FDA bans 7 Star Ariva and Stonewall dissolvable tobacco lozenges (that are very similar to NRT lozenges)

Discussion in 'FDA Regulations' started by Bill Godshall, Aug 29, 2014.

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  1. Bill Godshall

    Bill Godshall Executive Director
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    FDA bans seven (i.e. issued Not Substantially Equivalent Orders for) Star Ariva and Stonewall dissolvable tobacco lozenges (which are very similar to FDA approved nicotine lozenges) that Star stopped selling two years ago
    Misbranded and Adulterated NSE Tobacco Products
    This Week in CTP - FDA Issues Seven NSE Orders for Dissolvable Tobacco Products

    So much for FDA considering the continuum of risk in its regulatory decisions (as FDA has approved more than 50 SE orders for cigarettes).


    BTW Star Scientific is owned by Jonnie Williams, who became the US DOJ's star witness in its indictment of former VA Governor Bob McDonnell, whose trial ended today.
    The Juiciest Bits To Come Out Of The Trial Of Virginia's Ex-Governor : The Two-Way : NPR
     
  2. Kent C

    Kent C ECF Guru Verified Member ECF Veteran

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    Sigh, I'm now a criminal... thanks to Katya, who sent me some :laugh: Great for flights!
     
  3. Bill Godshall

    Bill Godshall Executive Director
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    FDA regs don't criminalize people for possessing or using banned products. Rather, they just ban the manufacturer from marketing the product.

    I have about a half dozen boxes of different flavored Star Ariva lozenges in my growing collection of tobacco/nicotine products (including more than a hundred products that FDA has ruled as Misbranded and banned).
     
  4. DrMA

    DrMA Ultra Member ECF Veteran

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    Darn. I was looking into dissolvables as a potential fall back if BG made it impossible to continue vaping.
     
  5. Kent C

    Kent C ECF Guru Verified Member ECF Veteran

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    Yeah... that was a bit of a joke for Katya ;)
     
  6. Kent C

    Kent C ECF Guru Verified Member ECF Veteran

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    I just got another 5 litres of nic base from Decadent Vapours(Wales UK) just in case PACT gets amended :)
     
  7. dragonpuff

    dragonpuff Ultra Member Verified Member ECF Veteran

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    I was too, but I had speculated that they might not be available in the U.S. :closedeyes: Nic water would have been nice, but they banned that too.

    Imagine a world in which they banned cigarettes, only cigarettes, but allowed every other nicotine product to be freely legal. That would actually make some sense... but of course that will never happen.

    Now, if they are blocked for not being SE, does that mean the deeming regs are already being imposed? Or are these products banned only if the regulations become final rule?
     
  8. Kent C

    Kent C ECF Guru Verified Member ECF Veteran

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    And perhaps, just the opposite will happen :facepalm:
     
  9. Katya

    Katya ECF Guru Verified Member ECF Veteran

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    I can't believe this.... I really can't. What is going on?

    Why are they banning dissolvables? Can Swedish snus be next????? This is frightening.
     
  10. Katya

    Katya ECF Guru Verified Member ECF Veteran

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    I don't leave home without them. What an outrage!
     
  11. Katya

    Katya ECF Guru Verified Member ECF Veteran

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    Very good question, indeed... Anyone?
     
  12. aikanae1

    aikanae1 Vaping Master Verified Member ECF Veteran

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    I haven't even had a chance to try them.
     
  13. sonicdsl

    sonicdsl Reviewers Mgr
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    I don't know if I'd like 'em or not, but if all hell breaks loose, I say road trip to Bill's! :D
     
  14. Kent C

    Kent C ECF Guru Verified Member ECF Veteran

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    Lol... For me, a little goes a long way. Again, esp. good, on flights (along with some stealth vapes ;- ) I also use snus on flights.
     
  15. KathyD26

    KathyD26 Senior Member ECF Veteran

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    Oh NO! These are my life savers at work!!! I thought the FDA approved them about 3 years ago.
     
  16. AgentAnia

    AgentAnia Vaping Master ECF Veteran

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  17. Jman8

    Jman8 Vaping Master ECF Veteran

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    From the link provided in OP:

    And considering the paragraph following this one, "banned" does not seem like the correct term for what FDA just did.

     
  18. dragonpuff

    dragonpuff Ultra Member Verified Member ECF Veteran

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    Good points. The FDA does have very strict requirements for SE, and it does not surprise me that these products do not meet those requirements.

    However, it still begs the question: does this mean the FDA is already enforcing their deeming regulations? Or are they just getting a head start and saying if the deeming regs go through, then these products do not meet the requirements for SE? I was of the understanding that there are no current enforceable FDA regulations in place for tobacco products, hence the proposed deeming.
     
  19. Jman8

    Jman8 Vaping Master ECF Veteran

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    I am under the impression that Tobacco Act speaks to existing tobacco products (or those around circa 2007) and that FDA has been enforcing regulations for those products. But those products didn't include items noted in the deeming, and so FDA seeks to have those included to gain more control over new(er) products on the market.

    Btw, the company mentioned in OP doesn't even market those products themselves as they are out of business, due to lack of sales. I think the political angle of the story does matter, but the business side, not so much.
     
  20. Katya

    Katya ECF Guru Verified Member ECF Veteran

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    Orwellian indeed....

    And from the horse's mouth.

    This Week in CTP - FDA Issues Seven NSE Orders for Dissolvable Tobacco Products

    BTW, I don't even know what the Star Scientific's predicate product was, exactly. I've only used the seven (yes, all of them) that have just been banned.

    Do we know what the e-cigarette predicate product is--as defined by the FDA? Has that been defined?
     
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