The FDA has announced the new and final Premarket Tobacco Application (PMTA) rule.
This implication of the new rule is that manufacturers will require a PMTA to receive marketing approval. This approval will be needed to ensure that the product is “appropriate for the protection of public health”. It must be submitted before marketing approval prove will be granted.
The new rule promises no aid to the small vaping businesses and manufacturers. The complex and expensive PMTA rule seems to be final. This is hardly good news for small companies. Many of these businesses run the risk of going out of business as the ease of legally running a vaping business is lowered.
In the words of American Vaping Association president Gregory Conley, “The blunt truth for small independent companies is nothing in this FDA rule signals that good news is ahead,” “The combination of the new PACT Act restrictions and the failure of the Trump administration’s HHS and FDA to streamline the PMTA process is going to make it increasingly difficult to run legitimate vape businesses in the coming months and years.”
The new PMTA rule includes the FDA’s responses to issues raised during the public comment period. Nothing has changed as the agency strongly disagrees with the commenters and maintains its former stance, although the regulators clarify some ambiguous points.
Some small vape industry advocates like the American Vapor Manufacturers Association have since lobbied the FDA( as well as the Department of Health and Human Services) for an easier and convenient PMTA procedure for small manufactures. Promises were made in early 2020 in effect to this by secretary Alex Azar.
However, the promises of an easier PMTA process were not fulfilled. Furthermore, the FDA has now directly rejected those requests for an easier process in the final rule.
While the small companies are left in a state of confusion, the big companies will be benefiting from the PMTA process as they have the budget to fund expensive researches, staff scientists, and in-house labs. Many small and medium-sized companies after submitting their applications risk receiving deficiency letters from the FDA, asking them to do more work and more additional testing.
These requirements are too expensive for most of these companies to handle and they will most likely fold up and be left out of business. An underground black market would be inevitable.
The bigger companies that receive PMTA approvals will regard these small underground markets as threats, competition, and a danger to their future.
“Bloomberg-funded organizations know that the misinformation campaigns have worked and that even lawmakers who profess to love freedom have grown reluctant to defend the so-called ‘unregulated’ vaping market,” says the AVA’s Conley. These anti-choice organizations are so dedicated to prohibition that even FDA-authorized products are not acceptable to them.
Once large companies get PMTAs authorized, the only rational legislative strategy for these companies will be to loudly encourage federal and state enforcement against manufacturers and retailers selling products without PMTAs.
This week, the FDA began enforcement against small companies selling vape products and e-liquid without having submitted PMTAs.
