Possible incomming Flavor Ban

[Rossum]

One question I have is how long it would take after the 90 day comment period for the FDA to restrict flavored eliquid. Does it require a process over time to enact this ban or can they pull the plug almost immediately?

Since this is an Advance Notice of Proposed Rulemaking, after they're done evaluating the comments they receive, the'll have to publish a Notice of Proposed Rulemaking, which has its own comment period, but it might be shorter. Then they have to publish a Final Rule. I would think that it will be at least a year, perhaps two before a Final Rule is in effect.

Of course, @untar is correct. If a liquid wasn't on the market on 2016-08-08, or wasn't been registered with the FDA by 2017-10-12, they could "enforce" against it immediately.

 

[ScottP]

Don't know if they're obliged to do some sort of grace period, but likely it doesn't matter anyways. If the liquid is newer than 8-2016 and doesn't have FDA approval then they can just wipe it off the market, flavor ban or not.

I am not sure of the exact time frame, but once they make new rules they do have an open period for comments before they are implemented.

FROM: FDA Rules and Regulations

The process that we use most often to issue rules is usually called “notice and comment rulemaking”. The first public step in the notice and comment rulemaking process is for us to issue a proposed rule (also called a “notice of proposed rulemaking” or “NPRM”). The proposed rule explains what we intend to require or intend to do, as well as our basis (e.g., scientific and policy reasons) and asks for public comment. Comments are generally submitted via the Federal Government’s electronic docket site, available at Regulations.gov.

If we need more information or have not decided on the details of a regulatory path, sometimes we issue a request for comments or an advance notice of proposed rulemaking (ANPRM). These kinds of Federal Register notices ask for public comment on broad issues or questions and seek data or other information. We use the information provided by the public comments to help us formulate the specific policy to be put forth in a subsequent proposed rule.

Currently the potential flavor ban is in the ANPRM phase. Once they decide on what the specific rules will be, it will then enter the NPRM phase and there will again be a comment period. The part I am not clear on is if there is a minimum length of time for comment in this phase. My BEST GUESS is that they will allow a minimum of 30 days and a maximum of 90 days. So if they do decide to ban flavors, you should still have at least 30 days to stock up. The real question will be can manufacturers keep up with the demand during that time, without having to restock supplies that they may not be able to unload once the rule goes through.

 

[mikepetro]

Your best insurance is to learn how to do DIY. It is simple, inexpensive, and will guarantee you the flavor of your choice should this go south. The flavorings themselves will always be around, just maybe not vape branded.

 

[zoiDman]

Does anyone Remember this from the Deeming Process?

https://www.reginfo.gov/public/reginfo/Regmap/regmap.pdf

https://www.reginfo.gov/public/reginfo/Regmap/index.jsp

 

[ScottP]

Does anyone Remember this from the Deeming Process?

https://www.reginfo.gov/public/reginfo/Regmap/regmap.pdf

https://www.reginfo.gov/public/reginfo/Regmap/index.jsp

Good find. Right now, we are on the optional (bottom) part of Step 3. Once this ends, they have to complete the normal part of step 3 and continue from there. Also it seems that the minimum time for the Comment portion in step 6 is 60 days. So at a minimum you will have 60 days to stock up once the rules are known. There may be additional time, considering step 8 is a final review process and step 9 says that "major rules are subject to a delayed effective date".

 

[zoiDman]

Good find. Right now, we are on the optional (bottom) part of Step 3. Once this ends, they have to complete the normal part of step 3 and continue from there. Also it seems that the minimum time for the Comment portion in steps 6 is 60 days. So at a minimum you will have a minimum of 60 days to stock up once the rules are known. There may be additional time, considering step 8 is a final review process and step 9 says that "major rules are subject to a delayed effective date".

Yeah... there is going to be Time involved for this Process to reach the End.

BTW - I would think that a Fundamental Talking Point which would be included in any Non Flavor Ban comment would be something alone these lines...

"If the Purpose of this Purposed Restriction on Flavoring Rule for e-Liquids is to reduce Underage e-Cigarette use, where is the Supporting Independent Data that Definitively and Quantitatively shows that such a ban would achieve the Desired Goal?"

 

[Rossum]

Does anyone Remember this from the Deeming Process?

https://www.reginfo.gov/public/reginfo/Regmap/regmap.pdf

https://www.reginfo.gov/public/reginfo/Regmap/index.jsp

Yep, the bureaucracy does not move quickly. Regulations generally take at least a year to get from NPRM to being finalized and effective, and we're not even at the NRPM stage with this.

So flavored liquids that were available prior to 2016-08-08 and that the manufacturers registered by 2017-10-12 should continue to be available for a while. But beware, the FDA can enforce against any product that doesn't meet both of these criteria at any time. I'll give just one example: There's a famous liquid that was extremely popular in years gone by, that had been discontinued because one of the flavor components was no longer available. It was recently re-introduced to the market. Since it's fairly obvious that at least one of the components changed, it doesn't qualify for the the 2016-08-08 grandfathering.....

 

[zoiDman]

Yep, the bureaucracy does not move quickly. Regulations generally take at least a year to get from NPRM to being finalized and effective, and we're not even at the NRPM stage with this.

So flavored liquids that were available prior to 2016-08-08 and that the manufacturers registered by 2017-10-12 should continue to be available for a while. But beware, the FDA can enforce against any product that doesn't meet both of these criteria at any time. I'll give just one example: There's a famous liquid that was extremely popular in years gone by, that had been discontinued because one of the flavor components was no longer available. It was recently re-introduced to the market. Since it's fairly obvious that at least one of the components changed, it doesn't qualify for the the 2016-08-08 grandfathering.....

Agreed.

As to be Noted. This entire e-Liquid "Flavor Ban" is a New Rule. Which could Very likely (almost Guaranteed) Supersede any existing Rules on e-Liquids.

This would make the Pre 8-8-2016 Distinction for e-Liquids mostly Meaningless. Because all but a Extremely Small Few would be Illuminated from the Market under this New Rule.

Making a PMTA N/A.

 

[Letitia]

2016-08-08 grandfathering.....

This is now back to 2007 if I understand correctly. Cole-Bishop amendment did not get included in the Omnibus Spending Bill.

 

[Rossum]

As to be Noted. This entire e-Liquid "Flavor Ban" is a New Rule. Which could Very likely (almost Guaranteed) Supersede any existing Rules on e-Liquids.

This would make the Pre 8-8-2016 Distinction for e-Liquids mostly Meaningless. Because all but a Extremely Small Few would be Illuminated from the Market under this New Rule.

Making a PMTA N/A.

Sure, but only after it goes through the entire rule-making process, is finalized, and goes into effect.

The question I was attempting to address is: How long have we got until that might happen?

 

[ScottP]

Yep, the bureaucracy does not move quickly. Regulations generally take at least a year to get from NPRM to being finalized and effective, and we're not even at the NRPM stage with this.

Sometimes we can be thankful it moves as slow as it does.

Agreed.

As to be Noted. This entire e-Liquid "Flavor Ban" is a New Rule. Which could Very likely (almost Guaranteed) Supersede any existing Rules on e-Liquids.

This would make the Pre 8-8-2016 Distinction for e-Liquids mostly Meaningless. Because all but a Extremely Small Few would be Illuminated from the Market under this New Rule.

Making a PMTA N/A.

How ...... would you be if you were a company that just paid for a PMTA, got approved, and then got hit with a ban anyway? OMG I can't even think about how angry I would be.

 

[Rossum]

This is now back to 2007 if I understand correctly. Cole-Bishop amendment did not get included in the Omnibus Spending Bill.

That would be the "permanent" grandfather date. If you're selling something that was on the market in February of 2007, it's permanently grandfathered. However, it appears no vape product on the market actually qualifies for that.

Now if you're selling something that was on the market on 2016-08-08, and it's been registered with the FDA, it's temporarily grandfathered until the PMTA deadline (currently 2022), or until the FDA finalizes new rules regarding that product, or the FDA asks to see what progress you're making toward a PMTA and decides you're not serious about applying for one...

Anything that was introduced to market after 2016-08-08 is already technically not allowed.

 

[ericbnc]

my favorite flavor is spit and beer, they can never take that away.

 

[Letitia]

That would be the "permanent" grandfather date. If you're selling something that was on the market in February of 2007, it's permanently grandfathered. However, it appears no vape product on the market actually qualifies for that.

Now if you're selling something that was on the market on 2016-08-08, and it's been registered with the FDA, it's temporarily grandfathered until the PMTA deadline (currently 2022), or until the FDA finalizes new rules regarding that product, or the FDA asks to see what progress you're making toward a PMTA and decides you're not serious about applying for one...

Anything that was introduced to market after 2016-08-08 is already technically not allowed.

Thank you. I was hazy on how that all works.

 

[zoiDman]

Sure, but only after it goes through the entire rule-making process, is finalized, and goes into effect.

The question I was attempting to address is: How long have we got until that might happen?

JMO. But I think for this New Rule, I believe it will follow a more "Standard" Timeline. And not the Long, Extended one we saw leading up to 8-8-2016.

Because Deeming is Fully In Place. And it has come out of a Federal Court Challenge virtually Unscathed.

How Long do we actual have? I Dunno?

But I know One Thing, there will be a New Rule.

 

[zoiDman]

...

How ...... would you be if you were a company that just paid for a PMTA, got approved, and then got hit with a ban anyway? OMG I can't even think about how angry I would be.

Yeah... That would bring a Whole New Meaning to the term "Adding Insult to Injury".

But I also believe this was also Why the FDA decided to Extend the PMTA Filing date. Because they knew that just about everyone would wait until the Deadline Neared to do the bulk of their PMTA work.

And the FDA has Planned to Restrict Flavorings in e-Liquids since about Deeming's Day 1.

 

[Rossum]

JMO. But I think for this New Rule, I believe it will follow a more "Standard" Timeline. And not the Long, Extended one we saw leading up to 8-8-2016.

Right, but I still think that a "standard" time frame to satisfy all the requirements shown in the Reg Map is not less than a year from where we are now.

But I know One Thing, there will be a New Rule.

Unfortunately, I think you are correct in this.

 

[zoiDman]

Right, but I still think that a "standard" time frame to satisfy all the requirements shown in the Reg Map is not less than a year from where we are now.

...

Yeah... I could see a Mid 2019 roll out of a New Rule such as this.

 

[440BB]

I wonder how many vapers will be here voicing total surprise a year from now.

 

[Baditude]

I wonder how many vapers will be here voicing total surprise a year from now.

We long time vapers have been warning the flock for a long time.