Micro-comment #3 for FDA Deeming - re: cardiac effects

Electronic cigarettes are not tobacco products and should not be treated as such. Deeming them as tobacco is a grave error with deadly consequences for more than 40 million American smokers who will be denied access to an alternative that is more than 1,000 times safer than combustible tobacco.

The proposed deeming regulations would remove more than 99% of electronic cigarette (ecig) products from the market and deliver the entire ecig business into the hands of Big Tobacco, doing more damage to public health than any cigarette company ever accomplished. This is because many of its premises are constructed on faulty assumptions (http://link.springer.com/article/10.1007/s00204-013-1127-0), junk science (http://tobaccoanalysis.blogspot.com/2014/05/glantz-review-article-is-little-more.html), and unsubstantiated propaganda (http://tobaccoanalysis.blogspot.com/2014/03/new-study-on-electronic-cigarettes-by.html) from the tobacco control industry (TCI).

Existing research already indicates that the risk profile of ecigs is actually vanishingly small. For example, a recent study by Farsalinos et al. (2014; http://www.ncbi.nlm.nih.gov/pubmed/24958250) examined the acute effects of ecig use on cardiac function and contrast these against the effects of smoking combustible tobacco cigarettes. The study concluded that “acute smoking causes a delay in myocardial relaxation, electronic cigarette use has no immediate effects. Electronic cigarettes' role in tobacco harm reduction should be studied intensively in order to determine whether switching to electronic cigarette use may have long-term beneficial effects on smokers' health.”

Another study conducted research on the direct effects of ecig vapor on cultured myocardial cells (http://www.mdpi.com/1660-4601/10/10/5146) and concluded that ecig vapor was significantly less toxic than tobacco smoke extract. The toxicity of vapor to myocardial cells in culture was generally low, and only observable at the highest concentrations tested. Moreover it was not related to nicotine content, rather to specific constituents of flavoring additives. The majority of the vapor samples were found to have no adverse effects on cardiac cells, with cell survival rates similar to controls. However, there were 4 samples showing reduced cell survival suggesting that a very small proportion of flavorings may cause some harm, albeit orders of magnitude lower compared to tobacco cigarettes. Even the worst performing e-liquids in this study were 3 times less harmful compared to cigarette smoke. Since flavors play an important role in the acceptance and success of ecigs, all flavors should be tested in order to identify which may be harmful to use.

Taken together, these results strongly indicate that the risk profile of ecigs is vanishingly small, and may well be reduced even further by thoughtful research of flavoring compounds. The FDA has a mandate and a moral obligation to protect public health by encouraging all smokers to switch to far less hazardous electronic cigarettes and to fund research that will further improve their risk profile. Researchers who are not conflicted by any current or previous association with the tobacco control industry, pharmaceuticals, or tobacco should be supported and encouraged to pursue these studies. Continued improvement and innovation of electronic cigarettes is in the interest of public health, not snubbing them by deeming as tobacco products.

Comments

There are no comments to display.

Blog entry information

Author
DrMA
Views
510
Last update

More entries in ECF Blogs

More entries from DrMA