Vanguard Neurologist

Dr. Perlmutter’s comment: Read this article keeping in mind that tobacco kills more than half a million Americans each year.

From nytimes.com

In its sharpest criticism yet of the tobacco legislation pending in Congress, the Bush administration has said it “strongly” opposes the effort to give the Food and Drug Administration regulatory authority over tobacco.

The criticism came Monday in a letter by Michael O. Leavitt, the secretary of health and human services, which some saw as a signal that a veto would be likely if the legislation cleared the House and Senate.

The letter was sent to Joe L. Barton of Texas, the highest-ranking Republican member of the House Energy and Commerce Committee, which approved the bill in April. Mr. Barton voted against the bill.

The White House and the F.D.A. commissioner, Dr. Andrew C. von Eschenbach, have previously raised concerns about the legislation. The letter provided the strongest indication yet that the administration would try to block the bill.

The proposal has broad support in the House but, in the Senate, it is believed to be three votes short of a majority sufficient to override a veto. The House could vote on the measure as early as this month.

In the letter, Mr. Leavitt said his department supported efforts to encourage adults who smoke to quit and to keep children from starting, and he said the department would spend $680 million toward those ends in 2008.

But he said the administration had “serious concerns” that the bill could overload the F.D.A. by piling on “significant added responsibility” that is inconsistent with the agency’s mission of ensuring the safety of food, drugs and medical devices.

The new regulations included in the bill may cost more to impose than the bill raises in revenues through user fees and taxes, the letter said.

“This could result in diverting personnel and resources from current programs within the F.D.A., with the potential to seriously undermine the public health,” the letter said.

Furthermore “adding tobacco to F.D.A.’s regulatory responsibilities could also leave the public with the misperception that tobacco products are safe, or at least safer, with the F.D.A. regulating them,” the letter said, predicting a “perverse and unintended consequence of lowering the perceived risk of tobacco.”

The legislation has the support of the nation’s largest cigarette company, Philip Morris USA, but most other cigarette makers oppose it.

The letter also raises new questions about the bill’s treatment of menthol cigarettes.

The bill would ban candy, fruit and spice-flavored cigarettes, including clove cigarettes, but menthol cigarettes would be exempt from the ban. Menthol cigarettes make up 28 percent of the United States cigarette market.

Indonesia, which exports a clove-flavored cigarette called kretek, has objected to the favorable treatment of menthol over other flavorings, Mr. Leavitt said. “The government of Indonesia has repeatedly objected to the bill on the ground that this disparate treatment is unjustified and incompatible with W.T.O. trade rules,” Mr. Leavitt wrote, in reference to the World Trade Organization.

In voicing concern about the menthol exemption, the administration finds itself on the side of black antismoking advocates who have criticized the bill.

Menthol cigarettes are chosen by about 75 percent of black smokers. Researchers have long worried that menthol may play a role in the disproportionate diagnosis of smoking-related cancers among blacks, possibly by masking tobacco’s harsh taste, and some research suggests that menthol smokers find it more difficult to quit.

Supporters of the bill have said that, although menthol is exempt from the ban on flavorings in the bill, the F.D.A. would have the power to limit or ban menthol if it is proved harmful. Some members of the Congressional Black Caucus have said they would press for a floor amendment of the bill to impose additional restrictions on menthol cigarettes or require a study of them.

From New York Times

The House Commerce Committee approved a bill Wednesday that would give the Food and Drug Administration sweeping regulatory authority over the tobacco industry, clearing the way for a floor vote on the legislation, which has long been sought by antitobacco activists.

The bill is meant to severely curtail tobacco marketing, to emphasize health warnings on tobacco products, to ban many flavored cigarettes, and to prohibit labeling of cigarettes as light or low tar. Dozens of health groups have supported the bill as potentially life-saving.

But despite broad support in both the House and the Senate, where a similar proposal cleared a committee in July, the legislation faces formidable obstacles.

The Bush administration and the Senate Republican leader, Mitch McConnell of Kentucky, have indicated their opposition.

In a statement shortly after the vote, a White House spokeswoman, Emily A. Lawrimore, said the administration thought that the legislation would do more harm than good, creating a false impression that regulated tobacco products were safe.

The administration believes that tobacco is not a drug or device to be regulated by the F.D.A., Ms. Lawrimore said.

A spokesman for Senator McConnell noted that he had said he would review the bill.

Senator Richard Burr, Republican of North Carolina, has reportedly threatened to filibuster the legislation if it reaches a vote on the Senate floor. In a statement Wednesday, shortly after the House committee vote, Mr. Burr said he remained opposed to the legislation, in part, he said, because it would strain an already burdened agency. The bill is also running up against an abbreviated election-year legislative schedule.

The House committee approved the bill 38 to 12, with much of the opposition from Republicans who argued that the F.D.A. was already overwhelmed and could not handle regulating another industry.

That position has recently been articulated in an advertising campaign by Reynolds American, the tobacco company that sells Camel cigarettes and other brands. But Representative Henry A. Waxman, Democrat of California, who sponsored the bill, said such arguments were clearly red herrings from those who are fundamentally opposed to regulating tobacco at all.

And Representative John D. Dingell, Democrat of Michigan and the Commerce Committee chairman, said he was separately working on legislation to clean up this mess at Food and Drug, and we plan to do it with all vigor and enthusiasm.

The tobacco bill has been endorsed by the cigarette maker Philip Morris, and some people have criticized it as a compromise that does not go far enough. For example, it prohibits the F.D.A. from raising the legal age for buying cigarettes beyond the current level of 18.

And while the bill prohibits the sale of candy-flavored cigarettes

which account for less than 1 percent of the market

it allows the continued sale of popular menthol cigarettes. One menthol brand, Newport, marketed by Lorillard Tobacco, is the nations second-leading cigarette, after the Philip Morris brand Marlboro. Lorillard has not yet taken a position on the legislation, a spokesman said.

Representative Mike Ferguson, Republican of New Jersey, offered an amendment that would have prohibited menthol flavoring. I think its inconsistent to say we want to protect kids from flavored cigarettes,

Mr. Ferguson said, but then we have a provision in the bill that allows menthol cigarettes.

Mr. Dingell acknowledged that the legislation was not ideal. In a perfect world, wed ban all cigarettes, he said. But the hard fact of the matter is that there are a lot of jobs depending on this. And more importantly, there are a lot of people out there who are addicted to this, and theyve got to have their fix.

Antismoking groups have sought regulation of the tobacco industry for years. In 1995, a former F.D.A. commissioner, David A. Kessler, drafted regulations declaring nicotine a drug and cigarettes a drug delivery device subject to F.D.A. authority, but these were struck down by federal courts.

The Senate approved a proposal in 2004, but the House has never voted on one.

Within minutes of Wednesdays action, statements supporting the committees vote were issued by supporters including Senator Edward M. Kennedy, Democrat of Massachusetts, who sponsored the Senate version of the bill; the American Academy of Pediatrics; and the American Cancer Society.

Although the White House had expressed its opposition, it has not yet threatened to veto the legislation. In testimony last fall, Dr. Andrew C. von Eschenbach, the current F.D.A. commissioner, indicated the Bush administrations reluctance to embrace a new regulatory role, citing wide efforts already begun by both state and federal agencies to reduce tobacco use.

The bill would create a center within the F.D.A specifically for tobacco regulation financed by industry fees projected to exceed $5 billion over the next 10 years.

It would also require disclosure of the contents of tobacco-based products and set standards that would require removal or reduction of harmful ingredients; require that the findings of industry research be made public; prohibit companies from making health claims about tobacco products, and require larger and more effective warning labels.

From New York Times

Tobacco could kill up to a billion people during the 21st century, as cigarette sales soar in poor and middle-income countries even as they drop in wealthier ones, says a report issued Thursday by the World Health Organization.

The report, financed by Mayor Michael R. Bloombergs foundation, suggests a six-point program for fighting the tobacco industrys influence.

The W.H.O. is described by the tobacco industry as its biggest enemy, Dr. Margaret Chan, the organizations director general, said at a news conference introducing the report. Today we intend to enhance that reputation.

Nicknamed Mpower and based on a partly successful program for fighting drug-resistant tuberculosis, the report suggests raising cigarette taxes, banning smoking in public places, enforcing laws against giving or advertising tobacco to children, monitoring tobacco use, warning people about the dangers and offering free or inexpensive help to smokers trying to quit.

The report, to which Bloomberg Philanthropies contributed $2 million, is the first to compile global data on how many smokers or tobacco chewers each country has, how much they pay in tobacco taxes, and how antismoking efforts are faring.

Among its conclusions: poor and middle-income countries collect 5,000 times as much in tax revenue from tobacco as they spend in fighting its use. Only 5 percent of the world has no-smoking laws like those in New York City. Uruguay does more than any other country to reduce smoking.

Mayor Bloomberg, who is well known for his antipathy to smoking, said in presenting the report that it would be re-issued annually and would grade countries. The United States would get a C or D, he said, New York, an A or a B.

His statement puts him at odds with W.H.O. The agency has traditionally been cautious about offending members, and in interviews, officials from its Tobacco Free Initiative specifically said countries would not be graded.

Perhaps the oddest aspect was that the report itself was presented as if it were a campaign for menthol cigarettes, full of pictures of happy children and mottos like fresh and alive. It even came with what appeared to be a pack of Mpower-brand cigarettes, with a cheerful blue bubbles logo and a mock warning on the box

which actually contained a pad and pens.

That also seemed to fly in the face of the sort of harsh ads that Mayor Bloomberg endorsed, like those showing dying smokers croaking through tracheotomy tubes.

After the presentation, officials hastened to explain that the cigarette pack was not meant for the public, but to catch the eyes of health and finance ministers in poor countries.

Were co-opting the tobacco industrys branding strategies to capture the attention of government officials, said Sandra Mullin, a spokeswoman for the World Lung Foundation, which contributed to the report. We want to show that they dont own those mottos

freshness and fun and health.