Deeming Regulations have been released!!!!

[ENAUD]

Even though it doesn't completely answer the questions in Sen. Ron Johnson's letter, I have a feeling the FDA is going to submit their Final Regulatory Impact Analysis (RIA) as part of their response. It is the most complex, confusing and contradictory report I have read so far. 156 pages of WTH?

I was pulling quotes from it last night and it's clear BT is the intended beneficiary. I'm going to write another letter to Johnson's committee, but there so much I want to say that it's hard to edit.

I may be cherry picking, but so is the FDA. However, unlike them, I have no financial interest in the matter. I just want access to the products that 4 years ago helped me to quit a 40-year smoking habit when nothing else worked. And I want current smokers to have the same options.

“We have…quantified the baseline number of ENDS products in terms of e-liquids and delivery systems. These counts contain some components and parts that are not made or derived from tobacco, including e-liquids not containing nicotine (if they are intended or reasonably expected to be used with or for the human consumption of a tobacco product and do not constitute a tobacco product accessory) and delivery systems not containing a tobacco- derived component. The costs for other components and parts are not quantified due to lack of data.”

“…at the low end of the average cost spectrum would be product lines of cartridge- or disposable e-cigarettes which have an identical underlying delivery system, flavor variants likely to share basic ingredients, and similar ingredients and constituents for which existing information can be used to support a PMTA. This case is assumed to have total costs of $285,656. The medium-cost case also involves a closed-system product line involving a smaller number of products and greater burden to conduct original research on their health effects and risk attributes. The total cost is somewhat higher at $440,725. Finally, at the high average cost end is a single open-system device requiring considerable original research and testing amounting to $2.6 million.”

It is clear this estimate gives an unfair advantage to the makers of cartridge or disposable e-cigarettes, which are what Big Tobacco companies currently have on the market.

I also have yet to find a clear definition of a “single open-system device.” Does that refer to the battery tube/box? The tank? The drip tip? The device I am using this very moment is made up of components from 5 separate companies. Does that really mean it would take 13 million dollars to bring the same configuration to market?

The word “Consolidation” appears 37 times in the report. According to my interpretation, it suggests Big Tobacco companies that can afford to comply with the regulations will buy-out smaller companies they forecast to be profitable. As for the rest, all they have to do is wait for the competition to exit the market.

“As described in previous responses and the FRIA, we have updated our estimate of the number of ENDS products currently on the market. We continue to assume a substantial amount of product consolidation and exit will occur as a result of regulation, as described in the final RIA.”

“We also note that the burgeoning market for ENDS is still in a state of flux. Considerable product consolidation might be expected to occur under the baseline due to industry life-cycle consolidation in coming years, as successful products gain rising market shares and less successful ones are driven out, and as larger firms or manufacturers of traditional tobacco products enter this market and perhaps absorb smaller manufacturers and products.”

“We agree that product exit is likely to occur, but much of this may occur as a result of consolidation of similar products within product lines instead of through exit by manufacturers, although we expect most vape shops that currently mix e-liquids will convert to a retail model once the initial compliance period for submission of PMTAs ends.”

“We do, however, expect there to be a substantial amount of product exit for certain product categories, such as ENDS.”

“…costs of market entry under the final rule are likely to be higher than they would be under the baseline, so we can expect the industry to become more concentrated more quickly than would be the case without the rule, as the substantial expense of seeking premarket authorization will represent an important new barrier to entry.”

“After the initial 24-month compliance period for the submission and FDA receipt of PMTAs expires, vape shops selling new newly deemed tobacco products, including e-liquid mixtures, for which neither they nor an upstream supplier has submitted an application for premarket review, will be subject to enforcement action. Therefore, we expect vape shops that mix e-liquids will overwhelmingly cease mixing. This does not necessarily imply closure of vape shops, but rather a change in business operations to pure retailing.”

I’m confused by the claim that “most vape shops that currently mix e-liquids will convert to a retail model.” If small manufacturers, such as ones that produce tanks, “open” device components, handmade drip tips, handmade wooden mod stands, vinyl protective mod covers and similar items that are now deemed tobacco products, can’t afford the cost of PMTAs (let alone trying to figure out they impact public health), what are the retail vape shops expected to sell?

This paragraph has me quite perplexed:

“We lack a baseline estimate of consumer valuation of tobacco product variety, making it impossible to estimate how consumers who continue to use tobacco products would value the potential loss of variety due to product exit under this final rule. Today we see very large numbers of products embodying minor variations. Even if considerable product consolidation were to occur, close substitutes would exist for discontinued products, which would limit the size of any ongoing impact on consumers who switch to a substitute product.”

They claim it’s impossible to estimate, but they do anyway.

And what is a “substitute product?” Does that mean giving up the “open” (which should really be “customizable”) system that has kept me cigarette free for 4 years, for a device produced by a Big Tobacco company?

“Close substitutes would exist for discontinued products,” reeks of GovSpeak for “the products you use are no longer on the market, but this device produces vapor, so it’s close enough.”

For more information on the Big Tobacco companies stake in the market I suggest reading this article from Forbes: Who Stands To Gain From The E-Cigarette Phenomenon? Who Stands To Gain From The E-Cigarette Phenomenon?

RIA:
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM500254.pdf

What about the tons of submissions by vapers commenting on the deeming about how the legislation might affect us? Where did all of those submissions go, were they read, was any rough data extrapolated form them?

 

[Hulamoon]

Gee, that's too bad....I had really gotten used to the convenience of wheels, copper piping, drawer handles and door/cabinet hinges. Oh well. If Mitch says they are tobacco products, then we'll just have to go without them.

 

[The Ocelot]

I ran across this gem last night: Reynolds executives express optimism, rather than gloom, with new FDA rules

Analysts have said it could cost millions of dollars for each product to go through the heightened regulatory requirements. The FDA estimates it would cost about $500,000.

In any case, analysts and vaping advocacy groups say the new regulatory cost could be cost-prohibitive for most small vaping companies, leaving e-cigs and vaping in the hands of Big Tobacco.

Debra Crew, president and chief operating officer of R.J. Reynolds Tobacco Co. said the company “feels confident in our ability to meet these requirements and met (sic) consumer requirements.”

“We were, and are, well prepared for regulation for these vapor products, such as being a closed system, and we’ve already done much of the steps required for the regulation process.”

 

[coldgin96]

I like that one!

Due to another run-in with an anti-vaping bully, my friend and I refer to my e-cig as my "smoking machine." This woman in one of my cycling groups send me a very nasty e-mail (coward much) stating that I should take my smoking machine far away from the group due to it being dangerous. Needless to say no one else in the group was/is bothered by it, and confirmed she's just a bully. But now we call it my smoking machine. I think I'm going to get a steampunk wrap for my pico, because that is what it calls to mind for me.

Honestly, with these deeming regulations, my fear is being ostracized again. I spent enough time having to hide somewhere to smoke, and really don't want to have to go back to that.

Just tell her to off.

 

[coldgin96]

Perhaps the government can finally answer the classic newbie question, "What juice tastes like a Marlboro?"

Been vaping since 2012 and I'm still looking for that one.

 

[The Ocelot]

What about the tons of submissions by vapers commenting on the deeming about how the legislation might affect us? Where did all of those submissions go, were they read, was any rough data extrapolated form them?

The "public" comments we responded to are toward the end of the Deeming Final Rule, although none contain any type of personal story. It appears most of the comments were consolidated (there's that word again) into topics the FDA wanted to answer.

 

[zoiDman]

What about the tons of submissions by vapers commenting on the deeming about how the legislation might affect us? Where did all of those submissions go, were they read, was any rough data extrapolated form them?

Any other questions?

 

[The Ocelot]

I like that one!

Due to another run-in with an anti-vaping bully, my friend and I refer to my e-cig as my "smoking machine." This woman in one of my cycling groups send me a very nasty e-mail (coward much) stating that I should take my smoking machine far away from the group due to it being dangerous. Needless to say no one else in the group was/is bothered by it, and confirmed she's just a bully. But now we call it my smoking machine. I think I'm going to get a steampunk wrap for my pico, because that is what it calls to mind for me.

Honestly, with these deeming regulations, my fear is being ostracized again. I spent enough time having to hide somewhere to smoke, and really don't want to have to go back to that.

She has your email address? Then I assume your have hers. Whatever shall we accidentally do with it?

 

[Bronze]

I ran across this gem last night: Reynolds executives express optimism, rather than gloom, with new FDA rules

Analysts have said it could cost millions of dollars for each product to go through the heightened regulatory requirements. The FDA estimates it would cost about $500,000.

In any case, analysts and vaping advocacy groups say the new regulatory cost could be cost-prohibitive for most small vaping companies, leaving e-cigs and vaping in the hands of Big Tobacco.

Debra Crew, president and chief operating officer of R.J. Reynolds Tobacco Co. said the company “feels confident in our ability to meet these requirements and met (sic) consumer requirements.”

“We were, and are, well prepared for regulation for these vapor products, such as being a closed system, and we’ve already done much of the steps required for the regulation process.”

It's what we said. The only ones who can afford the regs are BT but I was slammed for saying this and told that BT is on our side. What do I know?

 

[coldgin96]

It's what we said. The only ones who can afford the regs are BT but I was slammed for saying this and told that BT is on our side. What do I know?

Who in the (heck) told you BT was on our side?

 

[Woofer]

...

Debra Crew, president and chief operating officer of R.J. Reynolds Tobacco Co. said the company “feels confident in our ability to meet these requirements and met (sic) consumer requirements.” payed in advance to have the requirements meet our ability.

“We were, and are, well prepared for regulation for these vapor products, such as being a closed system, and we’ve already done much of the steps required for the regulation process.”, including hiring the FDA to writing the regs.

 

[Bronze]

Who in the Hell told you BT was on our side?

Kodiak. After I said you'd have to be naive if you didn't think BT/BP didn't write those regs.

 

[ENAUD]

I ran across this gem last night: Reynolds executives express optimism, rather than gloom, with new FDA rules

Analysts have said it could cost millions of dollars for each product to go through the heightened regulatory requirements. The FDA estimates it would cost about $500,000.

In any case, analysts and vaping advocacy groups say the new regulatory cost could be cost-prohibitive for most small vaping companies, leaving e-cigs and vaping in the hands of Big Tobacco.

Debra Crew, president and chief operating officer of R.J. Reynolds Tobacco Co. said the company “feels confident in our ability to meet these requirements and met (sic) consumer requirements.”

“We were, and are, well prepared for regulation for these vapor products, such as being a closed system, and we’ve already done much of the steps required for the regulation process.”

Smoking gun right there...

 

[coldgin96]

Kodiak. After I said you'd have to be naive if you didn't think BT/BP didn't write those regs.

Kodiak? The chew people?

 

[zoiDman]

It's what we said. The only ones who can afford the regs are BT but I was slammed for saying this and told that BT is on our side. What do I know?

Please make sure that you have me in the... " BT has NEVER and will NEVER be on 'our side' " column.

 

[Bronze]

Kodiak? The chew people?

No, an ECF member who posts on this thread. Said my claim was 'Nonsense".

 

[Bronze]

Please make sure that you have me in the... " BT has NEVER and will NEVER be on 'our side' " column.

That's where I pretty much have most everyone.

 

[crxess]

Well, Camel Lights were grandfathered in, but at the same time they weren't allowed to call them "light" anymore, and I don't think they had to file an SE to change the name to Blue since the change was forced by the FDA. Not sure though.

Has the tobacco industry evaded the FDA's ban on ‘Light’ cigarette descriptors?

 

[Bronze]

I mighta been born at night but it wasn't last night.

 

[zoiDman]

That's where I pretty much have most everyone.

As Columns go, it is a Pretty BIG Column.