FDA Boehner asks FDA to move Grandfathering date to April 2014 or time of final rule

[Bill Godshall]

I sent the House leaders letter to several national tobacco beat reporters with my following quote.

"While FDA's proposed "deeming" regulation would ban >99% of e-cigarettes now on the market, several thousand of these lifesaving products would remain legal to market if Congress changes the FSTCA's 2007 grandfather date to 2014 or later. This would reduce cigarette consumption far more than anything the FDA has done."

 

[Bill Godshall]

By changing the FSPTCA's grandfather date for newly deemed tobacco products to 2014, 2015 or 2016, Congress would save the e-cig industry, including hundreds or thousands of Premium Vaporizers and bottled e-liquid products that are currently on the market.

While that would freeze the market (and e-cig technology) to whatever is on the market at the time of the new grandfather date, it would keep lots of existing e-cig products legal to sell in the future (as long as the manufacturers submit good SE reports with lots of documentation).

 

[r77r7r]

Great news, so far.

 

[Kent C]

By changing the FSPTCA's grandfather date for newly deemed tobacco products to 2014, 2015 or 2016, Congress would save the e-cig industry, including hundreds or thousands of Premium Vaporizers and bottled e-liquid products that are currently on the market.

While that would freeze the market (and e-cig technology) to whatever is on the market at the time of the new grandfather date, it would keep lots of existing e-cig products legal to sell in the future (as long as the manufacturers submit good SE reports with lots of documentation).

For the exact same reasons given for extending the grandfather date - basically improvements and innovations - are the same reason no grandfather date should be set. That doesn't mean I don't welcome such a change from the current deeming, just that the ultimate solution would be no deeming at all.

We would need a few more seats in the Senate - Durbin, Boxer, Feinstein, Brown, Reed, (and Reid), Markey, Merkley, Blumenthal... for a start.

 

[SeniorBoy]

From the letter with my "ask/preference" bolded:

"...that the grandfather date for them be set at either April 25, 2014 (the date the proposed deeming regulation was published) or the date the final rule is published."

The difference in time is significant and innovation marches on and I see no current signs of it slowing down. Easily ballpark three or more years difference. An "imperfect" solution but far better than a stick in the eye!

 

[Firestorm]

We would need a few more seats in the Senate - Durbin, Boxer, Feinstein, Brown, Reed, (and Reid), Markey, Merkley, Blumenthal... for a start.

I voted to kick Durbin to the curb but unfortunately I was outnumbered.

 

[Nate760]

For the exact same reasons given for extending the grandfather date - basically improvements and innovations - are the same reason no grandfather date should be set. That doesn't mean I don't welcome such a change from the current deeming, just that the ultimate solution would be no deeming at all.

Substantial equivalence is an inherently stupid test in the first place (since it assumes, for no particular reason, that older products are preferable to newer products), and it becomes even stupider when it's applied to products for which it was never intended.

 

[JustJulie]

CASAA: A Step in the Right Direction: House Leadership Calls for a Change in the Grandfather Date for the Tobacco Control Act.

 

[Bill Godshall]

Nate wrote

Substantial equivalence is an inherently stupid test in the first place (since it assumes, for no particular reason, that older products are preferable to newer products), and it becomes even stupider when it's applied to products for which it was never intended.

Philip Morris, CTFK and GSK all agreed to include SE reports in the FSPTCA back in 2003 (to protect PM's Marlboro cigarette empire from market competition by new and superior products).

Regardless, submitting SE reports (to ensure products are nearly identical to those sold before grandfather date) is far far better for e-cigs than the proposed deeming regulation's ban on >99.9% of e-cig products (including all PVs and e-liquid).

I expect CTFK, ACS, AHA, ALA to denounce the House Republicans for proposing to change to the grandfather date by claiming "that would allow e-cig companies to keep marketing candy flavored e-cigs to young nonsmokers".

I also expect a bill will be introduced in the near future (by House Republicans and perhaps also by Senate Republicans) to change the grandfather date to either 2014 or to the day the FDA issues a Final Rule for the deeming regulation. That's what we need to rally vapers to contact their members of Congress.

 

[Kent C]

I voted to kick Durbin to the curb but unfortunately I was outnumbered.

Same here with Brown in '12 at 51%. But Durbin lost numbers - 53.1% in 2014 vs. 68% in 2008. We won't see him in 2020 - he nearly retired this time.

 

[Kent C]

Substantial equivalence is an inherently stupid test in the first place (since it assumes, for no particular reason, that older products are preferable to newer products), and it becomes even stupider when it's applied to products for which it was never intended.

SE only makes sense to regulators where they have something they've already approved. As I said above - IF there's any regulation at all - I'd prefer none of course - the idea of a 'baseline predicate product' that has to do with rational standards rather than chronological ones, makes more sense.

Basically what has happened in the evolution from discussions on this forum - no burning cartos, no glue, pyrex is best for those who have a plasticphobia or where plastics that interact with components, no cotton fillers (that has changed), air vents, certain batts for certain uses, use the charger provided, don't charge non-rechargeable batts (which was our first 'accident' where I found the cause, by the picture of the burnt battery, btw, where almost everyone was blaming the mod maker), and various other ideas and observations by all present and some gone.

 

[Nate760]

Basically what has happened in the evolution from discussions on this forum - no burning cartos, no glue, pyrex is best for those who have a plasticphobia or where plastics that interact with components, no cotton fillers (that has changed), air vents, certain batts for certain uses, use the charger provided, don't charge non-rechargeable batts (which was our first 'accident' where I found the cause, by the picture of the burnt battery, btw, where almost everyone was blaming the mod maker), and various other ideas and observations by all present and some gone.

This forum has done more to advance the safety and efficacy of vapor product technology than 200 years of FDA regulation would.

 

[Rickajho]

The skeptic in me has a much more simple take on this, letter coming after the elections - and the unfettered campaign money that went into the elections - and all that:

Having seen the light - and falling revenue from sale of tobacco - if a certain company wants to keep their Vuse in the market, our dear Congress critters are pushing exactly what is needed for that to be allowed. That is all. Should we happen to see a side benefit from this - great. But don't let this blind side you to the potential for restrictions and regulations either - like a ban on internet sales, import restrictions etc. - among other things. Should that happen you could always get your Vuse at the nearest gas station, drug store, Kwikee Mart - any ole place that currently sells cigarettes.

It's what is not said in those two pages that you have to still consider. Who will still get to "innovate" and at what cost? Proceed with caution.

 

[Kent C]

The skeptic in me has a much more simple take on this, letter coming after the elections - and the unfettered campaign money that went into the elections - and all that:

Having seen the light - and falling revenue from sale of tobacco - if a certain company wants to keep their Vuse in the market, our dear Senators are pushing exactly what is needed for that to be allowed. That is all. Should we happen to see a side benefit from this - great. But don't let this blind side you to the potential for restrictions and regulations either - like a ban on internet sales, import restrictions etc. - among other things. Should that happen you could always get your Vuse at the nearest gas station, drug store, Kwikee Mart - any ole place that currently sells cigarettes.

It's what is not said in those two pages that you have to still consider. Who will still get to "innovate" and at what cost? Proceed with caution.

It's not the Senators (Dems) - they're still on the same page. They're not 'pushing' anything new. And Boehner (House Speaker) only brings this up when they (Sen. Dems) are (will be) no longer in control, otherwise, I doubt he would have brought it up. IOW, the politics are right to do so where they weren't before. He voted against all FSPTCA House bills.

I don't expect any free ride from the Republicans - lots of RINO's and 'moderates' still there - just a better ride than the one that was provided.

 

[Kent C]

This forum has done more to advance the safety and efficacy of vapor product technology than 200 years of FDA regulation would.

It was Hayek's main argument in Road to Serfdom, against 'central planning'. They simply don't have that immediate access to what's happening in the market in order to control it. The ultimate in 'decentralization' is individual choice. Hence, Free to Choose by Milton Friedman, Hayek's 'student' and compatriot.

 

[y cherry y]

The skeptic in me has a much more simple take on this, letter coming after the elections - and the unfettered campaign money that went into the elections - and all that:

Having seen the light - and falling revenue from sale of tobacco - if a certain company wants to keep their Vuse in the market, our dear Congress critters are pushing exactly what is needed for that to be allowed. That is all. Should we happen to see a side benefit from this - great. But don't let this blind side you to the potential for restrictions and regulations either - like a ban on internet sales, import restrictions etc. - among other things. Should that happen you could always get your Vuse at the nearest gas station, drug store, Kwikee Mart - any ole place that currently sells cigarettes.

It's what is not said in those two pages that you have to still consider. Who will still get to "innovate" and at what cost? Proceed with caution.

Vuse was never in danger. Cigalikes from companies with unlimited cash to spend on SE or new product apps would be the only ecigs to survive the deeming regs. I don't read this as a gift to RAI or Altria at all. I'm not sure what to make of it. But, then again, you know. . .gift horse/mouth.

 

[wv2win]

Boehner, a.k.a. "the Orange Man", is doing something right for a change. Do wonders ever cease?

But at least he is so much better than the alternatives: Harkin, Rockefeller, Durbin, Waxman, Pelosi...............

 

[Nate760]

Vuse was never in danger. Cigalikes from companies with unlimited cash to spend on SE or new product apps would be the only ecigs to survive the deeming regs.

Yup. Vuse and MarkTen were designed specifically to satisfy the deeming regs (tobacco/menthol only, tamper-proof cartos, ridiculously detailed health warnings, etc.).

 

[Papa_Lazarou]

Question....

If the grandfather date were adjusted to 2014 (or the time of the deeming), would not every product in the market at that time be "legal" and not subject to SE filing (which would seem to be a circular argument)? I get that upgrades or new products after that date would need to file SE applications.

I ask because I'm reading talk (elsewhere) of SE applications needing to be filed for existing products even with the date adjustment.

 

[Kent C]

Question....

If the grandfather date were adjusted to 2014 (or the time of the deeming), would not every product in the market at that time be "legal" and not subject to SE filing (which would seem to be a circular argument)? I get that upgrades or new products after that date would need to file SE applications.

I ask because I'm reading talk (elsewhere) of SE applications needing to be filed for existing products even with the date adjustment.

From the deeming doc:

"Tobacco products that were commercially marketed (other than for test marketing) in the United States as of February 15, 2007, are not “new tobacco products” subject to the premarket requirements, and FDA refers to these products as “grandfathered.”

And from http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM394933.pdf

"iii. Grandfathered Products
Although not required by chapter IX of the FD&C Act, tobacco product manufacturers may submit information to demonstrate that a product was commercially marketed in the U.S. as of February 15, 2007, and therefore is a grandfathered product. FDA published a draft guidance, “Draft Guidance for Industry and FDA Staff: Establishing that a Tobacco Product was Commercially Marketed in the United States as of February 15, 2007,” for public comment on April 22, 2011 (Ref. 105). It is uncertain how frequently manufacturers would submit this information and ask the agency for a determination, but they would be most likely to do so when they intend to use a grandfathered product as the basis for introducing a new product."