There are some nasty rumors spreading like wildfire across the Internet and social media that Mitch Zeller and his cronies have repealed the FDA deeming regulations. Vapers beware. This is completely untrue, but those spreading the rumor may have simply misunderstood the new FDA updates.
It all began with an official announcement by the FDA on November 16, 2016. The press release was referring to the Pre-Market Tobacco Application (PMTA) process and some changes to the submission protocols involved. The entire announcement was written in a language that was very difficult to understand, largely because of all the legal mumbo-jumbo used to write the document. The following paragraph is what is fueling many of the false rumors online.
“The Food and Drug Administration (FDA) published in the Federal Register of August 8, 2016, a direct final rule regarding procedures for refusing to accept premarket tobacco product submissions. The comment period closed October 24, 2016. FDA is withdrawing the direct final rule because the Agency received significant adverse comment. FDA will consider the comments we received on the direct final rule to be comments on the companion proposed rule published at 81 FR 52371 (August 8, 2016).”
What is the new status of the FDA deeming regulations now?
Mitch Zeller and the FDA are essentially trying to clarify some long-standing questions related to the PMTA process. For example, what if an e-liquid supplier pays the $300,000 to perhaps $3 million for the application, which is later rejected by the FDA? Must the vape shop start all over again? Is the owner required to fork over another hefty fee to the FDA?
These were some very good questions being asked by both small business owners and certain members of Big Tobacco, namely Altria’s Philip Morris of Marlboro cigarettes. By releasing the November 16 update, the FDA is clarifying the original deeming regulations by saying that a simple amendment process will be implemented to save the retailer both time and money. Unfortunately, many mistook this statement to mean that the FDA deeming regulations were being repealed entirely, which is decidedly not the case.