When a teenager fell victim to yet another e-cig explosion while riding the Hogwarts Express at Universal Studios this weekend, mainstream media picked up the ball and ran with it. It’s the perfect storm of a news story involving a 14-year old child, potential danger, loud noises, fear mongering, and of course, Harry Potter. In the midst of all the finger-pointing, the newscasters seem to have forgotten one simple fact. The FDA took over the regulation of the e-cig industry exactly six months ago. And what have we got to show for it?
For several years prior to the FDA deeming regulations being announced last May, the FDA, the CDC, and nearly every other government agency has been irritating everyone about the importance of government oversight of the vaping industry. “We must protect our children against the dangers of vaping and e-cigs,” scream Democrats and Republicans alike. Well, FDA? This latest explosion occurred on your watch. So, it’s time to fess up and take at least part of the responsibility.
‘Federal regulation’ means more than just PMTA fees and tax increases
When the FDA deeming regulations were first announced, the vaping industry was slapped with a new requirement to file a Pre-Market Tobacco Application (PMTA) that was once only reserved for Big Tobacco. Even though only one PMTA application has been approved in nearly seven years, the cost to file a PMTA (and for all of the related scientific research to go along with it) is about $1 million per product when all is said and done. That’s a huge chunk of additional revenues going into the cash registers of the FDA.
To be fair, the FDA probably hasn’t had a huge surge in new PMTA applications just yet. The FDA deeming regulations have only officially gone into effect on August 8. But that’s not the point. The FDA wanted to “take over” the vaping industry. So what are they doing about all of these explosive mishaps usually caused by carelessness or defective technology.
Dr. Michael Siegel weighs in on the Hogwarts Express incident
To make matters worse, the FDA deeming regulations now make it illegal for vape shops to help their customers with these types of maintenance and safety issues. Furthermore, manufacturers of electronic cigarettes and other technology cannot make any additional updates or improvements to their technology without filing a million-dollar PMTA that will take who-knows-how-long to approve?
“The (FDA) has failed to set any standards, or even to issue a guidance or advisory, for electronic cigarette battery safety. Moreover, the FDA’s Center for Tobacco Products has actually institutionalized the problem of exploding batteries because it promulgated regulations that prohibit e-cigarette companies from repairing the defects that are causing these explosions. Since August 8, companies have been prohibited from making any safety improvements on their products, including fixing the problem of exploding batteries. To correct such problems would amount to selling a new ‘tobacco product,’ something that is not allowed under the FDA’s regulations.” -Dr. Michael Siegel, Professor of Community Health Sciences, Boston University School of Public Health
Dr. Seigel makes a very good point. Imagine being the manufacturer of the electronic cigarette that harmed the little girl last week. Then imagine having to explain to her parents that the company was aware of the defect but was prohibited by the FDA from repairing it unless they paid a million bucks and waited six months or longer for approval? The sheer idiocy of these FDA deeming regulations is now beginning to cause irreparable damage to public health, starting with this 14-year old girl in Orlando.
Article Credit: Matt Rowland