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

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

 

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.

 

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

 

I Don't believe that is true.

 

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.

 

Welcome to the Wonderful World of FDA Deeming.

LOL

 

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.

 

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.

 

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.

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

 

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.

 

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.