New FDA regulations and effect on DIY?

[Robert Cromwell]

Question, if the grandfather date would essentially be meaningless to nicotine base that was on the market prior to the grandfather date, then why would we waste time supporting HR 2058.

My understanding is that all HR 2058 aims for is a more reasonable grandfather date.

My understanding, was that all products that were on the market prior to the 2007 grandfather date were exempt from having to file for approval.

Nope they just have a cheaper and simpler process to go thru.

I could be wrong but do not think so. Will be happy if I am wrong.

As I understand it ALL vaping products will have to have some kind of FDA approval on them within 2 years from 8-10.

I think the grandfather date works as a true grandfather date for cigs but not vaping stuff.

 

[Sugar_and_Spice]

Here is a link to the calendar that Oliver(formerly know as Smokeyjoe) posted. It shows when everything is due, just click and read.

Dropbox - VTA Guidance - Deeming Compliance Calendar - FINAL.pdf

 

[Frocket]

Nope they just have a cheaper and simpler process to go thru.

I could be wrong but do not think so. Will be happy if I am wrong.

As I understand it ALL vaping products will have to have some kind of FDA approval on them within 2 years from 8-10.

I think the grandfather date works as a true grandfather date for cigs but not vaping stuff.

Yup, I'll be surprised if any vape products do not require a PMTA.

The only exception may be for nic liquid - I don't know what nic liquid was available before the grandfather date, if any. However, if nic liquid was available, a nic liquid currently marketed with the same ingredients and nicotine strength would possibly be considered "substantially equivalent". If so, a full PMTA is not required, just has to show the product generally has the same ingredients and properties.

IMO, this will probably only be of interest to tobacco companies. They're free to change their packaging, small changes to designs, and minor tweaks to cigarettes already on the market, without having to submit a full application - they can just show that the "new" product is substantially equivalent to other cigarettes.



BOOM!

 

[Bob Chill]

I think nic base will be regulated and quite possibly choked off from consumers to directly acquire. If the Feds don't do it then many States probably will. IMHO- we are nearing the end of free flowing 100mg nic from multiple suppliers. Not sure how fast it will happen but I'm not taking any chances either way.

 

[zoiDman]

...

My understanding, was that all products that were on the market prior to the 2007 grandfather date were exempt from having to file for approval.

I think by People/Us using the term "Grandfather Date" that it gives the Wrong Impression. Because there are going to be No Tobacco Products that are going to be able to be sold in the USA without an FDA Market Order.

We should have been saying is that Feb 5th, 2007 is the "Predicate Date".

The Predicate Date basically say's that if you have a Tobacco Product that you would like to sell, and your Product is Very Similar to a product that was already being sold in a US Market before the Predicate Date, then you do Not have to do a PMTA. You can do a Significant Equivalence (SE) application to obtain a Market Order. Which would be Easier and Less Costly to do. And have a Greater chance of being successful.

 

[Rossum]

I think by People/Us using the term "Grandfather Date" that it gives the Wrong Impression. Because there are going to be No Tobacco Products that are going to be able to be sold in the USA without an FDA Market Order.

We should have been saying is that Feb 5th, 2007 is the "Predicate Date".

The Predicate Date basically say's that if you have a Tobacco Product that you would like to sell, and your Product is Very Similar to a product that was already being sold in a US Market before the Predicate Date, then you do Not have to do a PMTA. You can do a Significant Equivalence (SE) application to obtain a Market Order. Which would be Easier and Less Costly to do. And have a Greater chance of being successful.

Color me confused. Why does anything that was on the market as of February 15th, 2007 require a "market order" to remain on the market, provided it is unchanged?

 

[Robert Cromwell]

Color me confused. Why does anything that was on the market as of February 15th, 2007 require a "market order" to remain on the market, provided it is unchanged?

I doubt if anything on the market now is exactly like it was then.
Maybe 808 carto and 180 mah stick battery?
They are referring to the US market now not the world market.

I am sure all the juice now is different since then it was all Chinese juice. And very high PG.

 

[Rossum]

I doubt if anything on the market now is exactly like it was then.
Maybe 808 carto and 180 mah stick battery?
They are referring to the US market now not the world market.

Oh yes, when it comes to vapor products, I agree. But zoiD didn't limit his comment to vapor products. He said, "No Tobacco Products". To me, that includes combustibles and oral products as well, and there are plenty of those that were available on the magic date.

 

[Robert Cromwell]

I think tobacco products pretty much get a free ride on this.
At least cigarettes and such.

 

[zoiDman]

Color me confused. Why does anything that was on the market as of February 15th, 2007 require a "market order" to remain on the market, provided it is unchanged?

Let me Clarify that. Because I did a Poor Job with that Explanation.

Every Tobacco Product after Aug 8th 2016 will need a Market Authorization from the FDA to be sold in the USA. Be it a PMTA or a SE or a Modified Risk.

And the FDA has allowed a Window of Time for these products to "come into Compliance".

For Combustible and Smokeless Tobacco, there is a Long List of Products that meet the Feb 5th, 2007 Predicate Date.

But for e-Cigarettes, for all intent and purposes, there were No Products being sold in the USA Market before the Predicate Date.

 

[mhertz]

Check zoiDman's post a little bit up in this thread: New FDA regulations and effect on DIY?

Linked article stating grandfathered products are as you stated exempt from filling approval through PTMA, but still needs a SE filling, which is less burdensome... It's hence not meaningless, but not a loophole either

Edit: Doh! Sorry, I replied to last post on previous page thinking it was the last post! Sorry for redundant posting!

Edit2: Just noticed I totally misunderstood the content I clarified above! Sorry!

 

[Robert Cromwell]

Check zoiDman's post a little bit up in this thread: New FDA regulations and effect on DIY?

Linked article stating grandfathered products are as you stated exempt from filling approval through PTMA, but still needs a SE filling, which is less burdensome... It's hence not meaningless, but not a loophole either

Yep and it is not guaranteed to be approved by the FDA.

 

[Robert Cromwell]

Now if Monsanto or ADM was making ejuice....

 

[mhertz]

I added an edit to that post of mine above(twice!), as I not only posted redundant content as I replied to last post of previous page thinking it was the last post made(doh!), but I also managed to completely misunderstand and mis-clarify it's and zoiDman's content! I'm having a great day today, lol Sorry folks!

 

[Rossum]

Every Tobacco Product after Aug 8th 2016 will need a Market Authorization from the FDA to be sold in the USA. Be it a PMTA or a SE or a Modified Risk.

Every new product? Sure. Even minor changes to products require this. But I don't see where a product that has not changed since February 15, 2007 will ever require it.

 

[zoiDman]

Every new product? Sure. Even minor changes to products require this. But I don't see where a product that has not changed since February 15, 2007 will ever require it.

As I understand it, If it Doesn't have an existing FDA Market Authorization, unless Something changes with the Deeming, it will have to obtain one.

Either by PMTA, or SE, or the Modified Risk pathway.

 

[Rossum]

As I understand it, If it Doesn't have an existing FDA Market Authorization, unless Something changes with the Deeming, it will have to obtain one.

Either by PMTA, or SE, or the Modified Risk pathway.

I think you're right -- for every "Newly Deemed" product.

But not the old products that were defined as "tobacco products" in the Family Smoking Prevention Act, i.e. cigarettes and smokeless tobacco, that remain unchanged since 2007.

 

[GunMonkeyINTL]

That's how I understood it as well. Marlboro Reds, Camels, Virginia Slims etc. won't have to get any additional authorization from the FDA to remain on the market- that is the crux of the hypocrisy in this whole thing.

It's only products that were introduced after 2/15/07 that will have to pursue one of the three authorization vehicles; PMTA, SE, or MR.

 

[JustWondering1]

That's how I understood it as well. Marlboro Reds, Camels, Virginia Slims etc. won't have to get any additional authorization from the FDA to remain on the market- that is the crux of the hypocrisy in this whole thing.

It's only products that were introduced after 2/15/07 that will have to pursue one of the three authorization vehicles; PMTA, SE, or MR.

Isn't harm reduction an authorization vehicle as well?

 

[zoiDman]

I think you're right -- for every "Newly Deemed" product.

But not the old products that were defined as "tobacco products" in the Family Smoking Prevention Act, i.e. cigarettes and smokeless tobacco, that remain unchanged since 2007.

OK... Here is a Question for you.

Now that Deeming has been Enacted, and if No Changes are made to it, can ANY Tobacco Product be sold in the USA after Aug 8th 2018 (or if the FDA Grants a PMTA, SE, Modified Risk Application extension) if it does NOT Have a Marketing Authorization from the FDA?