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  • E-Lites notches up another court victory in fight for soul of e-cigarettes

    The UK based electronic cigarette company, E-Lites, has overturned an attempt by a European government to have electronic cigarettes classified as medical devices.

    The Administrative Court in Estonia last week found in favour of Zandera Ltd, owners of the E-Lites brand, and against the Estonian State Agency of Medicines.

    This decision comes at a time when the EU is proposing to classify electronic cigarettes as medicinal products under the revised EU Tobacco Products Directive (TPD).

    It follows similar recent court decisions in Germany, the Netherlands and the US. All refused medicinal classification for electronic cigarettes.

    “We are delighted common sense has prevailed,” said Michael Ryan, chairman of Zandera, in welcoming the decision in Estonia.

    “E-Lites are not designed as a medicine; they’re designed as an alternative consumer product choice for smokers.

    “We welcome the Estonian Court’s decision and we hope it will persuade other governments and regulatory bodies to review any similar proposals.”

    The TPD, as drafted, would have the effect of removing from the market, pending medicinal authorization, virtually all electronic cigarettes, despite the fact they are proving a popular alternative for smokers and are increasingly widely recognised as being safer than cigarettes are.

    “We are confident e-cigs are an exciting breakthrough and potentially ‘transforming’ product and we want to work with governments and regulators across Europe to agree the appropriate regulatory framework,” said Ryan.

    “Public health experts are proclaiming the significant contribution to tobacco harm reduction e-cigs are already making and we desperately want that to continue.”

  • Public debate sought on e-cigarettes

    Israel’s Health Ministry is asking for public feedback on electronic cigarettes before deciding whether or not to ban them, according to a story by Judy Siegel-Itzkovich for the Jerusalem Post.

    This is despite a ministry committee’s having recommended that the marketing, import and use of e-cigarettes be prohibited for five years and that the prohibition then be assessed.

    According to the story, lot of people lined up to say they wanted electronic cigarettes banned on the grounds that they had not been proved to be safe; so the thinking seems to be that the traditional cigarette, a product that has been found to be unsafe, should be allowed to continue to be on sale when electronic cigarettes, which a lot of people use to wean themselves from traditional cigarettes, should be banned.

    Nowhere in the story does anybody make the point that it is the tar from traditional cigarettes that is believed to be the risk factor in smoking and that tar is totally absent from electronic cigarette vaping.

    The public’s views are being sought via the website www.shituf.gov.il until March 25.

    The ministry will announce its decision over the summer.

  • E-cigarettes and this sporting life

    In a re-play of the tobacco industry’s former close connection with sport, Totally Wicked, a supplier of electronic cigarettes, on the weekend announced a sponsorship deal with St Helens’ RFC, one of England’s top rugby league clubs.

    According to a PRNewswire story, under the deal, the club’s Langtree Park North Stand is to be renamed the Totally Wicked Stand.

    Totally Wicked products will be available to buy throughout the stadium on match days.

    And the club will hold a ‘cigarette amnesty’ where fans will be able to swap their tobacco cigarettes for a St Helens branded electronic cigarette.

  • E-cigarettes clearly less dangerous than are traditional cigarettes

    Dr. Michael Cummings, a tobacco researcher at the Medical University of South Carolina’sHollingsCancerCenter, says e-cigarettes could be an effective product to help people quit smoking, but that research hasn’t proven the product’s safety or efficacy, according to a WCBD-TV2 report.

    “It could absolutely be a tool, but I think we need good studies to evaluate the claims,” said Cummings, who added that current products such as nicotine patches, gums and lozenges had relatively low quit rates.

    Cummings said the effectiveness of e-cigarettes was inhalation – the most efficient form of delivering a drug to the brain. It was the same reason smoking was so addictive, whether it was in relation to nicotine or other drugs.

    But Cummings and some other health advocates are worried about what they see as the unknowns of e-cigarettes. Earlier tests by the FDA, he said, had found chemicals similar to those used in car washes.

    And he is worried about the ‘metal tubings’, which he says ‘potentially could contain lead’. The metal could leach into the inhaled vapor and be dangerous for the smoker and bystanders, he said.

    However, he said that vaping e-cigarettes was clearly less dangerous than was smoking a cigarette because you could hardly get more dangerous than smoking a cigarette.

  • Fighting for change

    Vapor companies are meeting with the White House as it reviews the FDA’s proposed rules for e-cigarettes.

    By Timothy S. Donahue

    And the waiting continues. Deeming regulations for the U.S. vapor industry are now with the Office of Management and Budget (OMB). The Food and Drug Administration (FDA) sent its final rule to regulate additional tobacco products, including e-cigarettes and cigars, for White House review on Oct. 19. Currently, the FDA only regulates vapor products that are marketed as therapeutic devices. Various vapor companies have met or are getting ready to meet with the OMB to discuss the FDA’s proposal. However, it could still be weeks or even months before the rule is actually released.

    FDA spokesman Michael Felberbaum said the OMB is required to review all significant regulatory actions and has 90 calendar days to do so. “However, this time frame can be extended to allow for additional interagency discussion,” he said. “At this time, the FDA cannot provide any further comment until the final rule is published.” This would put a possible completion date somewhere in mid-January or mid-February. However, the OMB could extend the date well beyond those time frames.

    While some companies have already had their meetings with the OMB, at least two companies that spoke with Vapor Voice on the condition of anonymity said that they had appointments to discuss deeming regulations scheduled well into mid-December. This would imply that the OMB is taking review of the proposed rule seriously. Talking with the OMB while they review the document will be one of the final opportunities for industry stakeholders to voice their opinion. The next opportunity would likely be after the fact—in court.

    Based on what they saw in the original draft, which was proposed more than a year ago, some players have been preparing for litigation. However, several e-cigarette regulatory experts expect major changes. “There are likely to be some surprises in the final rule, things people aren’t anticipating,” said Andrew Perraut of the San Francisco-based advisory firm Radiant Strategies and a former staffer at the White House Office of Information and Regulatory Affairs (OIRA), a statutory arm of the OMB.

    After reviewing the proposed rule before leaving the office in August 2014, Perraut said there is more room for change in this rule than in any other he’s previously reviewed. “The requirements may very well change because the state of the science is very different [from before],” he said during a vapor association conference in Washington, D.C. Perraut added that the FDA has a particular perspective concerning the vapor industry—the protection of public health. “The impact on the regulated community is not of great interest to them,” he said.

    The OIRA, however, serves a different role, taking into consideration the impact of regulations on the affected industry and society at large. “As ‘deeming’ wraps up, OIRA is a place where your interests will really be taken into account. It is your best chance to impact how these policies come about,” he said. According to Perraut, the FDA will have to justify its thinking because the science seems to indicate that e-cigarettes are substantially less risky than the agency has admitted in its proposed rule.

    A crucial aspect of the OMB’s review will be determining the regulations’ likely economic impact on the $3.5 billion industry. This type of analysis typically examines the effect of a regulatory change by measuring changes in business revenue, business profits, personal wages and/or jobs.

    The FDA’s own economic-impact analysis, carried out in 2014, was met with some skepticism because, among other things, the agency was unable to accurately estimate the number of e-cigarette products and manufacturers in the U.S. “The FDA’s estimate is grossly understated,” says Julie Woessner, executive director of the Consumer Advocates for Smoke-free Alternatives Association (CASAA), a vapor advocacy group. “A year and a half ago, CASAA estimated more than 100,000 products on the market, and that number has only continued to grow.”

    Some states, local governments and even vapor industry manufacturers are already initiating several FDA suggestions from the initial deeming proposal. For example, sales of vapor products to minors have been outlawed by state and local legislation in 47 states. Many manufacturers have started to print nicotine warnings on their products. E-liquid manufacturers also expect the FDA to require them to register a list of ingredients for their products.

    Interestingly, a recent study by Yale University’s Abigail Friedman, published in the Journal of Health Economics, showed that prohibiting sales to minors could be counterproductive. “Bans on e-cigarette sales to minors yield a statistically significant 0.9 point increase in the smoking rate among 12- to 17-year-olds.” Friedman said that it was enough of an increase to negate all the progress made by other avenues to reduce youth smoking rates.

    One vapor advocacy group claiming to have obtained a copy of finalized deeming regulation (but is refusing to release it to the public), says the FDA aims to leave intact the provision that most concerns the industry: a mandate that any nicotine delivery devices that hit stores after Feb. 15, 2007, will have to apply retroactively for approval. The FDA has previously stated it lacks the authority to alter or amend the grandfather date because it was set by statute in the TCA [Tobacco Control Act]. Industry groups argue the process would cost millions of dollars, making it prohibitively expensive for companies to keep their products on store shelves.

    Greg Conley, president of the American Vaping Association, said that without a change to the grandfather date, 99.9 percent of the 100,000-plus vapor products currently available on the market will be banned. “When even Big Tobacco is worried about getting their products through [the FDA’s premarket review] process, no one in the vapor space should delude themselves into believing that this proposal will benefit their company,” said Conley. “In its current form, the FDA’s proposal is not about regulation; it’s about prohibition.”

    There is still hope, however. Proposed legislation, such as the Cole Bill, would amend the TCA to change the grandfather date for “deemed tobacco products.” This change would allow all vapor products currently on the market to remain on the market without being subject to the burdensome premarket FDA approval application process.

    Another bill, sponsored by Alabama Republican Representative Robert Aderholt, would similarly prevent the FDA from requiring premarket reviews of e-cigarettes that are already on the market. The bill would essentially limit the FDA by prohibiting the agency from spending money on regulation of newly deemed tobacco products unless it allows products already on the market to stay. Like the Cole proposal, this bill would move up the grandfather date and allow companies to use grandfathered products when seeking to file substantial equivalence applications.