FDA Rep Tom Cole introduces bill (HR 2058) to change SE date from 2007 to 2015 for newly deemed products

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WorksForMe

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No, they will become the products that establish what new products will have to be substantially equivalent to.

That's what I thought, but after the Final Rule is in place, there has to be a way for the FDA to know which products are grandfathered and which ones are new. For example, there has be a way for the FDA to document that Avail Vaper makes Strawberry juice, but Pioneer Vapes does not. With all the vapor products on the market right now, it's going to be a paperwork nightmare for somebody.
 

Lessifer

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That's what I thought, but after the Final Rule is in place, there has to be a way for the FDA to know which products are grandfathered and which ones are new. For example, there has be a way for the FDA to document that Avail Vaper makes Strawberry juice, but Pioneer Vapes does not. With all the vapor products on the market right now, it's going to be a paperwork nightmare for somebody.

I could be wrong, but I believe that onus relies with the manufacturer. So if Avail Vaper wants to continue selling Strawberry Juice, they have to register it as a product and provide proof that it was marketed prior to the grandfather date. What that actually entails, I have no idea.
 

Alexander Mundy

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Done:

Dear Rep. Long,

I write today to ask you to support H.R.2058 - FDA Deeming Authority Clarification Act of 2015 dealing with the "grandfather date" that is hard coded into the FSPTCA. This date, February 15, 2007, is the date the FSPTCA was enacted into law by Congress. The date is important since it is the date which beyond no new tobacco product could be marketed without going through extremely expensive (on the order of a million dollars per very specific product) new product approval or substantial equivalence. (This does not guarantee a product approval, it is the research and fees to submit for approval)

H.R. 2058 would make the "grandfather" date for any newly deemed tobacco products (deeming puts a product under FDA authority to regulate) the date the deeming becomes final, just as the hard coded date did with cigarettes. The FDA is in the process of deeming ecigarettes as a tobacco product. As it stands this hard coded date would make all ecigaretee products not on the market before the date subject to the expensive approval.

Congresses intent was to leave products on the market before the date of deeming available, however the hard coded date has (unforeseen at the time) dire impact on the ecigarette market. If the hard coded date is kept, then greater than 99% of all existing e-cigarette products will be effectively banned and the whole industry will be turned over to big tobacco since they are the only ones that can afford to put their products through the process.

Further exacerbating the issue is that big tobacco "cigalikes" are less effective at keeping people off cigarettes than the products that will be effectively banned. I myself smoked cigarettes for over 20 years and although I tried gums, lozenges, cold turkey, hypnosis, and Chantix (which I wouldn't wish on my worst enemy) I was unable to stop. I had resigned myself to smoking for whatever lifespan I had left. One day I tried a big tobacco "cigalike" but over the course of several weeks was back to smoking. I ran across someone using what is referred to as a "mod" which is a second generation ecigarette that has no resemblance to a cigarette and he conveyed to me that he had tried cigalikes with similar results but the mod had worked for him. I ordered one (there were no brick and mortar shops in Springfield at the time) and have not touched a cigarette in over over 2 years and have no urge to. I feel better, can breath better, taste food, and no longer smell like an ashtray. Am I less likely to die from the effects of ecigarettes than from combustible cigarettes? Research is pointing that direction, but that is not what this bill is concerned with. It is concerned with my personal liberty to choose to use second and third generation ecigarettes (which will be effectively banned) instead of smoking combustible cigarettes.

Please consider supporting H.R. 2058 and even co-sponsoring it. Do not let big tobacco win and take over the industry with their inferior cigalikes.

Received this reply. Seems kinda formish but refreshing in content.


Dear Mr. Xxxxx,

Thank you for contacting me regarding the Food and Drug Administration's (FDA) recent actions related to tobacco products.

On April 25, 2014, the FDA proposed a rule that would subject cigars, e-vapor products, and other tobacco products to the Tobacco Control Act of 2009. The proposed rule set February 15, 2007 as a grandfather date for newly deemed tobacco products because it was the date the Tobacco Control Act was introduced in the 110th Congress. There are growing concerns that the proposed rule's grandfather date for newly deemed tobacco products will impede innovation and impose unnecessary regulatory burdens on both the FDA and regulated industries.


Over the last few decades the federal government has regulated the activities of the American people in increasingly minute detail. This micro-regulatory state is strangling businesses, preventing job creation and costing our economy hundreds of billions of dollars each year. Even worse, this degree of regulation is incompatible with a free people enjoying a limited representative government. Should any legislation come to a vote regarding e-cigarette regulation, I will certainly keep your views in mind.

Again, thank you for contacting me on this important issue. Hearing the views of all Missourians gives me the opportunity to better understand how important issues could impact the people of the Seventh District and the future interests of the nation.

For additional information regarding current legislation, my representation of the Seventh District, and to sign up to receive my monthly newsletter, I invite you to visit my website at http://long.house.gov


Sincerely,
BillyLongSig.png

Billy Long
Member of Congress
 

WorksForMe

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This is a fantastic bill but I fear it has no chance of passing. If it does pass house and senate does the president need to sign it? I don't think he would if that is the case. Either way I filled out the CASAA form and it has been sent.

IIRC, if it passes the House and the Senate, it’s sent the President. He has 10 days to either sign it or veto it. If he does nothing, it automatically becomes law.
 
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Jman8

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I currently know of no other political action that vaping consumers can engage in that would alter the scope of the deeming, as much as this piece of legislation. I still think this angle is as big of news as the proposed regulation, and is the best chance we have going forward.

With that said, here is what I submitted via the CASAA CTA:

I am writing to express support and gratitude for your bill, the FDA Deeming Authority Clarification Act of 2015 (H.R. 2058), which would protect my access to the variety of quality vapor products (otherwise known as e-cigarettes) currently on the market. Moreover, H.R. 2058 is a boon to the millions of current smokers who are seeking an effective means to help them transition away from combustible cigarettes.

As written, the Food and Drug Administration’s (FDA) proposed regulations adversely impact the legal and recreational use of vapor products in the present market by subjecting manufacturers to a costly premarket approval application process that only a few large companies might hope to navigate. Consumers would be left to choose from a very limited number of products that were on the market prior to the February 2007 grandfather date -- products that are remarkably less effective and, by some accounts, less safe. As a result, not only would a large number of the current consumer group likely return to smoking, but millions of current smokers would plausibly see continued smoking as the better option.

For the vast majority of smokers who are not willing and able to just quit, electronic cigarettes offer them a satisfying, low-risk substitute. For many, electronic cigarettes are often the only path away from abusive smoking other than dying. In my case, I have changed from being an abusive smoker, to a proud moderate smoker. I smoke less than a pack a month, and have a history of quitting cold turkey (for more than 10 years of my adult life). While I honor those who seek a path of cessation, I find that vaping provides a suitable alternative to eradicate abusive smoking from the planet as was previously the norm for the last hundred years.

I and my fellow members of the Consumer Advocates for Smoke-free Alternatives Association (CASAA) thank you for considering my comments and look forward to your continued support of Tobacco Harm Reduction policies. We are truly grateful for your introduction of H.R. 2058 and would like to offer any assistance we can to advance this bill.
 

SeniorBoy

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That's what I thought, but after the Final Rule is in place, there has to be a way for the FDA to know which products are grandfathered and which ones are new. For example, there has be a way for the FDA to document that Avail Vaper makes Strawberry juice, but Pioneer Vapes does not. With all the vapor products on the market right now, it's going to be a paperwork nightmare for somebody.

Well here is part of your answer which of course the FDA can change, amend, or basically modify it any way they want. Think "enforcement discretion" :)

TITLE:

Guidance for Industry - Dated September 2014

Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007


http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM416498.pdf

HTH
:)
 

WorksForMe

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Thanks SB. That’s exactly what I was looking for. It looks like every manufacturer (including B&Ms and Chinese companies) will have to prove to the FDA that their products are grandfathered. That could get interesting for juice manufactures that make lots of different flavors in different nic strengths.
 
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SeniorBoy

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Yep! Down the road for ejuice it's a much softer landing with a new grandfathered date but a ton of paper work. So, a given vendor sells a given juice in various incarnations of NIC + VG and or PG per. Back of the napkin WAG about 7 varieties per x say 30 different juices is 210 submissions to the FDA. I think ? they guessimated 12 hours to compile a single submission so that's over 2500 hours of labor. Assuming a vendor has the necessary proof.

Joke: Hope you like our Funky Duck Flavor which will never change. /lol

Of course theirs Fasttech! /gulp
 

AndriaD

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Sounds like the politically correct translation for "protection racket".

That's exactly what it is, and the FDA together with BP need to be indicted on RICO charges.

Andria
 

SeniorBoy

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WOW! Thanks. Grover Norquist and the Gang! I could be fuzzy on this but isn't the ATR a pledge/document that Rs have to sign and support otherwise Grover insures they are toast as in Grover finds an opponent, throws a ton of money behind them, and insures that his candidate gets elected? If I have my ducks in a row ?? /lol this could turn out to be a huge huge huge battle with perhaps the Rs tying up the final rule which must hit Congress for years and years. Not to mention all the noise and delays the Rs can create in the Confirmation hearings for the next Commisioner of the FDA aka Desk Killers. I could certainly be wrong and I might be overstating Commander Grover's power?

Any political wonks want to set me straight or help explain this?
 

nicnik

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WOW! Thanks. Grover Norquist and the Gang! I could be fuzzy on this but isn't the ATR a pledge/document that Rs have to sign and support otherwise Grover insures they are toast as in Grover finds an opponent, throws a ton of money behind them, and insures that his candidate gets elected? If I have my ducks in a row ?? /lol this could turn out to be a huge huge huge battle with perhaps the Rs tying up the final rule which must hit Congress for years and years. Not to mention all the noise and delays the Rs can create in the Confirmation hearings for the next Commisioner of the FDA aka Desk Killers. I could certainly be wrong and I might be overstating Commander Grover's power?

Any political wonks want to set me straight or help explain this?

Grover Norquist has lost much of his former political clout. He's been a great supporter of THR, though.
 

Kent C

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WOW! Thanks. Grover Norquist and the Gang! I could be fuzzy on this but isn't the ATR a pledge/document that Rs have to sign and support otherwise Grover insures they are toast as in Grover finds an opponent, throws a ton of money behind them, and insures that his candidate gets elected? If I have my ducks in a row ?? /lol this could turn out to be a huge huge huge battle with perhaps the Rs tying up the final rule which must hit Congress for years and years. Not to mention all the noise and delays the Rs can create in the Confirmation hearings for the next Commisioner of the FDA aka Desk Killers. I could certainly be wrong and I might be overstating Commander Grover's power?

Any political wonks want to set me straight or help explain this?

About the Taxpayer Protection Pledge | Americans for Tax Reform

It's a pledge to a candidate's constituency:

ONE, oppose any and all efforts to increase the marginal income tax rates for individuals and/or businesses; and

TWO, oppose any net reduction or elimination of deductions and credits, unless matched dollar for dollar by further reducing tax rates.

Grover can't really 'insure' they are toast if they go back on the pledge. However, he may help organize any campaign against the candidate/office holder. This really is no different than the DNC, RNC, Emily's list (fem Pac), Club for Growth Pac, Sierra Club, NRA, NEA, etc. etc. etc. They will put up primary fights against those who don't follow their pledges, goals, purposes, ideologies.

The reason guys like Grover or Stephen Moore (CFG), Wayne LaPierre, etc. make the news as sometimes ogres, is they're mainly Republicans. You won't either know or hear about the head of Sierra, NEA or Emily's list since the media likes all those guys :facepalm: :laugh: So they're heroes/heroines but the others are villains. Got it now? lol
 

nicnik

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About the Taxpayer Protection Pledge | Americans for Tax Reform

It's a pledge to a candidate's constituency:

ONE, oppose any and all efforts to increase the marginal income tax rates for individuals and/or businesses; and

TWO, oppose any net reduction or elimination of deductions and credits, unless matched dollar for dollar by further reducing tax rates.

Grover can't really 'insure' they are toast if they go back on the pledge. However, he may help organize any campaign against the candidate/office holder. This really is no different than the DNC, RNC, Emily's list (fem Pac), Club for Growth Pac, Sierra Club, NRA, NEA, etc. etc. etc. They will put up primary fights against those who don't follow their pledges, goals, purposes, ideologies.

The reason guys like Grover or Stephen Moore (CFG), Wayne LaPierre, etc. make the news as sometimes ogres, is they're mainly Republicans. You won't either know or hear about the head of Sierra, NEA or Emily's list since the media likes all those guys :facepalm: :laugh: So they're heroes/heroines but the others are villains. Got it now? lol
It used to be that no Republican would dare not sign and adhere to the Pledge. He had a real grip on the party, because the backlash from defying him would be huge. In recent years, some Republicans have been more willing to break from the rigidity.

Edit: Grover's been advocating for ecigs all along, and it I'm sure it's helped some. This support for HR2058 is bound to have some influence, but it's not a game changer.
 
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Kent C

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It used to be that no Republican would dare not sign and adhere to the Pledge. He had a real grip on the party, because the backlash from defying him would be huge. In recent years, some Republicans have been more willing to break from the rigidity.

There have always been Republicans who have not signed the pledge - the 'usual suspects'. And there have been just a few who have broken the pledge - Lindsay Graham - d'uh. lol. I had a hard time getting an actual list. Googling you'll find people who won't sign the pledge rather than those who broke it. But if you know their politics - ie. libertarian/leaning, conservative, or neocon (mostly former Dems) and Republican 'establishment' types - then you'll know who might sign and who might not and who if they do sign may not honor it.

As far as whether the 'grip' is looser now than it was, I'm not so sure. We know the NEA and AFSCUME unions have a much tighter grip on Dems than the NRA or ATR or Club for Growth has on Republicans. Their lives and jobs actually depend on the Dems upholding more gov't spending and the taxes to pay for their jobs. Not so for ATR, NRA, etc.
 
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