Azar Promises Streamlined PMTA Approval for Small Vape Businesses

Alex Azar says the FDA will not shut down vape shops and small vaping companies in May, when manufacturers must submit Premarket Tobacco Applications (PMTAs), and that the agency will “streamline approval” for small companies.

President Trump’s secretary of Health and Human Services made the surprising comments during an interview on an Ohio radio station Tuesday. The HHS is the parent agency of the FDA, and Azar reports directly to the President. Trump recently told Azar that getting personally involved in the vaping issue had been a mistake for Trump.

Vape shop owner and Ohio Vapor Trade Association president James Jarvis suggested the question to host Scott Sands, and recorded and posted the exchange on SoundCloud (link below). Sands’ program is broadcast on Toledo station WSPD News Radio 1370.

“The vape industry has 100,000 people who work in that sector,” Sands told Azar, “with 15,000 small businesses around the country, and some of the President’s new restrictions would run all those people out of work.”

"The agency has promised before to “work with” small companies to help shepherd their applications through the process."

“[We] would not at all do that, just to reassure you,” answered Azar. “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.”

The first thing to note is the weird distinction between vaping products and e-cigarettes, which is very similar to a statement made by Trump adviser Kellyanne Conway last November. “We should stop using ‘vaping’ and ‘e-cigarettes’ interchangeably,” Conway told a group of reporters. She went on to say that, while the FDA has jurisdiction over e-cigarettes through the Tobacco Control Act, the agency does not have jurisdiction over vaping.

Most observers assumed she was using the term “vaping” to specifically refer to cannabis vaping, which the FDA in fact does not have jurisdiction over (in large part because cannabis is illegal federally). But whatever Conway meant, the HHS secretary should have a more thorough understanding of the products his agency is responsible for regulating and the terminology used to describe them.

When he says “not all vaping products” have to go through premarket approval, does he mean cannabis vaping products—or is he referring to some new interpretation of the Deeming Rule that has yet to be explained?

Asked specifically about the cost of completing a PMTA, Azar told the interviewer that open-system products like mods and bottled e-liquid are not the FDA’s focus, and that the agency would assist small businesses to complete the process..

“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,” Azar said.

“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.”

The approval system was indeed created by Congress in the 2009 Tobacco Control Act. The Deeming Rule was implemented in 2016, based on the authority granted to the FDA in the TCA to “deem” any product containing “nicotine derived from tobacco” to be a tobacco product. The FDA did just that, and instantly millions of tobacco-free vaping products became “tobacco products,” subject to the same approval processes as new products containing combustible leaf tobacco.

Does Azar have a plan to lighten the burden of PMTAs for small vaping businesses? Or is this just more of the same regulatory doubletalk the FDA has engaged in for years? James Jarvis, who owns several Ohio Vapor Station shops, hasn’t heard of any changes.

"What Azar described in his interview is exactly what small vaping businesses have been begging for."

“Being one of those small manufacturers, we have been told nothing of an alternative pathway or them reaching out to work with small manufacturers,” Jarvis told Vaping360 yesterday. “If there was an email or invite, somehow all of us got left off the mailing list.”

The agency has promised before to “work with” small companies to help shepherd their applications through the process. However, the regulators have never created a set of published standards and specific requirements for an approved application, let alone a streamlined pathway to approval.

What Azar described in his interview is exactly what small vaping businesses have been begging for. James Jarvis says he hopes the Trump administration finds a way, and the FDA is able to distinguish between closed-system products like prefilled pod vapes and open products like bottled e-liquid.

“If the FDA truly wanted the open-system market to survive, they would have developed a Best Manufacturing Process based on the lab visits they’ve done over the last three years with small independent liquid manufacturers,” said Jarvis.

“Let’s hope President Trump sees through this red tape and really does care about true public health and letting small independent businesses achieve the American Dream.”

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Article Author: Jim McDonald