Discussion Topic: e-cigarettes

Home Forums Medical Device Development Regulatory Basics for Medical Devices Discussion Topic: e-cigarettes

This topic contains 24 replies, has 23 voices, and was last updated by  williamzembricki 6 months, 3 weeks ago.

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  • #892

    Josh
    Course Facilitator

    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.

    • This topic was modified 1 year, 5 months ago by  Josh.
  • #3882

    thuytienlecao
    Participant

    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

    E-cigarettes: Good news, bad news


    http://www.bmj.com/bmj/section-pdf/187647?path=/bmj/345/7876/Feature.full.pdf
    https://www.fda.gov/tobaccoproducts/labeling/rulesregulationsguidance/ucm394909.htm

    • #4081

      cy268
      Participant

      I don’t think e-cigarettes should be classified as a Class III medical or drug delivery device. From this week’s module, in order for a device to be considered as a medical device, the manufacturer first needs to make a claim that his device would have medical benefits. Although e-cigarette companies advertise that e-cigarettes help cessation from smoking, they have not yet filed a claim with the FDA suggesting it as a drug delivery device or a medical device that delivers therapeutic benefits.

      E-cigarette brands make unvalidated claims their product helps people quit smoking

      Nicotine from e-cigs activates the same reward pathways in the brain that recreational drugs do. If the question: if e-cigs help smokers break their habits or not, then I think that irrespective of type of substances inhaled through each of these devices the end effect is the same. The regular smoker who receives say 70% of the desired effect from cigarettes, e-cigs give him about 30%. As long as e-cig companies take advantage of the loopholes in the FDA policies, use of these devices will continue. But one cannot argue that banning or tight regulation of e-cigs will not only make people resort to regular (more harmful) cigarettes again but also create a larger demand in the black market for e-cigs which is again hard to regulate.

  • #3887

    amandaally1029
    Participant

    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/

  • #3889

    alexandrabuga
    Participant

    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.

  • #3893

    mark abdelshahed
    Participant

    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.

  • #3895

    dag56
    Participant

    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

    • #4011

      Josh
      Course Facilitator

      So given the content for this week, let’s think about this. Some of you are saying, and pointing out, that e-cigs are drug delivery devices rightfully regulated by the FDA. If this is a Class III device, it would mean that clinical trials are necessary for EVERY e-cig on the market. So, if I want to copy a competitor’s e-cig model, I still need to run a clinical trial on my own e-cig.

      You will see in our Clinical Trials module that running studies like that is not cheap. Keep in mind that companies who want to get involved in selling e-cigs have none of the apparatus that J&J or even a small med device company has, i.e. a regulatory department, QA/QC, implementation of ISO 13485, etc. This would instantly put them out of business.

      I am playing devil’s advocate here, but think for a moment about how many companies are suddenly marketing illegal products.

      Also look at this: https://www.nytimes.com/2017/07/28/health/electronic-cigarette-tobacco-nicotine-fda.html

  • #3896

    asimbana
    Participant

    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.

  • #3899

    reshamn
    Participant

    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

  • #3910

    myton
    Participant

    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.

  • #3929

    Bhargav
    Participant

    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.

  • #3933

    aaq2
    Participant

    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.

  • #3934

    aaq2
    Participant

    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

  • #3944

    gingeranderson
    Participant

    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.

  • #3956

    hv42
    Participant

    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

  • #3961

    woolynn
    Participant

    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.

  • #3964

    anhtong
    Participant

    A cigarette is a very dangerous substance and doesn’t warrant approval by the FDA thus makes me wonder about the next subject an E- Cigarette. I really love innovations and always believed that we are not at the end of the road when it comes to Medical advancements so I always give a positive perspective to all new ideas administered in the Medical Line.
    No studies have shown that the vapors provided by an e cigarette is harmful to users and thus warrants the question what merit does it possess, Although I hate smoking and smokers alike but I believe that an E cigarette can reduce the dangers of smoking for potential smokers, and a preferred option to Tobacco.

  • #3969

    dbonanno1
    Participant

    Based on the research I was able to find the FDA does regulate all cigarettes, smokeless (e-cigs), and roll your own tobacco and these regulations have been in effect since 2009. On August 8th, 201 the FDA finalized a rule to regulate ALL tobacco products.
    In my opinion I do not think there is a difference between cigarettes and e-cigs in terms of regulation. Both are products or devices which allow the user to inhale chemicals into their body. Regardless of the delivery system, the end user is still ingesting harmful chemicals that can affect their health. From this standpoint I feel that both products should share the same regulations.
    As I mentioned above, the FDA does in fact regulate normal cigarettes and has been since 2009.
    In my opinion, I do believe that e-cigs should be a considered a drug delivery device (class III medical device) since a large part of that determination is based on risk. Since there is not a substantial evidence which details the long term effects of e-cigs, I believe there is still a lot of medical risk associated with these products. There should be a much deeper understanding of the ingredients (chemicals) that go into the e-cigs in combination with its delivery system (water vapor), and how all it affects the human body. Until we have this knowledge we should be treating these products with a much high risk level, which should the in turn demand the control (regulations) of these products.

  • #3976

    rachelpatel1796
    Participant

    E-cigarettes are currently regulated by the FDA, as said by their website. Since e-cigarettes use electronic nicotine delivery systems, it is regulated by the FDA. Although not all e-cigarettes contain nicotine, they are still regulated by the FDA because they may contain other products, such as vegetable glycerin, propylene glycol, flavoring, and other products. The FDA specifically regulates cigarettes through the Tobacco Control Act signed by President Obama in June 2009. The good thing about e-cigarettes, however, is that there are no side effects recorded from using it. It contains less than 1% of tobacco or other toxic chemicals found in normal cigarettes. It is also found to help many people quit normal cigarettes. However, many have argued that it can cause many people to start smoking cigarettes since they can get addicted to the nicotine in the vapor in the e-cigarettes. In this case, there are some similarities and some differences that should be considered when regulating e-cigarettes. Many times, e-cigarettes come in different types, shaped like regular pencils or pens, making it particularly difficult to regulate as well. However, since it is electronic, I do believe that it should be regulated in terms of that. There were some products that were catching fire or exploding, which needs great regulation.

    As of now, I do believe that an e-cigarette can be used for a drug delivery system. Each product should be tested separately to ensure the safety of the public. Although it becomes a nuisance, it should be done if everyday users are able to obtain them with ease.

  • #3991

    dh239
    Participant

    Although e-cigarettes are currently regulated by the FDA, they come with hazards that are overlooked because they are viewed as a “healthy” alternative to smoking. The combination device works by vaporizing water with organic compounds including nicotine and delivering it to the lungs of the user. While this does not involve smoke inhalation, which has been linked to lung cancer and tar buildup in the lungs, it does allow for potent drug delivery. Often times, it is difficult to gauge how much nicotine is being delivered while vaping as there is so much variation between devices. This, in turn, leads to the opportunity for rapid addiction and adverse health effects that have not been well studied to this point. As a cultural phenomenon, smoking and, now, e-cigarette use is condoned by the general public. While smoking has been on the decline, it is important to ensure that users are aware of the harmful effects of vaping before they begin to manifest themselves as public health issues.

  • #4010

    lianhuajin
    Participant

    I saw an interesting news about e-cigarette that teens actually using e-cigarette more than tobacco cigarette. and the trend is growing. And the Center of the Disease says now teens using vaporizers three times more than they did in the 2012. The liquid used in the e-cigarette has different flavors like berry, mango, grape, and those flavors appeals teens. And also there is a study about e-cigarette shows e-cigarette containing nicotine raised from 1 per month in 2010 to 215 per month in 2015, and nicotine overdoes can cause nausea, vomiting, diarrhea. So e-cigarette may help people to quit the tobacco cigarette, but e-cigarette itself can cause other problems.

  • #4052

    jlw23
    Participant

    Based on my research, the FDA started regulating tobacco in 2009 by the passage of the Family Smoking Prevention and Tobacco Control Act. What I found interesting is that the Family Smoking Prevention and Tobacco Control Act specifically states that FDA cannot ban an entire category of tobacco products, such as cigarettes. FDA’s regulatory role for drugs and devices is usually based on a safety and effectiveness standard. The tobacco control act establishes a new standard: to regulate tobacco products based on a public health and population health standard.
    FDA regulates all tobacco products, including e-cigarettes, hookah tobacco, and cigars. If you sell tobacco products, you must comply with all applicable federal laws and regulations for retailers.
    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, including components and parts of ENDS . However, products marketed for therapeutic purposes (for example, marketed as a product to help people quit smoking) are regulated by the FDA through the Center for Drug Evaluation and Research (CDER). I think it is necessary to ensure that ingredients in ENDS products are studied, evaluated and determined to be safe for use. With this regulatory oversight, there is hope that more information about ENDS, those long-term effects, and potential harms vs. benefits will be available soon. FDA’s oversight will also prevent companies from making misleading claims about electronic nicotine delivery systems and will help restrict youth access to these products.
    In my opinion companies making e-cigs should work with companies like J&J or Merck to get their e-cigs on the market as a medically sound product with proper testing and research.
    1- http://www.cnn.com/2016/05/06/opinions/fda-electronic-cigarettes-caudle/index.html
    2- https://www.fda.gov/tobaccoproducts/labeling/rulesregulationsguidance/ucm394909.htm

  • #4054

    tilak
    Participant

    Vaporizers, E-Cigs, hookah pens, etc. are all terms used to describe what the FDA calls Electronic Nicotine Delivery Systems (ENDS). The organic compounds along with the vaporized water contain nicotine and other compositions of flavors. In 2016, the FDA extended their ruling and passed regulation to cover all tobacco products and ENDS devices that meet the definition of a tobacco product. In most cases, the only substance in common with e-cigarettes and normal cigarettes is nicotine. The amount of nicotine can also differ in both. For this reason, I think e-cigs can be considered different from normal cigarettes in terms of regulation. Normal cigarettes contain many more substances that are significantly more harmful than that of the contents in e-cigs. As a result, regulating normal cigarettes is not as easy of a decision to make. Because of the additional harmful chemicals in normal cigarettes along with tobacco, it is harder for the FDA to regulate. On the contrast, an e-cig can be considered a medical device and has very few chemicals making it drastically different. E-cigs can be used by people who are fighting addiction to normal cigarettes as well. I believe a lot more can be done with e-cigs if they are put through a full clinical trial.

    reference: https://www.fda.gov/TobaccoProducts/Labeling/ProductsIngredientsComponents/ucm482563.htm#regs

    • This reply was modified 6 months, 3 weeks ago by  tilak.
  • #4100

    williamzembricki
    Participant

    The Electronic cigarette industry should be looked at very similarly to the Nicotine Gum and Patch industry. They are attempting to assist in the quitting of all tobacco related product. One thing that has not been discussed is that there is a great deal of personal modification available to these vaporizing devices. Over powering or trying to something that the vape is not capable of has caused combustion leaving people injured. Also, this is an inhalant if a company is not packaging safely or is allowing containments to enter juices or packaging there can be serious consequences for the user. There seems to be no clinical proof that the product can help relief cigarette addiction. I think the product should be viewed based on what the company is claiming. If a company is claiming it can help quit an addiction then the product should be viewed as a Class III medical device. If the company is claiming it is a recreational form of nicotine consumption then it should be tobacco product. If a company wants to claim it can help in the quitting of cigarettes is should have to earn that claim just like any other medication.

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