Just last week, the U.S. Food and Drug Administration (FDA) missed a couple of very important deadlines with the federal government that automatically resulted in a delaying of portions of the FDA deeming regulations that threaten the American vaping industry.
Originally, all manufacturers of e-cigs and vaping products released prior to August 8, 2016 were required to file a Pre-Market Tobacco Application (PMTA) with the FDA by December 31. That deadline is now pushed back by six months to June 30, 2017, which is a nice little bonus for small business owners facing Christmas expenses and end-of-the-year taxes.
FDA deeming regulations and the PMTA process
The PMTA process is very expensive and time-consuming. A single application can cost in upwards of $1 million per product, a fee that most Mom and Pop vape shops simply cannot afford. The deadline extension gives business owners a bit more time.
Many are blaming the FDA’s failure to file paperwork with the proper authorities on the agency’s miscalculation of the vast number of new PMTAs being filed as December 31 draws ever closer. PMTAs must be filed through the FURLS system (FDA Unified Registration and Listing System), a database that was previously reserved for use by only Big Tobacco until the FDA deeming regulations were announced last May. FURLS, by most accounts, is already very outdated technology. And the tens of thousands of new applications doesn’t help matters much.
FDA fails to file ‘toxic list’
Another theory is that the FDA failed to file paperwork simply because the agency does not have the compiled data required. Part of the paperwork to be filed includes a long list of toxic chemicals that the FDA claims are found in the vapor of e-cigs and vaping technology.
The vaping industry has long refuted these claims, even sometimes publicly stating that the FDA is outright lying about the supposed toxicity of electronic cigarettes as a way demonize them with the American People. When the FDA failed to file the list, conspiracy theorists saw this as a sign that the list of toxic chemicals actually doesn’t exist.
However, the FDA also warns that manufacturers should not consider the deadline extension as a sign that the FDA deeming regulations are going to be eventually overturned. Vape shops should still plan to comply by the new June 30, 2017 deadline or face the consequences. Still, many are secretly hoping that the anti-regulation-favoring Donald Trump will quickly repeal the e-cig regulations almost immediately taking office on January 20.