The FDA is the reason sketchy Chinese disposables flooded the market. They killed the industry here to protect tobacco tax revenue.
Before that, there were manufacturers using ISO certified cleanrooms to produce eliquid who voluntarily submitted to 3rd party audits. They all closed doors because the FDA forced them to submit every SKU to the PMTA process, which costs $250k-2m per SKU.
That means that for one eliquid flavor, they’d need to submit a separate PMTA request for every nicotine strength and base ratio, which could end up costing tens of millions for nothing if the PMTA was denied.
The FDA is the reason sketchy Chinese disposables flooded the market. They killed the industry here to protect tobacco tax revenue.
Before that, there were manufacturers using ISO certified cleanrooms to produce eliquid who voluntarily submitted to 3rd party audits. They all closed doors because the FDA forced them to submit every SKU to the PMTA process, which costs $250k-2m per SKU.
That means that for one eliquid flavor, they’d need to submit a separate PMTA request for every nicotine strength and base ratio, which could end up costing tens of millions for nothing if the PMTA was denied.