FDA may soon propose regulation that could ban many/most e-cigarette products, eliminate many/most companies

[McDougal]

Well, I didn't start vaping to have this happen. I agree with the other posters who have said we need to ban together and fight this! What is it with other people dictating what is right and how we should live our lives? I just don't get it. I thought we were the land of the free.

Unfortunately, unfettered control by corporations over what are supposed to be agencies working in the public interest is the problem here. In a profit driven system of governance, the behemoth corporations will pile giant sums of cash onto the issue, breaking the small businesses into submission. It won't matter how many people have benefited from vaping, because profit is their motive, and a loss of democracy is the byproduct of the tyrannical power structure of corporations.

 

[Thulium]

The FDA's connections to Big Pharma are sickening. This is what happens when decision makers in the FDA were also decision makers in pharmaceutical corporations.

You need to understand that there is a *bleep*-TON of money at stake for these Big pHARMaceutical companies. Setting aside the funding they'd lose from annual Master Settlement Agreement and other tobacco taxes from the 46 Million current smokers in the US successfully quit, or the sales of expensive NRT's and other profitable drugs like varenicline that practically GUARANTEE repeat business (as long as they are only used for 12 weeks, you'll need to try quitting with their drugs 8-11 times before you "get it right")...Let's just look at the 8.6 Million smokers who most want and need to stop smoking as they already suffer from a chronic illness that is caused or worsened by smoking: Upwards of $32 BILLION is spent every year treating these diseases, and if/when it develops into cancer, chemotherapy and radiation treatments are the bread & butter of many health systems.... COPD Will Cost U.S. Over $800 Billion Over Next 20 Years

But according to Polosa's study, if instead of giving these smokers thousands of dollars in pharmaceuticals to try to get them to stop smoking only to have the overwhelming majority of them relapse back to smoking, we simply gave them a $50 starter kit, it would reduce smoking by more than HALF, and that was among smokers who didn't want to quit.

Honestly, it disgusts me that pharmaceutical companies are allowed to call their products "safe and effective"--how can you reasonably call them "effective" when more than 58% of smokers say they want to quit, yet thanks to the "quit or die" LIE the FDA has been preaching, the smoking rate hasn't budged in over a decade!?! How can you call them "safe" when it takes decades to die from smoking-related diseases, and multiple lifetimes of SHS exposure to increase your risks in any statistically significant way, but varenicline (aka Chantix/Champix) might just cause you to kill yourself and/or a loved one in the first week?!? Chantix lawsuit Settlement | Chantix Side Effects

 

[McDougal]

You need to understand that there is a *bleep*-TON of money at stake for these Big pHARMaceutical companies. Setting aside the funding they'd lose from annual Master Settlement Agreement and other tobacco taxes from the 46 Million current smokers in the US successfully quit, or the sales of expensive NRT's and other profitable drugs like varenicline that practically GUARANTEE repeat business (as long as they are only used for 12 weeks, you'll need to try quitting with their drugs 8-11 times before you "get it right")...Let's just look at the 8.6 Million smokers who most want and need to stop smoking as they already suffer from a chronic illness that is caused or worsened by smoking: Upwards of $32 BILLION is spent every year treating these diseases, and if/when it develops into cancer, chemotherapy and radiation treatments are the bread & butter of many health systems.... COPD Will Cost U.S. Over $800 Billion Over Next 20 Years

But according to Polosa's study, if instead of giving these smokers thousands of dollars in pharmaceuticals to try to get them to stop smoking only to have the overwhelming majority of them relapse back to smoking, we simply gave them a $50 starter kit, it would reduce smoking by more than HALF, and that was among smokers who didn't want to quit.

Honestly, it disgusts me that pharmaceutical companies are allowed to call their products "safe and effective"--how can you reasonably call them "effective" when more than 58% of smokers say they want to quit, yet thanks to the "quit or die" LIE the FDA has been preaching, the smoking rate hasn't budged in over a decade!?! How can you call them "safe" when it takes decades to die from smoking-related diseases, and multiple lifetimes of SHS exposure to increase your risks in any statistically significant way, but varenicline (aka Chantix/Champix) might just cause you to kill yourself and/or a loved one in the first week?!? Chantix lawsuit Settlement | Chantix Side Effects

Great post, and I have to say that using E-cigarettes kept me from entering my third decade of smoking. I had smoked for 15 years, and nothing worked except for this. And a quickly growing group of people are saying the same thing. They don't care about public health. They care about the corporations they are supposed to be regulating.

 

[rothenbj]

McDougal, welcome aboard and you very well understand the issue. This is a fight of very few against a ton of money. Insurmountable odds which somehow, we need to overcome. Don't become a stranger.

 

[Bill Godshall]

To better understand the many dozens of different Chapter IX provisions/regulations that e-cigarette products (containing nicotine derived from tobacco) and e-cigarette manufacturers and importers would face (if FDA proposes and subsequently approves of a new regulation to apply Chapter IX of the FSPTCA to e-cigarettes (and other currently unregulated tobacco products), I strongly urge everyone to go to
http://frwebgate.access.gpo.gov/cgi...=111_cong_public_laws&docid=f:publ031.111.pdf
mark it as a favorite website (for future reference) and print out the entire 84 pages (of FSPTCA text).

On page 9 of the document, under Title I - Authority of the Food and Drug Administration, please note that
Section 101(rr)1 defines a "tobacco product" as "any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco products". This is the clause cited by Judge Richard Leon when he struck down the FDA's legal authority to regulate e-cigarettes as "drug devices" and ruled that e-cigarettes fit the definition of "tobacco product" in the FSPTCA, and that the FDA had the legal authority to regulate e-cigarettes as tobacco products.

On page 10 of the document, please note that "Chapter IX - Tobacco Products" begins
a continues to at least the end of Section 919 User Fees on page 56.

If the FDA proposes a new regulation to apply Chapter IX to e-cigarettes and other currently unregulated tobacco products, it would do so under the Congressionally granted authority cited in Sec. 901 FDA Authority Over Tobacco Products
(on page 12) per Sec. 901(b) Applicability -- This chapter shall apply to all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and to any other tobacco products that the Secretary by regulation deems to be subject to this chapter.


It appears that Chapter IX also includes Sec. 102 Final Rule beginning on page 56 (which were from 1996 to reduce cigarette and smokeless tobacco sales to minors and reproduced at FR Doc 2010-6087
Sec. 103 Conforming and Other Amendments to General Provisions on page 59,
Sec. 104, and Sec. 106 on page 67.

Title II - Tobacco Product Warnings; Constituent and Smoke Constituent Disclosure
(beginning on page 68 and going to page 76) is NOT part of Chapter IX, but rather it amends the FCLAA.


Title III - Prevention of Illicit Trade in Tobacco Products (beginning on page 76 and ending on page 78
is also part of Chapter IX, everything after Division B - Federal Retirement Reform Act (beginnning on page 78) is not part of Chapter IX.

As you review Chapter IX, please note that the words printed in the margins (e.g. Deadline, Regulations, Notice, Establishment, Effective Date, Publication, Reports, Hearings, etc.) cite the many different regulations, other activities and deadlines that FDA was/is/will be required to fulfill.

After you read through the entire document, I suggest rereading it another half dozen times to better undertand what implications and ramifications could or would occur if FDA proposes and subsequently approves a new regulation (that FDA stated its intent to propose back on April 25) to apply Chapter IX of the FSPTCA (and subsequently of the FDCA) to e-cigarettes and other currently unregulated tobacco products.


Per several comments posted on this thread, please note, however, that the FDA's proposed regulation entitled "Non-Face-to-Face Sale and Distribution of Tobacco Products and Advertising, Promotion, and Marketing of Tobacco Products" (that was cited by the cigar industry in the article I posted at the beginning of this thread) and at
Regulations.gov
would currently only apply to cigarettes, cigarette tobacco, Roll-Your-Own tobacco, and smokeless tobacco products.

But if the FDA proposed and subsequently finalized a new regulation to apply Chapter IX of the FSPTCA to e-cigarettes and other currently unregulated tobacco products, the proposed regulation "Non-Face-to-Face Sale and Distribution of Tobacco Products and Advertising, Promotion, and Marketing of Tobacco Products", many other already approved FDA tobacco regulations, and dozens of forthcoming FDA tobacco regulations would ALSO apply to e-cigarettes and other currently unregulated tobacco products (which is why the cigar industry cited that recently proposed regulation (whose public comment deadline is Dec 8).

Per inquiry by sqirl1, although none of the provisions in Chapter IX (if applied to e-cigarettes) would explicitly ban flavored e-cigarette products (as it only bans certain flavorings for cigarettes), its possible the FDA could rule that flavorings used in e-cigarettes not on the market prior to February 15, 2007 are not "substantially equivalent" to flavorings used prior to that date and that they can therefore be banned because they are "New Tobacco Products" unless/until approved by the FDA. Also, Chapter IX gives the FDA the authority to adopt future regulations for tobacco products that could include a ban on certain (or all) flavorings. But even if the FDA banned flavorings in e-cigarettes, the flavorings could be marketed in separate packages (than e-cig products), and then added to various e-cigarette products by consumers. But all of these flavoring ban possibilities (cited in this paragraph) are speculative at this time.

 

[FreakyStylie]

That's an awful lot of words to say "we want to control every aspect of your life". Sorry, it just irritates me to no end, and eloquence is not my strong suit, LOL.

 

[Bill Godshall]

Please note the in regards to Section 910 of the FSPTCA (that prohibits new cigarettes and smokeless tobacco products that weren't on the market prior to February 15, 2007 unless the FDA determines that the product is "substantially equivalent" to a product on the market prior to that date), back in July the FDA issued a final rule on Exemptions from Substantial Equivalence Requirements (for a manufacturer of a grandfathered tobacco product that makes a minor product modification) at:
http://www.ofr.gov/OFRUpload/OFRData/2011-16766_PI.pdf

Sorry, this weblink is no longer valid, as the FDA has apparently changed it but didn't include a forwarding to the correct link. Not sure where that document is filed.

 

[cookiebun]

Bill we'd be up the creek with out you.
Thanks for all your hard work and to CASA as well.

 

[skinny]

"To better understand the many dozens of different Chapter IX provisions/regulations that e-cigarette products (containing nicotine derived from tobacco) and e-cigarette manufacturers and importers would face"

Bill Since you are much more in the loop of the regulations currently than any of us--would you mind giving a bottom line comment on what Manufacturers will be looking at IE: what will happen to current product in stores/warehouses.
*What will need to be done to get certs on products/e-liquid?
*Will the hardware need to be regulated/cert?
*If products made in China will need to have the Chinese factories certified as well....and so on?

I've looked through so much, and for the life of me, I can't find this information--there's all this talk about regulation, but (to me anyway), no clue on what our government wants from us to do the regulations that they speak of.
Which by the way I am for, we do need some standard to go by, but all this other @#$%! is just muddying the waters.

 

[trying]

With regard to the hardware, does that mean what people here would rightly consider improvements to the basic E-cigarette design of 2007, the FDA would consider as "NOT" substantially equivalent ?

Does anyone still have a pre-Feb 2007 design ?

 

[cracker75]

--there's all this talk about regulation, but (to me anyway), no clue on what our government wants from us....

They want you to die. Slowly and painfully. Hopefully you'll spend lots of money doing it, and even better if you borrow said money to die, and pay their sponsors interest to boot.

 

[Bill Godshall]

Per my posting at 107 of this thread, please note in September the FDA issued a draft guidance demonstrating the substantial equivalence of a new tobacco product (per Section 910 for tobacco products regulated by Chapter IX of the FSPTCA): responses to frequently asked questions; seeks public comments at
Draft Guidance for Industry and FDA Staff Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions

 

[skinny]

Thank you Bill G.
From the looks of it, unless your e-cig is made the same as the first e-cigs made back in 2007, it is considered a new product.
That would mean a lot of us got some forms to fill out!

Again I will say, this is why our country is going down the tubes. The way "they" structure things, it is so hard for companies to do business here in the US.

 

[Bill Godshall]

After the FDA stated its intent to regulate cigars in April 2010 and again in December 2010, some folks in the cigar industry convinced Republican Rep. Bill Posey and Democrat Sen. Bill Nelson (both from Florida) to introduce HR 1639 and S 1461 respectively, apparently created the Cigar Rights of America, and issued an alert at:
CRA - Cigar Rights of America

Information about HR 1639 and S 1461 is available at THOMAS (Library of Congress)

The Cigar Rights of America's most recent update states that there are now 126 Reps cosponsoring HR 1629 and four Senators cosponsoring S 1461 at
Cigar Rights of America

While the Cigar Rights of America's campaign is focussed solely on preventing the FDA from proposing/passing a new regulation to apply Chapter IX of the FSPTCA to premium cigars, since the FDA is likely to propose a new regulation to apply Chapter IX in the FSPTCA to all currently unregulated tobacco products, the cigar industry's campaign has indirectly benefitted e-cigarettes.

 

[Our House]

Per my posting at 107 of this thread, please note in September the FDA issued a draft guidance demonstrating the substantial equivalence of a new tobacco product (per Section 910 for tobacco products regulate by Chapter IX of the FSPTCA): responses to frequently asked questions; seeks public comments at
Draft Guidance for Industry and FDA Staff Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions

The FDA says this:

'6. Question:
If a manufacturer markets a cigarette as "Brand X" on February 15, 2007, and, after that date, continues to market Brand X but also begins to market the identical cigarette under the additional name "Brand Y," would "Brand Y" be a "new tobacco product," and subject to the substantial equivalence provisions?

Response:

Yes. “Brand Y” is a new tobacco product subject to the premarket requirements of sections 905(j) and 910, and the manufacturer must follow one of the regulatory pathways for legal marketing in the United States, i.e., submission of a substantial equivalence report under 905(j), or a pre-market tobacco application under 910(b).'

Doesn't this mean that EVERY ecig (except for maybe 1 or 2 brands from back in 2006/2007) is a new tobacco product in the FDA's eyes?

EDIT: And as far as I can tell, the scope of "substantial equivalence" is very limited. The FDA mentions change or addition/subtraction of ONE ingredient, as an example.

 

[Our House]

I'd also like to add my disgust to the many others who commented in this thread. Doesn't the FDA need to apply reasonable regulations to ecigs (and other reduced harm tobacco products), according to the spirit of Judge Leon's ruling? Allowing only exact copies of a 4081 or 801 3-piece design (marketed before Feb 15, 2007) and banning the rest* only circumvents the law, as laid out by Judge Leon and the Court of Appeals.

*By "banning the rest", I mean requiring all other ecigs that are not 99.9999% identical to the original to make application as a "new tobacco product", and then outright ignoring or denying any applications. The FDA did the same thing to ecig companies who followed the FDA's directions and submitted new drug applications throughout the course of the trial. FDA required these ecigs to make application as a new drug, and then outright ignored or rejected any applications made. System of checks & balances my ...!

 

[VapApe]

Now what I like to know is does the FDA even have samples of e cig and liquid from 2007 to compare? To say what is in complainants and whats not.
Or are they going to make it up as they go.

 

[sqirl1]

I saw that they mentioned "heating source", which is obviously a reference to e-cigs. I just wonder if they'll try to treat a cartomizer like they'd treat rolling papers.

 

[Our House]

Now what I like to know is does the FDA even have samples of e cig and liquid from 2007 to compare? To say what is in complainants and whats not.
Or are they going to make it up as they go.

My guess is the FDA will place the burden on the supplier to show that their products are legal...which is a nightmare for a large majority of suppliers. It's times like this when groups like CASAA will be invaluable for the industry. Hopefully everything about the pre-2/15/07 prototypes will be public knowledge soon, and it will be that much less legal hassle for the suppliers who are looking to seek approval.

 

[Ruppy]

The FDA will not be able to make regulation regarding hardware. Manufacturers can market them as something else. The FDA only has authority to regulate the "tobacco Product" which is the liquid. As long as the hardware is not directly sold with liquid they will be fine. I have a flashlight attachment for my ecig.... Prove its not a flashlight.... The FDA would lose in court if they tried to regulate devices.

Lets not forget that you can go out and buy "other smoking devices". They cannot make regulation that "assumes intent" on how a consumer will use the device. There just has to be proof that there "could be" a alternative use.

Cartomizers and attys are questionable.... I think a argument could be made there but it would be a bit more tricky.

All that said we cant lose sight of the current goal. Keeping e-cigs(eliquid) OUT of the Chapter IX provisions/regulations

In the end we will most likely face some sort of regulation. Our goal has to be making it realistic. I think most users are prepared for some sort of tax and regulation provided its within reason. The current regulation/legislation is far from realistic.