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New Study Of E-Cigarette Users Finds Implementation Of FDA Deeming Rule Could Create A Black Market For Vaping Products And Drive Users Back To Tobacco

A new study released today by the UK-based Center for Substance Use Research (CSUR)has identified the potential for serious adverse health effects to arise from recently implemented regulations governing e-cigarettes. These include the very high likelihood that current e-cigarette users will continue to use vapor products by circumventing regulations in a number of ways or, if they are unable to legally purchase e-cigarettes and vapor products, will increase their consumption of conventional tobacco cigarettes. 


A new study released today by the UK-based Center for Substance Use Research (CSUR) has identified the potential for serious adverse health effects to arise from recently implemented regulations governing e-cigarettes. These include the very high likelihood that current e-cigarette users will continue to use vapor products by circumventing regulations in a number of ways or, if they are unable to legally purchase e-cigarettes and vapor products, will increase their consumption of conventional tobacco cigarettes. 


The FDA Deeming Rule imposes much tighter regulations on the manufacture and sale of e-cigarettes and e-liquids with the likely result that the vast majority of e-cigarettes and e-liquids being sold within the US today will cease to be legally available. All devices developed after the February 15, 2007 predicate date will be required to undergo lengthy and costly assessment before receiving the necessary approval for their continued availability.


In this study, 9,040 US-based current users of electronic cigarettes (8,451 current e-cigarette users who were former smokers, 282 current e-cigarette users who were also current smokers, and 307 current e-cigarette users who had never smoked) were asked what they would do if, as a consequence of the Deeming Rule, the e-cigarette products they use right now were taken off the market. Approximately 75 percent of those questioned said that in advance of the rules being implemented, they would stock up on their preferred e-cigarettes; nearly 70 percent said that they would buy their e-cigarettes and e-liquid from a non-licensed vendor (i.e. the creation of an unregulated "black market"); 66 percent said they would import e-cigarette products from overseas; and 65 percent said that they would make and mix their own e-liquid on their own premises. In stark contrast to these high percentages, less than 20 percent of e-cigarette users said they would switch to a FDA approved e-cigarette in the event that their current preferred product was no longer available.


Worryingly, 15 percent of the former smokers questioned said that they would likely go back to smoking tobacco cigarettes if the e-cigarettes they are currently using were no longer being sold. In addition, 33 percent of current smokers said they would likely smoke more tobacco, and 10 percent of non-smokers who currently use e-cigarettes said they would be more likely to start smoking, if they find themselves in a situation where they cannot buy their preferred e-cigarette products.


Dr. Christopher Russell from the Centre for Substance Use Research who led the research, commented that, "This research shows there is an enormous gulf between the expressed intentions of the FDA and what many e-cigarette users see as being the likely impact of the regulations. The regulators' aims of improving the quality standards in e-cigarette production, improving the accuracy of labeling, ensuring the safety of e-cigarettes, and to reducing young people's access to e-cigarettes are all laudable aims in themselves. However, if in the wake of these regulations, significant numbers of e-cigarette users turn to the black-market to source their preferred products, then the positive impact of the regulations will have been diminished and significant harm could be caused to those users. It is vitally important that FDA and policy makers recognise the harms that would potentially be caused if, after August 8th 2018, the majority of current e-cigarette users sampled, who may represent many millions more, act on their expressed intentions to pursue ways to continue to using e-cigarette products that are taken off the licit market by the FDA's Deeming Rule." 


"There is a clear need for the FDA to monitor the impact of these rules to identify whether these adverse effects are occurring and, if they are, to consider reconfiguring the regulations," Dr. Russell continued. "Clearly it is not in anybody's interests to drive the population of current e-cigarette users towards the black-market. One way of avoiding these adverse unintended consequences would be for the FDA to allow current e-cigarettes and e-liquids to continue to be the subject of a lighter form of regulatory assessment whilst imposing much stricter regulatory controls on any future products being developed by the industry."


There are currently an estimated 8.34 million e-cigarette users in the United States, according to the U.S. Centers for Disease Control and Prevention (CDC). The CSUR's survey contained 12 questions that assessed participant demographics, actions intended to be taken when the FDA Deeming Rule comes into effect, and perceptions of the likely impact of the Deeming Rule on various stakeholders, among other questions. Of the survey respondents, the majority (91.6 percent) were current e-cigarette users and former smokers, with 3.1 percent current e-cigarette users and current smokers (dual users), 3.3 percent current e-cigarette users and never smokers. The remaining two percent of respondents either identified themselves as "something else" or did not answer the question. Survey respondents represented all 50 states and four of six territories.


Additional key findings:

  • 72 percent of respondents indicated they would bulk-buy in large quantities before the Rule takes effect, raising serious concerns about product degradation and consumer safety.

  • 69 percent of respondents indicated they would buy products on the black market from local non-authorized vendors.

  • 65 percent of respondents indicated they would make their own e-liquids at home.

  • 66 percent of respondents indicated they would purchase devices, products, and liquids from online vendors not subject to domestic regulations, tax regimes, or electronic product standards.

  • Only 6 percent of current e-cigarette users who described themselves as former smokers (no cigarette smoking, not even a puff, within the past 30 days) indicated an intention to stop using e-cigarettes after the regulations come into effect, and even fewer (1 percent) indicated an intention to stop using e-cigarettes before the regulations come into effect.

  • There was little indication that respondents intend to replace e-cigarettes with other nicotine products post-regulations; 3 percent said they would start using snus/smokeless tobacco, and 12 percent said they would start using or use one or more Nicotine Replacement Therapy (NRT) products, like patches, gum, or lozenges.

  • 15 percent of former smokers said they would likely go back to smoking tobacco once they are no longer able to legally buy the e-cigarette products they currently use.

  • 69 percent of respondents who were former smokers, 57 percent of dual users, and 64 percent of never smokers who currently use e-cigarettes indicated they would continue to use e-cigarettes by buying products and supplies on an unregulated black market.


(Resourced from GLASGOW, Scotland, Aug. 15, 2016 /PRNewswire/ )


NicoPure Sues FDA Over Deeming Regulations

The first lawsuit against the deeming regulations the FDA will be putting into place has been filed, and it is NicoPure that is leading the way.

NicoPure Labs LLC is an American manufacturer of e-liquids that was established in 2009 and is a founding member of the Vapor Trade Association. They filed their lawsuit in the federal district court in Washington, D.C., alleging that the FDA’s move to regulating the vaping industry under the 2009 Smoking Prevention and Tobacco Control Act is unconstitutional.

The ruling to allow FDA jurisdiction over the vaping industry was handed down last Thursday, and it is being reported by The Hill that vape companies like NicoPure see the rule-making process as a violation both the First Amendment and the Administrative Procedure Act. This act is the federal statute that dictates the process in which administrative agencies, like the FDA, can propose and establish regulations that fall within their realm of expertise.

“We are committed to responsible manufacturing based on superior product standards and stringent quality requirements. FDA’s rule does not protect the consumer from low-quality products; instead, it places a disproportionate and unjustified regulatory burden on compliant companies such as ourselves, who are determined to drive the industry to the highest standards of quality and innovation,” said Jason del Giudice, the CTO and co-founder of NicoPure, said in a statement released earlier this week.

Most of the provisions of the coming regulations are welcome by the vaping industry. This includes health warnings on product pages, ingredient lists for e-juices, and the prohibiting the sale of vape products to anyone under the age of 18, which is already standard practice in the industry.

But there is one rule that has the entire industry worried, and is the main reason that NicoPure filed its lawsuit. The FDA has a rule that stipulates that any vape product that was sold after February 15, 2007, must go through a costly approval process that takes up to two years for review and can cost upwards of $2 million.

Because the vape industry wasn’t fully formed until around 2009, this means that all the products currently on the market will have to undergo this process, including new products that will be introduced from this point on. This causes a problem for vape companies, as most are small businesses that cannot afford multi-product review process — and the FDA requires each individual product be reviewed separately — and will subsequently be put out of business.

NicoPure’s lawsuit against the FDA is thought to be one of many companies considering possible legal action. Fortem Ventures hasn’t ruled out the possibility of a lawsuit, but many are sitting tight to see what the outcome of the NicoPure lawsuit might be. We will keep you updated with more information on how this affects you as a vaper as this story develops.

E-Cigarettes Found To Be Less Addictive Than Cigarettes
December 11th, 2014
E-cigarettes appear to be less addictive than cigarettes for former smokers - and this could assist in efforts to understand how to curb cigarette smoking, according to researchers.
The popularity of e-cigarettes, which typically deliver nicotine, propylene glycol, glycerin and flavorings through inhaled vapor, has increased in the past five years. There are currently more than 400 brands of "e-cigs" available. E-cigarettes contain far fewer cancer-causing and other toxic substances than cigarettes, however their long-term effects on health and nicotine dependence are unknown.
To study e-cigarette dependence, the researchers developed an online survey, including questions designed to assess previous dependence on cigarettes and almost identical questions to assess current dependence on e-cigarettes. More than 3,500 current users who were ex-cigarette smokers completed the Penn State Cigarette Dependence Index and the Penn State Electronic Cigarette Dependence Index.
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