Vaping industry wants to push back FDA grandfather date

[oplholik]

Not new news, but it came up this morning, so thought I'd post it.


By Eric Pianin 3 hours ago


Vaping industry wants to push back FDA grandfather date

 

[skoony]

Thanks for the post.
One thing I would like to know is if the FDA can't change the grandfather date who
made the grandfather date? Was it congress?
Regards
mike

 

[curiousJan]

The date comes straight from the FSPTCA.

 

[Jman8]

The date comes straight from the FSPTCA.

I don't see anyway to read the act (where 2007 date appears) and not realize we are currently in a black market.

The fact that vaping items haven't been deemed tobacco products (yet) would mean it is a gray market. But the moment they are legally deemed 'tobacco products' means all new products not registered/approved with FDA, are in fact operating in a black market.

Obviously, because FDA is playing catch up on this, it will be viewed as gray market with desire to get everything into the legal market, and yet here is PRECISELY where the FDA rejections could AUTOMATICALLY lead to their (the FDA) creating a black market. One that technically exists now, and thus FDA is responsible for making it all legal, or realizing that they are in fact co-creators of an illegal market. With help from anyone that supports FSPTCA.

Realistically, it is the demand that establishes that market. Attempts to control supply side might seem like they serve a higher purpose, but chances of exercising full control on supply side ought to be fully acknowledged as impossible. And if you are one that supports thorough testing, prohibitive costs, strong regulations where very few (or even none) exist in the current (black) market, then you are essentially endorsing a black market.

The kids are going to love that.

 

[Kent C]

Thanks for the post.
One thing I would like to know is if the FDA can't change the grandfather date who
made the grandfather date? Was it congress?
Regards
mike

The grandfather date is the date that Henry Waxman (D) introduced the FSPTCA Bill into Congress.

 

[skoony]

The grandfather date is the date that Henry Waxman (D) introduced the FSPTCA Bill into Congress.

Thanks. Have they done this in the past? This seems an awful like retroactive legislation by proxy.
Doesn't this date have to be spelled out in the bill? I know they have done such things concerning
taxes but, the dates were specifically spelled out in the legislation.
Regards
Mike

 

[Jman8]

Thanks. Have they done this in the past? This seems an awful like retroactive legislation by proxy.
Doesn't this date have to be spelled out in the bill? I know they have done such things concerning
taxes but, the dates were specifically spelled out in the legislation.
Regards
Mike

It is spelled out in the bill.

Would you like a link to the bill, or for me to quote where it spells it out?

Essentially, any product after 2007 is a new tobacco product (pretty straight forward) and before it can go to market, it must be registered (approved) by FDA. Which leads to the idea that if there is a (huge) market for a new tobacco product that is not registered with the FDA, then all those products must be operating in a black market. Or gray market, at best.

 

[philoshop]

What better way to ban any product than to pick a regulatory grandfather date prior to innovation?
These aren't stupid people, just incredibly misguided.

 

[skoony]

It is spelled out in the bill.

Would you like a link to the bill, or for me to quote where it spells it out?

Essentially, any product after 2007 is a new tobacco product (pretty straight forward) and before it can go to market, it must be registered (approved) by FDA. Which leads to the idea that if there is a (huge) market for a new tobacco product that is not registered with the FDA, then all those products must be operating in a black market. Or gray market, at best.

Its there then. That's what I needed to know. Now my fuddled mind is more confused. So we are after
all tobacco product users. Talk about mega-marginalization. I wish they would explain to me how and
why I am a stakeholder in all of this. Am I a stakeholder?

Regards
Mike

 

[WharfRat1976]

Even if HR2058 passes, states can still tax vape products out of existence. See Chicago tax on eliquid thread.

 

[bigdancehawk]

What better way to ban any product than to pick a regulatory grandfather date prior to innovation?
These aren't stupid people, just incredibly misguided.

The statute wasn't crafted with that in mind. Very few people knew about e-cigarettes at the time and the statute doesn't even mention them.

 

[AndriaD]

The statute wasn't crafted with that in mind. Very few people knew about e-cigarettes at the time and the statute doesn't even mention them.

All the more reason that someone intelligent in Congress -- if such a critter exists -- should stand up and holler E-CIGARETTES AREN'T TOBACCO PRODUCTS, YOU IMBECILES!

Andria

 

[skoony]

The statute wasn't crafted with that in mind. Very few people knew about e-cigarettes at the time and the statute doesn't even mention them.

Then someone just pulled the date out of their a...er hat?
I am sure there is legal doctrine or prior examples in legislation to explain how this all
works. somewhere,right?
If e-cigs were not on the scene for lets say 4 or 5 more years would there still be a 2007
grandfather date?

Mike

 

[bigdancehawk]

All the more reason that someone intelligent in Congress -- if such a critter exists -- should stand up and holler E-CIGARETTES AREN'T TOBACCO PRODUCTS, YOU IMBECILES!

Andria

As I think you know, the statute defines "tobacco product" to include anything derived from the tobacco plant and lays out an elaborate regulatory and approval process for new tobacco products which was never intended to apply to e-cigs. The FDA was mighty ...... off that they weren't allowed to regulate e-cigs as drug delivery devices and the "deeming" regulation is the result.

 

[bigdancehawk]

Then someone just pulled the date out of their a...er hat?
I am sure there is legal doctrine or prior examples in legislation to explain how this all
works. somewhere,right?
If e-cigs were not on the scene for lets say 4 or 5 more years would there still be a 2007
grandfather date?

Mike

"In 1996, FDA conducted an extensive rulemaking process to determine effective methods to reduce youth smoking. The rulemaking process included 700,000 public comments, resulting in a rule regarding the sale and advertisement of cigarettes. Due to litigation, the rule was never implemented. Rather than engaging in yet another lengthy rulemaking process and delaying the protection of our children from the dangers of tobacco use, the bill gives the rule the force of law." LINK

The FSPTCA was crafted early in the following year and that date was written in at the time.

 

[skoony]

"In 1996, FDA conducted an extensive rulemaking process to determine effective methods to reduce youth smoking. The rulemaking process included 700,000 public comments, resulting in a rule regarding the sale and advertisement of cigarettes. Due to litigation, the rule was never implemented. Rather than engaging in yet another lengthy rulemaking process and delaying the protection of our children from the dangers of tobacco use, the bill gives the rule the force of law." LINK

The FSPTCA was crafted early in the following year and that date was written in at the time.

Clearly this bill didn't have e-cigs in mind. It was directly tied to first generation tobacco products the
most important of those being the cigarette. Just saying it is a tobacco product doesn't make it a
tobacco product. Even though the judge indicated the FDA could pursue e-cigs as a tobacco product
does this mean they are according to law? My impression of the ruling was it was more of a guidance
telling the FDA they could pursue different strategies not a out right branding of e-cigs as tobacco.
Does the court have that authority?
Regards
mike

 

[DC2]

It would be helpful if everyone understood the reason for the Grandfather Date...
Congressional Record, Volume 161 Issue 62 (Tuesday, April 28, 2015)

Questions may be raised as to why the so-called predicate/grandfather
date of February 15, 2007 was picked in the Act. If you look at the
legislative history, February 15, 2007 was the date the Act was
introduced in the 110th Congress. There was no other specific reason
for the date chosen in the Act.

 

[AndriaD]

Clearly this bill didn't have e-cigs in mind. It was directly tied to first generation tobacco products the
most important of those being the cigarette. Just saying it is a tobacco product doesn't make it a
tobacco product. Even though the judge indicated the FDA could pursue e-cigs as a tobacco product
does this mean they are according to law? My impression of the ruling was it was more of a guidance
telling the FDA they could pursue different strategies not a out right branding of e-cigs as tobacco.
Does the court have that authority?
Regards
mike

This exactly. Just saying the emperor has lovely new clothes doesn't actually clothe him.

Andria

 

[QU1T]

@skoony - Just saying it is a tobacco product doesn't make it a tobacco product..

I would think the delivery of nic in ecigs is the issue & connection, since it is only found in baccy, patches and gum, till vaping came along... hence baccy product.
(Not that I agree)

 

[AndriaD]

@skoony - Just saying it is a tobacco product doesn't make it a tobacco product..

I would think the delivery of nic in ecigs is the issue & connection, since it is only found in baccy, patches and gum, till vaping came along... hence baccy product.
(Not that I agree)

So... are patches and gum considered "tobacco products"????

I THINK NOT!!!!

Andria