Vaping braces for Sept. 30 PMTA deadline
An FDA deadline on vaping products is looming, and vapers and vape shop owners alike may be caught off-guard. In late July 2017, the newly appointed Commissioner Scott Gottlieb announced that portions of the Obama-era deeming regulations would be rolled back until 2022. Unfortunately, the September 30 milestones were never included in this delay.
Per the original compliance deadlines, manufacturers have until this date to register with the federal government. They must also submit a complete list of the vaping products that they manufacture. While the majority of retailers has likely completed these tasks, the confusion over the Gottlieb announcement of just two, short months ago may have left others in the lurch. Vaping advocacy groups worry that smaller, Mom and Pop Shops may have misunderstood the Gottlieb referendum.
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Only the final PMTA deadline is delayed for another 5-years. The FDA has offered a brief reprieve for manufacturers located in cities impacted the Hurricanes Harvey and Irma.
However, even vape shops who change or modify the packaging of e-liquids sold within the United States must also comply, even if the vape shop in question does not technically manufacturer the product. Vape shops who do not register by October 1 will be in non-compliance and susceptible to permanent confiscation of all non-registered products by the FDA.
What does the Sept. 30 PMTA deadline mean for the vaping community?
The possibility of hundreds of e-liquid manufacturers failing to comply with the PMTA rule leads to many growing concerns. The first is that loyal customers of non-registered brands might find their favorite e-juices immediately unavailable almost overnight. The second is perhaps more detrimental for the future of vaping in America overall.
If the FDA begins to find that hundreds of vape shops and manufacturers have failed to comply with the September 30 deadline – for whatever reason - this could be depicted as a vaping industry run amuck. The negative press could be yet another significant setback for an American vaping movement that is already highly demonized in mainstream media.
Registration for PMTA compliance might seem like an easy task. Although the system is relatively streamlined and allows for online registration, the agency’s processing system named FURLS (FDA Unified Registration and Listing System) is somewhat sluggish and antiquated. Completing the forms by-hand and mailing them in to the FDA is another option, but at this late date, may prove problematic.
Manufacturers must not only list each brand of e-liquid, they must also list every bottle size, nicotine concentration, PG/VG ratios, and other variations. So, if a vape shop offers 100 different flavors of e-liquid, each available in 18, 12, 6, 3, 0 mg/mL and with varying PG/VG percentage of 70/30, 30/70, and 50/50, that’s about 4,500 different entries that must be registered with the FDA. As the industry braces for the September 30 deadline, many vapers are stockpiling their favorite e-liquid flavors – just in case.