Tobacco.org

• FDA warns Web companies not to sell flavored cigs 

The Food and Drug Administration said Friday that it has warned several companies to stop selling banned flavored cigarettes to U.S. consumers online.

The agency sent letters this week to more than a dozen Web-based companies saying they are violating a new ban and asking the companies to describe in writing what action they have taken to comply.

The FDA banned candy-, fruit- and clove-flavored cigarettes in September. Federal health authorities and regulators say those products appeal especially to young people and are thought to attract new smokers.

"FDA takes the enforcement of this flavored cigarette ban seriously," Dr. Lawrence R. Deyton, director of FDA's Center for Tobacco Products, said in a statement. "These actions should send a clear message to those who continue to break the law that FDA will take necessary actions to protect our children from initiating tobacco use."

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AAFP Offers Guidance on FDA Tobacco Regulation 

The AAFP has weighed in with numerous suggestions to a July request from the FDA for public input on how the agency should implement its newfound authority to regulate tobacco.

The FDA gained the authority to regulate the manufacture, marketing and distribution of tobacco products to protect public health and reduce tobacco use in minors when President Obama signed the Family Smoking Prevention and Tobacco Control Act in June.

In its comments, the AAFP lauded the agency's recent ban on cigarettes with fruit, candy or clove flavoring and suggested the agency go a step further by forcing manufacturers to remove menthol as a flavoring agent.

The Academy also recommended that the FDA

* ban single sales of little cigars to reduce initiation of smoking among adolescents;

* broaden restrictions on misleading information on cigarette packaging;

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• State Medicaid Coverage for Tobacco-Dependence Treatments --- United States, 2007 

The prevalence of tobacco use among adults in the United States has been reduced by half since the 1960s (1,2). Despite this progress, low-income populations, such as Medicaid enrollees, continue to smoke at substantially higher rates than the general population (33% versus 20%) (1). The Public Health Service's Clinical Practice Guideline (2) and the Partnership for Prevention's Call for ACTTION (3) recommend comprehensive insurance coverage of tobacco-dependence treatments without barriers such as copayments, limitations in duration of treatment, prior authorization, and stepped-care therapy. Healthy People 2010 aims to expand coverage of evidence-based treatments for nicotine dependency to all 51 Medicaid programs (objective 27-8b) (4). To monitor progress toward that objective, in 2007, the Center for Health and Public Policy Studies at the University of California, Berkeley, surveyed all 51 Medicaid programs. This report summarizes the results of that survey, which found that 43 (84%) programs offered coverage for some form of tobacco-dependence treatment to Medicaid enrollees in traditional fee-for-service (FFS) Medicaid, with four Medicaid programs adding coverage since 2006 and 20 programs adding coverage in the past decade. Only two states (New Mexico and New Jersey) reported access to tobacco-dependence treatments without any limitations or restrictions. Of the 25 states covering pharmacotherapy for Medicaid enrollees in both FFS and managed-care organizations (MCOs), only 13 covered the same tobacco-dependence treatments for enrollees in both populations. Research demonstrates that providing access to comprehensive tobacco-dependence treatments increases quit rates. Providing Medicaid coverage for these treatments would ensure that all enrollees can access and benefit from these treatments.

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• Most state Medicaid programs offer limited access to tobacco-dependence treatment 

Medicaid coverage for various smoking cessation treatments is limited in most states, according to a report published in Morbidity and Mortality Weekly.

Although smoking rates in the United States have been reduced by half since the 1960s, smoking rates among low-income adults are higher than in the general population (33% vs. 20%). According to the report, 43 of 51 (84%) state Medicaid programs offer some form of tobacco-dependence treatment in a traditional fee-for-service manner. Twenty Medicaid programs have added coverage over the last decade and four Medicaid programs have added coverage since 2006. Of the 43 programs that offered tobacco-dependence therapies, 41 placed some form of limitation on the coverage in the form of copayments (32 states), limiting duration of treatment (25 states), requiring prior authorization (21 states) and requiring enrollment in behavioral modification programs as a precondition for receiving pharmacotherapy (13 states). Only New Jersey and New Mexico offered access to tobacco-dependence treatments with no limitations or restrictions on coverage.

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RJR try falls short: Federal judge rejects request for injunction blocking tobacco law 

R.J. Reynolds Tobacco Co.'s bid to carve out a "free speech" marketing niche for innovative products received a setback yesterday.

A U.S. District Court judge denied a motion for a preliminary injunction by Reynolds regarding the Family Smoking Prevention and Tobacco Control Act, which became law in June.

Judge Joseph McKinley ruled that "the plaintiffs have little likelihood of success" in challenging the modified-risk tobacco-products provision of the law.

A lawsuit was filed Aug. 31 in the Western District of Kentucky against the federal government and the Food and Drug Administration by Reynolds; Conwood Co. LLC, a sister company with Reynolds American Inc.; Lorillard Inc.; Commonwealth Brands Inc.; and two other parties.

The companies said they are trying to "protect their First Amendment right to communicate with adult tobacco consumers about their products." . . .

However, Adam Spielman, an analyst with Citigroup Global Markets Inc., said he believes that regulation will not undercut Reynolds' smokeless innovations. "The rules on new products do not require sign-off from the FDA if the product is substantially equivalent health-wise to existing products," he said.

The decision comes at a time when the National Cancer Institute has provided grants for a new series of medical studies on smokeless-tobacco products, some focused on whether the products provide a less harmful alternative to conventional tobacco products.

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Judge won't bar new federal tobacco marketing regs 

A federal judge ruled Thursday that tobacco companies hoping to block new restrictions on their marketing have little chance of succeeding.

The companies had asked U.S. District Judge Joseph H. McKinley Jr. to issue a preliminary injunction in a lawsuit they filed in August claiming new tobacco regulations violate their right to free speech.

The companies, including two of the industry's three largest, are challenging provisions of a law that gave the U.S. Food and Drug Administration new authority over tobacco. In a 29-page decision, McKinley outlined the arguments in the lawsuit and found that blocking the provisions was not warranted. The ruling focused on a narrow portion of the legal challenge dealing with modified-risk tobacco products.

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RJR v. FDA 

The question before the Court is whether Plaintiffs have met their burden of showing the need for the “extraordinary remedy” of a preliminary injunction against enforcement of the MRTP provision. Tennessee Scrap Recyclers Ass’n v. Bredesen, 556 F.3d 442, 447 (6th Cir. 2009). In determining whether to issue a preliminary injunction, courts consider four factors: (a) whether the movant has a strong likelihood of success on the merits; (b) whether the movant would suffer irreparable injury without the injunction; (c) whether issuance of the injunction would cause substantial harm to others; and (d) whether the public interest would be served by the issuance of the injunction. . . .

Assuming that the MRTP provision implicates the First Amendment, it seems likely that its restrictions on speech are constitutionally permissible. . . .

In sum, the Court concludes that Plaintiffs have little likelihood of success on the merits of their facial First Amendment challenge to the MRTP provision except on the theory that it operates as a prior restraint on speech and lacks a reasonable time limit for FDA review. . . .

Having considered each of the required factors, the Court finds that the “extraordinary remedy” of a preliminary injunction is unwarranted.

29

III. CONCLUSION

For the foregoing reasons, Plaintiffs’ motion is DENIED.

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Request denied to halt enforcement on new tobacco rules  

A federal judge has turned down a request by the nation's No. 2 cigarette-maker and others to immediately halt enforcement of new federal regulations on tobacco products.

Their challenge to new U.S. Food and Drug Administration powers to regulate what tobacco firms say about their products has little likelihood of success, except on one point, Judge Joseph H. McKinley Jr. of the U.S. District Court in Bowling Green, Ky., ruled yesterday.

Because of that, and because the businesses couldn't show they faced irreparable harm, McKinley rejected tobacco companies' request for a preliminary injunction stopping FDA enforcement of rules limiting what they say about products they believe reduce the risk of using tobacco.

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Obama promises Native Americans place on agenda  

President Obama pledged Thursday to redeem broken promises made to American Indians, saying he's empathetic because of his own history as an "outsider."

"Few have been more marginalized and ignored by Washington for as long as Native Americans, our first Americans," Obama said in opening the White House Tribal Nations Conference.

"I know what it means to feel ignored and forgotten, and what it means to struggle," he said. "So you will not be forgotten as long as I'm in this White House."

The administration invited representatives from the 564 federally recognized tribes to participate in the conference, the first White House meeting of its kind since 1994. Leaders from nearly 400 tribes attended. The event came as some American Indians are locked in a long-standing legal battle with the federal government over land royalties.

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• Judge rejects challenge to tobacco marketing regs 

A federal judge ruled Thursday that tobacco companies hoping to block new restrictions on their marketing have little chance of succeeding.

The companies had asked U.S. District Judge Joseph H. McKinley Jr. to issue a preliminary injunction in a lawsuit they filed in August claiming new tobacco regulations violate their right to free speech.

The companies, including two of the industry's three largest, are challenging provisions of a law that gave the U.S. Food and Drug Administration new authority over tobacco. In a 29-page decision, McKinley outlined the arguments in the lawsuit and found that blocking the provisions was not warranted. . . .

The companies say the law, which takes full effect over three years, prohibits them from using "color lettering, trademarks, logos or any other imagery in most advertisements, including virtually all point-of-sale and direct-mail advertisements." Their complaint also says the law prohibits tobacco companies from "making truthful statements about their products in scientific, public policy and political debates."

The tobacco makers say new mandated warnings for cigarettes would relegate their branding to the bottom half of cigarette packaging and make it "difficult, if not impossible, to see."

In its response to the lawsuit, the FDA said the new marketing rules do not restrict free speech and serve a greater public health interest.

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Judge denies RJR motion for injunction 

R.J. Reynolds Tobacco Co.'s bid to carve out a "free speech" marketing niche for innovative products was dealt a blow today.

A U.S. District Court judge in Richmond denied a motion for a preliminary injunction sought by Reynolds and other tobacco manufacturers regarding The Family Smoking Prevention and Tobacco Control Act.

A lawsuit was filed Aug. 31 against the federal government and the Food and Drug Administration by Reynolds, Conwood Co. LLC, a sister company with Reynolds American Inc., Lorillard Inc. and Commonwealth Brands Inc.

The companies had sought a preliminary injunction against The Family Smoking Prevention and Tobacco Control Act. They said they are trying to "protect their First Amendment right to communicate with adult tobacco consumers about their products."

But Judge Joseph McKinley ruled that the "plaintiffs have little likelihood of success" in their challenge to the modified risk tobacco products provision in the law.

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2 N.C. judges nominated for 4th Circuit 

Albert Diaz

Albert Diaz, 48

HOMETOWN: New York City, now lives in Charlotte.

CURRENT JOB: Special Superior Court judge for complex business cases, one of three in North Carolina.

EDUCATION: Bachelor's degree, University of Pennsylvania, 1983; New York University School of Law, 1988; Master's in Business Administration, Boston University, 1993.

EXPERIENCE: U.S. Marine Corps Legal Services Support Section and U.S. Navy Office of the Judge Advocate General. Left active duty in the Marine Corps in 1995 and worked as an associate at Hunton & Williams law firm. Appointed to the N.C. Superior Court in 2001. Served as a reserve military judge in the U.S. Navy-Marine Corps Trial Judiciary until he retired from the military in 2006 at the rank of Lt. Colonel. . . .

He left the service in 1995 for private practice. He made a name for himself at the law firm of Hunton & Williams representing Philip Morris during tobacco lawsuits in the late 1990s.

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Sadie Nardini: Mr. President: I Challenge You To Quit! 

So before all you smokers brush off the "healthy" chick, let's be clear that I'm talking to the sometime smoker in my own mirror, too.

And I don't think I accept my friends' offers to join them outside because movies and the media make it so inviting. I, like the president, am not easily swayed by advertising executives marketing to my target group. I also have a sneaking suspicion that if Barack Obama wants to smoke, it's not because he wants to be just like Joe Camel.

So, Mr. President, and readers, I invite you to do what I promise to do this month--own our proclivity for bumming smokes (and smoking) and stop this nonsense together. In so doing, I will teach you, readers, how to get all the benefits of a cigarette--without ever smoking another one again.

Because really, we're after the ritual, the alone time, the sense of calm and space and camaraderie and relationship we get with this often-deadly lover. None of us want to be codependent, but, dysfunctional or not, we are. They might be hurting us, but cigarettes are always there for us when we need them, and we keep going back for more.

Though cigarettes are quite the stimulant, smokers most often cite the sense of calm, and centering as their primary reason to reach for one. . . .

Mr. President, if anyone in this country needs a freakin' ciggy, it's you. I get it. But let's get all of us that moment of Zen--and the buzz, too--without all the carcinogenic accoutrements. . . .

THE BUTT-KICKING BREATH:

Use this technique any time you would normally choose to smoke, or any time stress or anxiety gets the better of you.

This breath has been shown to slow your brain waves down, switching your central nervous system from the fight-or flight of anxiety to the still waters of the parasympathetic, and release endorphins that give you that same glad-to be alive buzz without, oh, say, the carbon monoxide. . . .

It's just this bad habit of yours has been fooling you into thinking you're handling your stress. In fact, the smokes are managing you.

Yoga and mindful breathing is all about taking control, real control, of your life. I know you can get the relief and peace you're looking for in another, more life-affirming way. And I'm all for trading up.

In fact, Mr. President, and readers...I'm starting today.

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Electronic Cigarette Association Urges Unbiased Evaluation of E-cigarettes as Debate Intensifies Around These Devices  

As the debate heats up concerning the use of electronic cigarettes, Electronic Cigarette Association (ECA) President Matt Salmon today encouraged those involved in this discussion to carefully and honestly study how these devices work and recognize that the more than one million adult committed smokers, who use electronic cigarettes, are seeking an alternative to combustible cigarettes that contain a multitude of toxic, harmful chemicals.

The debate on these devices has intensified in recent months as events have fueled and focused attention on electronic cigarettes, including a front-page story last week and a follow-up editorial in yesterday's edition of USA Today and stories or editorials in other major newspapers such as the New York Times and Los Angeles Times. Governor Schwarzenegger's veto of a bill that would have denied California citizens the right to purchase electronic cigarettes and a warning by the Food and Drug Administration (FDA) based on a flawed, narrow study have also contributed to the growing debate.

"Unfortunately, many of the arguments we've seen recently against electronic cigarettes have been driven by fear of the unknown, insufficient evidence, political agendas, and ignorance about our members' products," said Salmon. "As in the case of California Governor Schwarzenegger, we've found that reasonable people, when willing to honestly and intellectually evaluate the information about electronic cigarettes, find that these products provide smokers a viable alternative to combustible tobacco cigarettes."

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• Seneca Nation of Indians president to meet with Obama today  

Seneca President Barry E. Snyder Sr. will travel to Washington, D.C. to participate in a first-of-its-kind national Indian nations conference to be staged by President Barack Obama. The all-day conference will take place today.

"During his 2008 presidential campaign Obama promised to go beyond a government-to-government relationship with Native Americans and create a nation-to-nation relationship. This conference indicates he is interested in giving nations a true voice," President Snyder said. "I look forward to taking part in this critical dialogue."

In October 2008, Obama pledged, if elected, he would appoint an American Indian policy advisor to his senior White House staff and would host an annual tribal leadership conference. . . .

In recent weeks, the Seneca Nation has made a strong stance against renewed efforts by some New York State elected officials to collect taxes on tribal tobacco sales. The Senecas have reiterated their position that long-standing federal treaties prohibit states and other governments from taxing Indian nations. The Senecas are also looking for federal assistance to overturn the Kempthorne policy which prohibits off-reservation gaming.

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