As Azar hits at ’streamlined’ PMTA, federal flavor ban goes into effect tomorrow

Today is the last day to legally purchase refillable, flavored, pod- and cartridge-based vapor products due to a recently enacted partial ban by the Trump Administration. Exempt from the new regulations will be tobacco and menthol flavors, separated bottled e-liquids used in open-tank systems, and flavored disposables like the NJOY Daily.

Retailers who choose to continue selling these flavored vapes will be subject to enforcement by the U.S. Food and Drug Administration (FDA).  Manufacturers of some vapor products may be required to submit a rather costly Pre-Market Tobacco Application (PMTA) by May 11, 2020 or be forced to remove their products from store shelves.

All that is required – for now – is a submission of the application.  Approval by the FDA is the next step, but retailers will be allowed 12-months for this process to run its course.

HHS Secretary hints at ‘streamlined’ PMTA approval process

Interestingly though, the president’s Secretary of Health and Human Services Alex Azar admitted in an interview with WSPD News Radio 1370 in Toledo, Ohio that open-rank e-juices and products are not the focus on the Trump flavor ban.  The FDA’s primary concern is centered around prevention of the sales of flavored non-refillable pod products like JUUL which the administration believes appeals most to youth vapers. 

“We’re working with small businesses and the vaping association to actually create pathways that would streamline approval for the open-tank small vape shop-based products…”
“What we’re focused on are the cartridges in the systems with kid-attractive flavors, not the…open-tank vaping systems, and as to all products we’re committed to working with all actors in the system to get them through the regulatory process that Congress set up as expeditiously as possible. That regulatory process is not something the President created. That was created by Congress back in the Obama administration. We just have to implement it.”
“[We] would not at all do that, just to reassure you…The President has struck a very balanced approach. Under the law, by May of this year, all e-cigarettes—not all vaping products—just e-cigarettes, which are nicotine delivery devices, are required to come in and seek FDA approval. They’ve been on the market illegally up to this date, because they’ve not been approved by FDA.”

Whether Azar’s comments about a streamlined PMTA approval process are accurate or just more political double talk is still unclear.  But there is a rather notable change in the ways in which Trump Administration officials are now talking about “vaping products,” in general.

Related Article:   WH Presser: Trump plans to ban flavored vapes; no mention of THC or smoking

For example, shortly after the president announced in mid-September his intentions to enact a flavor ban of some kind, Political Advisor Kellyanne Conway told reporters, “We should stop using ‘vaping’ and ‘e-cigarettes’ interchangeably.” She then went on to make the somewhat controversial statement that the FDA has the legal authority to regulate e-cigarettes per the Tobacco Control Act, but it lacks the ability for federal oversight of separately sold e-liquids and other “vaping products.”

In Azar’s radio interview, he specifically stated that “not all vaping products” will be required to seek PMTA approval.  This statement in itself is highly contradictory to what the majority of the American vapor industry currently assumes to be true.  So, does this mean that a massive change in the PMTA process in the works?  Only time will tell.  

Related Article:   In new presser, FDA repeatedly and intentionally misuses the term ‘vaping’

(Image courtesy of Shutterstock)

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