After months of silence, the FDA has begun to move against companies that failed to file Premarket Tobacco Product Applications (PMTA's) by the deadline of September 9th, 2020. The PMTA deadline required companies to submit a literature review, sales and marketing plans, lab test results and studies, product safety and manufacturing information, and much more to the FDA in order for their products to continue to be legally sold in the United States.
As discussed in previous blog posts, the immediate effect of the PMTA deadline was a huge rise in black and grey market vape products as many companies ignored the PMTA requirements and continued with business as usual. However, it was only a matter of time before FDA enforcement caught up to them and that process has officially begun.
On January 15th, the FDA dropped its first round of warning letters, putting manufacturers on notice that continuing to manufacture or sell vape products without a PMTA will not be tolerated. More warning letters went out on the 29th of January and the 12th of February, and we expect this trend to continue. Although so far only less than 50 companies have received warning letters, these companies have a combined total of hundreds of thousands of vape products listed with the FDA so the impact could be significant when these products are abruptly withdrawn from the market.
You can track the warning letters going out on the FDA website.
The FDA is also going after black market imports, with particular focus on the types of vape products known to be most widely used by underage individuals. The FDA has stated that it will prioritize enforcement against vape products that are "most appealing and accessible to youth." Disposable pod-style devices, such as those made by Juul and Puff Bar, are high on FDA's enforcement list and the FDA scored a win when it intercepted a giant shipment of illegal knockoff products on it's way to Texas from China.
With the help of Customs and Border Protection, the FDA seized nearly three quarters of a million dollars worth of product making up a total of 33,681 individual units.
“Many counterfeit, unapproved or unauthorized products are likely produced in unregulated facilities with unverified ingredients posing a serious health concern to consumers,” said Customs and Border Protection Port Director Timothy Lemaux.
Mr. Lemaux has a point. The outbreak of EVALI in 2019 was initially incorrectly attributed to legal vaping products, however, the cause was ultimately found to be illegal, black market THC cartridges contaminated with vitamin E acetate. Preventing unscrupulous or careless companies from causing outbreaks like EVALI is, ultimately, what the PMTA process aims to accomplish.