FDA Blessing Sought for 'Modified Risk' Tobacco Product

[NatureBoy]

Do you know what the legal alternatives are for labeling them?

1) Drug Delivery device
2) tobacco Product
3) "Modified Risk" tobacco Product

Which would you prefer?

Can I choose 'none of the above'?

Realistically, none of them really apply. Shame the people leading the crusades against these devices really have little clue as to what they're fighting.

Considering it doesn't necessarily need to be used as a 'drug delivery' device, nor does it have anything to do with tobacco. If there has to be a choice though, I suppose #3 is probably the least harmful to it's image. But man I hate to see tobacco even be there at all.. it just isn't tobacco!!

 

[TropicalBob]

How did I miss this? Star Scientific is my number one go-to alternative to cigarettes. I quit cigs using Stonewall before I discovered e-smoking in Jaunary 2008. Ariva is Stonewall's weaker sibling; 1.5mg vs Stonewall's 4mg.

I am speechless at debook's ignorance. I'm too angry to say what I'd like to .. just as well.

Fact: The products from Star Scientific have the lowest TSNA levels of any alternative, including e-cigs. Do some research before spewing disinformation that some equally ignorant people might believe.

Thanks for the factual posts from those who know.

 

[Bill Godshall]

debook wrote:
"These companies market to potential revenue streams, namely teens, and to allow them to market any tobacco as anything but high risk to me is irresponsible."

debook is simply repeating the intentionally inaccurate and misleading accusations that Campaign for Tobacco Free Kids claims in its press releases every week (some of which say the exact same thing about e-cigarettes).

If debook has any actual evidence that tobacco companies are target marketing their products to minors, please post (so I can review, and if meritorious I'll forward it to the State Attorneys General, who (if they also deem valid) will sue the company(ies) for millions of dollars violating the 1998 Master Settlement Agreement).

As one of the first activists to expose tobacco industry marketing to youth and to advocate local, state and federal laws and lawsuits (from 1988 till 2002) that banned tobacco sales to minors and required/funded enforcement of those laws, and that sharply reduced tobacco advertising/promotions/sponsorships targetting youth, I get very upset when anti-tobacco industry extremists/prohibitionists falsely accuse tobacco companies of market to youth (but offer ZERO evidence to substantiate their sensationalized claims).

And the same folks who continue making these false accusations (i.e. CTFK/ACS/AHA/ALA/AAP) are the same folks who have falsely accused e-cigarette companies of target marketing to youth.

See Star's press release at:
Star Scientific Files Application with FDA for Ariva Approval as First Modified Risk Tobacco Product
Star Scientific, Inc.STSI) - Investor Relations - News Release

Star Scientific seeks FDA approval for “safer” smokeless tobacco (Richmond Times-Dispatch 2/23/10)
Star Scientific seeks FDA approval for "safer" smokeless tobacco | Richmond Times-Dispatch

Star's Ariva tobacco lozenge so closely resembles GlaxoSmithKline's Commit nicotine lozenge that in 2001/2002 GSK/CTFK/ACS/AHA/ALA petitioned the FDA to reclassify Star's tobacco lozenges as "unapproved drug devices" in an attempt to ban the products from the market (because Star never applied for and because FDA never approved the products to be marketed as smoking cessation aids).

Thankfully, the FDA rejected those deceitful petitions back in 2002 or 2003, and correctly ruled that Star's tobacco lozenges are tobacco products, and pointed out that (at that time) the FDA didn't have the authority to regulate tobacco products.

Unfortunately, FDA/CTFK/ACS/AHA/ALA have been trying to do the exact same thing with e-cigarettes (i.e. reclassify them as drug devices in an attempt to ban them from the market), which would protect cigarettes and NRT from market competition, would result in tens of thousands of e-cigarette users switching back to deadly cigarettes, and would deny 45 million cigarette smokers legal and affordable access to far less hazardous alternatives.

A study comparing Commit to Ariva is at http://www.starscientific.com/404/stepanov tsna in.pdf

 

[rothenbj]

It seems like such a tidy little circle. BT is the bad guy. The anti-tobacco user organizations (I refrain from calling them anti-smoking groups because they have moved way past that) get contributions from BP, to aid them in their efforts. Massive funds enter the government from both BT and BP. Part of these funds get split out to the FDA and the other national health organizations. Some of that money gets allocated for scientific studies such as the ones done in VA and California.

Everyone claims to want to rid the world of the smoking hazard, but they want the useless Parma products to be the answer. I see reduced risk moving to the Parma industry by changing the view of there NRT products. The gum and lozenges will be marketed as longer term products, they'll move the
inhaler to OTC and suggest the use of multiple products to eliminate the use of cigarettes.

The strategy probably won't work, but It doesn't have to. BP will benefit, BT will get most smokers back and the anti-organizations will continue to be funded and continue to expand their activism.

Stomp out anything that sits outside the circle. I'm just glad the E cig was there when I needed it to kick my 43 year habit and hope our judicial system keeps the hope up for others.

 

[sherid]

Disinformation? Any tobacco use involves a heightened risk of health problems, the link is well established even to smokeless tobacco (which contains nitrosamines and up to 28 other carcinogens). Snus, dissolvables, and nasal snuff may contain less than cigs /snuff / chew but still more than allowed in food and other products.

Allowing tobacco companies to market under any 'safe' or 'safer' moniker masks the inherent risk of using tobacco. 98% safer doesn't matter to the other 2%. No latitude should be given to any tobacco companies, especially in their marketing which we all know is aimed at kids and teens so they can continue the enormous revenue streams for years without regard to the health issues. That's the only point I'm trying to make.

Were you a smoker?

 

[Thornak]

I think its a trick!!
If they classify it as modified risk tobacco product, then it would officially be a tobacco product and the FDA gets full control over it.

 

[rothenbj]

* deleted dup *

 

[DC2]

I think its a trick!!
If they classify it as modified risk tobacco product, then it would officially be a tobacco product and the FDA gets full control over it.

The FDA is going to get control over it no matter what.

They get FULL control over it if it is classified as a drug delivery device.
They get way too much control over it if it is classified as a tobacco product.

If it is classified as a modified risk tobacco product, then who knows how much control they get.
There are no rules yet for a modified risk tobacco product.

But it has to be better than the other two options.

 

[NatureBoy]

Why are those the only choices though? Who decided that it has to be classified as one of those and not something entirely different?

 

[DC2]

Why are those the only choices though? Who decided that it has to be classified as one of those and not something entirely different?

The people who decide these things decided that.
I'm not sure if that is the FDA, or Congress, or a combination of the two.



We're just lucky the modified risk category is actually being seriously considered.

So far it doesn't even exist as far as I know, but it might be possible soon.
From what I understand they are trying to work out how they will regulate such a category.

Some one PLEASE correct me if I'm wrong.

 

[Vicks Vap-oh-Yeah]

The 'modified risk' category was created with the bill that got passed last summer granting the FDA authority to regulate tobacco. They have not yet created the standards that will allow companies to pursue the 'modified risk' label (they've been simply too busy trying to stamp out PV's), but my thoughts on the new classification is that it'll be frustratingly hard to achieve this designation - the FDA will insist on proven harm standards on par with pure mountain spring water instead of comparing new products with cigarettes.

Which, ironically, dismisses the entire concept of 'reduced harm,' or modified risks. They simply can't see it, and approve anything (outside the 'acceptable side effects of BP products) that carries some risk (however small) of chemical dependence or health hazard.

Gawd, I'd love to slap some sense into some of 'em.

 

[Thornak]

Gawd, I'd love to slap some sense into some of 'em.

Oh they have sense, they know exactly what they are doing. they just lack even a hint of humanity.

 

[Vocalek]

Ironically, though, they view themselves as great humanitarians. They refuse to see the damage that their actions cause. They manage to convince themselves that they are blameless. It's the victim's fault.