Many Firms Received FDA Marketing Denial Overnight

According to sources, numerous companies received marketing denial orders (MDO) from the U.S. Food and Drug Administration overnight. A major white label manufacture confirmed that several of their clients received MDOs. The FDA is expected today to announce the fate of the vaping industry when it makes final decisions on premarket tobacco product applications submitted by Sept. 9. 2020.

Credit: Zoran Milic

The manufacturer can not be named because he had yet to speak with his clients about the denial order. The exact number of products that have received MDOs could not be confirmed, but some are suggesting its “hundreds of thousands” of products.

Several companies have announced on Twitter having received them on Sept. 8, many late in the evening. Amanda Wheeler, president of the American Vapor Manufacturers Association (AVM) tweeted “Today was a tough day. Lots of very good people who I respect deeply and who helped thousands of smokers quit, got told by our government that their products were illegal. To all of you, I am so very sorry. To your customers, I am even more sorry. Our government is wrong on this.”

The FDA has yet to update its list of companies that received MDOs. Recently, the agency announced it had sent in total 34 MDOs from Aug. 27 to Sept. 1, covering more than 300,000 products. At least one company has already filed a lawsuit against the FDA, according to Vape Radio.

Many manufacturers have also said they would turn to synthetic nicotine because the FDA lacks the authority to regulate it. Vapor Salon will be switching to synthetic nicotine, the company wrote in a public Facebook post dated Aug. 26.

The post was published on the same day that the U.S. Food and Drug Administration denied some 55,000 marketing applications by Vapor Salon and two other companies on the ground that they “lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by well-documented, alarming levels of youth use of such products,” according to an FDA press release.

“VaporSalon is switching to TOBACCO FREE NICOTINE on Friday, 8/27/2021,” the Facebook post reads. “The main purpose of this is to be outside of the FDA’s regulations with their hefty PMTA requirement which takes full effect on Sept 9th 2021 with needing an approved PMTA, or your product can no longer be sold. There has been 0 approved PMTA’s for anything ENDS related to-date.”