Next FDA TPSAC meeting on November 2 and 3 to continue discussing dissolvable tobacco products

[Bill Godshall]

The FDA issued this notice yesterday, but FDA hasn't updated website with this information.



[N] 76 FR 58019 -- Sep. 19, 2011 [DQG8019A]
------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

tobacco Products Scientific Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public.
Name of Committee: tobacco Products Scientific Advisory Committee (TPSAC).
General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on November 2, 2011, from 9 a.m. to 5 p.m., and on November 3, 2011, from 8 a.m. to 5 p.m.
Location: Center for tobacco Products, Food and Drug Administration, 9200 Corporate Blvd. rm. 020B, Rockville, MD 20850, 1-877-287-1373.
Contact Person: Caryn Cohen, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 1-877-287-1373 (choose option 4), e-mail: TPSAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), and follow the prompts to the desired center or product area. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.
Agenda: The committee will continue the discussions of issues related to the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children, as part of TPSAC's required report to the Secretary of Health and Human Services. Discussion will include such topics as the composition and characteristics of dissolvable tobacco products, product use, potential health effects, and marketing.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at Advisory Committee Calendar. Scroll down to the appropriate advisory committee link.
Procedure: On November 2, 2011, from 1 p.m. to 5 p.m., and on November 3, from 8 a.m. to 5 p.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before October 19, 2011. Oral presentations from the public will be scheduled between approximately 11 a.m. and 12 noon on November 3, 2011. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 11, 2011. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 12, 2011.
Closed Committee Deliberations: On November 2, 2011, from 9 a.m. to 12 noon, the meeting will be closed to permit discussion and review of trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)). This portion of the meeting must be closed because the committee will be discussing trade secret and/or confidential data provided by the tobacco companies regarding dissolvable tobacco products.
Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Caryn Cohen at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

Dated: September 13, 2011.

Jill Hartzler Warner,

Acting Associate Commissioner for Special Medical Programs.

[FR Doc. 2011-23868 Filed 9-16-11; 8:45 am]

BILLING CODE 4160-01-P

 

[Pamdane]

Has anyone pointed out to the FDA that liquid nicotine is already dissolved in its medium, and therefore does not fit the description of dissolvable?

Just curious Not that they even CARE...

 

[sqirl1]

alright time for round 2! good luck guys!

 

[Bill Godshall]

I called the FDA TPSAC phone number this morning to inquire when Monday's announcement about the TPSAC November 2/3 meeting would be posted on FDA's website, and was informed (after being put on hold for ten minutes) that it would be posted later today.

Per inquiry by Pamdane, nobody has suggested that e-liquid is a dissolvable tobacco product.
Rather, dissolvable tobacco products refer to Star's Ariva, Stonewall, Ariva BDL and Stonewall BDL, RJ Reynold's Camel Orbs, Strips and Sticks, probably Altria's Marlboro and Skoal Sticks, and to other new dissolvable tobacco/nicotine lozenges that are likely to be on the market soon.

 

[Placebo Effect]

I'd like to try my hand at public speaking at this event. That should be fun.

 

[Bill Godshall]

It would be helpful if a half dozen or more tobacco harm reduction advocates and consumers presented during the public comment period at the next TPSAC meeting, as the FDA has been trying to perpetuate the manufactured contraversy on tobacco harm reduction by portraying tobacco companies as supporting harm reduction and public health advocates as opposing harm reduction.

 

[sqirl1]

I called the FDA TPSAC phone number this morning to inquire when Monday's announcement about the TPSAC November 2/3 meeting would be posted on FDA's website, and was informed (after being put on hold for ten minutes) that it would be posted later today.

Per inquiry by Pamdane, nobody has suggested that e-liquid is a dissolvable tobacco product.
Rather, dissolvable tobacco products refer to Star's Ariva, Stonewall, Ariva BDL and Stonewall BDL, RJ Reynold's Camel Orbs, Strips and Sticks, probably Altria's Marlboro and Skoal Sticks, and to other new dissolvable tobacco/nicotine lozenges that are likely to be on the market soon.

Altria/Phillip Morris makes Skoal? never knew that. when is the FDA most likely to develop their final regulations on dissolvables? I know you said something about it in the other thread but remind me again.

 

[rothenbj]

It would be helpful if a half dozen or more tobacco harm reduction advocates and consumers presented during the public comment period at the next TPSAC meeting, as the FDA has been trying to perpetuate the manufactured contraversy on tobacco harm reduction by portraying tobacco companies as supporting harm reduction and public health advocates as opposing harm reduction.

The difficulty with what you're asking is that I don't believe any disolvable products have been test marked anywhere close to Washington. I might be wrong, but I remember Colorado and some mid-west sates being concerned about them, but nothing on the east coast. I think Tropical Bob was getting them in Florida but I don't know if they were available locally there or if he was getting them mailed to him.

I think Elaine mentioned trying them but where she got them is an unanswered question. When I started using snus, I couln't find any locally but now Camel is regularly available.

 

[DC2]

I'd like to try my hand at public speaking at this event. That should be fun.

I hope you do as I'm sure you would do great.

I'd like to try my hand as well someday, if only all the decisions were not being made in a land far, far away from me.
It's probably for the best though, since my sense of decorum does not always leave the house with me.

And at 6'5" I've been told I scare people when I get angry.
That's probably not a good thing.

But hey, I'm willing to push a few buttons before being removed from the proceedings.
Yeah, probably not a good thing.


I just have to say, HUGE AND AMAZING PROPS to those of you fighting in the trenches and keeping your cool.
I usually opt for blast mode.

 

[Vocalek]

The difficulty with what you're asking is that I don't believe any disolvable products have been test marked anywhere close to Washington. I might be wrong, but I remember Colorado and some mid-west sates being concerned about them, but nothing on the east coast. I think Tropical Bob was getting them in Florida but I don't know if they were available locally there or if he was getting them mailed to him.

I think Elaine mentioned trying them but where she got them is an unanswered question. When I started using snus, I couln't find any locally but now Camel is regularly available.

I got my Camel products in Colorado when I went to visit my son & his family in late June. Placebo Effect picked me up some Marlboro sticks, but I'm not sure where those were being tested. If you make it down to Vapercon in Richmond, I will will bring along what I have gathered so that people can see what they look like. I'm hoping that some Star Scientific folks stop by, since they are located so close.

 

[Bill Godshall]

FDA has posted a notice about the TPSAC meeting on November 2 & 3 to continue discussing dissolvables.
November 2-3, 2011: Tobacco Products Scientific Advisory Committee Meeting Announcement

rothenbj wrote

The difficulty with what you're asking is that I don't believe any disolvable products have been test marked anywhere close to Washington. I might be wrong, but I remember Colorado and some mid-west sates being concerned about them, but nothing on the east coast.

Star has been selling its Ariva and Stonewall dissolvables for nearly a decade in all 50 states. Reynolds has test marketed Camel Orbs, Strips and Sticks in Portland OR, Columbus OH & Indianapolis IN, and is now test marketing them in Colorado. Altria is now test marketing Marlboro and Skoal Sticks in Kansas.

And of course, GSK has been marketing Commit lozenges (now called Nicorette just like the gum) in all 50 states for the past 15 years.

 

[usamare]

I got my Camel products in Colorado when I went to visit my son & his family in late June. Placebo Effect picked me up some Marlboro sticks, but I'm not sure where those were being tested. If you make it down to Vapercon in Richmond, I will will bring along what I have gathered so that people can see what they look like. I'm hoping that some Star Scientific folks stop by, since they are located so close.

Here's an interesting video showing several of the products.
Dissolvable tobacco: Camel vs. Stonewall - YouTube

I only have firsthand experience with the Stonewalls (via mail-order), and of course the Commit lozenges. It may be a sad statement, but the child-proofing on the tobacco products is superior.

 

[rothenbj]

"Star has been selling its Ariva and Stonewall dissolvables for nearly a decade in all 50 states."

If that's true, they are invisible 30 or so miles outside Philadelphia. I very rarely go to tobacco stores (almost a year and eight months ago looking for snus which they didn't have) but I always check the tobacco sections in convenience stores and have never seen them. I guess the big boys have those pretty well locked down, but I'm going to start asking.

 

[Vocalek]

Here's an interesting video showing several of the products.
Dissolvable tobacco: Camel vs. Stonewall - YouTube

I only have firsthand experience with the Stonewalls (via mail-order), and of course the Commit lozenges. It may be a sad statement, but the child-proofing on the tobacco products is superior.

You should watch the Public Testimony from the first TPSAC meeting on Dissolvables. You can read the transcript, if you don't want to watch the videos: http://www.fda.gov/downloads/Adviso...uctsScientificAdvisoryCommittee/UCM270283.pdf

Pediatrician Jonathan Winickoff testified that dissolvables would poison children and claimed that the tobacco products had inferior child-proof packaging. He stated that once you got the Camel orbs package open, you could spill out multiple orbs. I kept holding up the blue container of Commit lozenges I had brough along, popping it open with one thumb, and spilling loads of logenges into my palm before pouring them black in the blue tube. Dr. W conveniently managed to ignore me. When he finsihed speaking, he saw that his seat had been taken. There was an empty seat next to me, but he walked right past it and went to the back of the room. Was it something I said?

I plan to testify again and bring along both the big blue tubes of Commit and the cute little blue container that the Nicorette mini-lozenges are packaged in. You may have seen these in the commercial about the shark, and the one showing two cops. You can spill out three 4-mg lozenges at a time from the Nicorette mini-lozenges container. You can probably figure out how to open it with one hand, too. The Camel lozenges box takes three hands to open.

I should also bring along some Stonewall and some medications that are packaged identically, in individual bubble that you must open by peeling up one corner of the backing.

Winickoff was one of the "Public Health Experts" mentioned in the July 2009 FDA Press Release on e-cigarettes. FDA and Public Health Experts Warn About Electronic Cigarettes

In Concerns Voiced by the Public Health Experts About Electronic Cigarettes: No Demonstrated Public Health Benefit
his quote reads:

“It looks like a cigarette and is marketed as a cigarette. There's nothing that prevents youth from getting addicted to nicotine.”
Concerns Voiced by the Public Health Experts About Electronic Cigarettes

Harvard professor Gregory Connolly (funded by the Legacy Foundation) spoke at the TPSAC Public Meeting on Dissolvables and also talked about children being poisoned. It had already been established during the Q&A after Winickoff's testimony that no children have been fatally poisoned by tobacco products, but Connolly tried to imply that one child had died.

We analyzed the data and we came up with a number of tobacco poisonings over a three-year period, reports to the poison center. And I think of these, there was one death. But that's one too many, in my opinion. To have a child die and say, well, that's not a big deal I think is a very cruel, cruel thing to say, in my opinion.

I believe Dr. Connolloy might have been referring to a statement I made in my testimony:

Dr. Gregory Connolly examined data on 13,705 tobacco product poisoning cases and found only one case caused by a dissolvable tobacco product.

Notice that I did not say that there was a death. I said that only one of the poisonings (i.e. exposures) was caused by a dissolvable tobacco product. Most exposures were from tobacco cigarettes. There were no deaths reported in his study that I was referencing in my speech.

Connolly GN, Richter P, Aleguas A Jr, Pechacek TF, Stanfill SB, Alpert HR. Unintentional child poisonings through ingestion of conventional and novel tobacco products. Pediatrics. 2010 May;125(5):896-9. Epub 2010 Apr 19. Unintentional Child Poisonings Through Ingestion of Conventional and Novel Tobacco Products

Source of the statement I made in my speech:

At least 1 case of ingestion of Orbs by a 3-year-old child (Oregon Poison Control Center, personal written and oral communication, July 27, 2009) and 2 cases of mild poisonings in children 2 and 3 years of age resulting from ingestion of snus (a flavored, oral, tobacco product packed in small paper pouches and sold without explicit warning to protect against child ingestion) (Indiana Poison Control Center, personal written communication, May 13, 2009) have been reported.

Table showing poisoning sources: Unintentional Child Poisonings Through Ingestion of Conventional and Novel Tobacco Products

[One of the scientists from Star Scientific told me later that one child died in 2001 (not one of the three years analyzed by Connolly) and had cigarette butts in his stomach. But the kids probably would not have died if he had not also been doped up on Valium! The Poison Control Center credited the death to the Valium, considering the presence of the cigarette butts to be a seconadary issue.]

Connolly then proceeded to claim that the smoking rate in Sweden is higher than it is in the USA and snus has not cut down on smoking and dual use is very dangerous. All of this is poppycock! The facts are quite easy to verify.

Consumers are getting sick and tired of people who consider themselves healers using propaganda techniques to mislead the public so that they can achieve their goal of preventing smokers who want to improve their health from switching to much safer products. This must stop. These men manage to view themselves as knights in white armor, defending the children. But the reality is that they are misusing their power and, as a result, parents and grandparents of these children are dying needlessly.

 

[DC2]

These people are disgusting slimeballs of the highest order.

I just might prefer mafioso, or possibly even druglords.
And that is just what we'll get if they succeed in eliminating the currently legal competition.

I'm wondering how the underground nicotine juice movement is going to work.

I seriously have no words to express my disgust for these people.
Do they really, honestly believe in their cause?

I don't know which options is more frightening, them truly believing in spite of all evidence.
Or them being paid off like expert witnesses by Big Pharma and the ALL-FOR-PROFIT health organizations.

God, I wish I could crawl back in my hole and unlearn all I've learned about greed and corruption.

 

[cigarbabe]

I'm still amazed that they sink to these levels and more people aren't outraged by this type of misinformation spinning of study results and out right lying....
Why isn't congress or someone reigning them in?
Not that I think congress is smart enough to do so!
C.B.

 

[Vocalek]

Here is the latest research on 27 years of tobacco poisoning exposures in the U.S.

Frequency and outcomes of accidental... [Regul Toxicol Pharmacol. 2011] - PubMed - NCBI

Abstract

This review assesses published literature related to frequency and outcomes associated with accidental ingestion of tobacco and pharmaceutical nicotine products among young children. Twenty-seven years of annual reports by American Association of Poison Control Centers (AAPCC) were analyzed for occurrence and outcomes associated with accidental ingestion events involving tobacco and pharmaceutical nicotine products among young children. Over a 27-year period, and of >50 million contacts for all categories combined, 217,340 contacts involving ingestion of tobacco products were reported. Approximately 89% involved children <6years old. One fatality was reported, however the co-ingestion of both cigarettes and diazepam complicates an assessment of a contributory role of tobacco. The rate of major, non-fatal, outcomes was <0.1%. Data from AAPCC reports and other sources indicate the frequency of accidental poisoning events is relatively low for tobacco products compared with other products such as drugs, dietary supplements, cleaning products, and personal care products. These findings, along with those for pharmaceutical nicotine products, are consistent with published case reports and reviews, indicating that the frequency and severity of outcomes associated with accidental ingestion of tobacco products by young children appear to be relatively low. However, adults should keep tobacco products out of the reach of children.

 

[NorthOfAtlanta]

I've been following this thread and realized that if there had been a provable death due to nic poisoning in the last 20-30 years the ANTZ would have been all over it. They would still be using it in anti-tobacco ads today.

 

[Bill Godshall]

sqirl1 inquired:

when is the FDA most likely to develop their final regulations on dissolvables?

The TPSAC requires the FDA's TPSAC to research and write a report about dissolvable tobacco products that is due next spring or summer.

Although I was outraged when Senators Jeff Merkley (OR) and Sherrid Brown (OH) falsely accused Reynolds of target marketing dissolvables to children back in 2009 when they convinced all other Democrats on the Senate HELP Committee to approve their amendment (to require TPSAC to study and report on dissolvables), I'm now pleased that TPSAC is studying them, as its an excellent opportunity for harm reduction advocates to point out all the scientific and empirical evidence finding that smokeless tobacco products are far less hazardous alternatives to cigarettes, that there is no evidence (just false allegations) that tobacco companies are marketing dissolvables to children, and that abstinence-only tobacco prohibitionists are once again grossly exaggerating the very low health risks of smokefree tobacco products (just as they did with e-cigarettes and snus) and are once again falsely accusing companies of target marketing to youth.

It will be very difficult for the TPSAC to deny or ignore the fact that dissolvable tobacco products are far less hazardous alternatives to cigarettes, and that smokers can reduce their health risks by switching to or substituting dissolvables for cigarettes.