Since the FDA deeming regulations were first announced last May, the U.S. vaping industry has been reeling from the aftermath. Thousands of vape shops are threatened with bankruptcy due to an overly expensive Pre-Market Tobacco Applications process that could cost in upwards of $1 million per product, including new brands of e-liquids. Now the FDA wants to update the regulations by introducing a new rule that would require all vaping devices to undergo a clinic trial process, as well.
Several years ago, the retailer NJOY filed a historic lawsuit against the FDA who wanted to regulate e-cigs as medical technology. NJOY won the case, but the ruling left a loophole. According to the judge’s decision, the FDA can only regulate e-cigarettes as a tobacco product UNLESS THEY ARE MARKETED AS A SMOKING CESSATION DEVICE. It's that last part that creates the loophole for the clinic trials. If the FDA gets its way and the new rule is approved, then the following issues could result:
- Much like alcoholism, smoking addiction would be reclassified as a disease.
- Clinical trials for new vaping technology could take several years to gain approval and cost millions of dollars in the process.
- This builds on the already cumbersome Pre-Market Tobacco Applications process, which is estimated to cost between $300,000 to $1 million per product with an approval time of approximately 6-months.
- With the increased approval time, technological innovation would slow to a snail’s pace, even more than it already has post-FDA deeming regulations.
- Manufacturers and retailers would be prevented from marketing their e-cigs and vaping products as smoking cessation devices unless the products have undergone the clinical trial process.
- Sharing of customer testimonials claiming that vaping is a useful method to quit smoking would also be abolished.
- And much, much more.
Dr. Siegel’s take on clinic trials
Pro-vaping advocate and Boston University School Professor in the Department of Community Health Sciences, Dr. Michael Siegel, believes that the new FDA deeming rule will be disastrous for public health. He disagrees with the notion that smoking addiction is a disease, instead considering it more of a behavioral issue. Therefore, requiring clinic trials for a device that is not technically medical equipment is not constitutional.
“If a smoking cessation claim is itself not a therapeutic claim, then why is the FDA able to regulate nicotine replacement therapy and varenicline as drugs? The reason is that these products are designed and intended to treat a disease: nicotine dependence. The DSM recognizes nicotine dependence as a disease and nicotine withdrawal is a health symptom. Since these products are primarily intended to treat nicotine dependence and to prevent withdrawal symptoms, they are rightfully considered to be drugs.”
The new FDA deeming rule is currently being reviewed by the White House Office of Management and Budget (OMB). If adopted into the current regulations, then purchasing of new vaping equipment would become nearly impossible almost immediately. Overnight, nearly 99 percent of all e-cig and vaping products would be illegal for purchase until they have passed the clinic trial process. The estimated date for the final decision on the new FDA deeming rule could takes several years or perhaps as little as a few days.