News: FDA Regulation AGAIN! Page 3

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Cynicism and Big Tobacco
April 22, 2008
Congress wants to give regulators more authority over the tobacco industry – so what else is new? The surprise is that currently there are no plans to give it to the Environmental Protection Agency. Surely cigarette smoke qualifies as a dangerous pollutant.
Not that Congress needs any ideas, but handing off tobacco to the EPA makes about as much sense as its nearly completed pass to the Food and Drug Administration. A bill expected to be voted on soon would impose new restrictions on marketing, raise cigarette taxes, and police the ingredients in tobacco products, including nicotine levels. Any reckless FDA policy is bound to be popular, and sure enough, the bill has 220 co-sponsors in the House and 54 in the Senate, including all three Presidential contenders.
This is all phenomenally cynical, even for Congress. Since the 1964 Surgeon General’s report, the health consequences of this hazardous if legal product have been ubiquitous, which no doubt accounts for the 58% plunge in smoking among U.S. adults. The FDA tobacco gambit is explainable only because the politicians have dumped public health for public revenue.
The 1998 litigation settlement between 46 states and the industry was supposed to recoup the Medicaid costs of treating sick smokers, but the $150 billion payout was promptly redirected to other political priorities. The feds joined in the shakedown, building a $280 billion racketeering case that resulted in a mere $10 billion in 2006. Government has also bought a stake in lucrative tobacco profits by using cigarette taxes as the first-resort fundraiser for new domestic programs, most recently last fall’s abortive Schip expansion.
The FDA bill would further prop up this tobacco-politician partnership, by prohibiting the agency from banning tobacco products, and – to buy the support of Big Tobacco – by creating protections against smaller competitors. Existing products would be grandfathered in, but new ones would be subject to premarket approval and advertising curbs, effectively freezing the market. The industry would also be relieved from further lawsuits, since it could claim compliance with FDA product-safety scrutiny. Philip Morris, maker of the No. 1 Marlboro brand and the world’s largest tobacco company, is understandably thrilled by the proposal.
The FDA is not as lucky. The agency is barely capable of managing its existing workload, which includes responsibility for about 25 cents out of every dollar spent in the U.S. FDA Commissioner Andrew von Eschenbach told Congress in October that the $5 billion in “user fees” over the next decade wasn’t enough to kickstart a tobacco division and that the FDA “may have to divert funds from its other programs.”
The FDA’s own advisory panels say it lacks the expertise and resources to keep pace with scientific advances. So of course it makes sense that the agency will continue to do more things badly instead of a few priorities well. And as if the FDA wasn’t already hypersensitive to political pressure, now it will take over a political motherlode.
Mr. von Eschenbach also pointed out that the legislation actively undermines his core mission, which is to promote public health. FDA regulations are devised to prove that medical therapies are safe and effective. When used as directed, cigarettes produce disease. The logical response – if the FDA is going to be implicated in what ought to be a matter of individual responsibility – should be to remove cigarettes from the market.
But since Capitol Hill has cut itself in on the business, Congress will instead apply every other regulation for pharmaceuticals and medical devices short of prohibition to new tobacco products. For instance, only “modified risk” cigarettes will be allowed onto the market. Manufacturers will have to prove not that they are “safe,” but that they are less likely to lead to lung cancer, emphysema, etc., requiring long-range randomized clinical trials. In the absence of any therapeutic benefits from smoking, this is unethical, not to mention unscientific.
All the more so because it contradicts the premise of the federal government’s case against Big Tobacco. Initiated by Janet Reno and continued by the Bush Administration, the federal suit argued that the industry committed fraud by falsely implying that light or low-tar cigarettes were healthier than standard smokes. Now Congress wants the FDA to mandate less nicotine and tar – the very practices it once claimed to find so odious.
In a final irony, the politicians backing this bill, especially sponsors Ted Kennedy and Henry Waxman, are the same ones demanding that the FDA crack down on “Big Pharma.” They say it isn’t doing enough to protect the public from risky but possibly beneficial new drugs. So: Lend the FDA imprimatur to an inherently dangerous product to fatten it up for taxation, while at the same time slow down or block the approval of life-saving therapies that treat disease instead of cause it. Congressional priorities are rarely so grotesque.
http://online.wsj.com/article/SB120882121714933013.html 

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Support of FDA Tobacco Legislation is Devoid of Substance; Television Debate Between Jacob Sullum of Reason and Dick Woodruff of ACS is Very Revealing
April 8, 2008
By Michael Siegel
In a news segment on CNBC yesterday, the station featured a debate on the FDA tobacco legislation between Jacob Sullum, senior editor at Reason Magazine (who opposes the legislation), and Dick Woodruff, senior director of the American Cancer Society’s Cancer Action Network (who supports the legislation).
I urge readers to listen to this segment, because I find it very revealing. Beyond the fact that Woodruff was quite rude (interrupting Sullum on the first question, which was directed to Sullum, and answering the question himself – Sullum waited patiently and courteously until Woodruff was finished and he was called on), the most telling thing to me was the fact that the American Cancer Society representative offered no substance to support his position, while Sullum offered several compelling substantive points which were not addressed by his opponent.

The only point which the American Cancer Society seemed capable of making was that this is “very important legislation” that will help the kids. Woodruff repeated this argument over and over, but offered no argument or explanation of why this legislation is important or how it will protect kids. He asserted that the legislation will stop tobacco industry marketing to youths, but offered no explanation for how that would occur. He asserted that the legislation would curtail youths’ addiction to cigarettes, but offered no explanation for how that would occur. In sum, he presented no evidence to back up any of his assertions about the legislation. It was support without substance.

In contrast, Sullum made several very specific arguments, backed by evidence, to argue that the legislation would actually be harmful to the protection of consumers.

First, the legislation would harm consumers by allowing the FDA to reduce (but not eliminate) nicotine levels. Research shows that this would result in people smoking more, and thus being exposed to higher doses of toxic and carcinogenic tar. The result would be increased disease and death among smokers.

Second, the legislation would harm consumers by making it impossible for safer cigarettes to enter the market. The legislation places insurmountable obstacles to the introduction and approval of safer cigarettes. It essentially freezes the current market, ensuring that competition from smaller companies which might seek to market safer cigarettes is stifled. In addition to protecting the leading company – Philip Morris – from competition, the legislation essentially ensures that the current mix of cigarettes on the market will be sustained in perpetuity. The legislation stifles what might otherwise be a free market competition to produce a truly reduced risk cigarette.

Third, the legislation would harm consumers by interfering with the accurate communication of relative risks of various tobacco products. For example, companies could not state that smokeless tobacco is a less hazardous alternative to smoking cigarettes, even if they could support that statement with extensive documentation.

Interestingly, Woodruff failed to respond substantively to any of these points. He merely reiterated his rhetoric about how this is important legislation that will protect kids.

What is so frustrating to me about this interview is that it seems the anti-smoking movement is no longer able to respond substantively to its critics. It is no longer able to provide a science-based, evidence-based argument in support of a federal tobacco control policy it favors. It has become a purely political movement, advancing political rhetoric that is devoid of scientific, rational, or evidential substance.

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FDA-Approved Cancer Sticks
The difference between preventing smoking and protecting smokers
Jacob Sullum | April 9, 2008
Last week the House Energy and Commerce Committee overwhelmingly approved legislation that would authorize the Food and Drug Administration to regulate tobacco products. Since the FDA is usually portrayed as a benevolent (if occasionally sleepy) watchdog, you might assume the bill is all about consumer protection. But it’s actually aimed at consumer prevention, which is not quite the same thing.
A consumer protection bill that reduced competition, raised prices, restricted choice, blocked information, and made products more hazardous could not really be counted as a success. Yet the Family Smoking Prevention and Tobacco Control Act, which has broad support in both houses of Congress, promises to do all these things in an effort to discourage consumption.
The act imposes new regulatory burdens and advertising restrictions that will help industry leader Philip Morris, which supports the bill, maintain its market-share advantage over smaller cigarette manufacturers, which oppose the bill. The compliance costs and reduced competition are likely to raise prices, which counts as an advantage if your goal is “smoking prevention” but a disadvantage if your goal is to buy a pack of cheap smokes.
Likewise, the bill restricts variety, which consumers like but public-health paternalists do not. Under the act, smokers will be allowed to choose any cigarette flavor they like, as long as it’s menthol (which happens to be the one flavor Philip Morris uses). Although people above the age of 18 have been known to enjoy the occasional clove cigarette, Camel Crema, or Kool Caribbean Chill, these flavored varieties have been deemed too kid-friendly and therefore inconsistent with the goal of smoking prevention.
While added flavors (except for menthol) are unambiguously evil, toxins and carcinogens may have a positive role to play if they discourage people from smoking by raising the specter of cancer, heart disease, and emphysema. Hence the bill instructs the FDA to approve a “modified risk tobacco product” only if it would “benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.”
To make that judgment, the FDA is supposed to consider “the increased or decreased likelihood that persons who do not use tobacco products will start using the tobacco product that is the subject of the application” as well as “the increased or decreased likelihood that existing users of tobacco products who would otherwise stop using such products will switch to the tobacco product that is the subject of the application.” In other words, the FDA could decide to keep a demonstrably safer cigarette off the market because it might attract new smokers or dissuade current smokers from quitting.
Worse, an existing product can be deemed a “modified risk tobacco product” subject to FDA approval if its manufacturer indicates on the package, in advertising, or in any other forum that it’s less hazardous than cigarettes. If an executive at a smokeless tobacco company mentioned in a TV interview or an op-ed piece that his products were much safer than cigarettes, which is indisputably true, those products could suddenly be considered illegal.
Here the concern is not fraud but accurate information that consumers might “misuse” (by, for example, switching from cigarettes to oral snuff instead of giving up tobacco altogether). As far as this bill’s authors are concerned, you can’t handle the truth.
The bill not only authorizes the prohibition of safer tobacco products and the censorship of potentially lifesaving information about relative risks; it gives the FDA permission to make cigarettes more dangerous by ordering reductions in nicotine content. Such a mandate, aimed at making cigarettes less attractive to new smokers, would force current smokers to absorb higher levels of toxins and carcinogens to obtain their usual doses of nicotine.
According to its supporters, this bill, backed by the biggest tobacco company, will enable the FDA to protect smokers from Big Tobacco. Who will protect smokers from the FDA?

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US House panel backs bill giving FDA tobacco power
April 2, 2008

A U.S. House of Representatives committee on Wednesday passed a bill for the first time that would give the Food and Drug Administration broad authority to regulate tobacco.

Funded exclusively by millions of dollars of user-fees levied on the industry, the bill would give power to the FDA over cigarettes and other forms of tobacco, an idea backed by public health groups, some tobacco companies and many Democrats.

Supporters cited the grim public health toll of smoking, which is the biggest preventable cause of death in the United States, responsible for 400,000 deaths and $100 billion in health care costs annually.

“It’s hard to believe that the FDA regulates toothpaste but not cigarettes,” New Jersey Democrat Frank Pallone said in backing the bill. “This will force companies to substantiate claims” about the risks of cigarettes, he said.

The bill passed the House Energy and Commerce committee in a 38-12 vote and would authorize the FDA to police cigarette labeling, restrict sales, prohibit flavored cigarettes and recall tobacco products seen as unreasonably harmful.

The FDA would also have to approve all new cigarettes and other tobacco products, and set standards for so-called reduced-risk products. The agency would not be empowered to ban cigarettes or require nicotine levels of zero under the bill.

Total fees to fund the new activities would be ramped up from $85 million in the first year to $712 million in the tenth year and beyond. The fees would be assessed based on market share per product for each tobacco company.

The bill’s most vocal proponent from industry has been the nation’s largest cigarette maker, Philip Morris, a unit of Altria Group Inc (MO.N: Quote, Profile, Research). The legislation has recently won support from a host of smaller tobacco companies and retailers.

After a decade of failed efforts in the House, backers said the tide has turned with most of the public opposed to smoking, and lawmakers less tied to tobacco interests.

“It’s a different day in Congress on tobacco,” said Gregg Haifley, director of federal relations with the Cancer Action Network. “Finally public health is winning.”

The bill is expected to pass the full House, but will face a tougher fight in the Senate where it is procedurally easier to block bills.

Last August, a Senate committee endorsed a similar bill with the support of health groups and Altria.

Since then, the bills have picked up significant bipartisan support on Capitol Hill. The House measure now has about 220 co-sponsors, while the Senate version has at least 55.

Some companies say the bill could spur industry consolidation because bigger companies would be best able to comply with it. A provision was added to the House bill requiring the Federal Trade Commission to study the impact the law would have on competition in the industry.

Some tobacco companies have opposed FDA regulation and the White House is wary of the idea. Continued…

A U.S. Health and Human Services spokesman said the Bush Administration has “significant concerns” about the bill, and is worried it would load new responsibilities on the FDA and possibly create a misconception that tobacco is safe.

FDA Commissioner Andrew von Eschenbach, a Republican appointed by President George W. Bush, has said the bill would be extremely difficult to implement.

Reynolds American Inc (RAI.N: Quote, Profile, Research), maker of Camel cigarettes, staunchly opposes the bill, saying, like many Republican lawmakers, that the FDA is already stretched thin just regulating drugs and food.

Reynolds has been running advertisements in districts of lawmakers with tobacco interests.

“It’s not the FDA’s role in my opinion to be the cigarette cops on the beat,” said Rep. Joe Barton of Texas, the ranking Republican on the committee.

Barton and some other Republicans suggested that another agency, such as the Federal Trade Commission, would be a more appropriate authority.

Parts of the bill giving smaller tobacco companies more time to comply and requiring foreign tobacco products to be subject to the same rules won over some prior opponents.

“In my home district of eastern North Carolina, tobacco is more than just an agricultural product, it is a livelihood,” said Rep. G.K. Butterfield, a Democrat who now supports the bill. (Additional reporting by Kevin Drawbaugh, editing by Gerald E. McCormick and Tim Dobbyn)

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McCain’s stand on tobacco is put to test
Senator steps back on oversight measure

March 26, 2008
By Michael Kranish, Globe Staff

WASHINGTON – Ten years ago, Senator John McCain took on the tobacco industry, saying he would never back down from legislation to regulate the industry. He also supported a $1.10-per-pack tax on cigarettes to fund programs to cut underage smoking. “I still regret we did not succeed,” he said as recently as last October.

Now, McCain’s longtime effort to crack down on tobacco is being put to a new test. Within weeks, the Senate is expected to vote on legislation to allow the Food and Drug Administration to regulate tobacco. McCain agreed months ago to cosponsor the current bill with Senator Edward M. Kennedy, but McCain’s policy adviser said the senator won’t commit to voting for it until he sees the final legislation.

McCain has also dropped his support for increasing cigarette taxes. Last year, McCain voted against legislation that would have used a 61-cents-per-pack tax to expand a children’s health program. He told a television reporter earlier this year that he would have a “no new taxes” policy as president.

McCain’s decade of work on tobacco, one of the most significant efforts of his congressional career, has earned him enmity from the industry and from some fellow Republicans over the years. At the same time, public-health advocates have celebrated his support of tobacco regulation. But now, some antismoking activists are disappointed that the presumptive Republican nominee for president has backed off from the tobacco tax, which they consider key to improving public health.

Matthew Myers, president of Campaign for Tobacco-Free Kids, said McCain’s support for regulating tobacco has been notable because of his “passion and commitment . . . he devoted countless hours to it.” Myers’s group has labeled McCain “one of the good guys” on the issue. But Ron Pollack, president of Families USA, a nonprofit healthcare advocacy group, said it is “disingenuous” for McCain to oppose the 61-cents-per-pack tax for the children’s health program when he supported the $1.10-per-pack tax in the 1998 tobacco bill. “He very much trimmed his sails on that,” Pollack said.

When asked during a policy forum in October why he opposed the tobacco tax for the children’s health program, McCain seemed to reject the logic that taxing tobacco would reduce its use, and instead suggested the government would be profiting from a dangerous practice.

“Now help me out here: We are trying to get people not to smoke, and yet we are depending on tobacco to fund a program that’s designed for children’s health?” McCain said. “I can’t buy that.”

McCain and tobacco have long been intertwined. He wrote in his autobiography that he was a heavy smoker and noted that he once dated the daughter of a North Carolina tobacco magnate. But at the urging of his second wife, Cindy, McCain quit smoking at the time of their marriage in 1980, according to friends.

In 1997, when he was chairman of the Senate Commerce Committee, Republican leaders asked him to get involved in negotiations to expand a landmark settlement between state attorneys general and tobacco companies, in which the companies ultimately agreed to give $368 billion to the states.

McCain, who previously had said little publicly about tobacco, jumped on the issue, saying he wanted to ensure the money was spent wisely on public health. During negotiations with the Clinton administration, he agreed to back an additional measure, the $1.10-per-pack tax hike, with the money to be used for programs designed to cut underage smoking, among other health measures.

Philip Morris USA, a tobacco company, originally viewed McCain as a key ally. In an internal company memo, a company official described McCain as having “supported the industry on most issues of interest to us over the years.”

But the memo, part of a file released as part of the tobacco settlement, said McCain had become “very discouraged” by the release of documents that raised questions about the industry’s truthfulness.

The memo noted that among the Philip Morris representatives slated to attend a meeting with McCain was Charlie Black, who was a lobbyist for the tobacco company and is now McCain’s senior campaign adviser.

In an interview, Black said McCain initially welcomed industry representatives to make their case in various ways and said the Arizona Republican wanted to strike a compromise that would satisfy the industry and public-health advocates.

During this period, McCain’s falling out with the industry intensified, not least because he backed the $1.10-per-pack tax. The industry ended up spending an estimated $40 million to defeat the bill, one of the most expensive campaigns against a piece of legislation at the time, with McCain as the primary target.

“Is there anybody left in Washington who thinks that the McCain Tobacco Tax Bill is all about kids? . . . Contact your member of Congress now and tell them you oppose the McCain Tobacco Tax,” said a typical newspaper advertisement, paid for by Philip Morris and several other tobacco companies.

McCain confronted the tobacco lobbyists, according to Black.

“He called me and said: ‘Look, I’m not talking to you anymore about tobacco. I’m going the other way,’ ” Black said. “I said, ‘You’re kicking us out our your office?’ He said, “That’s right.’ “

Black said he didn’t talk to McCain about tobacco legislation after that, although Philip Morris continued to aggressively target McCain in its campaign against the bill. Black stopped working for the company in 2001 and said he hasn’t discussed any issues related to his clients with McCain while serving as the senator’s senior adviser in the current campaign.

With public opinion against tobacco companies at a low point, McCain’s bill passed out of his Senate Commerce Committee by a 19-to-1 vote.

But Republicans leaders began to object to the bill, which included both the regulation of tobacco and the new tax. Trent Lott of Mississippi, the Senate majority leader at the time, said his constituents weren’t interested in the issue. Newt Gingrich, who was speaker of the House, blasted McCain and his backers. “They want bigger bureaucracies. They want higher taxes. They want more government. What does that have to do with smoking?” Gingrich said.

McCain was undeterred. Appearing on “The NewsHour with Jim Lehrer” on April 21, 1998, McCain was asked whether he would give up in the face of objections from the Republican leadership.

“Never,” McCain responded.

Taking to the Senate floor one month later, McCain excoriated the industry. “They have sacrificed the truth and our children to their greed,” he said.

After a monthlong debate, McCain fell three votes short of the needed 60 to end a filibuster.

Two years later, when McCain made his first run for the presidency, the tobacco legislation proved particularly unpopular in the crucial state of South Carolina, which held the nation’s second primary. A group funded by the tobacco industry ran ads that pilloried McCain’s support of a tax hike on cigarettes. McCain’s main opponent, George W. Bush, benefited from the fallout; it helped him win the state.

The issue could again become a focus of a presidential campaign – but because of McCain’s opposition to taxing cigarettes, rather than his support for it.

When McCain won backing for the tobacco regulation bill with the $1.10-per-pack tax 10 years ago, he issued a news release saying: “The problem of youth smoking is not a bipartisan issue – it’s a nonpartisan issue . . . The health and well-being of America’s children is a cause that transcends party affiliation.”

The two Democratic contenders, Senators Hillary Clinton and Barack Obama, are supporting the current proposal for a 61-cents-per-pack tobacco tax to expand the children’s healthcare program, a tax increase McCain opposes, making it likely that the matter will become an issue in the campaign this fall.

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Tobacco Control Bill Advancing in Congress

March 12, 2008
By Susan Jones, CNSNews.com Senior Editor

(CNSNews.com) – A House subcommittee on Tuesday approved a bill that would grant the U.S. Food and Drug Administration the authority to regulate tobacco products.

Anti-smoking activists hailed the Family Smoking Prevention and Tobacco Control Act as a way of protecting the nation’s health and curbing smoking among children. But at least one tobacco company objects to giving the FDA “overly broad authority.”

“This is a very strong bill that provides the FDA with ample resources and effective authority to bring about fundamental change that will promote public health,” said the Campaign for Tobacco-Free Kids.

The anti-smoking group said tobacco use kills more than 400,000 people and costs nearly $100 billion in health care bills each year. It also says tobacco companies take advantage of a lack of regulation to design and market products that entice children, create and sustain addiction to nicotine, and discourage current smokers from quitting.

The bill passed by the House Energy and Commerce Subcommittee on Tuesday would allow the FDA to restrict tobacco ads; ban candy-flavored cigarettes; require companies to disclose the contents of tobacco products; and remove or reduce harmful ingredients such as nicotine.

The bill also would ban health claims about “reduced risk” products; prohibit terms such as “low-tar,” “light” and “mild”; and require larger, more effective health warnings on tobacco products.

The legislation would prohibits tobacco manufacturers from claiming that any tobacco product has been approved by the FDA.

Tobacco companies would have to pay fees to cover the cost of regulating tobacco. The higher cost ultimately would be borne by smokers.

A companion bill passed a Senate panel on Aug. 1. Anti-smoking activists insist that Congress has the votes to pass the bill — and they’re urging quick action.

“By enacting this legislation into law this year, Congress can finally end the special protection the tobacco industry has enjoyed for far too long and instead protect our children and the nation’s health,” the Campaign for Tobacco-Free Kids said.

Some tobacco companies support the Family Smoking Prevention and Tobacco Control Act. Philip Morris USA said it believes FDA regulation would bring “predictability and clear standards” to the tobacco industry.

The bill in question “establishes a regulatory structure and standards for the manufacturing and marketing of all tobacco products that will provide its greatest benefits to tobacco consumers,” Philip Morris said on its Web site.

But R.J. Reynolds Tobacco Company said the Family Smoking Prevention and Tobacco Control Act should serve only as a “starting point” for a national discussion on tobacco. While the company agrees with some of the bill’s provisions, it objects to others.

The bill, according to Reynolds, would give the FDA “overly broad authority” over the tobacco industry.

The company also said the bill raises “serious constitutional/free speech issues” with its limitations on advertising and marketing. It said dramatic reductions in nicotine levels might affect “consumer acceptability.”

“We also have a concern over what appears to be developing as a rush to judgment and passage by Congress,” Reynolds said on its Web site.

Congress tried to give the FDA authority to regulate tobacco products in 2004, but the effort failed. Similar legislation introduced in 2005 also died.

FDA Commissioner Andrew von Eschenbach has raised a number of concerns about FDA regulation of tobacco.

Last year, he warned that smokers might smoke more cigarettes and inhale more deeply if nicotine levels are reduced. He also expressed concern about the public misinterpreting FDA “regulation” for FDA “approval” of tobacco products.

Von Eschenbach also has questioned whether regulating tobacco would cost the FDA more money than Congress will give the agency for that purpose.

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FDA tobacco legislation is on hold for now
December 13, 2007
By Sean Mussenden
WASHINGTON – A plan to give the Food and Drug Administration the power to regulate cigarettes is on hold for now, but supporters said today it likely will resurface in Congress early next year.
“By no means is it dead,” said William V. Corr, executive director of the Campaign for Tobacco-Free Kids, a public health advocacy group that has long sought FDA regulation of cigarettes.
Supporters of a pair of similar bills in the House and Senate – including several leading anti-smoking and cancer research groups – argue that FDA regulation would further curtail tobacco marketing messages aimed at young people and bring about a reduction in cigarette nicotine levels.
Opponents – including the Bush administration -argue that tobacco oversight by an agency charged with protecting public health could fool smokers into thinking cigarettes are safe.
Fifty-four senators are co-sponsoring the Family Smoking Prevention and Tobacco Control Act.
It passed a key health committee earlier this year and likely will come to a vote in the full Senate “early next year,” said Melissa Wagoner, a spokeswoman for Sen. Edward M. Kennedy, D-Mass.
In the House, more than 200 representatives have lined up as co-sponsors, but the bill has not yet emerged from committee. A committee vote could come “early in the new year,” Wagoner said.
Though the proposal has attracted strong support in both the House and Senate, it still faces significant hurdles.
Sen. Richard Burr, R-N.C., who opposes the legislation, earlier this year promised a filibuster if necessary to prevent a vote if it reaches the Senate floor. At least 60 votes are needed to overcome a filibuster.
“He’s going to continue to find a way to improve tobacco products in a way that makes sense and does not harm North Carolina farmers,” said his spokesman Chris Walker.
Should Congress eventually approve it, the Bush administration has signaled its clear opposition to the legislation.
In an October letter to the House health subcommittee, which held a hearing that month on tobacco regulation, FDA Commissioner Andrew von Eschenbach wrote that “approval of tobacco products that are dangerous to health even if used as directed runs directly counter to FDA’s historical mission to protect and promote public health.”
Rep. Henry Waxman, D-Calif., a lead sponsor of the legislation in the House, discounted that argument at the October hearing.
“Some have raised concerns that FDA is not the right agency for this job. I disagree. No other agency shares FDA’s strong, scientific foundation, together with a public health mission and comprehensive regulatory authority,” he said.

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