Federal judge rules that tobacco industry lawsuit against FDA panel can go forward

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(CBS/AP) A federal judge has denied a Food and Drug Administration (FDA) motion to dismiss a suit filed by two of the nation's largest cigarette makers that claimed the advisory panel that reviewed tobacco products for the FDA had financial conflicts of interest.

FDA: Dissolvable tobacco better for health, but could lead to more users
FDA: Menthol makes it harder to quit smoking

In an order posted Wednesday, U.S. District Court Judge Richard Leon in Washington said that the suit filed by Lorillard Inc. and R.J. Reynolds Tobacco Co. can move forward. The suit filed last year alleges financial conflicts of interest and bias by several members of the Tobacco Products Scientific Advisory Committee and asks the court to stop the federal agency from relying on the panel's recommendations.

The panel is tasked with advising the FDA on tobacco-related issues, including the public health impact of menthol cigarettes and dissolvable tobacco, two industry growth areas.

"Because of the limited number of viewpoints on these issues, the scientific -- as opposed to political -- nature of those viewpoints, and the distinct responsibilities of the committee, I believe I have sufficient standards which I can evaluate the agency's discretion," Leon wrote in his order.

Representatives for the FDA and R.J. Reynolds would not comment on pending litigation.

In a statement, Lorillard said: "The practice of appointing members to a government scientific advisory committee who have financial interests that violate conflict-of-interest laws and regulations should be subject to judicial review, as the court has now recognized."

The FDA won the authority to regulate tobacco in 2009. The law doesn't let the FDA ban nicotine or tobacco, just regulate what goes into tobacco products, require the ingredients be publicized and limit how tobacco is marketed, especially to young people. The agency's panels advise it on scientific issues. It doesn't have to follow their recommendations, but usually does.

In the suit, the tobacco companies allege that the panel fails to meet the federal requirements that committee members should be fairly balanced and not inappropriately influenced by any special interest. The suit specifically alleges that some committee members have conflicts of interest because they were paid expert witnesses in anti-tobacco lawsuits and have financial ties to pharmaceutical companies that make smoking-cessation products.

The agency, however, argued that the panel meets federal standards and that the cigarette makers' "alleged injuries are entirely speculative," and "not fairly traceable." The FDA also argued that the court lacks jurisdiction to review the conflict of interest challenged raised by the companies.

Several cigarette makers, including Altria Group Inc., parent company of Philip Morris USA, had previously asked the federal agency to remove members of the panel for conflicts of interest. Altria is not part of the suit.

Lorillard, based in Greensboro, N.C., holds about 35 percent of the U.S menthol market with its top-selling Newport brand. R.J. Reynolds and its parent company, Reynolds American Inc., based in Winston-Salem, N.C., sell brands like Camel and Pall Mall, as well as several dissolvable tobacco products -- finely milled tobacco pressed into shapes like tablets that slowly dissolve in a user's mouth.

Vince Willmore, a spokesman for the Campaign for Tobacco-Free Kids, said the suit is an effort by the tobacco companies to "obstruct effective policies to reduce tobacco use and to discredit anyone who advocates such policies."

The suit comes amid two advisory panel reports mandated by the law that gave the FDA authority to regulate the tobacco industry.

A panel report issued last March said removing menthol cigarettes from the market would benefit public health because the flavoring has led to an increase in smokers -- particularly among teens, African Americans, and those with low incomes. It also said that they make it harder for them to quit. The report, however, said menthol smokers are not likely to be at a higher risk of disease or exposed to a greater number of toxins. They did not advise for a full ban because they thought it may increase the likelihood of smuggling and counterfeit cigarettes. In their own independent research, the tobacco industry claimed to the FDA that menthol cigarettes does not increase health risks compared to other cigarettes and shouldn't be banned. The FDA is conducting an independent review on the issue.

In a report earlier this year, the panel said that dissolvable tobacco products could reduce health risks compared with smoking cigarettes but also could increase the overall number of tobacco users. Dissolvable tobacco products are gaining the attention of tobacco companies looking to make up for a decline in cigarette use as smokers face tax hikes, growing health concerns, smoking bans and social stigma. The panel also noted a lack of research on dissolvable products.

[tobnomore]

I see the paid goons of the tobacco industry are already posting here.

The tobacco industry pays 10s of millions to lobbyists and bogus research institutes each year supporting its murderous agenda. The amounts funding anti tobacco lobbying are dwarfed by these efforts. All foundations supporting scientific research in the US are taxed at lower rates. This includes the Howard Hughes Medical Institute, the American Heart Foundation, the Susan Komen Foundation for Breast Cancer and many others that funded eminent scientific breakthroughs making the US the world leader in medical research.

The FDA panel members are distinguished scientist and physicians with outstanding expertise in their respective research areas that is frequently requested by the government and initiatives to develop treatments for smoking cessation. Smoking cessation treatments have saved many smokers from death from cancer and emphysema and reduced the customer base of the tobacco industry. Of course they are wailing and fighting tooth and nail against FDA control of menthol and dissolvable products. More and more studies have shown that menthol smoking increases morbidities with higher frequencies of stroke and other conditions. Second hand smoke has been shown to increase asthma in children.

The efforts of the tobacco industry in the US only distract from the huge increase in sales of their addiction products in developing countries in Asia, Africa and South America, adding hundreds of millions of smokers world-wide and dwarfing the markets in the western world. This will cause a huge health crisis in the next decades with millions of cancer and emphysema deaths.

The US is fighting two wars and numerous campains against Al Qaeda, spending 1000s of lives and trillions to defeat an organization that killed 3000 Americans. In the meantime, CDC calculated that tobacco products have killed more than 400,000 Americans per year, more than 4 million Americans since 9/11 ! It is time we end the wars and fight the real fight at home against the real enemy. Each life taken by tobacco is one life too much !

[tobnomore]

I see the paid goons of the tobacco industry are already posting here.

The tobacco industry pays 10s of millions to lobbyists and bogus research institutes each year supporting its murderous agenda. The amounts funding anti tobacco lobbying are dwarfed by these efforts. All foundations supporting scientific research in the US are taxed at lower rates. This includes the Howard Hughes Medical Institute, the American Heart Foundation, the Susan Komen Foundation for Breast Cancer and many others that funded eminent scientific breakthroughs making the US the world leader in medical research.

The FDA panel members are distinguished scientist and physicians with outstanding expertise in their respective research areas that is frequently requested by the government and initiatives to develop treatments for smoking cessation. Smoking cessation treatments have saved many smokers from death from cancer and emphysema and reduced the customer base of the tobacco industry. Of course they are wailing and fighting tooth and nail against FDA control of menthol and dissolvable products. More and more studies have shown that menthol smoking increases morbidities with higher frequencies of stroke and other conditions. Second hand smoke has been shown to increase asthma in children.

The efforts of the tobacco industry in the US only distract from the huge increase in sales of their addiction products in developing countries in Asia, Africa and South America, adding hundreds of millions of smokers world-wide and dwarfing the markets in the western world. This will cause a huge health crisis in the next decades with millions of cancer and emphysema deaths.

The US is fighting two wars and numerous campains against Al Qaeda, spending 1000s of lives and trillions to defeat an organization that killed 3000 Americans. In the meantime, CDC calculated that tobacco products have killed more than 400,000 Americans per year, more than 4 million Americans since 9/11 ! It is time we end the wars and fight the real fight at home against the real enemy. Each life taken by tobacco is one life too much !

[wakeupall]

This is so laughable! "Vince Willmore, a spokesman for the Campaign for Tobacco-Free Kids, said the suit is an effort by the tobacco companies to "obstruct effective policies to reduce tobacco use and to discredit anyone who advocates such policies." Want to know why Willmore is saying this? Because Tobacco-Free Kids was created and funded with $84,000,000 in start-up money by the Robert Wood Johnson Foundation. RWJF is the philanthropic front group for Johnson & Johnson. J&J makes Nicorette gum, Nicorette lozenges, Nicoderm, and Nicoderm CQ. TFK's not defending the credibility of those on the FDA panel who have received funding (grants, awards, etc.) from RWJF, they're defending their OWN credibility! Look at the funding the FDA panel has received from RWJF, J&J, Pfizer and GSK. In fact, someone should be investigating the HUGE financial ties to big pHARMa by the members of the 2000 and 2008 Guideline Panel "Treating Tobacco Use and Dependence"! They're now recommending to the FDA that there be PERMANENT use of NRT products instead of limiting the 12 week use. Maybe someone should study the effects the nicotine gum has on users! They call it "nico crack" - see for yourselves http://www.askapatient.com/viewrating.asp?drug=18612&name=NICORETTE

[LadyGoodmann]

1. If the tobacco companies are so concerned with the influence of special interests on regulators and law-makers, then they should shove all of their parasitic lobbyists back under the rocks from which they came.

2. If we applied this standard to all government officials, we could shove every last one of them back under the rocks from which they came.

3. Menthol cigarettes are more addictive because they have more fiberglass in the filters, which makes eety-beety cuts in your mouth, throat and lungs, thereby facilitating faster delivery of nicotene to the brain.

4. These evil bastards have diversified and now own "food" companies, e.g., RJ Reynolds owns Kraft. All of them are using the same tactics to poison us with so-called food they use to poison us with cigarettes.

Rule #1: DON'T KILL THE CUSTOMER. That way, you don't have spend so much money on manipulating children into consuming your products in order to replace the adults you kill. I believe "replacement smokers" is the industry term.

[harleyrider1778]

Your beloved report on ETS wasn't even written by real EPA scientists, who were against calling secondhand smoke a human carcinogen. It was written by handpicked anti-smoking activists, using illegal pass-through contracts. And on the board of directors of the crooked EPA contracting firm, ICF, sat President George H.W. Bush's campaign manager, Fred Malek, along with a prominent Democrat.

http://www.smokershistory.com/etslies.htm

And, all their so-called "independent" reports were ring-led by the same guy, Jonathan M. Samet, including the Surgeon General Reports, the EPA report, the IARC report, and the ASHRAE report, and he's now the chairman of the FDA Committee on Tobacco. He and his politically privileged clique exclude all the REAL scientists from their echo chamber. That's how they make their reports "unanimous!" Now, tell me how many of those doctors whose opinion you think we're supposed to respect even know about these things. As long as they don't know, it is irrelevant how many ignorant, clueless and/or malice-ridden quacks you trot out.

Johnathan Sammet is the lead on the FDA panel!