FDA FDA rejects Citizen Petition to truthfully say smokeless tobacco is less hazardous than cigarettes

[Bill Godshall]

FDA protects cigarettes yet again by rejecting 2011 Citizen Petition from Reynolds to change mandatory and intentionally misleading 1986 warning on smokeless tobacco products from
“WARNING: This product is not a safe alternative to cigarettes.” to
“WARNING: No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.”

FDA’s rejection letter to Reynolds falsely claims “The current warning is factual and not misleading”, grossly misrepresent the scientific evidence about comparable risks (i.e. smokeless tobacco products are 99% (+/-1%) less hazardous than cigarettes).
Regulations.gov (FDA rejection of Citizen Petition)

Regulations.gov (Citizen Petition by Reynolds)

 

[skoony]

thanks for the post Bill.
one thing i would like to ask.
i am trying to get my mind around the concept of comparable risk.
seeing smokeless tobacco products being 99% +or-1% safer than
smoking and in trying to describe what that means in the real world,
could one say do not use snuff,its as dangerous as not using snuff?
my recollection of statistical analysis seams to indicate this is so.
regards
mike

 

[Bill Godshall]

While cigarette smoking causes nearly 500,000 deaths in the US annually, the epidemiology research indicates that smokeless tobacco use causes several dozen deaths.

The CDC estimated that 3,686 of 4,973 (74%) male and 1,182 of 2,525 (47%) female oral cancer deaths annually in the U.S. from 1997 through 2001 were attributable to cigarettes.
Annual Smoking-Attributable Mortality, Years of Potential Life Lost,
and Productivity Losses --- United States, 1997--2001

The CDC also estimated that 303 (6%) male and 57 (2%) female oral cancer deaths in 2001 were attributable to alcohol. Alcohol-Attributable Deaths and Years of Potential Life Lost ---
United States, 2001

Thus, the CDC has estimated that 80% of male and 49% of female oral cancer deaths in this country are due to cigarettes or alcohol.

In sharp contrast, the epidemiology studies indicate that smokeless tobacco users have about 10%-20% increased risk of oral cancer deaths than do never tobacco users, which means that smokeless tobacco causes several dozen oral cancer deaths annually (i.e. about 1% of all male oral cancer deaths).

 

[Bill Godshall]

A study of West Virginians, who for many decades have had the nation's highest per capita usage of smokeless tobacco (i.e. 15 cans/person/year), which is more than four times the national average (i.e. 3.3 cans/person/year), found that incidence and mortality rates for oral cancer in West Virginia from 1950 to 1980 were lower than the national rates.
Bouquot JE, Meckstroth RL, Oral cancer in a tobacco-chewing US population – no apparent increased incidence or mortality, Oral Surgery Oral and Maxillofacial Pathology, 1998, Vol. 86, No. 6. 697-706.

A twenty year follow-up study of 6,779 NHANES I participants who were over 45 years at baseline found no increased oral cancer risk for exclusive smokeless tobacco user compared to never users of tobacco, and didn’t find any oral cancer cases among the 414 exclusive smokeless tobacco users.
Accortt NA, Waterbor JW, Beall C, Howard G, Cancer incidence among a cohort of smokeless tobacco users (United States), Cancer Causes and Control, 2005, Vol. 16, 1107-1115.

I could cite another dozen studies on smokeless tobacco, but the FDA's Mitch Zeller has decided (just as he did a decade ago when he worked for GSK to lobby the Tobacco Control Act) that he doesn't want smokeless tobacco users, cigarette smokers or anyone else knowing that smokeless tobacco is 99% less hazardous than cigarettes.

Same goes for e-cigarettes.

 

[AndriaD]

it seems to me that the most important question is, how do we get rid of him? How do we get rid of all these nannies who KNOW WHAT IS BEST FOR EVERYONE AND ARE DETERMINED THAT IT SHALL BE DONE!

I mean, I have just HAD IT with people trying to mind my business for me, and LYING!!! just so they can very childishly get their way!

I want all of them GONE, out of office, in jail, OFF THE PLANET with the rest of humanity. They don't deserve to live with their fellow humans, since they're so determined to make all of us do exactly what they want -- they clearly haven't matured past pre-school age.

Andria

 

[Bill Godshall]

Please note that:
- new Presidents (especially those from the other party) typically fire all federal officials who were appointed by their predecessor,

- FDA's Mitch Zeller, CDC's Tom Frieden, DHHS' Bill Corr and many other THR opponents were appointed by Obama,

- many Democrats in Congress (but no Republicans) have aggressively lobbied for the FDA Deeming Regulation, and

- next year a new President will be elected in the US.

 

[caramel]

FDA’s rejection letter to Reynolds falsely claims “The current warning is factual and not misleading”

Quick question - if a smoker that tried really hard, smoking for many years those cigarettes with various pictures and cancer claims, didn't get any, could he sue FDA for misleading / false claims advertising?

 

[SeniorBoy]

it seems to me that the most important question is, how do we get rid of him? How do we get rid of all these nannies who KNOW WHAT IS BEST FOR EVERYONE AND ARE DETERMINED THAT IT SHALL BE DONE!

Also, please remember that Obama must appoint a NEW Commissioner for the FDA since Hamburg resigned in 3/15. This Presidential appointment will require Congressional approval and that means the Presidental appointment must appear before a Committee (Confirmation Hearings) and answer questions. Widely regarded as next in line for the Commisioners job is Robert Califf, M.D, FDA Deputy Commissioner for Medical Products and Tobacco. He was appointed to this FDA position in 1/15 by Desk Killer Hamburg.

IMHO, Califf is far worse than any current or previous high level executive at the FDA. He is the most conflicted, brazen, smug, potential candidate on the face of the planet. Bought and paid for in spades by BP. If he is appointed by Obama, we have an opportunity to voice are concerns LOUDLY with the politicians and hopefully either delay the confirmation for many many years or convince our Politicians to reject Califf.

HTH

 

[AndriaD]

Also, please remember that Obama must appoint a NEW Commissioner for the FDA since Hamburg resigned in 3/15. This Presidential appointment will require Congressional approval and that means the Presidental appointment must appear before a Committee (Confirmation Hearings) and answer questions. Widely regarded as next in line for the Commisioners job is Robert Califf, M.D, FDA Deputy Commissioner for Medical Products and Tobacco. He was appointed to this FDA position in 1/15 by Desk Killer Hamburg.

IMHO, Califf is far worse than any current or previous high level executive at the FDA. He is the most conflicted, brazen, smug, potential candidate on the face of the planet. Bought and paid for in spades by BP. If he is appointed by Obama, we have an opportunity to voice are concerns LOUDLY with the politicians and hopefully either delay the confirmation for many many years or convince our Politicians to reject Califf.

HTH

I hope you more-politically-inclined vapers will supply us with info if that occurs, and links as to where we can post our objections. Trying to hunt down emails or URLs for individual lawmakers is so tedious that not many will do it; if I wasn't already on my congressman's mailing list, I'd have that problem myself, but since my congressman so kindly supplies his email address on those newsletters, that one is pretty simple. But my senators? Heck I only know who one of them is; one of mine resigned and I have no earthly who his replacement might be -- even though I voted for him/her -- that was last year! That info has left the bldg -- and my brain!

Andria

 

[Verb]

That warning was part of the reason I switched from dip to cigs when I was 20.

Evil Fauchs.

 

[nomore stinkies]

I find it ironic that Obama was (?) a smoker. Yet he opposes efforts for others to have a safer alternative to smoking. One would think he would empathize with the smoker. There is an ulterior motive there. I just can't put my finger on it. Maybe because he had so much negative press regarding his smoking he is now mad as hell and got his phone and pen out. Just can't figure that guy out.

 

[caramel]

"If I can't have it then no one else shall".

 

[AndriaD]

I find it ironic that Obama was (?) a smoker. Yet he opposes efforts for others to have a safer alternative to smoking. One would think he would empathize with the smoker. There is an ulterior motive there. I just can't put my finger on it. Maybe because he had so much negative press regarding his smoking he is now mad as hell and got his phone and pen out. Just can't figure that guy out.

Well considering it was the lunatic ANTZ who were on his case about smoking, wouldn't it make more sense to piss them off by declaring vaping to be the next thing to the Second Coming?

Andria

 

[caramel]

Well considering it was the lunatic ANTZ who were on his case about smoking, wouldn't it make more sense to piss them off by declaring vaping to be the next thing to the Second Coming?

Andria

Health Care Industry Donates More To Obama Than GOP Candidates

 

[AndriaD]

Health Care Industry Donates More To Obama Than GOP Candidates

Ohh, well then... guess he can't piss off his PAYING CUSTOMERS!

But considering he's not eligible to run again, why does he care? Seems to me a lame-duck prez at the end of his 2nd term has plenty of room to do what's right, and hang the contributors.

Andria

 

[nicnik]

I find it ironic that Obama was (?) a smoker. Yet he opposes efforts for others to have a safer alternative to smoking. One would think he would empathize with the smoker. There is an ulterior motive there. I just can't put my finger on it. Maybe because he had so much negative press regarding his smoking he is now mad as hell and got his phone and pen out. Just can't figure that guy out.

I see in him psycological damage due to smoker shaming. Also, he's heavily funded by interests that stand to lose a lot of money if vaping spreads, so now he empowers the professional smoker/vaper shamers.

 

[choochoogranny]

Obama may be leaving, but the Democratic Party is not. Any Democrat running will want that money too and Obama will not want to ruin it for the Party! ........Politicians are now working for their party over nation.

 

[Robino1]

Politicians are now working for their party over nation.

Quoted for truth.

 

[AndriaD]

So... since the D's and R's are BOTH doing such a crappy job of BEING AMERICANS, what can we do? Bring back the Whigs and Know-nothings? I'd say everyone in DC is eligible for the "Know-nothings".

Andria

 

[NorthOfAtlanta]

Get rid of the 17th amendment and return the Senate to what it was supposed to be.