Bill Godshall urges opposition to FDA deeming reg at FDLI conference because it would give e-cig industry to Big Tobacco

[montara]

Good job bill thank you for the good work you have done for this community

You took the words right out of my mouth.

Bill, love 'ya man

 

[Roger_Lafayette]

As always Bill, your command of the facts, the history, and the English language is beyond stellar.

I have a couple Qs:

1) Given that the FDA is undoubtedly hell-bent on getting this rule into place, would it be correct to say that the only two formal mechanisms for preventing that result are rejection of the final draft of the proposed rule (i.e. after the comment period, etc.) by OMB or the: Congressional Review Act - Wikipedia, the free encyclopedia ?

2) If neither of those methods work, then only aggrieved parties (with standing to sue) can challenge the rule's application in specific cases, I believe?

For ex., I don't think I could sue the FDA merely because they refused to allow Vision to market a spinner, on the grounds that I like using them. Vision would have to do that. And that's even assuming that Vision was willing to apply to the FDA w/i the 2-year window. If they didn't, then FDA could pull Vision spinners out of the product stream once the window was closed - and Vision would have no recourse. (This example fails if spinners were available prior to Feb '07, but let's just assume that they weren't for purposes of discussion.)

 

[Mossy]

Thank you Bill, you're command of the spoken and written word is always impressive.

 

[Tecner]

This is the best thing i have read all day, hell... all year! Thank you very much for this, we all need to stick together and fight this!

 

[randyith]

I am, MAD AS HELL. Uggg, bash and slam.

 

[rothenbj]

Thank you Bill, that was thrilling to read. I hope they felt it when you slapped them with your words. May I have your permission to copy this and send it along with my letters to SC Senate and Representatives?

That was my thought as well as duplicating it in social media. It would then get read not only by vapors and smokers, but non-smokers as well.

 

[aikanae1]

I pulled this comment from a Reuter's article yesterday and was a bit confused by it:

Mitch Zeller, head of the FDA's tobacco division, said at a briefing that the agency would be seeking more information during the public-comment period on whether the "substantial equivalence" pathway is even valid for e-cigarettes.

If it is not, e-cigarette companies would have to use a different process, which would require them to prove their products are appropriate for public health, a higher hurdle to clear.

A higher hurdle?

 

[Bill Godshall]

Thanks again for the many kudos.

rothenbj wrote:

I can only assume the reaction you got from the audience on your very upfront and honest presentation.

Interestingly, most of the approximately 75 folks in the audience at Tuesday's FDLI conference were lawyers and FDA regulatory compliance staff for tobacco companies, and most of them strongly agreed with my presentation (and many told me so, although they'll never publicly criticize the FDA deeming reg for benefiting their tobacco company at the expense of many small competitors).

aikanea1 posted the following from a news article

Mitch Zeller, head of the FDA's tobacco division, said at a briefing that the agency would be seeking more information during the public-comment period on whether the "substantial equivalence" pathway is even valid for e-cigarettes.

If it is not, e-cigarette companies would have to use a different process, which would require them to prove their products are appropriate for public health, a higher hurdle to clear.

In order to submit an SE application, the applicant will have to obtain and conduct lots of laboratory tests on a nearly identical product from 2007. But none of the 2014 cigalikes are similar to 2007 cigalikes, and I'd be shocked if anyone has batch samples of e-liquid products that were manufactured and marketed in 2007 (to conduct lab tests on to demonstrate they are nearly identical to e-liquid products now on the market). Thus, it is unlikely any SE applications will be approved, or even submitted, for e-cig products. That's why the deeming reg will ban all e-cig products (or >99% of them) if/when the premarket approval is imposed two years after the Final Rule is issued.

Per Roger's inquiry about the process, it is unlikely that the FDA will issue a Final Rule for the deeming reg for at least two years (as that's how long it takes nearly all other new federal regs), but if the FDA doesn't issue a Final Rule within 32 months (i.e. December 2016), it is unlikely to do so if a Republican wins the 2016 election (but could do so after 2016 if Hillary or another Dem is elected president).

Also, if Republicans take over the US Senate later this year, the chances of Obama's FDA issuing a Final Rule on the deeming reg (and many other regs proposed by Obama agencies) will greatly diminish.

If Obama's FDA issues a Final Rule on the deeming reg (before Obama leaves office), then litigation is the only way to stop the deeming reg from becoming implemented.

If Obama's FDA decides (or is instructed by Obama administration) to not issue a Final Rule for the deeming reg, they'll never say so publicly, and nobody will know for sure (even after Obama leaves office in December 2016).

I remember when OSHA proposed a federal regulation to ban smoking in most US workplaces back in 1994. After a million comments were submitted to the agency pro and con, OSHA never issued a Final Rule for that proposed regulation, but still hasn't said so publicly (even though that occurred 20 years ago), as government agencies almost never publicly admit that they screwed up.

 

[DetraMental]

Thank you for being so proficient in the language of legislation and vaping and all that it encompasses. I can't even begin to tell you how much your involvement means and a mere thank you does not suffice yet that is all I can offer you with my most humblest and sincerest words.

 

[Norman Clature]

I just submitted Bill's words at:

Regulations.gov

They are way too long for the "comments" section but I created an MS-Word document and chose "upload file" and it works that way.

Thanks Bill,

Norman

 

[Bill Godshall]

Please note that there are several statements in my FDLI presentation (which was made before FDA proposed the deeming reg) that are not accurate because FDA's proposal exempted e-cigs from the 2011 deadline in Section 910 that would have banned all e-cig products, and because FDA proposed some other changes for e-cigs as well (compared to Chapter IX requirements for cigarettes and smokeless tobacco products).

So if you want to quote me on the deeming reg, please wait till I prepare a comprehensive analysis of what FDA just proposed.

Its better to wait to submit accurate comments to FDA (as FDA just ignores comments that contain inaccurate statements).

 

[CabinetGuyScott]

Please note that there are several statements in my FDLI presentation (which was made before FDA proposed the deeming reg) that are not accurate because FDA's proposal exempted e-cigs from the 2011 deadline in Section 910 that would have banned all e-cig products, and because FDA proposed some other changes for e-cigs as well (compared to Chapter IX requirements for cigarettes and smokeless tobacco products).

So if you want to quote me on the deeming reg, please wait till I prepare a comprehensive analysis of what FDA just proposed.

Its better to wait to submit accurate comments to FDA (as FDA just ignores comments that contain inaccurate statements).

Is that a comedic straight-line or what?

Just begging for ...


Btw - thank you Bill! That's for all the passion and commitment you bring to clear, sensible thinking on the issues we all value so much!!

 

[Roger_Lafayette]

Thanks for your reply, BIll.

I do want to be sure that I understand the process, so please tell me if I correctly discern the thinking behind your answers.

[...] but if the FDA doesn't issue a Final Rule within 32 months (i.e. December 2016), it is unlikely to do so if a Republican wins the 2016 election (but could do so after 2016 if Hillary or another Dem is elected president).

Q1) And you are saying this because a Dem Pres' OMB is more likely to approve any Final FDA Rule, and/or a Dem Pres is more likely to veto any congressional disapproval under the Congressional Review act, right?

Also, if Republicans take over the US Senate later this year, the chances of Obama's FDA issuing a Final Rule on the deeming reg (and many other regs proposed by Obama agencies) will greatly diminish.

Q2) You are saying this because of the potential for congressional action under the Congressional Review Act, correct?

If Obama's FDA issues a Final Rule on the deeming reg (before Obama leaves office), then litigation is the only way to stop the deeming reg from becoming implemented.

Q3) And this is because Obama could (probably successfully) veto any congressional disapproval under the Cong. Review Act - regardless of what happens this Nov?

Q4) And that in turn means that there are only three ways to prevent the final rule from resulting in the kind of devastation to that we all fear - namely litigation (possible), legislation that changes the FDA's authority (very unlikely), or (c) unanticipated behavior on the FDA's part (also extremely unlikely)?

***

(Let me switch gears to strategy, and see if you'd be so kind as to let us pick your brain on this one ...)

[...] Per Roger's inquiry about the process, it is unlikely that the FDA will issue a Final Rule for the deeming reg for at least two years (as that's how long it takes nearly all other new federal regs) [...]
If Obama's FDA decides (or is instructed by Obama administration) to not issue a Final Rule for the deeming reg, they'll never say so publicly, and nobody will know for sure (even after Obama leaves office in December 2016). I remember when US OSHA proposed a federal regulation to ban smoking in most US workplaces back in 1994. After a million comments were submitted to the agency, OSHA never issued a Final Rule for that proposed regulation, but still hasn't said so publicly (even though that occurred 20 years ago).

It's good to know that we have some time. It sounds as if we also may have an opportunity to make harder for the FDA to move quickly?

 

[Norman Clature]

Please note that there are several statements in my FDLI presentation (which was made before FDA proposed the deeming reg) that are not accurate because FDA's proposal exempted e-cigs from the 2011 deadline in Section 910 that would have banned all e-cig products, and because FDA proposed some other changes for e-cigs as well (compared to Chapter IX requirements for cigarettes and smokeless tobacco products).

So if you want to quote me on the deeming reg, please wait till I prepare a comprehensive analysis of what FDA just proposed.

Its better to wait to submit accurate comments to FDA (as FDA just ignores comments that contain inaccurate statements).

Sorry to have "jumped the gun."

Thanks for all you do,

Norman

 

[Jeffk123]

Thanks for this,
Vaping has been my love and passion and has been for a few years now. Makes me happy to read this kinda stuff. We will get through this tooth and nail.

 

[ICantStandYous]

bill, We are extremely lucky to have you on our side. We fully support your approach and are ready to come together as a community behind your lead. Thank you for all that you do for us.

 

[Bill Godshall]

Per Roger's questions,

The FDA and other e-cig prohibitionists chief goal will be to get FDA to issue the Final Rule while Obama is still in office (as many/most newly elected presidents push their own regulatory agenda, and often scrap those of the preceding administration).

So our key goal must be to prevent the FDA from issuing a Final Rule while Obama is in office. The best tactic to delay the regulatory process is to request more than 75 days to submit public comments (especially since it took dozens of FDA staff and lawyers nearly three years to write the complex 241 page proposal).

If Republicans win control of the US Senate in November, the Obama administration will sharply scale back its huge regulatory agenda (which will significantly increase our chances of preventing Obama's FDA from issuing the Final Rule), as Durbin, Brown, Blumenthal, Boxer, Markey, Merkley will lose control and much of their influence (to lobby for the FDA deeming reg, increase e-cig taxes, and ban e-cig advertising).

 

[Bobbilly]

Just tie this deeming reg to Obama care somehow and the republicans will fight It to their deathbeds

 

[Myrany]

Per Roger's questions,

The FDA and other e-cig prohibitionists chief goal will be to get FDA to issue the Final Rule while Obama is still in office (as many/most newly elected presidents push their own regulatory agenda, and often scrap those of the preceding administration).

So our key goal must be to prevent the FDA from issuing a Final Rule while Obama is in office. The best tactic to delay the regulatory process is to request more than 75 days to submit public comments (especially since it took dozens of FDA staff and lawyers nearly three years to write the complex 241 page proposal).

If Republicans win control of the US Senate in November, the Obama administration will sharply scale back its huge regulatory agenda (which will significantly increase our chances of preventing Obama's FDA from issuing the Final Rule), as Durbin, Brown, Blumenthal, Boxer, Markey, Merkley will lose control and much of their influence (to lobby for the FDA deeming reg, increase e-cig taxes, and ban e-cig advertising).

Would adding a request for extension in time to analyze the document due to its length and complexity to all our emails and contact with various governmental agencies as we work through the list of making our feelings bout this thing known be of any help in getting that extension?

In other words I enough of us ask in a reasonable and rational way for more time help? I am thinking if congresspeople and the FDA hear the request from enough constituents it will carry some weight. Maybe we need to add it to our talking points on all fronts of this fight.

 

[Mowgli]

Thanks Bill.


To the top