FDA Alex Azar promises "streamlined" PMTA approval for small vape businesses

[Stu Dowling]

Okay, so during an Ohio radio show Tuesday Health & Human Services Secretary Alex Azar said the FDA would "work with" small vape shops to get their applications through. He was quite vague about the details though, in other words, he didn't really say how the FDA would do that. When asked about the cost, which is the biggest factor in whether companies can submit their PMTAs, Azar said, “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.” I noticed he said "working", that means currently, like now. So which businesses are they "currently" working with, or did he really mean "plan to" in the future. You have to remember, Azar is a public official, so he's a politician, and we know how politicians speak. Though this sounds like a big win, I feel like we must be cautious, because Azar is anti-vape, in my opinion, and this whole thing about "helping" small businesses complete their applications, again, sounds like politics as usual to me. So let's say they cut costs so businesses don't have to pay hundreds of thousands of dollars, what about states who are taking it upon themselves to pass their own bans? There are at least 50 bills in 18 states that involve some kind of vaping or flavor ban. What about the Supremacy clause in the Constitution, where it says state laws can't supersede federal laws? Azar Promises Streamlined PMTA Approval for Small Vape Businesses - Vaping360

 

[zoiDman]

 

[puffon]

It is confusing.
Is it the vape shops that need PMTA approval, or the product that's being made in China?

 

[zoiDman]

... So let's say they cut costs so businesses don't have to pay hundreds of thousands of dollars, what about states who are taking it upon themselves to pass their own bans? There are at least 50 bills in 18 states that involve some kind of vaping or flavor ban. That leaves me with the question of the Supremacy clause in the Constitution, where state laws can't supersede federal laws? I was under the assumption that's why the judges had ruled against the bans in MI and NY, because they're bound by the Constitution and can't rule any other way. ...

States are Free, and have the Right, to Ban something like Flavored e-Liquids within their respective boarders. Or e-Cigarettes in General for that matter.

AS Long as they follow the Existing Statutory Process by which each State Governs themselves by.

It was the Subversion of these Statutory Processes by Governors/Health Departments that caused Many of the "Emergency Bans" to be overturned. Not a Violation of the Supremacy Clause.

 

[zoiDman]

It is confusing.
Is it the vape shops that need PMTA approval, or the product that's being made in China?

As I understand it, a PMTA Always applies to a Specific Tobacco Product.

 

[Stu Dowling]

Both! All companies involved with the manufacturing, importation, and retail of ENDS in the USA need to submit a PMTA. So retailers would essentially be applying and paying for almost everything they sell in the store! Not for say 20 of the same item, that would only be considered one, but for every different brand of eliquid or different type of device, or SKU (stock keeping unit). Hope that helps, I'm still a little confused myself. What is a PMTA?

 

[Stu Dowling]

AH yes, okay, I remember hearing something about if Governors wanted to enact a state emergency, then they had to go through a process that involved public hearings and that they didn't do that. Am I close on this?

 

[zoiDman]

Both! All companies involved with the manufacturing, importation, and retail of ENDS in the USA need to submit a PMTA. ...

I Don't believe that is true.

 

[Stu Dowling]

I don't know, that's what the link says. I have heard some vape shop owners talk about having to apply for every SKU, but rather than a separate application per SKU, which would be ridiculous, they could include all the SKUs per application, or something like that. And THAT, the cost, is what was going to kill them.

 

[zoiDman]

AH yes, okay, I remember hearing something about if Governors wanted to enact a state emergency, then they had to go through a process that involved public hearings and that they didn't do that. Am I close on this?

It Varies from State to State.

But usually, a Governor with the support of another State Agency can Enact a "State of Emergency" when certain Conditions are meet, and there is an Immediate Need for Action.

So the Earthquake hits and Funds are Needed NOW to help in Rescue/Recovery Efforts. There Isn't Time to have Public Hearings and for a State Congress to Fiddle Fluck around.

After things settle down, now Congress can Debate how much Money should be Spent? And Exactly where it will come from? And Public Hearings can be held to let All Voice what they want to be done.

Most of these governors didn't want to go thru Congress. Or have Public Hearings. So they got their Health Departments to say that Vaping was a Public Health Emergency. Based mainly on the BS the CDC/Media was Spewing linking e-Cigarettes to those who were getting Sick Inhaling Black Market THC

So they went around Congress and the Entire Legislative/Regulatory Process in the name of a "State of Emergency".

But when Judges asked to see the Evidence that these Emergency Bans would do what they say they would do, State Health Departments had almost Nothing to show them.

So the Judges told these governors if they wanted to Ban Flavors, they had the Power to do so. Just go back to your State and do it the way it is Supposed to be done. Via the Legislative/Regulatory existing process.

 

[zoiDman]

... I have heard some vape shop owners talk about having to apply for every SKU, but rather than a separate application per SKU, which would be ridiculous, they could include all the SKUs per application, or something like that. And THAT, the cost, is what was going to kill them.

Welcome to the Wonderful World of FDA Deeming.

LOL

 

[Stu Dowling]

Ugh... lol.

 

[Rossum]

There are at least 50 bills in 18 states that involve some kind of vaping or flavor ban. What about the Supremacy clause in the Constitution, where it says state laws can't supersede federal laws?

The only way Federal Supremacy would apply is if Congress passed a law forbidding the states from regulating vapes more tightly than the FedGov does. There is currently no such law, and I don't foresee such a law being passed anytime soon.

 

[Rossum]

Both! All companies involved with the manufacturing, importation, and retail of ENDS in the USA need to submit a PMTA.

No. Manufacturers need to submit one for each product, as do importers. But retailers are free to sell any product that the manufacturer or importer has PMTA'd without further ado from the FDA. I mean think about this for a moment, do you think every c-store that sells VUSE or Juul needs to apply for a PMTA?

Now if a shop mixes liquids, then they are a manufacturer and need to apply for PMTAs. This is why most shops have done away with "house juice". Heck, technically, if they so much as wrap and install a coil in a customer's RDA, they're a manufacturer.

 

[Stu Dowling]

So basically small juice manufacturers will be affected by this? I mean, on the hardware end there aren't any really small manufacturers, pretty much everything's Dovpo, Hellvape, Vandy Vape, SMOK, etc... And big juice makers like Beard Vape and Jam Monster will be able to afford the PMTA. They make it sound like it's going to put all the small vape shops out of work.

 

[Rossum]

I mean, on the hardware end there aren't any really small manufacturers, pretty much everything's Dovpo, Hellvape, Vandy Vape, SMOK, etc...

There are lots of small hardware manufactures. Svoemesto, Dicodes, Origen, etc. They tend to be primarily European, because most of the American ones have thrown in the towel already. Not being allowed to introduce new products after 8/8/16 made it somewhat pointless to be a hardware manufacturer in the USA.

And big juice makers like Beard Vape and Jam Monster will be able to afford the PMTA.

Don't forget, they need a separate PMTA for each and every flavor of liquid they make.

 

[Anise]

Plus a PMTA for every nicotine strength.

 

[Rossum]

Plus a PMTA for every nicotine strength.

No, I believe they've back-pedaled that and stated that different nicotine strengths could be included in the same PMTA.

 

[Anise]

Well that's one good thing!

 

[Rossum]

Well that's one good thing!

It helps a little, but it certainly doesn't lower the bar to the point where a a Mom & Pop B&M can get approval to mix and sell their own liquids like they used to.