Comment on FDA Proposal to Regulate Dissolvables

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Vocalek

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FDA has posted a document discussing dissolvable tobacco products. FR Doc 2010-6216

The public can leave a comment by accessing this page on Regulations.gov

Regulations.gov

With the exception of the comments by Dr. Joel Nitzkin and John Hughes, all the comments are negative, warning of children mistaking these for candy and overdosing, and children becoming addicted to nicotlne.

NOTE: If you leave a comment and you would like to see it published along with the others, do not select "Individual Consumer" as the "Submitter Category". Try "Consumer Group." We found out that FDA is "protecting the privacy" of Individual Consumers who leave comments by keeping those comments secret.
 
Well I posted earlier about the rjr reps pposting these "candy" like forms of nic around energy drinks and various junk food in the local stores.

I was jumped on by a few members of this board a few months back for sayinf IMHO the placement is directed towards kidlets and teens. Strips orbs and sticks have zero 100000000% no business being marketed near energy drinks.

In fact the FDA should be looking closer at these energy drinks instead of the "nicotine" candy as they put it.

In fact the whole FDA should get a rework and leave off the flavorings all together and stop trying to infringe on my adult choices I make. Last time I looked I was an adult and a tax payer and a US citizen.
 

Tom09

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Feb 22, 2009
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Relating to "regulation" of dissolvables: A similar bill to the intended prohibition in Utah (where it failed for this session) is presently pending in Idaho (S1363):
It shall be a misdemeanor for
10 any person or entity to sell, give or offer for sale dissolvable tobacco
11 that means finely processed tobacco developed in such a way as to allow the
12 substance to dissolve on the tongue or in the mouth and includes, but is
13 not limited to, strips, sticks, orbs and compressed tobacco lozenges. It
14 shall be an affirmative defense to the provisions of this section that the
15 dissolvable tobacco was sold, given or purchased pursuant to a prescription
16 by a licensed health care professional.
Not exactly a frienly environment for smokeless alternatives.
 

TropicalBob

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Jan 13, 2008
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I posted as a devotee of Stonewall:

Many of the responses to this topic will come from those with convictions about tobacco usage -- those who either want to prohibit it entirely or restrict alternative nicotine delivery sources. Their objections are a matter of principle.

I bring a different perspective. I have been a daily user of Star Scientific's Stonewall dissolvable hard snuff since it came on the market in 2004. In 2007, I turned to Stonewall and Swedish snus to kick a 50-year cigarette addiction. I had smoked 30 cigarettes a day until July 17, 2007. I have not had one since that date.

In January 2008, I purchased my first electronic smoking device and have since that date used e-pipes, e-cigars and e-cigarettes to satisfy the habit part of a smoker's practice.

At age 68, my health, by every medical measure, has improved substantially since quitting smoking. Every six months, I undergo blood tests, plus physical examinations. Smoking had taken me to the brink of stroke and surgery unclogged a 95% closed carotid artery. That became my impetus to quit smoking.

But I was and remain a nicotine addict. Truth is, I enjoyed smoking. I relished the alertness and relaxation that nicotine -- much like caffeine -- provides me. At the time I stopped cigarettes, I had no desire to quit nicotine, only to stop the harmful practice of inhaling combusted tobacco smoke into my lungs. Nicotine, after all, has known benefits. I have no reason to stop using it. I never intend to.

Many times in my life, I had tried to quit cigarettes. I have used, as directed, every one of the FDA-approved NRT products, with their abysmal success/failure ratios. None helped for long. I tried stepping down. I used the Quest nicotine-free cigarettes. I underwent hypnosis. I had a chemical concoction injected into my head -- at a cost of $400 -- that failed to help defeat the cravings for nicotine. I even went through horrible side effects while using Chantix.

They all fail for one reason: They provide nicotine but not the entire spectrum of alkaloids found in tobacco. That is a critical difference for smokers. Providing just nicotine results in a success rate not much better than a placebo. If nicotine were all a smoker needed, the NRT products would enjoy great success. They do not. Exactly the opposite happens. Smokers fail -- and pledge to never go through such agony again.

Dissolvable tobacco products provide nicotine and more. My Stonewalls have 4mg of nicotine per piece, much like the pharmaceutical lozenge. But Stonewall is a natural product, made from tobacco specially cured to create the lowest nitrosamine levels of any tobacco product. Being 100% tobacco, they provide me the full spectrum of tobacco alkaloids. I am satisfied in a way no NRT product can match.

I get the same satisfaction from Swedish snus, for the same reason.

I recently taped a YouTube video comparing the new Camel Orbs, Strips and Sticks to the older, more established Star Scientific products. The Camel products are inferior by all measures, but the one thing that struck me most was how childproof all of these dissolvable products are. Stonewalls are blister-sealed and difficult to reach. The Camel Orbs dispense one at a time -- but the plastic dispensing pack fails to yield one on many attempts. All of the packaging, for all dissolvable products, will frustrate an adult. Clearly, attempts have been made to keep these pieces from children. Also clearly, children are not the intended users -- and sales of all tobacco products should be limited to adults. No further laws on sales are needed. Enforcement is the problem.

These pellets do NOT look like candy, either. My Stonewalls look like what they are: compressed tobacco that creates a hard snuff pellet.

If the overriding goal of the FDA is to improve the health of this country's citizens, as it should be, then widely available, inexpensive, non-prescription, and far healthier alternatives must be available when a decision to quit smoking is made. Dissolvable tobacco is one such alternative.

I would encourage the FDA to fast-track alternative sources of nicotine. Every smoker who stops inhaling tobacco smoke surely adds quality time to his or her life and decreases the costs of smoking to society. Former smokers can use dissolvable tobacco products without endangering others with second-hand smoke, fire hazards or environmental litter. Those who understand harm reduction and nicotine addiction would call this a win-win situation.

Dissolvables are the most personal of nicotine products. Place one in the mouth, between cheek and gum, and absorption of nicotine and the other alkaloids begins. No bystander knows it is in use. No nuisance is created. No waste needs disposal after use.

And I can only laugh at the idea that children will desire these. No, they will still turn to the most dangerous two tobacco products -- cigarettes and chew tobacco. Focus your attention on keeping those products out of young mouths. Let adults choose far safer alternatives like dissolvables, snus, and e-cigarettes.
 

Vaporer

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Jun 23, 2009
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Away..
Nice write up TB. I need to go there and have my say. Politely as possible. Then see if it stays. lol

Vocalek,
I've read in other threads abt submissions not being posted or being deleted.
The new FDA transparency thing is so transparent to the point of being invisible.
It seems quite "clear" they are only going to allow comments they want people to see that supports their side in some way rather than the whole truth.
 
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