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

[Bill Godshall]

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

 

[Kent C]

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

 

[Bill Godshall]

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).

 

[DrMA]

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

 

[Kent C]

FDA regs don't criminalize people for possessing or using banned products..

Yeah... that was a bit of a joke for Katya

 

[Kent C]

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

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

 

[dragonpuff]

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

I was too, but I had speculated that they might not be available in the U.S. 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?

 

[Kent C]

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.

And perhaps, just the opposite will happen

 

[Katya]

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.

 

[Katya]

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

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

 

[Katya]

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?

Very good question, indeed... Anyone?

 

[aikanae1]

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

 

[sonicdsl]

I don't know if I'd like 'em or not, but if all hell breaks loose, I say road trip to Bill's!

 

[Kent C]

I don't know if I'd like 'em or not, but if all hell breaks loose, I say road trip to Bill's!

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.

 

[KathyD26]

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

 

[AgentAnia]

Carl Phillips just blogged about this: FDA signals that nothing is ever

It's a must read, but I suggest having some high-nic vape handy when you do...

 

[Jman8]

Why are they banning dissolvables?

From the link provided in OP:

Compared to the predicate products selected by Star Scientific, the FDA’s scientific review found that these new products had several differences. For example, most of the new products had increases in total nicotine content, additions of acetaldehyde, and/or substantial increases in other harmful and potentially harmful constituents (HPHCs). An increase in nicotine content has the potential to make these products to be more addictive than their predicates. Though the decisions for each product are based on multiple factors, changes to characteristics such as these may raise different questions of public health, and these factors combined with the lack of adequate evidence submitted by the manufacturer ultimately led the FDA to issue NSE orders for these seven products.

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

Going forward, the manufacturer has the option to seek marketing authorization by submitting another application to FDA, for example, a premarket tobacco application (PMTA). The FDA encourages all manufacturers to review the requirements of the three pathways to market for tobacco products and choose the appropriate pathway for their product applications.

 

[dragonpuff]

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.

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.

 

[Jman8]

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.

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.

 

[Katya]

Carl Phillips just blogged about this: FDA signals that nothing is ever

It's a must read, but I suggest having some high-nic vape handy when you do...

Orwellian indeed....

It is difficult to imagine a clearer test of FDA’s intention to use their authority to pursue prohibition, rather than pursuing beneficial regulation or obeying the spirit of the law that Congress thought they were passing.

And from the horse's mouth.

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

Previously, tobacco manufacturers determined what products came on and off the shelves without oversight – today’s actions underscore the importance of the Tobacco Control Act in granting the FDA the responsibility to guard the public health related to tobacco products. The FDA takes this responsibility seriously and will continue to take action as appropriate on all tobacco product reviews, including for currently marketed 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?