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.
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.
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.
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.
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.
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
Spiral Medical Development
www.spiralmeddev.com
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
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
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.
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.
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.
Yes, the FDA currently regulates e-cigarettes as well as all tobacco products. May 5, 2016 was when the FDA ruled on electronic cigarettes.
https://changelabsolutions.org/does-fda-regulate-e-cigarettes
https://www.federalregister.gov/documents/2016/05/10/2016-10685/deeming-tobacco-products-to-be-subject-to-the-federal-food-drug-and-cosmetic-act-as-amended-by-the
I do think that e-cigarettes and regular cigarettes should be regulated differently. The e-cigarette is a mixture of chemicals that contains similar chemicals to a normal but does not have the same side effects on the individuals health. Also, since it has the ability to be highly addictive, very easy to use and very easy to attain, just as normal cigarettes are, I do not think there should be different regulations from normal cigarettes. Both products should contain warning labels regarding the health risk and the addiction risk, and should be treated and regulated the same.
The FDA does regulate cigarettes as it affects the packing, labeling and distribution.
https://www.fda.gov/TobaccoProducts/Labeling/ProductsIngredientsComponents/ucm482563.htm
I think that e-cigarettes are a new device that delivers a new form of drug that they should be regulated as a class II medical device and should have to go through clinical trials. Nicotine is a highly addictive substance and if a company is claiming that the device to be used to help people stop smoking then there must be more research involved that proves it will actually help people stop smoking. Inhaling a mixture of chemicals can have different, negative effects on the lungs that the company should know does not harm the individual, before it claims it is a safe alternative to smoking normal cigarettes. Individuals use to not have a clear understanding of the health effects of smoking because there was no intensive research and trials. E-cigarettes can be the same way but it is the FDA's obligation to regulate and force clinical trials to ensure that this product that has reached millions of users, a lot of them underage, is safe for use and will not cause any long term health effects. Since E-cigarettes are so new there is not too much data on long term effects from consistent use, which is why the FDA must classify E-cigarettes as a class II device. It is a combination device that combines different chemicals, it is new to the market, it is highly addictive, and it can pose a serious risk to our generation and youth.
Technically, the FDA regulates all nicotine products including cigarettes and e-cigs. I however, don't believe that they should be classified as a class III medical device. Regulation has a tendency to kill small businesses, because it only takes one law and now you produce illegal goods. Dr. Simon was right when he said that larger companies can weather out the storm because they can afford to. Small businesses go bankrupt because they don't have the capital. If you regulate e-cigs it will be harder to create health studies to see whether or not e-cigs are better than normal tobacco products. That is why the FDA created the current rules they have, which are across the tobacco-related products board. Tobacco products are harmful, but they aren't banned. People have the freedom to still use them, as long as they obey the laws on the books. If you wish to say that e-cigs are drug delivery devices, then so are all tobacco products, because they all deliver nicotine and other chemicals. For now, more studies are needed on safety before such a regulatory judgement call is made.
[1] https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm506676.htm
I do not think e-cigs should be classified as a class III medical device due to the lack of studies regarding it's safety. Also, class III devices are classified as devices that have a high risk to the user. I think classifying e-sigs as class III would be too much. In 2016, FDA apparently required that e-cigs would go through the FDA approval process as regular smokes. I believe currently they require an "a nicotine warning label" that must appear on all tobacco products including e-cigs.
E-cigs are known to be less harmful to a person's health rather than regular cigars or cigarettes. E-sigs contain fewer toxins but do still deliver harmful chemicals. So I think it would be best to currently regulate the age e-sigs can be sold too. I think for now, we should only sell e-cigs to 18 years and above. We need further studies to prove e-sigs should be regulated like normal cigarettes before taking action.
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.
Yes, FDA does regulate e-cigarettes. In my opinion, the FDA got forced to regulate e-cigarettes. They were used to be a treatment option for regular smokers back in the data when VAPING was not there. Now the only reason FDA created a regulation in 8.8.2016 is that VAPING started to get used to recreational drugs. Because of that, they can eventually and indirectly cause deaths. In my opinion, e-cigarettes must not be banned since they are a really good and alternative way instead of smoking and it can be used to get cured of this addiction and eventually save yourself from various diseases such as lung cancer...
The U.S. Food and Drug Administration recently finalized a rule that extends its regulatory authority to all tobacco products, including e-cigarettes, cigars, and hookah and pipe tobacco, as part of its goal to improve public health. Before this final rule, these products could be sold without any review of their ingredients, how they were made, and their potential dangers,” explains Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “Under this new rule, we’re taking steps to protect Americans from the dangers of tobacco products, ensure these tobacco products have health warnings, and restrict sales to minors.” The FDA regulates all tobacco products, including (as shown): hookah, e-cigarettes, dissolvables, smokeless tobacco, cigarettes, all cigars, roll-your-own tobacco, pipe tobacco, and future tobacco products that meet the statutory definition of a tobacco product.
https://www.fda.gov/consumers/consumer-updates/facts-fdas-new-tobacco-rule
