GAO report criticizes FDA Center for Tobacco Products for SE application backlog, exposes how deeming reg would decimate e-cig industry

[Bill Godshall]

The US Government Accountability Office has issued an eye popping report exposing the FDA's Center for tobacco Products inner workings and failure to adequately process thousands of Substantial Equivalence (SE) applications filed by tobacco companies since 2010. The GAO report recommends set time frames for the agency's review process of SE applications for tobacco products (as agency has made final decisions on just 19 of more than 4,000 SE applications filed since 2010),
http://www.gao.gov/assets/660/657451.pdf
New Report Highlights Shortcomings in FDA Review Process - Legislative & Regulatory News - Convenience Store News

Senator Burr's press release (as he requested the GAO report)
Richard Burr, United States Senator of North Carolina: Press Releases

This report delineates the same (or very similar) SE application approval/denial process that e-cigarette companies will be forced to comply with if/when the FDA imposes the deeming regulation on e-cigs, as the agency has repeatedly stated its intent to do.

Since a SE or New Tobacco Product application would need to be submitted for every different e-cig product (even slightly different products made by the same company), even if FDA extends the grandfather date from 2007 to 2013 for e-cigs, the deeming regulation would eliminate the vast majority of e-cig products (if manufacturers are required to submit SE applications in 2015 saying their products are substantially equivalent to a product on the market in 2013).

While many e-cig manufacturers (especially small e-liquid manufacturers) market many different e-cig products (all of which would require its own SE application), Altria would only have to submit two SE applications for its two new e-cig products (menthol and nonmenthol).

In essence, the deeming regulation almost certainly would reduce the number of e-cig products on the legal market from more than 1,000 (currently) to no more than a dozen or so (if FDA approves any of the SE applications).

 

[Uma]

Senator Burr is rockin da house!!
or not.
Explain please. Is he trying to hold the FDA accountable for not testing or for not pushing the regs through in a timely fashion to start taxing them?
its always gibberish to me.
My first impression, was that he wanted to set them straight on their blatant bias and sabatage, but the news article suggests they are more concerned with getting the taxes rolling.

I'll go shut up now and hope you guys clarify things.

IGNORE MY ABOVE RAMBLINGS.
THIS EXPLAINS IT JUST FINE.
http://www.burr.senate.gov/public/_files/GAOReport Oct2013.pdf

ITS TO GET THE TAXES ROLLING AND THE STAKEHOLDERS SHARING.

off to make more coffee, this is going to be a long day

 

[stauglocal]

Typical government agency dragging their feet. If the FDA was privately owned, this problem would of never occured.

 

[Bill Godshall]

Uma inquired

Senator Burr is rockin da house!!
or not.
Explain please.

Please note that Sen. Richard Burr was the most vocal opponent (in the US Senate) of the Tobacco Control Act before it was enacted in 2009, and Burr requested this GAO investigation and report to expose the FDA's outrageous backlog of SE applications filed by tobacco companies.

While Burr's action represented the interests of RJ Reynolds (headquartered in Winston-Salem, NC), they also expose FDA's failure to adequately implement the SE application process that the TCA requires for all cigarettes, smokeless tobacco and RYO products.

If/when FDA imposes the deeming regulation on e-cigs, an SE or New Tobacco Product application would have to be submitted to the FDA for every different e-cig product (to allow it to remain on the market), and then the FDA will have sole discretion on which SE application(s) they decided to approve, not approve or delay taking action.

 

[JulesXsmokr]

It also sounds like a huge patent war would be ensuing and only allowing FDA approved devices to be on the market with certain patents..
..I am thinking too far ahead on this??

 

[Uma]

Thanks Bill. That was my first impression. The millions of dollars the FDA raked in, compared to few the FDA tested, exposed the tone quite well after all.

 

[Bill Godshall]

Patents have zero influence on FDA decision making.

The GAO report stated that FDA planned to spend $611 million in FY2012 for regulating tobacco products, but that the agency only spent $272 million. Sounds like another reason why the FDA replaced Lawrence Deyton with Mitch Zeller earlier this year.

 

[cookiebun]

You're saying this would push HARDWARE off the market? What if it's sold with out nicotine products?

 

[Bill Godshall]

Although the Tobacco Control Act defines a "tobacco product" as including components and accessories of tobacco products, it is not known if FDA will propose regulations to ban or regulate e-cig components and accessories.

But as long as e-cig hardware, batteries and other components and accessories are sold separately from the e-liquid or cartridges containing e-liquid (i.e. not in the same package, advertisement, promotion, etc.), the FDA couldn't legally ban the hardware, batteries or other components and accessories.

 

[Myrany]

Although the Tobacco Control Act defines a "tobacco product" as including components and accessories of tobacco products, it is not known if FDA will propose regulations to ban or regulate e-cig components and accessories.

But as long as e-cig hardware, batteries and other components and accessories are sold separately from the e-liquid or cartridges containing e-liquid (i.e. not in the same package, advertisement, promotion, etc.), the FDA couldn't legally ban the hardware, batteries or other components and accessories.

That is reassuring in the sense that hardware manufacturers could keep on going as long as they do not also sell the e-liquid. Unfortunately I just can't shake the paranoid feeling that the government will try to ban anyways and it will take lawsuits to sort it all out.

 

[NicoHolic]

Does the FDA not regulate separately sold rolling papers as tobacco products? I thought I read they did. Would atomizers, cartomizers, and clearomizers be similar?

Certainly, batteries, resistance wire, and wick material are used for other things and shouldn't be affected.

And PVs could be sold with 510-attached LED "signal lights."

 

[soba1]

As p o'd as people are I don't think they will touch it.

 

[jstaubin]

Since there are many people who smoke e cigs WITHOUT nicotine, I don't see how they can ban hardware or e liquid without nicotine.

 

[Horselady154]

Since there are many people who smoke e cigs WITHOUT nicotine, I don't see how they can ban hardware or e liquid without nicotine.

They are the government. They can do whatever they want and HAVE, since the American people stopped holding them accountable to the Constitution.

 

[soba1]

They are the government. They can do whatever they want and HAVE, since the American people stopped holding them accountable to the Constitution.

We have people in our corner fighting for us. We have us in our corner fighting for us

 

[Bill Godshall]

NicoHog inquired

Does the FDA not regulate separately sold rolling papers as tobacco products? I thought I read they did. Would atomizers, cartomizers, and clearomizers be similar?

Yes, but that's because Philip Morris made sure that the Tobacco Control Act delineated that RYO papers and tobacco would be regulated under Chapter IX regs. PM's goal was to eliminate as many RYO companies, products and sales as possible (since RYO was/is reducing sales of Marlboro cigarettes), just as Altria/PM now wants to do with competitor e-cig companies and products.

But FDA doesn't regulate cigarette lighters, which are arguably components or accessories of cigarettes (as you cannot smoke em if you can't light em). Then again, cigarette lighters are not sold by cigarette companies, and aren't sold in the same packages with cigarettes.

 

[NicoHolic]

Thanks for the insight, Bill. I appreciate it.