Herzog optimistic after attending Food and Drug Law Institute tobacco regulation conference

[Cool_Breeze]

WASHINGTON -- On Oct. 28, the Food and Drug Law Institute (FDLI) hosted a conference on FDA regulation of tobacco, featuring a number of industry speakers including director of the FDA's Center for tobacco Products (CTP), Mitch Zeller. According to Wells Fargo Securities analyst Bonnie Herzog, Zeller and other speakers echoed the sentiments famously expressed by Professor Michael Russell that "people smoke for nicotine, but they die from tar."

http://www.cspnet.com/category-mana...ata/articles/regulatory-stars-aligning-e-cigs

 

[WorksForMe]

Great find Cool_Breeze. With all the negative speculation and bad news we’ve heard lately, this article actually brought a tear of happiness to my eyes. I hope Bonnie’s right. It sounds like they could regulate e-cigs differently from cigarettes.

J.R.

 

[Exhaler]

Yes, this was optimistic news for once, but let's first see what the FDA comes out with before we celebrate.

 

[AgentAnia]

Good catch, CB. I want to believe in Herzog's optimism, but... well, we're just going to have to wait and see. :sigh:

 

[Bill Godshall]

That CSP article was based upon a report Herzog sent out yesterday. If anyone wants Herzog's report, please send an e-mail request to me at smokefree@compuserve.com

Below is my take on Herzog's report, which I e-mailed to many e-cig companies and vaping activists (when I forwarded them Herzog's report).



Herzog is getting bullish on the FDA giving the e-cig industry to Big
Tobacco, but she's spot on in writing

"The key question on e-cigs is how the FDA will deal with pre-market
approvals. In other words, will deeming regulations prevent, limit, or
restrict rapid innovation of the category.Bottom line - if e-cig
innovation is stifled, in our view this could dramatically slow down
conversion from combustible cigs, which would ultimately result in net
negative public health impact"

Unfortunately for the vast majority of e-cig companies and many vapers,
even if FDA changes the 2007 grandfather date in Section 910 to 2013
for e-cigs, e-cig companies would still be required to submit SE
applications (and FDA would have to approve them) for all of the 1,000+
e-cig products in 2014 or 2015 (or shortly after FDA approves the new
regs) in order to keep those products on the US market.

Although the big tobacco companies and some large e-cig companies can
afford spending a half million dollars or more to submit each SE
application, the vast majority of small e-cig companies (including
e-liquid companies) cannot afford to do so, which would sharply reduce
the number of e-cig products on the US market (i.e. from 1,000+
products to no more than several dozen, and probably fewer). Please
note that FDA has only approved about 20 NRT products in the past 30
years.

The only way a small e-cig company could survive is to submit no more
than one or two SE applications for just one or two e-cig products they
think has/have the best chance to generate a return on their
investment. Please note that Altria would only need to submit two SE
applications for their new MarkTen e-cigs (one SE for menthol and one
SE for nonmenthol).

That's why we need to continue exposing and opposing the FDA deeming
regulation.

 

[Cool_Breeze]

That CSP article was based upon a report Herzog sent out yesterday. If anyone wants Herzog's report, please send an e-mail request to me at smokefree@compuserve.com

Below is my take on Herzog's report, which I e-mailed to many e-cig companies and vaping activists (when I forwarded them Herzog's report)...<snip>

Hi, Bill,

Thanks for your take on Ms. Hertzog's report.

Is or will the text of the FDA's proposal to the OMB become publicly available?

 

[Uma]

Bookmarking, afraid to breathe lest I ruin the spell...

 

[AgentAnia]

....Is or will the text of the FDA's proposal to the OMB become publicly available?

Since Bill hasn't responded yet, I'll jump in. As I understand it, once OMB clears the FDA proposed regs, they will be published in the Federal Register, and a period for comments from the public begins.

 

[Bill Godshall]

Please note that the FDA has missed three previously stated dates that it said it would propose the deeming and other regs for e-cigs since 2011. Hopefully, the OMB or the White House will not give FDA permission to propose the regs.

 

[NorthOfAtlanta]

Please note that the FDA has missed three previously stated dates that it said it would propose the deeming and other regs for e-cigs since 2011. Hopefully, the OMB or the White House will not give FDA permission to propose the regs.

This, I don't think they want to stir up anything else at this time as they already have tobacco users po'ed about the go ahead and charge them more if you want to in Obamacare.

 

[hlk]

"The key question on e-cigs is how the FDA will deal with pre-market
approvals. In other words, will deeming regulations prevent, limit, or
restrict rapid innovation of the category.Bottom line - if e-cig
innovation is stifled, in our view this could dramatically slow down
conversion from combustible cigs, which would ultimately result in net
negative public health impact"

Unfortunately for the vast majority of e-cig companies and many vapers,
even if FDA changes the 2007 grandfather date in Section 910 to 2013
for e-cigs, e-cig companies would still be required to submit SE
applications (and FDA would have to approve them) for all of the 1,000+
e-cig products in 2014 or 2015 (or shortly after FDA approves the new
regs) in order to keep those products on the US market.

Although the big tobacco companies and some large e-cig companies can
afford spending a half million dollars or more to submit each SE
application, the vast majority of small e-cig companies (including
e-liquid companies) cannot afford to do so, which would sharply reduce
the number of e-cig products on the US market (i.e. from 1,000+
products to no more than several dozen, and probably fewer). Please
note that FDA has only approved about 20 NRT products in the past 30
years.

The only way a small e-cig company could survive is to submit no more
than one or two SE applications for just one or two e-cig products they
think has/have the best chance to generate a return on their
investment. Please note that Altria would only need to submit two SE
applications for their new MarkTen e-cigs (one SE for menthol and one
SE for nonmenthol).

That's why we need to continue exposing and opposing the FDA deeming
regulation.

It's ridiculous to think each of the hardware components of e-cigs needing to be approved..
in theory they all work the same.

They are treating this like a new food or drug hitting the market... On the juice side, they could also say what's allowable in the e-juice and anything different would have to be approved. The thought of this drives me nuts...

 

[5150sick]

What is a MOD??? A flashlight if sold with a flashlight head with a 510 connection on it. What is an atty? A medically necessary piece of a medial ......... users vape pen. Batteries are just batteries. PG and VG will never be outlawed and either will loranns candy flavors and TFA's cake/food flavoring. The nic is the only problem that loopholes will not make it around. If flavored eliquid were to be banned then what would stop a husband and wife mom and pop eliquid company from branching off into 2 separate companies. One to sell unflovored nic juice and the other to sell "flavor packets" clearly marked not to be mixed with nic juice only to be used for cooking or adding flavor to drinks and candy. There are going to be loopholes all over the place if the FDA doesn't come back in our favor.

 

[Cool_Breeze]

“It's a big waiting game because everyone [in the tobacco industry] is trying to figure out what the hell they are going to put out. The regs are sitting at the OMB, they are doing their due diligence and they're behind because of the shutdown,” said one Republican lobbyist representing electronic cigarettes.

The draft rules were expected out by the end of October, but the OMB has until the end of December to finish its review. That deadline could be extended into next year.

E-cigarette makers ramp up lobbying efforts | TheHill

 

[BobbyJohn]

“It's a big waiting game because everyone [in the tobacco industry] is trying to figure out what the hell they are going to put out. The regs are sitting at the OMB, they are doing their due diligence and they're behind because of the shutdown,” said one Republican lobbyist representing electronic cigarettes.

The draft rules were expected out by the end of October, but the OMB has until the end of December to finish its review. That deadline could be extended into next year.

E-cigarette makers ramp up lobbying efforts | TheHill

Good article. Thank you.

Their logic is that nicotine comes from tobacco, then its a tobacco product. Nicotine is a naturally occuring compound found is most places in the nightshade (solanaceae) family. Nicotine is in tomatoes, peppers, eggplants and other plants leaves.

 

[Cavediver]

This, I don't think they want to stir up anything else at this time as they already have tobacco users po'ed about the go ahead and charge them more if you want to in Obamacare.

I don't think they care. Tobacco users are, as you say, already po'ed; there's no reason not to kick them (us?) again now and get it over with... In fact, it's probably better than doing it later and stirring up another hornets' nest.

 

[Coastal Cowboy]

“It's a big waiting game because everyone [in the tobacco industry] is trying to figure out what the hell they are going to put out. The regs are sitting at the OMB, they are doing their due diligence and they're behind because of the shutdown,” said one Republican lobbyist representing electronic cigarettes.

The draft rules were expected out by the end of October, but the OMB has until the end of December to finish its review. That deadline could be extended into next year.

E-cigarette makers ramp up lobbying efforts | TheHill

Not a shot at you, but I disagree. FDA was supposed to have taken OMB's review process into account, and if they were confident that OMB could not allow them to make the 31-Oct-13 deadline, FDA should have punted and announced a new intention in the Federal Register.

That's the way things are supposed to be done, but then again... this administration and this HHS has done absolutely nothing according to well established rules for regulatory procedure.

SFATA or CASAA needs to explore legal action to make FDA either propose, or punt.