New Testing Method Keeps PMTA Dream Alive for Small Vape Companies

[Vapeon4Life]

"Small vaping manufacturers hoping to remain on the market beyond Sept. 9, 2021 are scrambling to begin the serious work of testing their products, so they’ll be able to show the FDA they’re making a good-faith effort toward completing the PMTA requirements.

The FDA has discretion to grant case-by-case extensions to manufacturers “for good cause.” Many believe that showing evidence of progress toward completing the testing requirements will earn a temporary reprieve from FDA enforcement.

Applicants that are serious about remaining on the market face major challenges completing the complex and expensive evaluations required of their products—including stability testing, toxicology reports, behavioral studies and HPHC testing.

HPHC is FDA shorthand for “harmful and potentially harmful constituents,” and refers to substances in e-liquid that might pose health concerns. The cost of HPHC testing has been a major hurdle for small manufacturers—more than $20,000 per e-liquid at a typical lab using the standard testing method. That’s out of reach for most small businesses with dozens (or more) of flavors that will require testing.

AVM’s new process makes HPHC testing affordable
The founders of the American Vapor Manufacturers Association (AVM) have created a much less expensive alternative HPHC testing method that costs just five to ten percent as much as standard testing. It’s a proprietary process, but is available to all AVM members.........."

See whole article here:
New Testing Method Keeps PMTA Dream Alive for Small Vape Companies

 

[K9Luvr]

New article on Vaping360 on the FDA PMTA denials:

FDA Has Now Denied PMTAs from 295 Vape Companies

 

[Vapeon4Life]

New article on Vaping360 on the FDA PMTA denials:

FDA Has Now Denied PMTAs from 295 Vape Companies

Essentially the FDA is attempting to outlaw most vaping in the US - Apparently there are legal grounds of contention, including special interests having undue and illegal influence on the FDA rulings.

Some might say that even the PMTA process itself was/is disingenuous - There was never any intention to legitimatize any vape products - In fact the PMTA process appears to be an attempt to make fools out of and to cost as much money as possible to vape manufacturers - to make it harder and harder to do business without actually declaring prohibition of all vaping - A cheaper and easier way to suck the life out of an industry{independent vape companies} - Is it to leave Juul and a few other big companies a monopoly???
We will see - In the meantime I am not a lawyer and have no commercial interest in vaping - So how the industry and its lawyers will play this I don't know.