Latest from SFATA Fly-In in Washington, DC

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EcigAdvanced’s Klaus Kneale is in Washington, D.C. today attending SFATA’s ‘day on the hill’ Fly-In.Β This event aims at bringing together e-cigarette industry leaders with legislators and those involved in policymaking relevant to the regulation of electronic cigarettes.

Klaus has relayed some preliminary points of interest from the event, the following should be taken as nothing more than statements made at the event and by no means reflect a set-in-stone reality for e-cigarette businesses or regulation:

-It is very possible that the Office of Budget and Management will not approve the FDA deeming draft. The FDA does not seem capable of proving that the cost of regulation (lost business, jobs, implementing fees, etc.) will be worth the benefits.

-There are rumors that the Small Business Association is looking into the FDA’s proposed regulations and will fight it on behalf of small electronic cigarette companies.

-The FDA regulation pipeline is so convoluted that we are not likely to see regulation of the industry for 2-3 years.

-If FDA deems electronic cigarettes as tobacco products, all provisions in the Tobacco Control Act must apply to them. Most of these wouldn’t make sense and the FDA can’t choose to apply only some provisions. This makes deeming regulation for electronic cigarettes easier to argue against.

-Even if e-cigs are regulated as tobacco products, those using synthetic or non-tobacco nicotine are likely to be exempt. At minimum this presents a difficulty for the regulators.

-There are alternate agencies under which e-cigarette regulation could occur rather than under FDA. The most likely candidates are the Consumer Products Safety Commission or the Center for Devices and Radiological Health. FDA still seems most likely though.

-We should be concerned with the regulatory movement against e-cigarettes in Europe because the FDA and US regulators may use regulations as a precedent for our own regulatory plans. The same goes for US local and state level ordinances.

-Brazil banned electronic cigarettes outright and the black market for the devices is growing very rapidly.

-Some common e-cigarette ingredients are legally considered safe for consumption, but are still considered lung irritants. Many companies will likely need to overhaul e-liquid recipes because of this issue.

We’ll keep you posted as Klaus gathers more information from this event.

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  1. Jeremy @ Cig says

    Thanks for the updates. Sounds like some positive developments for the e-cig industry… keeping our fingers crossed that new legislation will be kept to a minimum πŸ˜‰

  2. Dick D. says

    The Consumer Products Safety Commission would seem less onerous than the FDA. Could there be a role for perhaps randomly sampling ejuice for unhealthy constituents?

    The updates are appreciated, particularly when they illuminate less ominous possible outcomes from those often bandied about.

  3. aikanae says

    None of this addresses the fact that cities and states can do whatever they want on the local level. Maybe more attention should be focused there.

  4. Striker says

    I also wish to thank you for the information.

  5. Bill Godshall says

    While OMB may not allow FDA to propose the deeming and other regs for e-cigs, cigars and OTP, and while any final FDA regulations won’t be issued or take effect for 2-3 years, I don’t know that the following statement by Klaus is accurate “If FDA deems electronic cigarettes as tobacco products, all provisions in the Tobacco Control Act must apply to them.”

    That’s what I originally thought until SFATA and Venable lawyer Todd Harrison informed me that FDA could issue regs to somehow exempt e-cigs from Section 905(j) and Section 910’s defacto ban of all e-cigs.

    Section 905(j) required all regulated tobacco products that were on the market from 2007-2011 to submit Substantial Equivalence (SE) applications to FDA verifying they were virtually identical to a product on the market in 2007, but allowed those products to remain on the market pending FDA approval/rejection of their SE application.

    Section 910 requires all regulated tobacco products (that weren’t on the market before 2011) to submit SE applications to FDA (verifying they are virtually identical to a product on the market in 2007), but also requires FDA to approve the SE application BEFORE the product can be introduced into the market.

    If those same regulations are retroactively applied to e-cigs, all e-cigs will be effectively banned.

    That’s why I (and lawyers and execs at Big Tobacco and several large e-cig companies that have endorsed FDA regulation of e-cig) expect FDA to somehow exempt e-cigs from those provisions of Section 905 and 910 (probably by extending the 2007 grandfather date to 2013 for newly regulated products).

    But even if that occurs, SE applications would still need to be submitted to verify that the product was virtually identical to a product on the market in 2013, which (along with other e-cig regs) would essentially give most of the existing e-cig industry to Big Tobacco (and several large e-cig companies).

    Its unknown (but would be very helpful for the future of e-cigs) if FDA regs would give e-cig companies a grace period similar to what the TCA gave cigarette, RYO and smokeless companies (which allowed products on the market from 2007-2011 to remain on the market until/unless FDA rejects their SE application), or if the new FDA regs would require e-cig companies to file and FDA to approve SE applications (verifying the products are nearly identical to a 2013 product) before it is allowed on the market (which would also be a defacto ban on all e-cigs unless/until FDA approves a SE application).

    In sum, if FDA imposes the deeming and other regulations on e-cigs, all SE approved e-cig products will be worth hundreds of millions or billions of dollars, while all other e-cig products will be “misbranded” (aka black market).

  6. kelli perkins says

    Wish for once it was actually for the good of the people and not for who controls the bucks.

  7. unclerj says

    Thanks for being their for us klaus!

    At least for the moment, your report brings me some hope at least.

    I tried to read the FDA file (or whatever it is called) and it was unavailable. But I did manage to get that there were financial issues and no legal time limit for them to act.

    Hopefully that would translate to “never” but I am not quite that optimistic!

  8. Alan Selk says

    “Even if e-cigs are regulated as tobacco products, those using synthetic or non-tobacco nicotine are likely to be exempt. At minimum this presents a difficulty for the regulators.”

    All nicotine in all e-liquid is extracted from tobacco. There is no synthetic nicotine or other sources used.

  9. Laurie says

    We still have a HUGE problem as someone else who left a comment here said. It’s the cities that are banning the ecigs! This is a HUGE problem! With ALL the scientific data out there, it is WRONG! Not ONE of them, so far, has studied the evidence that there is NOTHING wrong with this vapor. Instead, because of the ‘name’ they are assuming these have something to do with them being cigarettes, which I resent!
    At least where I live it IS LEGAL ‘to smoke’/vape publicly IN parks, OUTSIDE, for heaven’s sake! The SORRY part is we are still GROUPED WITH SMOKERS! I quit this habit so I did NOT have to inhale Big Tobacco’s product any longer, and it is just WRONG that I have to abide by ‘smoking rules’. You can’t even vape in a restaurant OR a bar here where I live because they are afraid people think these ARE cigarettes, so getting other smokers to see these and hoping they quit the cancer sticks is out of the question, unless we go outside with them.
    I would like to see regulation on eliquid, but there already is a company in which eliquid makers can have come out to get certified, and everyone should be purchasing their liquids from those companies so we can show the government what WE have done!
    Also, we NEED more American made devices! Anyone out there want to start manufacturing these HERE? IF it’s going to possibly be another 2-3 YEARS, we have ALL the time in the world to get American companies up and running along with a company that oversees eliquid manufacturer’s to oversee the companies that make the Personal Vaporizers, We can stand up to the government again, and say, ‘Hey, WE did it ourselves!’
    Although, the FDA has made those 9 or 13, sorry I can’t remember the exact number, but the Quit Smoking facilities around the country. What’s up with that? They have that much extra money to do whatever their plans are with those places? That, worries me! Something is cooking with that! There is a reason for them, we just don’t know the TRUTH about them!
    What does anyone else think about those or what is the FDA planning with them?

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