A Senator's Unilateral Recommendation To Ban Menthol is Inconsistent with the Recommendations of the FDA Tobacco Advisory Committee

Senator Blumenthal states that his recommendation to ban menthol cigarettes is based on the report of the FDA Tobacco Product Scientific Advisory Committee. Unfortunately he must have not read the report in its entirety. The TPSAC made it clear that no action can be taken on a ban until the issue of contraband has been addressed.

A good example of menthol cigarettes is Kiss Superslims Menthol cigarettes.

Center for Regulatory Effectiveness (CRE) has informed TPSAC that China exports 400 billion cigarettes per year. CRE continues to issue reports based on information obtained from Chinese government publications which demonstrate that the contraband industry in China is flourishing and will be even more prosperous with a menthol ban. CRE presentations to TPSAC clearly demonstrated that a menthol ban will not only result in an increase in adult and underage smoking of tobacco products but in doing so both groups will be exposed to heavy metals at a level which is an order of magnitude greater than legal cigarettes.
Consequently, if the Congress is going to get involved in the FDA review of the TPSAC report they should do so only after they have read the entire record.

FDA says tobacco law doesn't apply to two smokeless lozenges

It's not often a tobacco company gets released from government regulation without asking.

But that's apparently what happened to Star Scientific Inc. after it asked the Food and Drug Administration to treat two versions of its smokeless, dissolvable tobacco lozenges as "modified risk" because they contain lower levels of carcinogens than other tobacco products.

The most demamded tobacco products are cigarettes as Marlboro Gold cigarettes or Winston cigarettes.

The FDA responded that the products aren't considered smokeless tobacco at all and don't come under the 2009 tobacco law, according to a Star Scientific announcement on Wednesday.

"We were very surprised. We obviously believed that these were smokeless tobacco products under the act," said Sara Troy Machir, Star Scientific's vice president for communications and investor relations.

Why FDA judged Ariva-BDL and Stonewall-BDL exempt from the tobacco law is a mystery.

Both the FDA and Star Scientific declined to release copies of the agency's decision because they said it contained confidential commercial information.

Machir said the FDA cited "details of the manufacturing process" -- which are secret – in exempting the products from oversight.

In a statement, the FDA said it recognizes that "there are uncertainties regarding the regulatory status of a variety of nicotine-containing products" including whether they should be regulated as drugs or tobacco.

The agency said it's "considering its legal and regulatory options regarding these products."

Star Scientific's announcement caused consternation among anti-tobacco activists who said it opens a loophole other smokeless tobacco makers will attempt to exploit.

The decision is puzzling and disappointing because the tobacco law "does not distinguish among smokeless tobacco products based on manufacturing process," said Matt Myers of the Campaign for Tobacco-Free Kids.

"The FDA's handling of this creates unnecessary uncertainty and the potential for widespread abuse," Myers said.

Lynn Kozlowski, dean of the School of Public Health at the University of Buffalo, said the decision highlights the difficulties in precisely defining everything a new law is supposed to cover.

"On one hand, you have common sense and on the other hand definitions and sometimes they don't mesh," Kozlowski said. "I can only speculate that there's something about [Star Scientific's] process that isn't covered by the definition FDA is using."

Psychiatric Patients Risking Lives For A Cigarette

Australia's involuntary mental health patients are so desperate to defy smoking bans they are poking electricity sockets with paper clips to get a spark and light up, The (Perth) Sunday Times reported.

The revelation based on a new report is being used by Western Australia's mental health watchdog, the Council of Official Visitors, to bolster its call for designated smoking areas for involuntary patients.

In its latest annual report, the watchdog warned one patient was soaking nicotine patches in tea "to get more of a nicotine fix" and it was "cruel" to force mental health patients to give up their addiction on admission.

It also highlighted "reports of patients using straightened paper clips in electricity outlets to obtain a spark to light a cigarette."

"It is not the right time to be asking people to go through the terrible nicotine withdrawal symptoms," the council wrote in the report tabled in parliament.

"The ban is also a further erosion of consumers' rights and not in accordance with section five of the Act which requires that people with a mental illness must receive care and treatment with the least restriction of their freedom and least interference with their rights."

But Australian Council on Smoking and Health president Mike Daube said the council's call was "misguided, retrograde and exaggerated."

He said the smoking ban, introduced on all public hospital sites in 2008, was "being very well implemented and there will always be one or two exceptions."

"There doesn't seem to be any concern about the physical health of mental health patients and we shouldn't just be worried about their health from the neck up," he said.

Cigarettes and Sinners

I'd rather be a Catholic than a cigarette company. Confessions are done in private, and priests (and God) are more forgiving of past transgressions than the Justice Department (and judges.) As Catholic On-Line explains it, "The basic requirement for a good Confession is to have the intention of returning to God like the "prodigal son" and to acknowledge our sins with true sorrow before the priest." Once a Catholic has confessed to a specific sin in the privacy of the Confessional, the appropriate punishment is imposed by the priest and the penitent can go on about his/her business confident that the transgression has been forgiven. The Pope's confessional is a kind of one stop shopping for forgiveness whereas the legal confessional, at least as interpreted by Judge Gladys Kessler of the U.S. District Court for the District of Columbia, more closely resembles Hawthorne's Scarlet Letter.

In 2006 Judge Kessler issued a final judgment in a civil RICO (Racketeering) case that the Department of Justice brought against the tobacco industry as a whole. She said tobacco companies violated civil racketeering laws and defrauded the American people by lying for decades about the health risks of smoking and their marketing to children. In her 1682 page opinion she said that:

"the Court will order Defendants to make corrective statements about addiction (that both nicotine and cigarette smoking are addictive); the adverse health effects of smoking (all the diseases which smoking has been proven to cause); the adverse health effects of exposure to ETS [environmental tobacco smoke](all the diseases which exposure to ETS has been proven to cause); their manipulation of physical and chemical design of cigarettes (that Defendants do manipulate design of cigarettes in order to enhance the delivery of nicotine); and light and low tar cigarettes (that they are no less hazardous than full-flavor cigarettes). Within sixty days of the issuance of this opinion and order, both parties will submit a proposal for the exact wording of these statements. After the Court approves particular statements, Defendants must publish such corrective statements in newspapers and disseminate them through television, Within sixty days of the issuance of this opinion and order, both parties will submit a proposal for the exact wording of these statements."
All the appeals have now been exhausted, Judge Kessler's opinion is final and the Justice Department has come up with proposed language that has been made public over the tobacco companies' objections.

Some of the Justice Department proposals as to what the cigarette companies must say in their ads and on cigarette packages are in the nature of a confession that might be heard by a priest in a confessional. One suggested confession says: "We falsely marketed low tar and light cigarettes as less harmful than regular cigarettes to keep people smoking and sustain our profits. We knew that many smokers switch to low tar and light cigarettes rather than quitting because they believe low tar and lights are less harmful. They are NOT." Another says: "We told Congress under oath that we believed nicotine is not addictive. We told you that smoking is not an addiction and all it takes to quit is will power. Here's the truth: Smoking is very addictive. And it's not easy to quit."

Not all the suggestions are in the nature of confessions. Some simply describe the hazards posed by the cigarette. One, for example, says: "A federal court is requiring tobacco companies to tell the truth about cigarette smoking. Here's the truth: . . . Smoking kills 1,200 Americans. Every day." Another says: "Just because lights and low tar cigarettes feel smoother, that doesn't mean they are any better for you. Light cigarettes can deliver the same amounts of tar and nicotine as regular cigarettes." Another says: For decades, we denied that we controlled the level of nicotine delivered in cigarettes. Here's the truth: Cigarettes are a finely-tuned nicotine delivery device designed to addict people; We control nicotine delivery to create and sustain smokers' addiction, because that's how we keep customers coming back; We also add chemicals, such as ammonia, to enhance the impact of nicotine and make cigarettes taste less harsh; When you smoke, the nicotine actually changes the brain-that's why quitting is so hard." This last statement is so detailed that it is probably similar to what a murderer might come up with when confessing sins in a Confessional.

March 3 will have been an exciting day. That is the deadline for the tobacco companies to respond to the language proposed by the Justice Department. It is not often the sinner has a chance to weigh in on the kind of punishment that is appropriate. Priests do not ask confessors how many Hail Marys they think are appropriate for the sins to which they've confessed. My guess is Judge Kessler, like a priest, will not give the sinners' suggestions much weight.

Evidence does not support menthol restrictions, Altria says

The scientific evidence does not justify a ban or restrictions on menthol flavoring in cigarettes, a representative for cigarette maker Philip Morris USA told a government advisory panel Wednesday.

"The weight of the scientific evidence indicates that menthol does not change the inherent health risk of smoking," said Jane Lewis, senior vice president for tobacco regulatory and health sciences at Altria Client Services Inc., which provides support functions for Henrico County-based Altria Group Inc. and its subsidiaries, including top U.S. cigarette maker Philip Morris USA,producer of Marlboro cigarettes which sells several menthol cigarette brands.

Lewis spoke at a meeting of the Tobacco Products Scientific Advisory Committee, a 12-member panel appointed to study tobacco-related issues and advise the Food and Drug Administration on regulating the industry.

The advisory committee is scheduled to submit a report about the public-health impacts of menthol cigarettes to the FDA by March 23. The group could recommend banning menthol, but the FDA is not required to adopt the findings.

A draft copy of the panel's report released this week said the evidence is insufficient to conclude that smokers face higher health risks from menthol cigarettes compared with unflavored cigarettes.

However, the report said menthol flavoring may make it easier for young people to start smoking and may increase the likelihood of addiction.

Lewis told the panel that the impact of menthol on smoking initiation is a "complex issue" that needs more study. The weight of evidence, she said, indicates that menthol flavoring does not increase smoking dependence.

A ban on menthol could instead have the unintended consequence of creating an illegal trade in menthol cigarettes, Lewis said.

David T. Levy, a professor of economics at the University of Baltimore, told the panel that his research indicates a ban on menthol would reduce smoking rates enough to prevent between 323,000 and 633,000 deaths from smoking-related diseases by 2050. He said the research was funded by the American Cancer Society and the American Legacy Foundation, a tobacco-control group.

Menthol brands make up about 30 percent of the U.S. cigarette market, and about 80 percent of black smokers use menthols, research from the Federal Trade Commission shows.

Niger Innis, a national spokesman for the civil-rights group Congress of Racial Equality, also argued before the committee that a ban on menthol would create an illicit trade.

He said his group supports "rigorous and early education about the dangers of smoking in the schools," but not a ban on menthol.

"If the government is not going to ban all cigarettes, then the obvious question is why should it selectively ban those cigarettes that African-Americans tend to prefer?" he said.

The committee's chairman, Dr. Jonathan Samet, a professor of medicine at the University of Southern California, said the report to the FDA would include research on the potential unintended consequences of a ban, such as an illegal, underground market.

Two of the nation's largest cigarette makers last Friday filed a lawsuit seeking to stop the FDA from relying on recommendations made by the scientific advisory committee.

The lawsuit, filed in U.S. District Court in Washington by Lorillard Inc. and R.J. Reynolds Tobacco Co., claims several members of the committee have a financial conflict of interest and bias because they have testified against tobacco companies in smokers' lawsuits or worked for pharmaceutical firms that make smoking-cessation products.

Altria Group is not part of that lawsuit, but the company has raised objections with the FDA about alleged conflicts of interest among members on the advisory committee.