WASHINGTON  – President Barack Obama has signed the strongest anti-smoking measure ever, calling it an extraordinary accomplishment that will help keep children from getting hooked on cigarettes.

Standing in the Rose Garden with a number of lawmakers and other guests, Obama declared: “It is a law that will save American lives.”

The legislation gives the Food and Drug Administration unprecedented authority to regulate tobacco and cigarette marketing.

Obama himself has struggled to quit smoking. He acknowledged in his comments how difficult it can be to quit the habit.

The White House embraced the law with a sun-splashed ceremony, and the dozens of invited guests included children from the Campaign for Tobacco Free Kids who were personally introduced by Obama.

WASHINGTON – Homeland Security Secretary Janet Napolitano predicted Tuesday that swine flu will crop up in additional states in the days ahead, although the Obama administration said it has no immediate plans for more stringent measures to prevent a wider spread of the disease from Mexico.

Authorities have confirmed about 50 cases of the illness in the United States so far, and the administration has begun moving stockpiles of antiviral drugs into the affected areas.

No flu-related deaths have been reported in the U.S., while neighboring Mexico has experienced more than 150 flu-related fatalities.

As the administration marshaled its forces, a spokesman at the Office of Management and Budget said there were no current plans to seek additional funds to deal with the possibility of a wider public health threat. One senior Democrat, Rep. David Obey, has said he wants to add an undisclosed amount of flu money to President Barack Obama’s request for funds for the wars in Iraq and Afghanistan.

“Whether or not this influenza strain turns out to have pandemic potential, sooner or later, some strain will,” said Obey, chairman of the House Appropriations Committee.

Democrats dropped efforts to include anti-pandemic funding in last winter’s economic stimulus bill as they maneuvered for key votes in the Senate.

Napolitano, interviewed on NBC, said officials “anticipate confirmed cases in more states.” She reiterated Obama’s statement that the spread of the disease is a cause for concern but not alarm.

She offered no estimate of how widely the flu might spread, nor how many cases might eventually occur.

Authorities have reported 51 confirmed cases of swine flu in the United States: 28 at a private high school in New York City, 13 in California, six in Texas, two in Kansas, one in Ohio and one in Indiana.

Health officials in Michigan said they have one suspected case, and five are suspected in New Jersey.

Asked about stricter measures, Napolitano said, “That’s something that always can be considered, but you have to look at what the costs of that are. We literally have thousands of trucks and lots of commerce that cross that border. We have food products and other things that have to go across that border.

“So there’s a – that would be a very, very heavy cost for – as the epidemiologists tell us – would be marginal, if any, utility in terms of actually preventing the spread of the virus.”

Some Asian countries have deployed thermal sensors at airports to screen passengers from North America for signs of fever.

At the same time, Napolitano said the administration wouldn’t wait for a World Health Organization declaration of a pandemic to deliver a pandemic-like response.

Noting that the international health body has elevated its alert status to Level 4 of a 6-step process, Napolitano said: “We’re prepared as if there were a pandemic. We’re not waiting.”

Obama on Monday responded to the first domestic emergency of his presidency by urging calm – and then dispatching officials to the cameras to again back up that message.

Richard Besser, the acting director of the Centers for Disease Control and Prevention, said his agency was aggressively investigating, looking for evidence of the disease spreading and probing for ways to control and prevent it.

The government also issued an advisory warning travelers to cancel any nonessential visits to Mexico – and gently took issue with a European Union health official who said the same thing about travel to parts of the U.S.

At the White House, a swine flu update, delivered by White House homeland security adviser John Brennan, was added to the president’s daily intelligence briefing. And on Capitol Hill, several panels scheduled emergency hearings for this week.

On Tuesday, Napolitano said that federal efforts to get antiviral medications to the states “is under way and is working.”

The Food and Drug Administration, for instance, issued emergency guidance late Monday that allows certain antiviral drugs to be used in a broader range of the population in case mass dosing is needed to deal with a widespread swine flu outbreak.

The agency originally approved the use of the antiviral drug Tamiflu for the prevention and treatment of influenza in adults and children age 1 and older. Another antiviral drug, Relenza, was
originally approved to treat people 7 and older and to help prevent flu in those 5 and older.

Napolitano was asked point-blank in one interview if the monitoring that the U.S. is now conducting at entry points in the country is sufficient. “We think that what we’re doing now at the land ports and the airports makes sense,” she replied.

Napolitano also said “absolutely yes” when asked if the Department of Health and Human Services, for which Kathleen Sebelius was still awaiting Senate confirmation, was ready to take on this kind of heavy challenge.

The Senate was debating the Kansas Democrat’s nomination Tuesday, and a vote was scheduled later in the day.

WASHINGTON  – The House was poised Wednesday to thrust tobacco companies under government control after years of attempts in legislatures and the courts to tame one of the country’s signature industries.

Senate action would still be required, as well as President Barack Obama’s signature, before the Food and Drug Administration could get authority for the first time to regulate cigarettes and other tobacco products.

Supporters were convinced that both those pieces were in place. They pointed to strong backing from the White House – where Obama has spoken of his own struggles to kick the cigarette habit – and an increased Democratic majority in a Senate that’s already shown itself inclined to support the bill.

If it does become law, the Family Smoking Prevention and Tobacco Control Act would amount to the biggest change ever in the government’s approach toward tobacco, which has remained largely hands-off even as the health hazards have become increasingly clear.

Although the FDA wouldn’t be allowed to ban nicotine or tobacco, the agency would be able to regulate the contents of tobacco products, make public their ingredients, prohibit flavoring, require much larger warning labels and control marketing campaigns, especially those geared toward children.

“This would be the most significant tobacco bill the Congress of the United States has ever enacted,” said Matthew Myers, president of Campaign for Tobacco-Free Kids. “It would bring about fundamental change in the marketing, manufacturing and sale of cigarettes.”

Opponents, including some tobacco companies and lawmakers from tobacco-growing states, contended that the FDA, which has come under criticism after fumbling a series of health scares, was already overburdened and couldn’t handle the job of regulating another big industry. U.S. tobacco production was valued at $1.3 billion in 2007.
  
Opponents also argued that the bill by Rep. Henry Waxman, D-Calif., was unrealistically aimed at ending smoking altogether and wouldn’t allow nicotine addicts to learn of alternatives like smokeless tobacco.

Adult tobacco users who have not quit “should be encouraged to move from tobacco products with higher risks to those with lower risks,” said Maura Payne, spokeswoman for R.J. Reynolds Tobacco Co.

The House was expected to vote Wednesday on an alternate bill by Rep. Steve Buyer, R-Ind., that would encourage development of less-harmful tobacco products and create a Tobacco Harm Reduction Center within the Department of Health and Human Services, instead of giving the job to the FDA.

The country’s largest tobacco company, Marlboro-maker Philip Morris USA, is supporting Waxman’s bill. Some analysts say the legislation could lock in Philip Morris’ market share while stunting the ability of other companies to compete.

Under President George W. Bush, who issued a veto threat after the House passed a nearly identical version of Waxman’s bill last year, the FDA said it didn’t want the job of regulating tobacco. The Obama administration is welcoming the task.

The White House issued a statement Wednesday saying it “strongly supported” the bill, and Obama’s nominee for HHS secretary, Kansas Gov. Kathleen Sebelius, backed it during a hearing this week.

The issue has a long history laced with lawsuits and politics. President Bill Clinton’s FDA chief, David Kessler, pushed hard for tobacco regulations. Around the same period, in 1994, Waxman summoned the heads of big tobacco to the famous hearing in which they testified that nicotine wasn’t addictive.

Subsequent lawsuits against tobacco companies resulted in big payouts to states, some of which funded smoking-reduction campaigns that have contributed to a decrease in smoking rates. About one in five adults in the U.S. now smokes cigarettes. But a 2000 Supreme Court ruling that FDA didn’t have the authority to regulate tobacco makes congressional action necessary.

RALEIGH, N.C. – Agriculture Commissioner Steve Troxler will be in Washington, D.C., Thursday to speak at a congressional hearing on tobacco.

Rep. Mike McIntyre, of North Carolina’s 7th District, invited Troxler to testify before the House Subcommittee on Rural Development, Biotechnology, Specialty Crops and Foreign Agriculture. McIntyre is the subcommittee’s chairman.

Troxler’s testimony will focus on the potential impact of federal regulation of tobacco on North Carolina farmers. Bills pending in the House and Senate would place tobacco products under federal oversight.
The hearing begins at 10 a.m. in room 1302 of the Longworth House Office Building.

Winston-Salem Journal

Unlike global warming and the environment, there is little if any debate over the adverse effects of smoking on health. As a result, more stringent government regulation of tobacco products is inevitable. A bill for regulation by the Food and Drug Administration passed in the U.S. House last year, and its supporters in the House this year stand a good chance for victory there and in the Senate. Sens. Richard Burr of Winston-Salem and Kay Hagan of Greensboro have crossed party lines to introduce an alternative bill that, while far from perfect, could lead to reasonable FDA regulation.

Burr and Hagan propose that a new agency be created to regulate tobacco. We believe that would be unnecessary and unwise. This is not the time to be growing government, and the agency that Burr and Hagan propose would have less power than the FDA. While the FDA may not have the best track record, it is the appropriate agency for regulating the manufacture and sale of tobacco, a legal, but habit-forming and deadly product.

As with our endorsement last month of a bill in the state House to ban smoking in virtually all enclosed workplaces and buildings open to the public in North Carolina, our support of FDA regulation of tobacco products is a break from the past. We have long opposed regulation. Tobacco has for generations supported farmers, factory workers and many others throughout our region. That picture is changing as we transform from a manufacturing to a high-tech economy, but tobacco still holds a strong place in the region.

We opposed FDA regulation out of concern that its marketing restrictions would cement Philip Morris as the nation’s No. 1 cigarette maker, to the detriment of Winston-Salem’s Reynolds American Inc., the nation’s No. 2 manufacturer. That’s been Reynolds’ argument as well. But Reynolds has had years to catch up with Philip Morris in an unregulated environment. Instead, it has continued to lose cigarette market share.

We also saw FDA regulation as government intervention. But the health effects of smoking are broad and significant. These dangers, which include cancer and heart disease and contribute to almost 14,000 deaths a year in North Carolina alone, have come to outweigh our concerns about the marketplace and government intervention. The FDA is charged with regulating prescription drugs and monitoring our food supply to protect us from harm. It should do the same concerning the harmful substances in cigarettes. The highly addictive nicotine in cigarettes is a drug.

Adult smokers have the right to use a legal product, and neither bill seeks to ban tobacco or regulate tobacco farmers. But the government has the right, and the duty, to protect its citizens from harm – especially when all Americans are affected by the health-care costs of a product. Tobacco costs the state of North Carolina $2.5 billion in health-care bills each year, according to the Campaign for Tobacco Free Kids.

Burr and Hagan’s opposition to FDA regulation is understandable. Under the FDA’s watch, at least eight people have died in recent months from eating tainted peanut products. As Time magazine noted earlier this month, that’s “the latest in a series of black eyes for the FDA over unsafe foods, dangerous medicines such as Vioxx and allegedly cozy ties with the pharmacy industry it regulates.”

President Obama has pledged to reform the FDA. His expected choice to lead the agency, Margaret Hamburg, is a results-driven public-health expert. The FDA has the needed experience to regulate tobacco and should do the job well if managed properly.

In contrast, Burr and Hagan’s bill would create a new body, the Tobacco Regulatory Agency. It would be under the Department of Health and Human Services. The senators want to protect the tobacco industry. Their proposal would submit it to regulation that would be far less stringent than the FDA’s under the bill proposed by Rep. Henry Waxman, a California Democrat.

The Burr/Hagan bill is “a step in the right direction,” said Maura Payne, a spokeswoman for Reynolds American. “It increases the likelihood that there will be some science-based discussion about what methods of regulating the tobacco industry might be most effective at making substantial improvements in public health. It is a much better place to start that discussion than the Waxman legislation.”

Both bills impose fees on tobacco companies to pay for the regulation. The Burr/Hagan bill estimates the proposed new agency would cost about $100 million a year, the Raleigh News & Observer reported recently. FDA regulation would ultimately cost several times that amount. The latter would be a heavy price, but critics say the cost estimate of the proposed new agency is not enough to support effective regulation.
The Burr/Hagan bill does eliminate most tobacco advertising, as does the FDA bill, and it requires disclosure to the Tobacco Regulatory Agency of all ingredients. It requires consultation with the FDA and the national Centers for Disease Control and Prevention on products that claim to be safer. But it gives tobacco companies much influence in the regulatory process.

And most important, though the Burr/Hagan bill limits the amount of tar in cigarettes, it makes no further regulation of content. “We are interested in providing full disclosure to consumers and giving them the list of ingredients in the product, but we are not interested in the government changing what the definition of a cigarette is,” said Caitlin Legacki, a spokeswoman for Hagan.

The Waxman bill would allow regulation of amounts of nicotine and other toxic ingredients, as well as the elimination of ingredients. That’s a crucial provision.

The Burr/Hagan bill could lead to meaningful compromise on FDA tobacco regulation. Supporters of this bill and the Waxman bill could start the process by agreeing on maximum levels of toxic ingredients that will be allowed in cigarettes. Perhaps the regulation could begin with cigarettes, and phase in other tobacco products gradually.

The human and financial costs of smoking are undeniable. More stringent oversight of tobacco products is needed. It’s time for FDA regulation.

By SEAN MUSSENDEN
Media General News Service

WASHINGTON—President Barack Obama’s picks to fill the top two positions at the Food and Drug Administration have repeatedly bucked tobacco companies and pushed for greater restrictions on cigarette marketing, second-hand smoke and sales to minors.

Though the FDA does not currently regulate tobacco products, Congress is moving ahead on long-stalled legislation to give the agency oversight of cigarette companies.

That could give Obama’s choice to lead the agency, Dr. Margaret Hamburg, and her top deputy, Dr. Joshua Sharfstein, great sway over the industry.

As New York City’s heath commissioner in the 1990s, Hamburg fought for a total ban on indoor smoking in public places long before states and cities began adopting such aggressive restrictions.

And as health commissioner in Baltimore, Sharfstein pushed through an indoor smoking ban in the city that paved the way for a similar statewide ban.

Neither Hamburg nor Sharfstein have publicly signaled their intentions regarding tobacco oversight since being tapped for the posts.

Hamburg couldn’t be reached for comment and Sharfstein declined to comment through a spokesperson at the Baltimore health department. 

 Obama reiterated this month that he supports giving the FDA oversight of tobacco.

And on Wednesday, a key House committee approved a bill sponsored by Rep. Henry Waxman, R-Calif., that would do just that. The full House is expected to give its approval soon.

In the Senate, where the measure failed to pass last year, supporters of the FDA plan believe they have the votes to pass it in that chamber this year.  But Sen. Richard Burr, R-N.C., and Sen. Kay Hagan, D-N.C., have proposed an alternate plan to create a new federal agency to regulate tobacco that could again stall the FDA proposal.

Because the Waxman legislation would give agency officials flexibility to develop new cigarette warning label standards and marketing restrictions, anti-tobacco groups said it was important for Obama to have nominated people who have worked to reduce smoking rates.             

“The buzz has all been very positive,” Kathleen Dachille, director of the Center for Tobacco Regulation at the University of Maryland Law School, said of Hamburg and Sharfstein.

Dachille worked closely with Sharfstein to enact stricter smoking regulations after he was tapped to lead the city department in 2005. 

He was the leading advocate to ban smoking in all workplaces in Baltimore – restaurants and bars included – and fought hard for a similar statewide ban.  

The proposal stalled at the state level because of resistance from tobacco companies and the restaurant lobby. After Baltimore passed its own ban in 2007, opposition to a statewide ban dwindled.     

“Baltimore was a major tipping point, and he was able to accomplish that.  It was the key jurisdiction that opened the door to statewide legislation,” Dachille said.

Last year, Sharfstein also pushed to ban sales of single small cigars – brands like Black and Mild and Swisher Sweets – after a health department investigation found the inexpensive smokes were popular with inner city minors. 

While some young people couldn’t afford to buy a pack of cigarettes for $5, the investigation found they could easily scrape together enough change to buy a single small cigar that sold for less than $1.     

When the state legislature did not pass a restriction that would have required Maryland retailers to sell the cigars in packs of five or larger, Sharfstein issued his own five per pack minimum requirement in Baltimore, which became the first city to do so. 

The measure was opposed by R.J. Reynolds Tobacco Co., Philip Morris and other tobacco companies, who threatened to fight the new restriction in court.

Before joining the Baltimore health department, Sharfstein worked on tobacco policy issues including FDA regulation as an investigator for Waxman, then the chair of the House Oversight and Government Reform Committee.

In 2003, he helped write an investigative report that concluded that Philip Morris continued to lie about control of nicotine levels in its cigarettes and that R.J. Reynolds was not being truthful about marketing to minors.  

As New York City health commissioner in the early 1990s, Hamburg fought successfully to ban cigarette advertisements on city subways. 

In the mid-1990s, New York banned smoking in most restaurants.  At the time, few states and cities had taken that step, but Hamburg wanted the city to go even further. 

At the time, she backed a total indoor workplace smoking ban, something the state and city did not enact until 2003.

“In many respects, she was ahead of her times,” said Matthew Myers, president of Campaign for Tobacco-Free Kids, an anti-tobacco group.   “She has a demonstrated track record of working to reduce tobacco use that will hold her in good stead if Congress grants the FDA jurisdiction.”

A spokeswoman for R.J. Reynolds declined to comment on how Hamburg’s views on smoking could affect the company.

“The real issue is whether the Food and Drug Administration is going to be able to appropriately regulate tobacco, given that it is by all appearances too overburden to meet its current obligations monitoring food and drugs,” said spokeswoman Maura Payne.

Sean Mussenden can be reached at smussenden@mediageneral.com or 202-662-7668.

A House panel is expected to approve today sweeping tobacco regulation that would put the bill on pace for House passage far earlier in the congressional session than in the last Congress.The House Energy and Commerce Committee vote, expected this afternoon or evening, would give the Food and Drug Administration the power to police the tobacco industry.

The Family Smoking Prevention and Tobacco Control Act (H.R. 1256) is nearly identical to a bill the House passed by a wide margin last summer. The Senate did not take action last year.

Health advocates — comfortable their bill will pass the House again this Congress — are already looking to the Senate where they ran out of time last year.

Some Republican House members grumbled that the committee, which has nine new members, was rushing to action without holding hearings on the health issue.

Rep. Phil Gingrey, R-Ga., a physician, argued today that FDA should focus on securing the nation’s food supply first. He said people understand the dangers of cigarettes and smokeless tobacco, which are blamed for taking the lives of 442,000 people each year.

“What they don’t understand is why a child should die from eating a peanut butter and jelly sandwich,” Gingrey said.

The arguments were similar to last year’s House committee debate.

“There’s nothing new before us today,” said former committee chairman John Dingell, D-Mich. “But then as now, the Senate is the obstacle to getting this legislation passed into law.”

The measure has split the tobacco industry, with industry giants Altria, Inc., parent company of Philip Morris USA, and United Smokeless Tobacco favoring the bill.

Reynolds American and Lorrilard Tobacco have argued the bill’s marketing restrictions and expansion of health warning labels would freeze the competitive market, favoring arch rival Philip Morris.

Rep. Steve Buyer, R-Ind., is planning to introduce a Republican alternative bill to create a new tobacco harm reduction center within the Department of Health and Human Services. The center would combine smoking cessation programs with industry strategies to reduce the harm from tobacco products, Republicans said.

Aides to Sen. Richard Burr, R-N.C. said he may introduce a similar bill in the Senate.

With Democrats winning expanded majorities in the House and Senate last fall, neither bill is expected to receive much support.

Democrats contend FDA is the right agency to police tobacco. They would pay for the regulation through a tax on cigarettes that would start at about a penny per cigarette pack this year and rise to at least 5 cents per pack within a decade, generating between $85 million and $712 million per year, according to committee staff.

Rep. G.K. Butterfield, D-N.C., who represents the largest tobacco-producing district in the country and serves on the commerce committee, praised the proposal for protecting tobacco farmers. The bill will allow farmers to “continue to earn a living … so they can support their families and their communities,” he said.

Dr. Robert Califf may have a second shot at running the Food and Drug Administration.

The respected Duke University cardiologist and head of the Duke Clinical Research Institute is among people mentioned as possible candidates for FDA commissioner in the administration of President-elect Barack Obama.

WASHINGTON – The Food and Drug Administration, bedeviled by a salmonella outbreak and tainted medicine from China, is likely to monitor imports and fresh produce more closely under an Obama administration.

With President Bush no longer a roadblock, health officials also can expect new powers to control tobacco, from cigarettes to the recently introduced smokeless products called snus.

President-elect Obama, a former smoker struggling to avoid relapse, is a sponsor of legislation giving the FDA authority to control, but not ban, tobacco and nicotine.

Long seen as the government’s premier consumer protection agency, the FDA stumbled under Bush. Recurring drug and food safety lapses came against a backdrop of shrinking budgets and long periods without a permanent leader. In Congress, a senior Republican complained the FDA had gotten too cozy with industry.

Obama is being urged to move quickly to appoint an FDA commissioner. Already more than a half-dozen names are in circulation: outside critics such as Cleveland Clinic cardiologist

Dr. Steven Nissen; insiders such as Susan Wood, a former director of the FDA’s women’s health office; and public health advocates such as Dr. Joshua Sharfstein, Baltimore’s health chief. Food safety will be a priority for Obama’s FDA. “He thinks this is a fundamental role of government to ensure that people’s food is safe and he has been concerned that we are not in a position to ensure that,” said Neera Tanden, a senior campaign adviser.

Obama will be working with a Democratic-led Congress, including lawmakers who have written legislation to bolster import inspections.

Only a fraction of imported food is inspected now. Foreign drug manufacturing plants can go years without an FDA visit. Democrats had considered fees on industry to pay for more FDA inspectors, but could not persuade the Bush administration to go along. They expect Obama to be receptive.

Tanden said Obama is open to the idea of requiring a tracing system for fresh produce. That became an issue during this summer’s salmonella outbreak, after the FDA spent weeks hunting for tainted tomatoes only to find the culprit might have been hot peppers.

“An Obama administration would swing the pendulum back more to protection of public health,” said William Hubbard, a retired FDA official who held top posts. “This bodes well for greater regulation in the food safety area, on imports, and on drug safety.”

Under the tobacco proposal, the agency would be able to order changes in tobacco products to make them less toxic and addictive, but could not ban tobacco or nicotine. The bill passed the House and Senate with bipartisan support, but a veto threat from Bush kept it from getting out of Congress.

Aides to Sen. Edward M. Kennedy, D-Mass., co-author of the tobacco bill, say there is strong interest in getting the legislation passed soon after the new Congress convenes in January. Obama is a co-sponsor.

The FDA could receive new powers from an Obama administration in the field of biologic drugs. These medications are not made from chemicals but from living cells, and represent the cutting edge of medical treatment for many intractable diseases. Industry officials expect the Obama administration to work with Congress to create a legal framework for the FDA to review and approve generic versions of biologic drugs. Brand name biologics are very expensive, easily costing $1,000 a month or more.