E-Cigarettes and the Future

Lou MaiellanoAs the FDA pokes around electronic tobacco devices, experts predict the products will evolve considerably in the coming years.
By Lou Maiellano.

While in Las Vegas last month, attending the National Association of Tobacco Outlets (NATO) conference, I attended a number of informative presentations. One of these presentations was on the “Current State of the E-cigarette” sponsored by the Smoke Free Alternatives Trade Association (SFATA), an e-cigarette trade association.

Bill Bartkowski, one of the pioneers of the U.S. e-cigarette market, provided an interesting take on the current state and future of the e-cigarette business.
Bartkowski began his presentation by asking those in attendance to examine the e-cigarettes currently available on the market. “I can say with some certainty that the e-cigarettes that are being imported and sold today look nothing like the e-cigarettes that will be offered for sale five years from now,” he said.

As an analogy, Bartkowski said to consider the cell phone. The cellular technology that existed 10 or 15 years ago looks nothing like the smartphones that more than 60% of all U.S. cell phone users have today.

“Technology and design is always changing, improving and enhancing the consumer experience,” he said. “It would be naïve to believe that e-cigarette technology and design would not proceed along the same path.”

Future Perfect
The technology enhancements that Bartkowski sees coming include excipients beyond today’s propylene glycol and vegetable glycerin power sources that do not involve lithium chemistry and devices capable of measuring, monitoring and metering precise amounts of nicotine per puff.  But, and perhaps most important, he sees devices that are specifically designed for automated manufacturing, making products manufactured in the U.S. competitive with those manufactured in Asia.

These enhancements will not only provide consumers with a more satisfying experience and retailers with far fewer headaches due to defects and returns, but will also provide the still nascent industry with a sophisticated, competitive product that should provide regulators and researchers the necessary data to support the product claims of safety and modified tobacco risk.

The last point is especially important in light of comments made by Mitch Zeller, the newly appointed head of the FDA’s Center for Tobacco Products, who participated in a panel sponsored by NATO at the conference. While Zeller was reluctant to go into any specifics about what the FDA was intending to do about e-cigarettes and pending regulations, he did say that the FDA was eager to learn as much as they could about the product.  “We need data,” he said emphatically.

Bartkowski made the point that current e-cigarette technology was not up to the task of supplying that data. “Virtually all of the research and development done since this product has been introduced has focused on limiting manufacturing defects—leaking and battery failures—and on flavorings. Very little, if any research or product development has centered on achieving more efficient nicotine uptake via deeper lung absorption or on electronics and power management that can dispense predetermined volumes of nicotine. The FDA wants all the data that can be produced as they evaluate this product and the industry has some obligation to provide it.”

Some recent entrants into the e-cigarette category are getting the message. Lorillard, the owner of Blu Cig, has commented on the record that they are researching deeper lung absorption. Three weeks after the NATO conference, Reynolds America reported that their new e-cigarette, Vuse, consists of a proprietary technology with microchips in both ends that communicate with each other to deliver consistent nicotine.

This is an important time in the developing history of the e-cigarette. Bartkowski summed up the challenge by saying the industry must, “keep the products safe for users, secure from restrictive regulations, develop better manufacturing practices and continuously invest in robust research.”
All of this points to one stark conclusion: Today’s e-cigarette is going to have to change.

Lou Maiellano spent more than 20 years in several operational positions with Sunoco, Mobil and Wawa and currently operates TobaccoToday (www.tobaccotoday.info), an interactive tobacco industry blog. He can be reached at (267) 229-3856 or via email at tazmktgconsultgr@aol.com.

  • itzza

    E-Cigs HAVE NO repeat NO TOBACCO

  • Lucas Chang

    It is a false presumption and stance to say that e-cigarettes will encourage the use of tobacco products. People use them because they do not want to use tobacco products anymore. Tobacco is disgusting and proven to kill you, so let people choose the route they feel necessary to substitute tobacco use.

    Lucas
    Accident Injury Claims Consultant

  • Bill Godshall

    If the FDA truly desires more “data” on e-cigarettes (as Mitch Zeller was quoted as saying), why has the agency refused our many requests to clarify or correct the many false and misleading fear mongering claims the agency made about their own lab report in 2009, why has the agency continued to misrepresent the data on e-cigarettes, why has the agency hired e-cigarette opponents to misrepresent the data on e-cigarettes at conferences/meetings it has hosted, and why has the agency done virtually no further research on the products?

    Regardless, if FDA proposes and subsequently approves the “deeming” regulation to apply Chapter IX of the FSPTCA to e-cigarettes (as the agency has repeatedly stated its intent to do since April 25, 2011), Section 905(j) and Section 910 would ban the sale of ALL e-cigarette products not on the market before February 15, 2007 (which includes ALL e-cigarettes currently on the market).

    Even if FDA proposes and approves an additional regulation (along with the deeming regulation) for e-cigarettes that exempts e-cigarettes from the 2007 grandfather date, the agency is likely to extend that grandfather date to 2013 or 2014, which would effectively ban ALL new e-cigarette products after that date unless a manufacturer submits and FDA approves either a SE application or a New Tobacco Product application, the latter of which is likely to cost millions of dollars (for each brand of e-cig), or about as much as submitting a Modified Risk Tobacco Product application.

    Even then, there is no assurance the FDA will approve any SE or New Tobacco Product application for e-cigarette products.

    Thus, if FDA proposes and subsequently approves a “deeming” regulation, the FDA may never approve any new e-cigarette products to be allowed on the marketed.

    I can already hear Mitch Zeller and others at FDA saying “we are required to enforce the law”, just as Deyton said before him.

    If FDA truly desired to reduce the leading cause of disease and death (i.e. cigarette smoking), the agency would never have unlawfully banned the products in 2009, would never have made false and misleading fear mongering claims about e-cigs, would have corrected and clarified all of their many false and misleading claims about e-cigarettes by now, and would have reversed its stated intent to impose the “deeming” regulation.

    The free market is allowing e-cigarettes to save the lives of millions of smokers, but the FDA remains intent to ban the sale of e-cigarettes (according to its repeated statements).

  • joe voll

    Legal tobacco cigarettes kill a half a MILLION Americans every year! And theyre worried about ecigs that contain no smoke, no tobacco and no cancer chemicals.

  • cassidy

    I agree that e-cigarettes have a long way too come, and I am interested in seeing how the market will evolve in the coming years.

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