“But at least they won’t have to deal with the smell of cigarettes which is what this has been all about in the first place.”

And I would strongly disagree. The antismoking movement has many roots and many motivations. To get a very quick idea of what I’m talking about please visit:

http://www.stahlheart.com/wispofsmoke/recovery.html

to read a one-page summary and an activist’s extension of some of the ideas in the first fifty pages of “Dissecting Antismokers’ Brains.”

The antismoking movement is a hydra. Concentrating too narrowly on any one aspect, motivation, group, or technique within it will result in failure as the other “legs” will simply pick up and run on by while you’re picking at the carcass of the beast you think you’ve just slain.

Michael J. McFadden
Author of “Dissecting Antismokers’ Brains”

To get new smokefree tobacco products on the market, manufacturers must apply for (and be approved by the FDA) the product to be a:

- “substantially equivalent” product to another one aleady on the market (e.g. Reynolds is likely to apply for Camel Orbs, Strips, Sticks as substantially equivalent to Star’s Ariva and Stonewall),

- “modified risk” product, which imposes impossible hurdles for approval (as it would cost hundreds of millions of dollars and 30 years of testing before a modified risk product could be approved by the FDA).

- “reduced exposure” product, which imposes far fewer hurdles for approval than “modified risk” products, some of which may be approved by the FDA for cigarettes and/or smokefree tobacco products (depending largely upon the biases or objectivity of FDA officials and its scientific advisory board).
From a public health perspective, if the FDA approves low nitrosamine smokefree products as “reduced exposure” products, this would likely benefit harm reduction. But if any “reduced exposure” cigarettes are approved by the FDA, smokers and the public once again will be duped into believing that “reduced exposure” cigarettes are less hazardous than other cigarettes (just as occurred during the 1950′s and 60′s with filtered cigarettes, and as has occurred since the 1970′s with low-tar, lights and ultralights).

The key harm reduction problem with the FDA legislation is that it continues (as CDC, NCI and US SG have done for 2 decades) to mislead smokefree tobacco product users and the public (via warning labels) to believe that smokefree products are just as hazardous as cigarettes, it doesn’t require the FDA to truthfully inform smokers (or the public) that smokefree tobacco products are far less hazardous alternatives, and it prohibits tobacco to cigarettes from truthfully informing smokers that smokefree products are less hazardous alternatives to cigarettes.

That’s why it should be called the Marlboro Monopoly Act.

I’m in Texas, and at my local Sam’s Club, jumbo-sized boxes of 2mg and 4mg nicotine gum are stacked on a shelf in the vitamin isle.

These boxes contained absolutely (and I looked hard) warning messages, labels or stickers. To the contrary, the copy on the box extolled the virtue of the products over and over.

I’m picturing someone buying those boxes and selling the nicotine gum to kids. The gum is small: 4 or 5 pieces would easily fit in the mouth. Times 4mg, 20mg or even more could be used at a time. That’s one third nicotine’s toxicity level of 60mg….in adults. Kids? Who knows?

I’m going to post this article link on SnusCentral.org. The more who see your excellent and informative posts.

Sincerely,

Larry

Also, the FDA hasn’t approved OTC sale of NRT products that contain more than 4mg of nicotine, hasn’t approved sales of $5-$10 daily dose NRT packages (and only permits sales of $40+ packages), and hasn’t approved NRT sales in convenience stores and other retailers that sell cigarettes.

The FDA also hasn’t approved NRT products being marketed as “less hazardous alternatives to cigarettes”
(only as smoking cessation aids), and hasn’t approved NRT products being marketed as “temporary” or “long term” substitutes for cigarettes or tobacco.

For the past year, I’ve also been championing an FDA petition to make NRT products more consumer friendly and let them more fairly compete against tobacco products in the nicotine markets. A growing number of health organizations and agencies have submitted comments in support of this petition (none have opposed it), but many anti tobacco and health groups still haven’t endorsed it, indicating that they don’t even support nicotine harm reduction (so they’ll never endorse tobacco harm reduction).

Several weeks ago, I sent the following to my e-mail list and posted in on several websites/blogs.

From: “smokefree”
To: “Bill Godshall”
Sent: Tuesday, May 05, 2009 11:17 AM
Subject: Urge FDA to help smokers, not cigarettes

More than 14 months have passed since NY State Health Commissioner Richard Daines petitioned the FDA to:
(1) allow nicotine gum, lozenges and patches to be sold by all retailers that sell cigarettes,
(2) allow these nicotine products to be sold in less expensive daily dose units, and
(3) change warning labels on these nicotine products to truthfully inform smokers that they are far less hazardous alternatives to cigarettes.

Please urge the FDA to approve this petition NOW. Simply go to:
http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=FDA-2008-P-0116
and click on the “Add Comments” icon to the right of the first document
“State of New York Department of Health – Citizen Petition”

Unless/until the FDA can reasonably and responsibly regulate the least hazardous nicotine alternatives to cigarettes, the FDA cannot reasonably or responsibly regulate cigarettes or other tobacco products (especially when the enabling legislation, sponsored by Waxman/Kennedy, requires the FDA to protect cigarettes from market competion by far less hazardous smokefree tobacco products).

So far, the following organizations/agencies/associations (along with many
health professionals and citizens) have submitted comments urging the FDA to approve the NY State Health Commissioner’s petition. Noticably absent
from the list are the Campaign for Tobacco Free Kids, American Heart Association, and the national office of the American Cancer Society (all of which have urged the FDA to ban similar e-cigarette nicotine vaporizers,
and also are lobbying Congress to enact FDA tobacco regulatory legislation they negotiated and agreed to with Philip Morris in 2004).

Bill Godshall
Smokefree Pennsylvania
- – -

Organizations/agencies/associations that have urged the FDA to approve the
NY State Health Commissioner’s petition (listed chronologically)

Association for the Treatment of Tobacco Use and Dependence
Herkimer County Public Health
Association of State and Territorial Health Officials (ASTHO)
North Carolina Department of Health and Human Services
New York City Department of Health and Mental Hygiene
Dutchess County Department of Health
American Medical Association
New York Chapter, American College of Physicians
New York State Public Health Association
Tobacco-Free Michigan
New York State Tobacco Use Prevention and Control Program Advisory Board
Society for Research on Nicotine and Tobacco
Smokefree Pennsylvania
Tobacco Cessation Center of Northern New York
Roswell Park Cancer Institute
American Association of Public Health Physicians
Partnership for Prevention
Southern Adirondack Tobacco Free Coalition
National African American Tobacco Prevention Network
GlaxoSmithKline
Michigan Dept of Community Health
Public Health, Delta and Menominee Counties
Community Tobacco-Free Coalition
RESET Center of the University of Pittsburgh
Action on Smoking and Health (UK)
American Legacy Foundation
American Council on Science and Health
American Lung Association
American Cancer Society of NY/NJ
Ohio Department of Health

I especially appreciate your highlighting Big Pharma’s flavored nicotine products…which require no warning labels, no restrictions, no behind-the-counter sales security, and people are in-fact encouraged to use them by the Federal Government.

Your little reminder that sales of all tobacco charges to minors are illegal in the United States is something Congress either keeps forgetting or doesn’t take seriously.

Well done!

Larry
SnusCentral.org

The US Senate HELP Committee approved S. 982 last night by a vote of 15-8.

The committee’s final passage vote was largely along party lines, with 12 of 13 Democratic Senators voting yes (Hagan voted no), and 7 of 10 Republican Senators voting no (Gregg, McCain and Murkowski voted yes). The same 12 Democrats (of the 23 member committee) voted NO to all amendments by Republicans. During most of the two day markup session, a quorum (12) of the committee wasn’t present (and many votes on amendments occurred by proxy).

S. 982 includes the provisions of H.R. 1256 (sponsored by Waxman and approved by the House) and includes amendments that were approved by the Senate HELP Committee in 2007, most notably Sen. Enzi’s amendment to require color-graphic warning labels covering 50% of all cigarette packages. Smokefree Pennsylvania was the only health organization to advocate that critically important public health amendment in 2007, while CTFK, ACS, AHA, ALA not only opposed the amendment, but also claimed that it was a poison pill trojan horse intented to sabotage the legislation.

The HELP Committee approved just one amendment to S. 982, a nonsubstantive one by Sens. Merkley and Brown for a report on dissolvable tobacco products. The amendment’s real intent was to poison and preempt passage of (and any objective discussion about) responsible tobacco harm reduction amendments (filed by Senate Republicans) that can significantly reduce cigarette consumpiton and save the lives of millions of smokers.

By repeatedly referring to Camel Orbs as “candy” and by falsely accusing Reynolds of target marketing them to youth (which if true, would be actionable violations of both the MSA and state minimum age sales laws), Senators Merkley, Brown, Harkin, Dodd and other Senate Democrats went over-the-top to protect to Philip Morris’ Marlboro’s lethal cigarette empire from harm reduction market competition by Reynolds’ far less hazarous smokefree alternatives.

At least 10,000 times more youth smoke Marlboro cigarettes than use Camel’s smokefree and spitfree tobacco products (which are similar to Commit nicotine lozenges), while cigarettes are at least 100 times more hazardous than these smokefree products.

Other amendments to S. 982 considered by the committee included Enzi 1, 2, 3, 5, 8; Hagan 1, 2, 5; Coburn 4, 5, 6, 9; and Burr 1.
The committee defeated Enzi 1, 3; Coburn 6; Burr 1; and Hagan 5, while Enzi 2, 5, 8; Hagan 1,2; and Coburn 4, 5, 9 were withdrawn for future consideration by the full Senate. Other filed amendments also can be offered for Senate consideration.

Following are a list of filed amendments to S. 982, with * indicating amendments endorsed by Smokefree Pennsylvania (because they could improve public health), and several related news stories.

Any e-mails to contact me (until further notice) should be sent to my other address: bill@smokescreen.org

Bill Godshall
Smokefree Pennsylvania
412-351-5880

- – -

* Amendments to S. 982 (Kennedy FDA tobacco bill) endorsed by Smokefree Pennsylvania because they would benefit public health.

Amendment Purpose
Burr #1 Complete substitute – new HHS office
* Burr #2 Change “public health” standard to “reduce youth tobacco use” standard
* Burr #3 Smokeless tobacco carveout
* Burr #4 Require reductions in tobacco illness and death
* Coburn #1 Internet sales
Coburn #2 No tobacco program, unless existing FDA products are certified safe
* Coburn #3 Including Native American retailers and manufacturers
* Coburn #4 7 year hard sunset
Coburn #5 E-cigarette carveout
Coburn #6 Medical marijuana
* Coburn #7 GAO study on metrics
Coburn #8 If youth smoking increases 3 years in a row, sunset
* Coburn #9 PACT Act
* Enzi #1 Move tobacco regulation to CDC
* Enzi #2 Higher civil penalties for tobacco companies
* Enzi #3 Menthol and health disparities
* Enzi #4 Imminent hazard authority
* Enzi #5 Strike adverse event reporting and require DSMB
Enzi #6 Premium incentive for cessation
Enzi #7 Reissue 1996 rule
* Enzi #8 Indexing user fees in outyears
Enzi #9 Strike findings
* Hagan #1 To ensure that performance standards are based on achievable technology
Hagan #2 No FDA on the farm
Hagan #3 Roll your own
Hagan #4 Definition of small manufacturer
Hagan #5 Testing only in US labs
Hagan #6 Definition of characterizing flavor
Hatch #1 No effect of Act unless FDA gets sufficient funding for major functions
Hatch #2 No effect of Act unless FDA gets sufficient funding for device review
Hatch #3 No effect of Act unless FDA gets sufficient funding for biologics review
Hatch #4 No effect of Act unless FDA gets sufficient funding for the Office of Generic Drugs
Hatch #5 No effect of Act unless FDA gets sufficient funding for drug evaluation and review
Hatch #6 HHS certification for tobacco importation
* Hatch #7 Standard for reduced risk products
Hatch #8 Appropriations trigger – all FDA
Hatch #9 Appropriations trigger – food safety
* Hatch #10 Performance and financial reports
* Hatch #11 Report on impact of program on SCHIP
McCain #1 No use of military TSP as pay for
Merkley/Brown #1 Dissolvable tobacco products
* Murkowski #1 Track and trace for tobacco
Kennedy #1 No implied seal, repeat Enzi warning labels
Kennedy #2 No implied seal of approval

- – -

Brown amendment on tobacco mints included in Senate bill

By Jessica Wehrman
Dayton Daily News
Tuesday, May 19, 2009, 08:50 PM
http://www.daytondailynews.com/blogs/content/shared-gen/blogs/dayton/ohiopolitics/entries/2009/05/19/brown_amendment_on_tobacco_min.html

A bill that would give the FDA regulatory authority over tobacco products now includes an amendment by Sen. Sherrod Brown aimed at cracking down on “tobacco candy” being marketed in Ohio and two other states.

Brown, D-Ohio, and Sen. Jeff Merkley, D-Ore., introduced a provision that would require the new Tobacco Products Scientific Advisory Committee to immediately study the public health effects of “tobacco candy” and report to the Food and Drug Administration on its findings.

Their recommendations would be hoped to give the FDA the necessary information to act promptly on the public health impact of the products, particularly risks pertaining to children.

R.J. Reynolds has been marketing “Camel Orbs” in Columbus, Portland, Ore. and in Indiana. The “Orbs,” are sold in containers resembling cell phones and are smokeless and dissolvable.

The Senate Health, Education, Labor and Pensions Committee voted to include the measure in its bill today and is expected to finish work on the bill in the next few days. The overall bill could be on the Senate floor within weeks.

- – -

Altria backs ban on flavored cigarettes

by Al Harris
May 19, 2009
http://www.richmondbizsense.com/2009/05/19/altria-backs-ban-on-flavored-cigarettes/

A U.S. Senate panel is considering tobacco legislation today that would ban certain cigarette flavorings including cherry, chocolate and cloves.

In what may be a surprise to some, leading tobacco product producer Altria supports the ban. The company has negotiated with anti-smoking advocates and lawmakers to reach a compromise on the bill.

The ban exempts menthol-flavored cigarettes, which account for 28 percent of all cigarettes sold in the U.S., according to the Specialty Tobacco Council. By comparison clove cigarettes account for just under one percent.

Clove-laced smokes are considered “trainer cigarettes” by the National Institute of Drug Abuse which they say lead to increased tobacco use among teens.

The House already passed a version of the Family Smoking Prevention and Tobacco Control Act last month.

But the export of clove cigarettes is big business in Indonesia, which exports $100 million worth of the product to the U.S. each year. The country is threatening to file a trade complaint with the World Trade Organization if the U.S. passes the ban, according to Bloomberg News.

Passing the law could also jeopardize $22 billion in annual trade with the between Indonesia and the U.S.

The bill also regulates labeling of cigarette packaging and would require manufacturers to include warnings on the front and back of the package that occupy the entire top half of the panel. Among the nine accepted warnings include: “Cigarettes cause cancer”, “Smoking can kill you”, and the slightly innocuous “Quitting smoking now greatly reduces serious risks to your health.”

- – -

Clove Cigarettes May Prompt U.S., Indonesia Dispute (Update1)

By Mark Drajem and Lorraine Woellert
http://www.bloomberg.com/apps/news?pid=20601087&sid=aveqxR0xUKwA&refer=home

May 19 (Bloomberg) — A U.S. effort to discourage teenagers from smoking is running into opposition from Indonesia, whose 4 million clove farmers may lose a market.

Cloves would be banned as a cigarette flavoring, along with cherry and chocolate, under tobacco legislation a Senate panel is to consider today. Altria Group Inc., the largest U.S. tobacco company, backs the measure, which would exempt mint- flavored menthol cigarettes such as its Marlboro Smooth.

Congress would be “blatantly favoring a domestically produced product over an imported one” if it bans cloves and not menthol, Sudjadnan Parnohadiningrat, Indonesias ambassador to the U.S., wrote last month to Senate Majority Leader Harry Reid, a Nevada Democrat. Indonesia vows to take the matter to the World Trade Organization if the proposed ban becomes law.

The dispute may force lawmakers to choose between jeopardizing a $22 billion-a-year trade relationship with Indonesia or rewriting legislation that took years to negotiate among lawmakers, anti-smoking advocates such as the Campaign for Tobacco-Free Kids, and Richmond, Virginia-based Altria.

The Senate Health, Education, Labor and Pensions Committee plans to vote as soon as today on the Family Smoking Prevention and Tobacco Control Act, which would give the Food and Drug Administration authority to regulate tobacco ingredients and advertising. The House passed the measure April 2, including the ban on most flavored cigarettes, which is meant to reduce temptations for children to smoke.

Trainer Cigarettes

Clove-flavored products are known as “trainer cigarettes,” and may lead to more tobacco use, a study by the National Institute of Drug Abuse found in 2006.

Cloves, native to Indonesia, are a spice taken from the dried flower buds of a tropical tree. Indonesia is the worlds largest producer of clove cigarettes, known as kreteks, exporting about $500 million worth of the product a year, according to the Indonesian ambassador.

“Tobacco in Indonesia is more about politics than business,” said Widyastuti Soerojo, head of tobacco control at Indonesia Public Health Association. Increasing taxes or banning sales in the U.S. wont affect demand or employment in the industry, she said.

About a fifth of the exports go to the U.S., and Indonesia says its cigarettes make up 99 percent of the U.S. market for the product. A ban would hurt Indonesian clove farmers and violate WTO rules, said Trade Minister Mari Pangestu.

U.S. Trade Disputes

“Its the principle of it,” she said in an interview the day before she met U.S. Trade Representative Ron Kirk in Washington on May 15.

A clove ban would add to a list of congressional actions that have sparked trade disputes. Lawmakers included rules requiring that certain funds in the $787 billion stimulus package passed in February be spent mainly on American-made products, prompting protests from Canada, the European Union and companies such as Peoria, Illinois-based Caterpillar Inc.

In a spending bill passed in March, Congress banned Mexican trucks from U.S. roads, leading Mexico to levy $2.4 billion in retaliatory tariffs. That measure also prohibited imports of chicken from China, which responded with a complaint at the WTO days later.

PT HM Sampoerna, the Indonesian unit of Philip Morris International Inc., which was spun off from Altria last year, doesnt export cigarettes to the U.S., said spokeswoman Niken Rachmad. Sampoerna is Indonesias biggest cigarette maker.

Gudang Garam

PT Gudang Garam, Indonesias second-largest cigarette maker, sold 11.3 percent of its cigarettes overseas in 2008, up from 9.7 percent a year earlier, according to the companys annual report.

Gudang Garam rose as much as 18 percent to 10,250 rupiah today, the most in five months, after Deutsche Bank AG raised its stock rating to buy from hold, citing signs of a turnaround at the company. The stock traded at 9,800 rupiah at 11:23 a.m. in Jakarta.

The tobacco bill specifies that the Food and Drug Administration could ban menthol cigarettes later if it finds them harmful.

Menthol-flavored products account for about 28 percent of all cigarettes sold in the U.S., compared with 0.09 percent for clove cigarettes, according to the Specialty Tobacco Council Inc., a trade group in Winston-Salem, North Carolina. Among its members is PT Djarum, Indonesias leading clove-cigarette manufacturer.

Health Reasons

“Our industry is not seeking to escape reasonable regulation,” the groups executive director, Henry C. Roemer III, said in a statement. An outright ban is “unjustified,” he said.

A trade complaint by Indonesia would hinge on whether the U.S. can prove to the WTO that its banning clove cigarettes for health reasons and not to protect domestic producers.

Kreteks, made from a mixture of cloves, tobacco and other additives, deliver more nicotine, carbon monoxide and tar than conventional cigarettes, according to the Centers for Disease Control and Prevention in Atlanta.

“The WTO would get involved if there is a question of discrimination,” said Claude Barfield, an analyst at the American Enterprise Institute, a public-policy research group in Washington.

The case will depend on “whether there is anything about cloves that allows you to say this is a health and safety issue,” Barfield said. The complaint “is certainly not something you could dismiss out of hand.”

To contact the reporters on this story: Mark Drajem in Washington at mdrajem@bloomberg.netLorraine Woellert in Washington at lwoellert@bloomberg.net.

- – -

Senate HELP Panel Begins Mark Up of Bill Placing Tobacco Under FDA Oversight

Capitol Hill Watch
Kaiser Daily Health Policy Report
May 20, 2009
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=58527

The Senate Health, Education, Labor and Pensions Committee on Tuesday began marking up a bill (S 982) that would allow FDA to regulate tobacco products, CongressDaily reports. The bill would allow FDA to place larger, color warning labels about the health risks of smoking on cigarette packs, as well as to regulate the marketing of tobacco products and advertising to children. The agency could not ban tobacco products or eliminate nicotine from cigarettes, but it could regulate their production and ban flavored cigarettes other than menthol. Sen. Chris Dodd (D-Conn.) said, “Over the years, this bill has been reviewed; it has been vetted; it has been debated, over and over and over again. The time has come to act.” The House in April passed its version of the bill, 298-112 (Hunt, CongressDaily, 5/20).

The committee by voice vote approved an amendment proposed by Sen. Jeff Merkley (D-Ore.) that would give FDA priority to review products that contain nicotine, such as candies. Committee ranking member Mike Enzi (R-Wyo.) proposed two amendments, one that would have given regulatory authority over tobacco to CDC and another that would have ordered FDA to study which flavors to ban, instead of a current provision that bans specific flavors. Both amendments were defeated. Enzi said, “I think the FDA is the wrong regulator. It approves cures, not poisons.”

The only Democrat who opposed the bill was Sen. Kay Hagan (N.C.), who said the measure would harm the tobacco industry in her home state (Armstrong, CQ HealthBeat, 5/19). The panel’s other member from North Carolina, Sen. Richard Burr (R), said he would filibuster the bill. He said, “I put my fellow senators on notice: This is something that will be a much longer time on the floor than it will be in this hearing” (CongressDaily, 5/20). The committee plans to continue marking up the bill Wednesday and possibly Thursday.

The Obama administration has expressed its support for the bill (CQ HealthBeat, 5/19). FDA Commissioner Margaret Hamburg also has said her agency should regulate tobacco (Armstrong, CQ HealthBeat, 5/18).

- – -

US Senate Panel Approves FDA Tobacco-Regulation Measure

CNN
May 20, 2009: 07:49 PM ET
http://money.cnn.com/news/newsfeeds/articles/djf500/200905201949DOWJONESDJONLINE001048_FORTUNE5.htm

WASHINGTON -(Dow Jones)- A bill giving the Food and Drug Administration power to regulate tobacco products won approval from a key U.S. Senate panel Wednesday, clearing the way for a full Senate vote.

The Senate Health, Education, Labor and Pensions Committee approved the bill by a 15-8 vote. According to Sen. Christopher Dodd, D-Conn., who shepherded the bill through the committee, the Senate could take up the legislation as soon as the first week of June.

The bill, introduced by Sen. Edward Kennedy, D-Mass., would give the FDA limited authority to monitor smoking products. It would impose strict controls on advertising that restrict ads to black and white and stop the use of terms ” mild” and “low tar.” A similar bill passed the House last month.

Dodd expressed confidence that supporters of the bill could overcome a 60-vote threshold to avoid a filibuster in the Senate.

“I think we’ll be in fairly good shape,” Dodd said.

An amendment introduced Wednesday by Sen. Richard Burr, R-N.C., would have replaced the bill with his own legislation. Burr’s amendment was defeated by a 13-9 vote.

Tobacco producers have a large presence in North Carolina, the home state of Burr and Democratic committee member Sen. Kay Hagen, who said Tuesday that 65, 000 jobs would be affected by the legislation.

Reynolds American Inc. (RAI) and Lorillard Inc. (LO), two leading tobacco companies, are based in North Carolina.

Burr’s alternative measure would have created a new agency within the Health and Human Services Department to regulate tobacco. Many Senate Republicans objected to giving the FDA power to regulate tobacco, saying that the agency is already hard-pressed to perform its drug-safety mission.

-By Patrick Yoest, Dow Jones Newswires; 202-862-3554; patrick.yoest@ dowjones.com

Smokefree Pennsylvania sent the following letter on S. 982 (Sen. Kennedy’s FDA tobacco bill) to Senate HELP Committee members today, along with amendment endorsements (below) to protect public health.

Please send your concerns NOW to all Senate HELP Committee members at: help_comments@help.senate.gov More contact info available below.

Yesterday’s markup session can be seen/heard at: http://help.senate.gov/Hearings/2009_05_19_E/2009_05_19_E.html
The committee will continue its markup today at 2:30PM (eastern time), which can be seen/heard at http://help.senate.gov/Hearings/2009_05_20_E/2009_05_20_E.html
- – -

Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
FAX 351-5881
smokefree@compuserve.com

May 20, 2009

Dear Senator

Many inaccurate and misleading claims were made about the least hazardous tobacco products (smokefree) by Senators Merkley, Brown, Harkin, Dodd and others at yesterday’s markup session, which primarily benefits the deadliest tobacco product (cigarettes) and Philip Morris’ Marlboro empire, as would enactment of S. 982 (a deal negotiated by the cigarette giant and CTFK in 2004). We urge you to support the amendments (below) because they would improve public health.

Reiterating concerns in my May 7 letter, S. 982 will cause the deaths of millions of more cigarette smokers (primarily Marlboro smokers) unless amended to truthfully inform smokers that cigarettes are 100 times deadlier than smokefree tobacco/nicotine products (including dissolvable tobacco lozenges, snus and electronic cigarettes) and to allow smokers access to these less hazardous products. Switching from cigarettes to smokefree tobacco/nicotine alternatives reduces smoker’s health risks nearly as much as quitting all tobacco/nicotine use, and millions of smokers have already sharply reduced their health risks by switching to smokefree alternatives.

Dissolvable smokefree tobacco lozenges are nearly identical to GlaxoSmithKline’s dissolvable nicotine lozenges (marketed for smoking cessation). While some Senators grandstanded yesterday against tobacco products that comprise less than 1% of the market share and/or are no longer on the market, nobody expressed concerns that GSK http://www.commitlozenge.com/Commit.aspx has been marketing nearly identical nicotine lozenges in Cappuccino, Cherry and Mint flavors.

Claims that tobacco companies still target market to youth ignores the facts that youth tobacco use has declined by 50% to 65% (depending upon product and age group) in the past decade, that the Master Settlement Agreement already prohibits tobacco companies from marketing to youth, and that all 50 states already ban tobacco sales to youth under 18. In contrast to claims that S. 982 would protect youth from tobacco marketing (and Senator Brown’s criticism of a cigarette marketed to his 19 year old daughter), S. 982 would do little to further reduce youth tobacco use primarily because it prohibits the FDA from banning tobacco marketing to high school seniors (age 18). The CBO recently estimated that H.R. 1256 (Rep. Waxman’s similar bill approved by the House) would only reduce youth smoking by 11% and adult smoking by 2% during the next DECADE.

Since 1990, Smokefree Pennsylvania has advocated policies to reduce tobacco smoke pollution indoors, increase cigarette taxes, reduce tobacco marketing to youth, preserve civil justice remedies for tobacco victims, expand smoking cessation services, and inform smokers that smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes.

Sincerely,

William T. Godshall, MPH
Executive Director

- – -

* Amendments to S. 982 (Kennedy FDA tobacco bill) endorsed by Smokefree Pennsylvania because they would benefit public health.

Amendment Purpose
Burr #1 Complete substitute – new HHS office
* Burr #2 Change “public health” standard to “reduce youth tobacco use” standard
* Burr #3 Smokeless tobacco carveout
* Burr #4 Require reductions in tobacco illness and death
* Coburn #1 Internet sales
Coburn #2 No tobacco program, unless existing FDA products are certified safe
* Coburn #3 Including Native American retailers and manufacturers
* Coburn #4 7 year hard sunset
Coburn #5 E-cigarette carveout
Coburn #6 Medical marijuana
* Coburn #7 GAO study on metrics
Coburn #8 If youth smoking increases 3 years in a row, sunset
* Coburn #9 PACT Act
* Enzi #1 Move tobacco regulation to CDC
* Enzi #2 Higher civil penalties for tobacco companies
* Enzi #3 Menthol and health disparities
* Enzi #4 Imminent hazard authority
* Enzi #5 Strike adverse event reporting and require DSMB
Enzi #6 Premium incentive for cessation
Enzi #7 Reissue 1996 rule
* Enzi #8 Indexing user fees in outyears
Enzi #9 Strike findings
* Hagan #1 To ensure that performance standards are based on achievable technology
Hagan #2 No FDA on the farm
Hagan #3 Roll your own
Hagan #4 Definition of small manufacturer
Hagan #5 Testing only in US labs
Hagan #6 Definition of characterizing flavor
Hatch #1 No effect of Act unless FDA gets sufficient funding for major functions
Hatch #2 No effect of Act unless FDA gets sufficient funding for device review
Hatch #3 No effect of Act unless FDA gets sufficient funding for biologics review
Hatch #4 No effect of Act unless FDA gets sufficient funding for the Office of Generic Drugs
Hatch #5 No effect of Act unless FDA gets sufficient funding for drug evaluation and review
Hatch #6 HHS certification for tobacco importation
* Hatch #7 Standard for reduced risk products
Hatch #8 Appropriations trigger – all FDA
Hatch #9 Appropriations trigger – food safety
* Hatch #10 Performance and financial reports
* Hatch #11 Report on impact of program on SCHIP
McCain #1 No use of military TSP as pay for
Merkley/Brown #1 Dissolvable tobacco products
* Murkowski #1 Track and trace for tobacco
Kennedy #1 No implied seal, repeat Enzi warning labels
Kennedy #2 No implied seal of approval

- – -

Phone and fax numbers for Senate HELP Cmte members, and an e-mail address to contact all members of the committee.

Senate HELP Committee Phone Fax

Edward M. Kennedy (D-MA) 202-224-5465 202-224-5128
Chairman
Christopher J. Dodd (D-CT) 202-224-2823 202-224-1083
Tom Harkin (D-IA) 202-224-3254 202-224-9369
Barbara A. Mikulski (D-MD) 202-224-4654 202-224-8858
Jeff Bingaman (D-NM) 202-224-5521 202-224-2852
Patty Murray (D-WA) 202-224-2621 202-224-0238
Jack Reed (D-RI) 202-224-4642 202-224-4680
Bernie Sanders (I-VT) 202-224-5141 202-228-0776
Sherrod Brown (D-OH) 202-224-2315 202-224-6519
Robert P Casey, Jr (D-PA) 202-224-6324 202-228-0604
Kay Hagan (D-NC) 202-224-6342 202-228-2563
Jeff Merkley (D-OR) 202-224-3753 202-228-3997

Michael Enzi (R-WY) 202-224-5375 202-224-6510
Ranking Member
Judd Gregg (R-NH) 202-224-3324 202-224-4952
Lamar Alexander (R-TN) 202-224-4944 202-228-3398
Richard Burr (R-NC) 202-224-3154 202-228-2981
Johnny Isakson (R-GA) 202-224-3643 202-228-0724
John McCain (R-AZ) 202-224-2235 202-228-2862
Lisa Murkowski (R-AK) 202-224-6665 202-224-5301
Orrin G. Hatch (R-UT) 202-224-5251 202-224-6331
Pat Roberts (R-KS) 202-224-4774 202-224-3514
Tom Coburn (R-OK) 202-224-5754 202-224-6008

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