Want create site? Find Free WordPress Themes and plugins.

The Tobacco Merchants Association is having its annual industry conference right now. We’re going to be providing notes from the event throughout the day based on what we think matters and what we can squeeze out during the rather busy schedule of the day. If you’d like to check out the schedule, you can find it here.

Joel Nitzkin, Chair of the Tobacco Control Task Force for the American Association of Public Health Physicians

If a product has a lower concentration of nitrosamines, we can infer it has lower risk.

We have no means to relate any chemical to risk. We don’t even know what chemicals in tobacco smoke cause disease.

There is concern that lower risk products will decrease quit rates but increase teen addiction.

There’s a contradiction is that the FDA Center for Tobacco Products gives priority to the concern of teen initiation and addiction. But the Center for Drug Evaluation and Research does not in regard to medications.

Teen users aren’t interested in modified risk tobacco products.

30% of electronic cigarette users can quit with zero nicotine products.

Clinical trials under current requirements are unrealistic. Incubation time of smoking related illness is 10-30 years. Number of people required for control too great.



Cynthia Cabrera, Representative of the Smoke Free Alternatives Trade Association

There’s just no way to go down the current Modified Risk Tobacco Product (MRTP) route.

The burdens in the MRTP landscape are unfathomable for most e cigs companies.

Electronic cigarettes are a new technology product with a lot of potential and possibility.

The idea that we could squelch something like this without due time and focus is unreasonable.

SFATA is not against MRTP designation if it can become a reasonable path.

“I have not met one adult non-smoker who has picked up an e-cig…Same for teenagers.”

SFATA is working to see more research done.

Ralph Tyler, Venable LLP, former FDA Chief Counsel and Counsel to SFATA

The rationale behind behind FDA control of tobacco is that cigarette smoking is a public health issue.

Technology moves faster than law, so the Tobacco Control Act (TCA) did not take into account electronic cigarettes.

Courts ruled in Sottera case that e-cigs aren’t drug delivery devices, but that FDA might be able to regulate them under the TCA.

be able to regulate them under the TCA. The FDA’s jurisdiction over e-cigs and their ability to deem them as tobacco products is questionable.

Additional Notes

Many agree that there is little that can be done to prevent or alter planned FDA decisions. For now, the industry needs to “Keep the faith” and “just have to keep moving forward.”

Many regulators don’t understand electronic cigarettes at all. We have to work to provide them with better information and leads.

Its possible that regulators are not willing to listen. A recent Committee on the Environment, Public Health and Food Safety (ENVI, a commitee of the European parliament) hearing invited no researchers and none of the studies were mentioned. An appointee named by the committee to investigate electronic cigarettes is more or less a prohibitionist. The lack of scientific presence at previous hearings was noted as “appalling.”

Researchers who support electronic cigarettes are routinely discredited as paid off by the industry.

20mg e-liquid is required to fully emulate the nicotine intake of smoking. A 4mg limit proposed by the EU is not based at all on science.

The FDA is in a bind regarding MRTP regulation because of the way Sec 911 of the TCA is written. It is believed that regardless of the legislation going on, the FDA still understands the ultimate goal is to improve public health.