Why Safer Non-Explosive E-Cigs Are Not Sold in the U.S.
The first vaping products designed to prevent fires and explosions have been safety-certified by the UL, the global safety company that tests and certifies tens of thousands of consumer products each year, and are scheduled to be available on the market in a matter of weeks. However these products will only be available in Canada and not in the US, and this is because of the FDA</div><div class=glossaryItemBody>Food and Drug Administration<br />Federal agency of the United States of America. It belongs to he U.S. Department of Health and Human Services and aims at promoting and protecting public health through the regulation and the supervision of various products among which tobacco products since 2009.</div>”>FDA.
“They have locked us into antiquated technologies,” said Tony Abboud, executive director of the Vapor Technology Association (VTA). “The U.S. government is suppressing innovation in a way that can only harm consumers going forward.”
Safety certified Innovative Products can be sold in Canada but not in the US
Southern California-based e-cig manufacturer Joyetech, is the first business that met this rigorous standard. However, an FDA regulation prohibits the sales of any new e-cigarettes that were not sold in the U.S. prior to August 8, 2016, without pre-market approval.
“We did this (UL certification) to protect American consumers, but we can’t sell directly to them,” said Joshua Church, Joyetech’s chief regulatory and compliance officer. “We’ve been frozen out of the U.S. market by the FDA whose last concern is product innovation. So, we’re sitting here stuck in the water.”
On the other hand, FDA press officer Michael Felberbaum, has pointed out that the agency is addressing these safety issues in a number of ways. “The FDA shares concerns about adverse effects associated with the use of e-cigarettes, such as overheating and exploding batteries, and the agency has taken several steps to address the issues.”
He added that these steps include a public workshop on potential safety hazards, educating consumers about how to avoid e-cigarette battery explosions and exploring product standards to address battery issues.
The PMTA’s lengthy process makes it impossible for US products to be up to date
However public health experts concur with e-cig manufacturers. Back in 2016 harm reduction expert, Dr. Michael Siegel</div><div class=glossaryItemBody><span id="result_box" class="" lang="en"><span title="Michael Siegel est un éminent médecin en médecine préventive issu de l’école de santé publique de Berkeley (USA).">Michael Siegel is a prominent physician in preventive medicine from the School of Public Health at Berkeley (USA). </span><span title="Il a suivi une formation en épidémiologie pendant deux ans au Centre de contrôle et de prévention des maladies à Atlanta avant de rejoindre Boston où il pratique actuellement.<br />">He trained in epidemiology for two years for Disease Control and Prevention Center in Atlanta before moving to Boston where he currently practices.<br /></span><span title="Prenant fermement position pour la cigarette électronique, Michael Siegel s’est vu attaqué personnellement et exclure de groupes de réflexion autour de la question du tabac et ce malgré sa très grande notoriété aux Etats unis et en Europe.">Taking a firm stand for electronic cigarette, Michael Siegel has been personally attacked and excluded from focus groups around the tobacco issue, despite his high reputation in the United States and Europe. </span><span title="Ses positons sont sans appel : la cigarette électronique réussit au moins aussi bien que d’autres traitements de substitution.">His positrons are clear: the electronic cigarette is at least as efficient as any other alternative treatments. </span><span title="Il dénonce l’influence aux Etats Unis d’une part des fabricants de cigarettes classiques (qui fournissent des aides considérables pour venir en aide aux familles les plus défavorisées et ce en termes de sécurité sociale) et de ceux qu’il appelle Big Pharma,">He denounces the influence of the US classic cigarette manufacturers (which provide considerable assistance to help the most disadvantaged families and in terms of social security) and those he calls Big Pharma; some </span><span title="influence qui nuiront au développement de l’industrie de la cigarette électronique.">influences that affect the development of the electronic cigarette industry.</span></span></div>”>Michael Siegel had pointed out that ironically the US Food and Drug Administration’s deeming rule is coming in the way of selling safer products.
He had explained that if these e-cig companies had to decide to change the batteries they use, this would constitute a new “tobacco product,” hence before being released on the market the company would have had to have applied for and received a PreMarket Tobacco Application (PMTA), from the FDA. This is a lengthy process that could take years and cost millions of dollars.
“So effectively, the FDA has banned safety improvements such as replacing defective batteries”, stated Siegel at the time, and sadly the situation has not really changed. E-cig manufacturers find it makes no sense to begin the costly and time-consuming application process, when by the time the process is finalized, a new technology would have been released on the market.
“Technology innovates in cycles of months, not years, so the products being sold today were first designed almost three years ago,” said the VTA’s Abboud. “Manufacturers have developed and are selling products in other parts of the world that have safety designs and safety protections in them, but we can’t make any changes to those products here in the U.S. without going through the FDA’s multimillion-dollar multi-year PMTA process.”
Read Further: NBC
From: Vaping Post