ATR Supports Change in Predicate Date for Vapor Products

[NoFumus]

ATR Supports Change in Predicate Date for New Tobacco and Vapor Products

"Today, Americans for Tax Reform sent a letter to members of Congress urging them to change the predicate date at which new tobacco and tobacco-derived products like premium cigars and electronic cigarettes must undergo expensive and unnecessary regulatory hurdles imposed by the Food and Drug Administration (FDA).

Dear Member of Congress,

I write today in support of efforts to save the thousands of small businesses in the United States who are selling tobacco-free technology products to adult consumers trying to kick their smoking habit. Though reliant on the sale of tobacco products for billions of tax dollars annually, Congress should help facilitate all efforts by the free market to accomplish what stiff regulations and taxes never could, getting smokers to quit for good.

Unfortunately, without Congressional action, an overreaching Food and Drug Administration (FDA) will proceed with an arbitrary bureaucratic hurdle for the sale of vapor products more akin to prohibition than reasonable regulation...

[...]

I urge Congress to amend the Tobacco Control Act predicate date for the tobacco-derived products in the electronic cigarette and vapor product category in an effort to protect public health and protect American jobs.​

 

[Elizabeth Baldwin]

Awesome!

 

[nicnik]

ATR Supports Change in Predicate Date for New Tobacco and Vapor Products

"Today, Americans for Tax Reform sent a letter to members of Congress urging them to change the predicate date at which new tobacco and tobacco-derived products like premium cigars and electronic cigarettes must undergo expensive and unnecessary regulatory hurdles imposed by the Food and Drug Administration (FDA).

Dear Member of Congress,

I write today in support of efforts to save the thousands of small businesses in the United States who are selling tobacco-free technology products to adult consumers trying to kick their smoking habit. Though reliant on the sale of tobacco products for billions of tax dollars annually, Congress should help facilitate all efforts by the free market to accomplish what stiff regulations and taxes never could, getting smokers to quit for good.

Unfortunately, without Congressional action, an overreaching Food and Drug Administration (FDA) will proceed with an arbitrary bureaucratic hurdle for the sale of vapor products more akin to prohibition than reasonable regulation...

[...]

I urge Congress to amend the Tobacco Control Act predicate date for the tobacco-derived products in the electronic cigarette and vapor product category in an effort to protect public health and protect American jobs.​

sofarsogood's been hitting comments sections, spreading the $$$ news. What a trouble maker!

I spent $3,000 a year to smoke a carton a week. Today I mix e liquid at home. The cost for a year supply is $50. I call my flavor Tax Reform.

 

[sofarsogood]

sofarsogood's been hitting comments sections, spreading the $$$ news. What a trouble maker!

I imagine this organization would like to see less being collected in taxes. Switching to vaping gets that done and the people who benefit most are not the smokers but their families This opportunity is not discussed anywhere. How can that be?

 

[Mad Scientist]

Changing the date is really just rearranging Titanic deck chairs. The end of device innovation by any small players will ultimately kill the industry as we know it.

In a sense, I can see regulating liquids for quality, purity and lack of adulterants. The base ingredients would have to come from FDA approved sources, but small juice shops would be able to create their own recipes from those approved ingredients. Seems sensible and reasonable.

FDA regulation of devices is simply silly and a complete overreach, regardless of any date used. Does the FDA regulate and approve every new lighter design used to ignite cigarettes? Haven't seen an FDA approved ashtray yet either. Where do I get some FDA approved rolling paper? But now we need FDA approved batteries and atomizers?! How about my rebuildables? Do I need to submit every coil and wick I make to the FDA along with scientific studies before I can vape on it? Where do I get FDA approved cotton or rayon? Since cotton can be used to make wicks, will the FDA be banning cotton balls and cotton pads presently sold in every pharmacy? I suppose 18650s will be banned from laptop packs and no more 3S lipos for the RC crowd now -- might be used for vaping after all. It's beyond silly moving more towards completely irrational and incomprehensible.

If this goes through, please just tell me where to send my contribution to support the federal lawsuit against the FDA. There is no rational basis for the government to essentially ban batteries and atomizers that could be used to vape.

 

[sofarsogood]

Changing the date is really just rearranging Titanic deck chairs. The end of device innovation by any small players will ultimately kill the industry as we know it.

It's a big planet with a lot of nations where the device makers will still do business. The market is going to grow very fast where ever there is no interference. And it might keep growing even where there is interference. Losing Europe or the US would be a blow but not the end of innovation.

In the long run the vape market might not be so big anyway. A year supply of DIY for $50? Mods, batteries, atomizers, wick and wire? Not much money there either unless you like to buy toys. If I wasn't stockpiling (which is only a few hundred dollars) and buying things I don't need, vaping costs about $100 a year out of pocket. 15 minutes a week to rebuild. 15 minutes a month to mix. Not much time involved either. In a perfect world the $100 billion tobacco market would shrink to a $4 billion vape market and the vape market would continue to decline. I figure the never smoking kids who try vaping will loose interest.

 

[skoony]

In a sense, I can see regulating liquids for quality, purity and lack of adulterants. The base ingredients would have to come from FDA approved sources, but small juice shops would be able to create their own recipes from those approved ingredients. Seems sensible and reasonable.

If the vendors are using food grade(GRAS) flavors and highest grade PG/VG and nicotine there is
no reason for further regulation. As far as I know all these ingredient already meet government
standards for purity. Quality is a different story. You either like the juice or you don't. Bad
tasting juice is bad tasting juice. I myself know of nor can think of any reason anyone would add adulterants
to e-juice. The belief that someone was,is or,will try to poison us is a myth.

Regards
Mike

 

[Mad Scientist]

If the vendors are using food grade(GRAS) flavors and highest grade PG/VG and nicotine there is
no reason for further regulation. As far as I know all these ingredient already meet government
standards for purity. Quality is a different story. You either like the juice or you don't. Bad
tasting juice is bad tasting juice. I myself know of nor can think of any reason anyone would add adulterants
to e-juice. The belief that someone was,is or,will try to poison us is a myth.

Regards
Mike

Looking at it from a different angle, regulation is coming. Status quo is long off the table. So if the FDA needs to feel relevant, they can place their stamp of approval on the base ingredients and be done with it. They should be regulating devices as much as they presently regulate cigarette lighters -- i.e. not at all.

For adulterants, that's a term of art. For example, if the label says "100% pure VG" but the bottle contains VG and distilled, deionized water, the water is an "adulterant" even though it's the purest of water. I'm ok with the FDA distracting itself with ensuring that what's on the label is what's in the bottle so long as they leave everything else alone.

 

[bigdancehawk]

FDA regulation of devices is simply silly and a complete overreach, regardless of any date used. Does the FDA regulate and approve every new lighter design used to ignite cigarettes? Haven't seen an FDA approved ashtray yet either. Where do I get some FDA approved rolling paper?

As absurd as it may seem, they're already regulating it. FDA Announced Additional Decisions on New Tobacco Products - Rolling Papers!

EDIT to add: On this day, we give thanks to God because we live in a free country. Well, sorta.

 

[skoony]

Looking at it from a different angle, regulation is coming. Status quo is long off the table. So if the FDA needs to feel relevant, they can place their stamp of approval on the base ingredients and be done with it. They should be regulating devices as much as they presently regulate cigarette lighters -- i.e. not at all.

For adulterants, that's a term of art. For example, if the label says "100% pure VG" but the bottle contains VG and distilled, deionized water, the water is an "adulterant" even though it's the purest of water. I'm ok with the FDA distracting itself with ensuring that what's on the label is what's in the bottle so long as they leave everything else alone.

Agreed. The FDA is going to regulate a product made of ingredients already regulated by government.
The big question in my mind is,how does one regulate a product made out of regulated products.
Adulterants can mean literally anything. It depends on the context. Generally when one speaks
of adulterants in a product it refers to things that don't have to be there and or can cause
harm as opposed to adulterants added as necessary to the product as a whole. The fact that
PG/VG are both hygroscopic and absorb water relative to the humidity in the air makes it
difficult to determine the amount of water in the juice aside from what a vendor may add
and is why you never or rarely see it listed as an ingredient. 70/30,50/50 or 100% of PG
and or VG just means the liquid was that grade when added. If the relative humidity is
30% the water content of your juice could be 8.xx to 9.xx % in a temperature range between
60 to 80 F.
Regards
mike

 

[Mad Scientist]

Agreed. The FDA is going to regulate a product made of ingredients already regulated by government.
The big question in my mind is,how does one regulate a product made out of regulated products.
Adulterants can mean literally anything. It depends on the context. Generally when one speaks
of adulterants in a product it refers to things that don't have to be there and or can cause
harm as opposed to adulterants added as necessary to the product as a whole. The fact that
PG/VG are both hygroscopic and absorb water relative to the humidity in the air makes it
difficult to determine the amount of water in the juice aside from what a vendor may add
and is why you never or rarely see it listed as an ingredient. 70/30,50/50 or 100% of PG
and or VG just means the liquid was that grade when added. If the relative humidity is
30% the water content of your juice could be 8.xx to 9.xx % in a temperature range between
60 to 80 F.
Regards
mike

An adulterant is anything not on the label where ingredient labels are required or anything not in the approval application where premarketing approval is required. So, for example, if USP VG is on the label, and an analysis of the contents meets the USP standard for VG, a bottle of USP grade VG is not adulterated even if it contains trace amounts of water (the standard allows for trace amounts of stuff that's not VG). If the manufacturer or bottler lets it sit in an open vat in a damp room for a significant period of time and it soaks up 8% water vapor (and who knows what else if handled in that manner) it is adulterated (8% or more water from the hygroscopic properties of PG or VG is a real lot).

 

[skoony]

An adulterant is anything not on the label where ingredient labels are required or anything not in the approval application where premarketing approval is required. So, for example, if USP VG is on the label, and an analysis of the contents meets the USP standard for VG, a bottle of USP grade VG is not adulterated even if it contains trace amounts of water (the standard allows for trace amounts of stuff that's not VG). If the manufacturer or bottler lets it sit in an open vat in a damp room for a significant period of time and it soaks up 8% water vapor (and who knows what else if handled in that manner) it is adulterated (8% or more water from the hygroscopic properties of PG or VG is a real lot).

Your thinking of it in the wrong way. When one thinks of adulteration one thinks of contamination
in respect to the product. 8% water is not a lot. Once the original container is opened it will absorb
water relative the the relative humidity in the air. Once the mixing process starts the water becomes
a changing variable.
Regards
Mike

 

[Mad Scientist]

Your thinking of it in the wrong way. When one thinks of adulteration one thinks of contamination
in respect to the product. 8% water is not a lot. Once the original container is opened it will absorb
water relative the the relative humidity in the air. Once the mixing process starts the water becomes
a changing variable.
Regards
Mike

Not to argue, but I'm not thinking about it at all. I'm just relating how FDA sees it. If it's not on the label or in the premarketing approval application as applicable, and it (whatever "it" is) is in the final product, it's an adulterant. Period.

 

[skoony]

Not to argue, but I'm not thinking about it at all. I'm just relating how FDA sees it. If it's not on the label or in the premarketing approval application as applicable, and it (whatever "it" is) is in the final product, it's an adulterant. Period.

You mean what ever the FDA approves is not an adulterant,every else banned or not is?
Your right from that point of view. As a layman I was getting stuck on the adulteration
as in deliberately adding something to spoil the product ie.,Tylenol.
Regards
Mike

 

[Mad Scientist]

You mean what ever the FDA approves is not an adulterant,every else banned or not is?
Your right from that point of view. As a layman I was getting stuck on the adulteration
as in deliberately adding something to spoil the product ie.,Tylenol.
Regards
Mike

Yes, the idea is (for products where ingredient labels are required, for example) that the end user can determine what's in it and figure out if maybe allergies or other interactions would render an otherwise suitable product unsuitable for a particular application or person. If it's not on the label it can't be in the product. Doesn't matter what "it" is.

For products that require actual approval, the approval is going to be based on scientific data related to the specific active compounds and other ingredients that when taken together are "safe and effective." If something, anything, is added, no matter how innocuous it may seem, the validity of the scientific data evaporates because the product was not tested and/or studied with whatever it is that is now in the product.

I think we're veering off course from the thread topic. To get back to the issue here, changing the date is just rearranging deck chairs on the Titanic. Eliminating all future small shop innovation in the U.S. and the entire U.S. market from reasonably priced new products designed and produced elsewhere will forever change the vape scene as we presently know it.

 

[skoony]

Yes, the idea is (for products where ingredient labels are required, for example) that the end user can determine what's in it and figure out if maybe allergies or other interactions would render an otherwise suitable product unsuitable for a particular application or person. If it's not on the label it can't be in the product. Doesn't matter what "it" is.

For products that require actual approval, the approval is going to be based on scientific data related to the specific active compounds and other ingredients that when taken together are "safe and effective." If something, anything, is added, no matter how innocuous it may seem, the validity of the scientific data evaporates because the product was not tested and/or studied with whatever it is that is now in the product.

I think we're veering off course from the thread topic. To get back to the issue here, changing the date is just rearranging deck chairs on the Titanic. Eliminating all future small shop innovation in the U.S. and the entire U.S. market from reasonably priced new products designed and produced elsewhere will forever change the vape scene as we presently know it.

This makes sense from a regulators point of view. From a layman's point of view it doesn't make sense.
This can only lead to eventually labeling everything. Look at GMO or the apple growing industry. New GMO's
are constantly developed and new strains of apples come on the market frequently. How would one label them.
What specific ingredient changed to make it different and what is it.
Look at the DIY'ers. I see them no more differently than those who grow there own tobacco and make
their own pipes. There are a lot of good studies indicating vaping is relatively benign compared to smoking.
So are we to totally ignore these and jump on the long term study bandwagon? Long term studies are a two
edged sword. There are just as likely to prove vaping is quite safe as compared to being as dangerous as
some people hope. The fact the FDA is arbitrarily going to make this decision is disturbing.
Regards
Mike

 

[Mad Scientist]

This makes sense from a regulators point of view. From a layman's point of view it doesn't make sense.
This can only lead to eventually labeling everything. Look at GMO or the apple growing industry. New GMO's
are constantly developed and new strains of apples come on the market frequently. How would one label them.
What specific ingredient changed to make it different and what is it.
Look at the DIY'ers. I see them no more differently than those who grow there own tobacco and make
their own pipes. There are a lot of good studies indicating vaping is relatively benign compared to smoking.
So are we to totally ignore these and jump on the long term study bandwagon? Long term studies are a two
edged sword. There are just as likely to prove vaping is quite safe as compared to being as dangerous as
some people hope. The fact the FDA is arbitrarily going to make this decision is disturbing.
Regards
Mike

Totally agree. The FDA can apparently declare that rolling papers are a "tobacco product." Sorry FDA, but the emperor has no clothes. Rolling papers are not tobacco products. Atomizers and batteries are not tobacco products. Actual tobacco and things made from actual tobacco -- ok, maybe they have at least some rational basis to regulate. So let's look at how they regulate. THR through vaping may save a billion lives worldwide or might be very harmful. We don't really know for sure. So FDA says prove it's not harmful. I say prove it won't save so many millions of lives in the U.S. We know smoking kills people; we know vaping is not smoking; we know quitting smoking will save lives. Put it to the FDA -- show us why you would rather see so many millions of people die from smoking rather than possibly be saved by vaping. FDA, prove your regulations won't kill millions.

 

[skoony]

This makes sense from a regulators point of view. From a layman's point of view it doesn't make sense.
This can only lead to eventually labeling everything. Look at GMO or the apple growing industry. New GMO's
are constantly developed and new strains of apples come on the market frequently. How would one label them.
What specific ingredient changed to make it different and what is it.
Look at the DIY'ers. I see them no more differently than those who grow there own tobacco and make
their own pipes. There are a lot of good studies indicating vaping is relatively benign compared to smoking.
So are we to totally ignore these and jump on the long term study bandwagon? Long term studies are a two
edged sword. There are just as likely to prove vaping is quite safe as compared to being as dangerous as
some people hope. The fact the FDA is arbitrarily going to make this decision is disturbing.
Regards
Mike

Agreed.
Regards
mike

 

[Stubby]

I think we're veering off course from the thread topic. To get back to the issue here, changing the date is just rearranging deck chairs on the Titanic. Eliminating all future small shop innovation in the U.S. and the entire U.S. market from reasonably priced new products designed and produced elsewhere will forever change the vape scene as we presently know it.

Changing the grandfather date is not the ideal way to go, but we are not dealing with an ideal situation. What we have to do is deal with reality. Changing the date is not at all like rearranging the deck chairs on the Titanic. If the choice is between keeping what we have today and a ban on everything the choice is obvious.

The big thing changing the grandfather date buys us is time. There would still be a viable legal market and over time we can change the law. It is not forever. A few years down the road there will be lots more people vaping even with the restrictions. Numbers matter with this as more people would be demanding a change in the law. Demanding a no compromise perfect is a sure way to lose everything.

 

[Kent C]

And there would be a lot more products that would pass the substantial equivalent standard.