with the drug for inhalation. In 2016 the FDA has extended their rule on CTP's regulatory authority to cover all tobacco products, including electronic nicotine delivery systems (ENDS) that meet the definition of a tobacco product. FDA now regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of ENDS, including components and parts of ENDS but excluding accessories.

If an e-cigarette would be used as a drug delivery medical device it would in fact be considered a class III device, this is due to the fact that it would have to undergo clinical trials to test whether it can be used to vaporize the drug and used for proper distribution in the human body, in terms of targeting the lungs, it is a known fact that it will but it all depends on the drug's application that will be used for testing and their intended use. Overall i believe that regular cigarettes should be regulated just as any human consumption product is. As mentioned before by the previous participant, the different flavors of e-cigarette are also regulated, which would mean that e-cigarettes are also considered a combination product.

 
Posted : 26/09/2017 6:30 am
(@reshamn)
Posts: 67
Trusted Member
 

FDA finalized a rule, effective August 8, 2016, to regulate all tobacco products." E-cigarettes are included in the category of ENDS -- Electronic Nicotine Delivery Systems -- products that use a liquid containing nicotine and varying amounts of flavor, glycerin, propylene glycol and other ingredients. This liquid is heated into an aerosol that users then smoke. It is often referred to as "vaping."

The question whether e-cigarettes are safer alternatives to regular cigarettes is in itself an answer to whether it should be classified as a Class III device. However, there is not much research available into the long term effects on ENDS on adults. Also, due to increasing trend children have been adopting e-cigarettes. There is hardly any substantial data of the effects on children to address this issue completely. There is a speculation that since ENDS products contain nicotine, not only it is addictive but also can adverse effects on development of brain of a child. The FDA regulation on this will have a positive effect on these companies who have false claims on the quantity of Nicotine. Needless to say that FDA needs to conduct more research and more data from these companies to classify this device properly. But in order to do a heavy screening needs to be conducted by FDA to put these products out in the market.

Reference: http://www.cnn.com/2016/05/06/opinions/fda-electronic-cigarettes-caudle/index.html

 
Posted : 26/09/2017 11:00 am
(@myton)
Posts: 77
Trusted Member
 

From the articles that I have read, legislation regarding the regulation of electronic cigarettes were passed in 2016. In this FDA ruling, the Center for Tobacco Products, which deals with the Tobacco Control Act, will oversee activities regarding electronic cigarettes and other electronic nicotine delivery system.
Since the product recently came out and a lot of suppliers distributed the product, the regulation for the product was not initially there. However, since time has passed, control and evaluation is catching up to the product and now, the FDA has laid down groundwork to control the distribution and use of electronic cigarettes.
I believe that the e-cigarette aerosol mechanism can be taken advantage of and can be used as a drug delivery mechanism. Because of this, I believe that it should be tested completely to make sure that it will work along with its organic compounds.

 
Posted : 26/09/2017 4:22 pm
(@bv87)
Posts: 29
Eminent Member
 

In 2016, the FDA issued a final deeming regulation that will regulate e-cigarettes as tobacco products, but the regulation, while addressing some key policy issues, still leaves significant regulatory gaps. In addition, the regulation will be phased in over the next few years, so even if it is not delayed as a result of litigation or other reasons, many requirements will not take effect until August 2019. I think that the e-cigarettes are considered a drug delivery system and should be classified as a class 3 medical device.

 
Posted : 29/09/2017 12:12 pm
 aaq2
(@aaq2)
Posts: 38
Eminent Member
 

The FDA as of 22 June, 2009 was granted the authority to regulate tobacco products. The part of the FDA that regulates tobacco products is known as the center for tobacco products. This department was officially established to implement the tobacco control act. The purpose of regulating tobacco products is to use the best available science to put an action in place to effectively help the public reduce the toll of illness and death caused by tobacco. For a product to be deemed “tobacco product” it has to be derived from tobacco that is intended for human consumption.
In 2016, the FDA finalized a rule extending regulatory authority to cover all tobacco products including electronic nicotine delivery systems.
The e-cigarette should not be considered a medical device since currently it has not been used to cure any disease. Per the FDA a device should be able to be used to diagnose a disease or other conditions, or used in a cure, mitigation, treatment or prevention of a disease. It also defines it as an accessory that is intended to affect the structure or any function of the body of man as long as it is not achieved through chemical action within or on the body of man. For a device to undergo clinical trial it must have the capabilities of curing a disease or helping one maintain a comfortable life due to some illness. The reason an e-cigarette is not classified as a class III device is because it is not considered to be a high risk device and therefore not subject to highest level of regulatory control.

 
Posted : 29/09/2017 12:30 pm
 aaq2
(@aaq2)
Posts: 38
Eminent Member
 

The FDA as of 22 June, 2009 was granted the authority to regulate tobacco products. The part of the FDA that regulates tobacco products is known as the center for tobacco products. This department was officially established to implement the tobacco control act. The purpose of regulating tobacco products is to use the best available science to put an action in place to effectively help the public reduce the toll of illness and death caused by tobacco. For a product to be deemed “tobacco product” it has to be derived from tobacco that is intended for human consumption.
In 2016, the FDA finalized a rule extending regulatory authority to cover all tobacco products including electronic nicotine delivery systems.
The e-cigarette should not be considered a medical device since currently it has not been used to cure any disease. Per the FDA a device should be able to be used to diagnose a disease or other conditions, or used in a cure, mitigation, treatment or prevention of a disease. It also defines it as an accessory that is intended to affect the structure or any function of the body of man as long as it is not achieved through chemical action within or on the body of man. For a device to undergo clinical trial it must have the capabilities of curing a disease or helping one maintain a comfortable life due to some illness. The reason an e-cigarette is not classified as a class III device is because it is not considered to be a high risk device and therefore not subject to highest level of regulatory control.

https://www.fda.gov/aboutfda/transparency/basics/ucm194423.htm
https://www.fda.gov/AboutFDA/Transparency/Basics/ucm194439.htm
https://www.fda.gov/TobaccoProducts/Labeling/ProductsIngredientsComponents/ucm456610.htm#regulation

 
Posted : 29/09/2017 12:31 pm
(@gingeranderson)
Posts: 78
Trusted Member
 

As everyone has stated above, e-cigarettes and cigarettes are regulated by the FDA. I do think e-cigarettes are different than cigarettes due to lots of people I have come across using them to quit smoking. This is exactly how the FDA feels( https://www.fda.gov/TobaccoProducts/Labeling/ProductsIngredientsComponents/ucm456610.htm). The FDA feels that e-cigarettes are primarily for "therapeutic purposes" so its regulated under the CDER. I believe research should be done to prove that the majority of people are using it for "therapeutic purposes". If research is provided to show that it is not being used as such then it should be re-evaluated and considered a drug delivery device.

 
Posted : 29/09/2017 2:59 pm
 hv42
(@hv42)
Posts: 42
Eminent Member
 

For sure cigarettes kills people and based on FDA agenda they should regulates cigarettes but I guess they are not regulating normal cigarettes because it contain pure processed tobacco but it will be regulated by FDA in near future[1]. On the other hand the e-cig is been regulated by FDA because it consider a device which delivers nicotine so can be consider a drug deliver device and besides that e-cig uses a liquid which is not a bio-compound, the liquid is made of chemicals which needs to approved by FDA that how badly it affects the lungs and for that we need pre-clinical research. Additionally e-cig also contains a electrical system so it has to FDA approved to make sure that it won't catch fire or bust and harm an individual physical. As the need of e-cig increasing day by day(More than 2 million middle and high school students were current users of e-cigarettes in 2016) it should be a class 3 because it potentially consider as a drug delivery device.
[1] https://www.fda.gov/TobaccoProducts/Labeling/ProductsIngredientsComponents/ucm527462.htm

 
Posted : 30/09/2017 11:22 am
(@woolynn)
Posts: 36
Eminent Member
 

Tobacco product - As stated in section 201(rr) of the FD&C Act in relevant part, a tobacco product: (1) Means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product); and (2) Does not mean an article that is a drug defined under section 201(g)(1) of the FD&C Act, a device defined under section 201(h) of the FD&C Act, or a combination product described in section 503(g) of the FD&C Act (parts 1100, 1140, 1143 ).E-cigarette use a liquid “e-liquid” that contain nicotine, as well as varying compositions of flavorings, propylene glycol, vegetable glycerin, and other ingredients. The liquid is heated into an aerosol that the user inhales.In 2016, FDA finalized a rule extending CTP's regulatory authority to cover all tobacco products, including electronic nicotine delivery systems (ENDS) that meet the definition of a tobacco product. FDA now regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of ENDS.

I believe that the e-cigarette required the clinical trial. It is a kind of drug definitely. There are damages exist without think. Insert into the bodies, it will cause some diseases. And different products component differently. So every product has to go through clinical trial.

 
Posted : 30/09/2017 12:12 pm
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