Vapor Manufacturers Identify Potential FDA Regulatory Loophole

Vapor Companies Consider Synthetic Nicotine To Escape FDA Regulations

The vapor industry, regulated as tobacco products by the U.S. Food and Drug Administration (FDA), is facing increasing challenges in getting its products approved for marketing and distribution in the U.S. As required by the FDA, deemed tobacco products–including vapor and e-cigarettes–were required to submit premarket tobacco product applications (PMTA) to the FDA by Sept. 9, 2020.

In a matter of days, the FDA is supposed to approve or deny the thousands of applications it has received. So far, vapor companies have not fared well in the process. Weeks ago, JD Nova Group received a Refuse to File (RTF) letter from the FDA, claiming many of its applications did not meet the filing requirements and that 4.5 million of its products had to be removed from the market as a result [read more here]. Weeks ago, the FDA issued Marketing Denial Orders (MDOs) to several companies, calling for the removal of over 55,000 flavored electronic nicotine delivery system products (ENDS) [read more here]. Many in the vapor industry now fear that the actions taken by the FDA so far indicate it is moving toward a flavor ban that will leave many companies having no products left to market and sell.