The Ecigarette Battles the FDA

The ecigarette has been under scrutiny since they came on the scene.  The FDA has been trying to get their grasp around the neck of the ecigarette world for sometime.  Luckily, the ecommerce platform and the importation of the majority of ecigarette products from China, this has been a tough road for them.  The FDA will eventually want ecigarette manufacturers to play by their rules and will do so with a open hand.

Big tobacco is diving into the e cigarette world themselves.  With electronic cigarette products launching as soon as September of this year from giants like Marlboro and Camel, I think we will start seeing the corruption of big money business shut down the smaller start up e cigarette companies.  Big tobacco will be able to control the FDA to some extent with their long reach in government and powerful lobbyist in their hire.

The e-cigarette game is going to be changing dramatically when the big tobacco giants start flooding the market.  I see them creating big restrictions and policies towards the selling of these e cigarette products and making it next to impossible to compete with the big boys.

It’ll be interesting to see where ecigarettes go over the next couple years.  We are already starting to see disposable ecigs in liquor stores and markets.  It’s only a matter of time before Phillip Morris starts pushing their weight around and edging these small e-cigarette guys out.

Ecigarette: The FDA Stance

The following is the FDA stance on Ecigarettes:

In May 2009, the US Food and Drug Administration (USFDA) Division of Pharmaceutical Analysis tested 19 varieties of electronic cigarette cartridges produced by two vendors NJOY and Smoking Everywhere. Diethylene glycol, a poisonous and hygroscopic liquid, was detected in one of the cartridges manufactured by Smoking Everywhere . Tobacco-specific nitrosamines (TSNAs), known cancer-causing agents, were detected in all of the cartridges from one brand and two of the cartridges from the other brand. Nicotine can also be traced in some claimed nicotine-free cartridges. Further concerns were raised over inconsistent amounts of nicotine delivered when drawing on the device. In some e-cigarettes, “Tobacco-specific impurities suspected of being harmful to humans—anabasine, myosmine, and β-nicotyrine—were detected in a majority of the samples tested.” It is not clear if these chemicals were detectable in exhaled vapor.

In July 2009, the FDA publicly discouraged the use of electronic cigarettes and raised concerns that electronic cigarettes may be marketed to young people and lack appropriate health warnings.

The Electronic Cigarette Association criticized the FDA testing as too “narrow to reach any valid and reliable conclusions.” Exponent, Inc., commissioned by NJOY to review the FDA’s study in July 2009, objected to the FDA analysis of electronic cigarettes lacking comparisons to other FDA-approved nicotine replacement therapy products where similar levels of TSNA were detected. Exponent concluded that the FDA’s study did not support the claims of potential adverse health effects from the use of electronic cigarettes.

Furthermore, FDA methods “have been lambasted in journals” by some medical and health research experts who noted that potentially harmful chemicals were measured at “about one million times lower concentrations than are conceivably related to human health.”

Additionally, The Tobacco Products Scientific Advisory Committee of the FDA is alleged to have several members who maintain consulting relationships with various pharmaceutical companies who manufacture smoking cessation products. If these allegations are true, this might represent a potential conflict of interest

FDA Ecigarette Warning Letters

The Department of Health and Human Services which is put of the Food and Drugs Administration (FDA) since 2010, has been sending out warning letters to various e cigarette companies.

The vast majority of the initial letters were directed at ecigarette companies that were making claims that their devices would help you stop smoking.  There were some warning letters that were sent to companies claiming that their product was a drug. And lastly, some e cigarette warning letters were sent to people packing violated certain labeled and promotion laws.

Although these are piecemeal seats, the major thing that is coming soon is the FDA finally deciding and announcing how they will handle ecigarettes as a whole.