One Remedy from US v Phillip Morris

Handsel Art

FOR IMMEDIATE RELEASE

2 December 2012

contact J.R. Few

handselart@gmail.com

or 870-427-1365

Tobacco Companies to Issue Corrective Statements

On November 27, 2012 Judge Gladys Kessler clarified remedies of her 2006 ruling  in U.S. v Phillip Morris that found the tobacco industry guilty of racketeering and fraud.  Tobacco companies must publish corrective statements that they lied about the dangers of smoking and manipulation of nicotine addiction,  the hazards of secondhand smoke, and the misconception of allegedly safer “light” and “low tar” cigarettes.   This remedy promises to be the most significant action the government has taken against the tobacco industry in nearly 45 years. 

In 1999 the Department of Justice (DOJ) filed suit under RICO statutes for a decades long conspiracy by the tobacco industry to deceive the American people.  In 2005 a D.C. appellate court denied the original remedies proposed to disgorge $280 billion from tobacco companies as illegal profit. This prompted the DOJ to  reassess remedies and highlight a 25 year $130 billion national tobacco cessation program.  This was a significant setback, though not the last in the DOJ’s case.  

Begun during the Clinton Administration, many involved were surprised when the Bush administration continued the suit.  Yet just days before going to the judge, a Bush political appointee, Robert McCallum, ordered lead counsel and DOJ career lawyer, Sharon Eubanks, to reduce requested remedies for the cessation program to just $10 billion.  McCallum was subsequently rewarded for his work in the DOJ with an ambassadorship to Australia.  (The litany of political interference in this case has been well documented by Ms. Eubanks in her book, Bad Acts.) Judge Kessler’s final order in favor of the DOJ involved 4 major remedies including: disjunctive remedies designed to prevent future RICO violations, eliminating deceptive “light” and “low tar” brand descriptors, disclosure of documents and marketing data, and corrective statements financed by the industry. 

The 2007 Best Practices for Tobacco Control, Health Communications Interventions notes that, “Aggressive state and national counter-marketing campaigns that have more directly confronted the tobacco industry’s marketing tactics have also demonstrated effectiveness but have often become targets for budget cuts.”  Requiring tobacco companies to admit criminal deceit, on their own dime, takes prevention to another and hopefully more effective level.  

The  tobacco industry has a history of manipulating public policy and serious oversight should be given.  But these statements have a timely potential.  An unfortunate aspect of tobacco prevention seeks a solution in making addicts quit and preventing youth initiation while ignoring the industry. The FDA’s recent introduction of 8 Tips for Talking with Youth about Tobacco and the DHHS’  new site BeTobaccoFree.gov  are packed with information about the health effects of tobacco use and nicotine addiction.  But both sites behave as if tobacco use were simply an accident of nature and completely omit the culpability of the tobacco industry in promoting a deadly product.  This promotion, not coincidentally, resulted in a criminal conviction for which these corrective statements hope to begin to remedy.  The terrible pandemic of tobacco related disease will not be resolved on the backs of the victims but on the rogue capitalists who profit from tobacco. This remedy from U.S. v Phillip Morris is a constructive step in that direction.

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A National Disgrace

I was coincidentally looking through the TTAC newsletter when Katherine Donald shared the link w her Coalition for a Tobacco Free Arkansas mailing list.  What I happened to fall upon in the table of contents was the link to the FDA Tobacco Products page and 8 Tips for talking to youth about tobacco. I get the FDA updates but don’t always follow up.  This is one reason why.

The CDC 2007 Best Practices for  Comprehensive Tobacco Control Health Communications Interventions makes the statement:

“Adolescents and young adults are very sensitive to perceived social norms and media presentations of smoking behavior. Nonsmoking adolescents exposed to tobacco advertising and promotional campaigns are significantly more likely to become young adult smokers. Because adolescents and young adults have been and continue to be so heavily exposed to images of smoking in the media, tobacco advertising, and promotional campaigns, public health counter-marketing campaigns are needed to focus on preventing initiation and promoting cessation.”

Nowhere in the FDA ‘tips’ for talking to youth is there any mention of tobacco advertising, tobacco promotion, marketing, or even the words “tobacco industry.” Instead, it focuses on how the young individual must decide, regardless if they are 11 years old or not, if they will become a nicotine addict.  This is just another example of how and why the Family Smoking Prevention and Tobacco Control Act is a national disgrace.

How is it that the Campaign for Tobacco Free Kids, the American Cancer Society, the American Heart Association, the American Lung Association, and a wealth of popular public health groups, not including the National African American Tobacco Control Network and Americans for Nonsmokers’ Rights, could support such a terribly flawed bill?

That is a huge question. How, or will, these groups rectify and apologize for their misspent support?  The greater issue is: how will the rest of us redeem a federal law that institutionalizes tobacco unlike never before?

Cigars, Candy, Litigation, and Laws

Cigars, Candy, Litigation, and Laws

In 2009 Congress passed the Family Smoking Prevention and Tobacco Control Act with support from major public health groups, and tobacco giant Philip Morris. Lauded by supporters as a landmark, the bill gave the Food and Drug Administration limited authority over tobacco.  But three years after passage, the bulk of the FSPTCA has been delayed or repealed by tobacco industry litigation.  Requirements that tobacco advertisement near where children are present be limited to black on white has been struck down.  Large graphic package warnings, scheduled to go in effect in 2012, are still delayed.  And most recently authority preempting local control over point of sale warnings has been delivered a setback in a New York appellate court.

While many consider the omission of menthol in the list of restricted cigarette flavorings a serious flaw in the FSPTCA, banning fruit and candy flavors have not been thwarted in the courts.  Unfortunately, pro tobacco forces in Congress have introduced a serious challenge in the Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2011.  Purportedly focused on high end cigar products, this bill would remove cigars from FDA regulatory authority.  However, that includes the smaller candy and fruit flavored cigars that are a significant feature of the tobacco cartel’s growth market.  These small cigars are more accessible to youth not only because they are sold in flavors but they are also sold individually and often the most inexpensive tobacco product available.  The 2012 Surgeon General’s Report on Youth and Young Adult Tobacco Use notes that 1 in 5 white male high school seniors is a current cigar smoker and that most typically consume more than one type of tobacco product. 

This proposed legislation should alarm local tobacco free advocates because 3 of Arkansas’ Representatives are co-sponsors.  Additionally, retailers in Arkansas are not yet required to place all tobacco products behind the counter. Product placement, like placing small cigars next to bubble gum, has long been a tactic in a sophisticated strategy making tobacco seem normal and desirable in stores where youth frequent.  

For all its flaws, the FSTPCA may show most promise in the potential for point of sale regulation. The new law allows state and local restrictions on the “time, place, and manner” but not “content”  of tobacco marketing. One locality, Haverstraw, NY, has become the first U.S. municipality to restrict tobacco displays, mimicking tactics public health advocates have employed in other countries.   

Protecting the marketing and promotion of inexpensive candy flavored tobacco with bill titles like “Small Business Jobs Preservation” would be silly if the cost to public health were not so tragic.  The Surgeon General’s Report  notes that 80% of high school smokers will go on to smoke into adulthood.  Half will die prematurely.  It is this compelling interest that should drive policy makers to recognize the tobacco cartel’s continued profit at the public’s expense, and end it.  

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FDA Releases Selection of Graphic Warnings

The FDA released Tuesday their final selection of 9 graphic warnings to be placed on all cigarette packaging and advertising by September 2012. These warnings will replace the ubiquitous black and white labels that have been in use for the past 25 years. The Federal Trade Commission found in 1981 that they had little deterrent effect. The new warnings will cover 50% of packaging and 20% of advertising.

CDC research conducted in 14 foreign nations has shown that graphic warnings spur smokers to think about quitting. However, there remains question as to the efficacy in a society as literate as the U.S. Are there really individuals that do not know tobacco will kill you? One of the critiques of youth focused prevention is that young persons do not grasp the same concept of long term health risk. Will these graphic warnings actually penetrate this worldview and prevent initiation?

One of the most unique criticisms of graphic warning labels comes from Martin Lindstrom author of the book Buyology. Lindstrom’s book is an analysis of the effectiveness of marketing tactics involving MRI and EEG brain scanning technologies called nueromarketing. His findings were that graphic warnings on cigarette packaging did little to inhibit craving and promote cessation. In an interview on NBC’s Today show in 2008 he remarked,

“We couldn’t help but conclude that those same cigarette warning labels intended to reduce smoking, curb cancer, and save lives had instead become a killer marketing tool for the tobacco industry.” The crux of his argument is that visual stimuli, like the graphic warnings, over time becomes associated with cigarettes as effectively as any overt branding.

None of the marketing reforms called for in the Family Smoking Prevention and Tobacco Control Act go to the lengths of eliminating branding and advertising called for in the WHO’s Framework Convention on Tobacco Control. Limiting advertising to black on white as well as a preclusion from claiming that a tobacco product was FDA approved were almost immediately held up by litigation. The judicial history of commercial speech in the U.S. may place significant obstacles to ratification in this country.

Perhaps the most positive aspect of these new warnings is the inclusion of the 1-800 QUIT NOW national quit line number. Getting a minimum of social support and counseling to smokers can only act as a prompt for cessation that did not exist previously.

Menthol? What Menthol?

Earlier this year the FDA Tobacco Products Scientific Advisory Committee , entrusted with investigating menthol in cigarettes, stopped just short of a recommendation that menthol be banned. The report noted that, “removal of menthol cigarettes from the marketplace would benefit public health in the United States.” This diplomatic missive, or cowardly depending on your perspective, recognized that menthol may not actually be harmful. But in cigarettes certainly causes harm.

Last week Congress threw another variable into the works when Montana Republican Denny Rehberg’s amendment to an appropriations bill was approved by the House Appropriations Committee. The amendment, in short, would preclude “consumer behavior” as a variable in determining whether a product was safe. Hence the fact that the Advisory Committee had noted that even though menthol played an integral part in the ease of youth initiation to nicotine addiction, and difficulties in cessation, it could not play a role in the decision on whether or not to ban menthol in cigarettes.

A release from Tobacco Free Kids, and others, notes that of the 29 to 20 committee vote, those voting in favor received 20 times the campaign contributions from tobacco companies than those opposing the amendment.

The moral here is a brief lesson in just how bad the passage of the Family Smoking Prevention and Tobacco Control Act was.

It is no secret that the major public health groups, led by the Campaign for Tobacco Free Kids, snuggled up with Phillip Morris to pass the FSPTC. Having the majority market share in the U.S. PM knew they had a good chance that the other tobacco companies would immediately file suit to block any problematic marketing reform. (They did, blocking black and white advertising and restrictions on claiming FDA approval of cigarettes, almost immediately.) While the Act did remove fruit and candy flavored cigarettes,( small cigars and spit tobacco were unaffected). Menthol was the deal breaker for PM because, some menthol is in all tobacco, and they knew they had legislators already paid for in Congress.

The first guiding principle for the World Health Organization's Framework Convention on Tobacco Control is that the interests of the tobacco industry and the public health are incompatible. In the U.S. some of us are learning hard lessons about the veracity of this guideline. Unfortunately, the rest of us will pay for it.

FDA Given Opportunity to ban Menthol

Handsel Art

20 March 2011

FOR IMMEDIATE RELEASE

contact J.R. Few

handselart@gmail.com

or 870-427-1365

Panel Releases Report on Menthol

On March 19 the FDA’s Tobacco Products Scientific Advisory Panel (TPSAP) released a draft of its report on menthol in cigarettes. Advocates had feared that the narrow scientific restrictions of the investigation would find that the menthol in cigarettes was relatively benign. But the panel, while failing to actually make the recommendation that menthol in cigarettes be eliminated, found for the larger concept of menthol’s harm in cigarettes. The panel found that menthol’s cooling effect made addicting youth easier and quitting more difficult. Virtually all tobacco products contain some menthol.

The report states, “The availability of menthol cigarettes in the marketplace could adversely affect public health through two consequences: (1) increasing the risk for the diseases caused by smoking cigarettes; and (2) increasing the number of people who smoke.” It goes on to conclude, “Removal of menthol cigarettes from the marketplace would benefit public health in the United States.” Unfortunately, the TPSAP did not make any specific suggestions on how to limit the harm to the public health.

The 2009 Family Smoking Prevention and Tobacco Control Act, giving limited authority over tobacco to the FDA, banned fruit and candy flavoring. But a political compromise charged the TPSAP to report on the public health impact of menthol in cigarettes. Many advocates opposed the compromise because 80% of African American smokers smoke menthol.

A statement released by the Campaign for Tobacco Free Kids applauded the report saying, “We urge the FDA to implement the committee's recommendation in a way that maximizes the public health benefits.” Tobacco Free Kids led several of the major public health groups in negotiations with tobacco giant Philip Morris to see successful passage of the Act.

American Legacy Foundation Distinguished Professor of Tobacco Control at UCSF, Dr. Stanton Glantz, noted that the most significant finding was that menthol, “has a complex pharmacological interaction with nicotine that affects the addictive potential of cigarettes.” He added that, “The question at this point is whether the FDA and the Obama Administration will have the backbone to ban menthol in all tobacco products (or, at least as a first step, all smoked tobacco products, which is more than just cigarettes) and whether the major health organizations will unambiguously press for such a ban.”

If the stock market is any prediction tobacco companies still have little to worry about. Lorrilard, maker of Newport, the leading menthol cigarette, saw its stock value rise 3.4% as drafts of the report were released.

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Local Control Given Setback

First the requirements of the Family Smoking Prevention and Tobacco Control Act that cigarette advertising be limited to black and white advertising where minors might view it were struck down. Now the ostensible overturning of Federal preemption for state and local authority to regulate point of purchase advertising was delivered a blow by a federal Judge in New York Wednesday, December 29.

The New york City Board of Health in 2009 voted to require tobacco retailers display graphic warnings of the dangers of tobacco use that included a number for free cessation services. However the decision delivered by U.S. District Judge Jed S. Rakoff considered that an infringement on the tobacco companies rights. “Even merchants of morbidity are entitled to the full protection of the law, for our sake as well as theirs," he said.

Tobacco free advocates were depending on Sec. 203 of the new law to allow local control preempted by the 1965 Federal Cigarette Advertising and Labeling Act. The law reads:

"Section 5 of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1334) is amended by adding at the end the following: ‘‘(c) EXCEPTION.—Notwithstanding subsection (b), a State or locality may enact statutes and promulgate regulations, based on smoking and health, that take effect after the effective date of the Family Smoking Prevention and Tobacco Control Act, imposing specific bans or restrictions on the time, place, and manner, but not content, of the advertising or promotion of any cigarettes.’’"

Apparently the graphic content denied those that profit from the leading cause of death and disease from the full protection of the law. Thus continues the odd saga in the United States of what is known only here as commercial speech. When applied to tobacco not only does it protect corporations’ speech it protects them from liability after 1969.

Supported by the major public health groups, and tobacco giant Phillip Morris, the new federal law giving limited authority over tobacco to the FDA is turning out to be yet another significant victory for tobacco companies.

Menthol Also Global Issue

The status of adding menthol to tobacco is at question for more reasons than the Family Smoking Prevention and Tobacco Control Act’s giving limited authority to regulate tobacco to the FDA. Globally, Article 9 of the Framework Convention on Tobacco Control proposes regulating the contents of tobacco products to eliminate any additive that is not tobacco.

The Louisville Courier-Journal quotes the President of the Lexington-based Burley Tobacco Growers Cooperative Association, Roger Quarles as saying, “The ingredients themselves (in burley tobacco) are not harmful whatsoever.” Mr. Quarles may well have missed several decades of the science surrounding tobacco and health. The problem here is that the harshness of burley tobacco smoke practically requires some flavoring to make it palatable. At issue is the 200 million pounds of burley is produced in the U.S. each year, 3/4 of which is exported. Kentucky’s 2009 burley crop was worth $274 million.

We’ll see what influences both the FDA and the Senate more, lives saved globally or dollars for a few farmers in Kentucky.

That Minty Fresh Taste in the Bile of Political Manipulation

In 2009 the Family Smoking Prevention and Tobacco Control Act was passed with huge support from status quo public health groups and opposition from tobacco companies, with the exception of Philip Morris, and a minority of tobacco prevention advocates. These minority advocates, before any particulars, knew that historically any collaboration with the tobacco cartel had been in the end only beneficial to the industry. That conclusion is being affirmed daily.

Prohibition of tobacco marketing assertions that claimed FDA approval of tobacco products was quickly struck down by the courts, as were the black and white advertising limitations. Passage of the bill was momentarily held up because while eliminating fruit and candy flavors it did not prohibit menthol flavoring for tobacco. The argument was that after passage there would be the opportunity to eliminate menthol as one of many substances in tobacco that had been proven to be a harm. Well guess what? The guidelines that dictate how and what the Tobacco Products Scientific Advisory Board can recommend may well preclude the elimination of menthol because menthol, by itself is not harmful. This at least is one of the argument that the industry will take in opposing any change in regards to menthol.

There is little doubt that menthol in tobacco is a key in the initiation of nicotine addiction. It acts as an anesthetic cooling tobacco smoke and making tobacco more palatable. Eliminating menthol in tobacco could prevent many youth from ever starting to use tobacco and make quitting more possible for other untold millions. The enormity of the potential lives saved by restricting this additive is almost incomprehensible.

One of the basic premises this bill’s advocates took was that if we knew what was in tobacco products their harm could be evaluated and the industry forced to remove them. But now it seems this harm could well be evaluated independently of tobacco. Dr. Joel Nitzkin describes the situation in a Globalink post: “In other words -- the problem is not the "science" related to menthol -- but a bureaucratic standard operating procedure adopted by FDA on the basis of an overly constrictive interpretation of the legal authority granted to them under the new FDA tobacco law.”

75% of African American smokers smoke a “menthol” brand but virtually all tobacco has to some degree menthol as an additive. The African American Caucus held up passage of the Family Smoking and Tobacco Prevention Control Act’s limited authority to regulate tobacco over the issue of restricting menthol flavoring just as the bill had eliminated fruit and candy flavors. However, objections from Philip Morris prompted supporters to compromise with the assurance that menthol could be eliminated after the bill’s passage. This may not be the case at all.

The panel has until 2012 to make its recommendations concerning menthol. This issue, if nothing else, displays quite well the irony and inanity of asking the FDA to regulate an inherently unsafe product without the authority to regulate it out of existence.

Dismantling FDA Authority for Tobacco Begins

A Federal court in Kentucky overturned the first advertising regulations of the Philip Morris FDA bill this week. While leaving in aspects for larger health warnings and prohibiting event sponsorships, two key parts of the marketing restrictions were tossed. The bill had stipulated that only black and white advertising in mediums where children were likely to view would be allowed. This was thrown out as overly broad. You think?

Tobacco companies can continue to use their color graphics and imagery in advertising which are integral to branding and normalization of tobacco promotion.

Additionally, restricting tobacco company language claiming that FDA regulation made their product safer was tossed. This was one of the more telling and foolish parts of the bill. Detractors began much of their criticism of this legislation saying that industry marketing would take advantage of giving regulatory authority to the agency that supposedly guaranteed the health and safety of our food and drugs. In response, this ridiculous and obviously unconstitutional restriction was tacked onto the bill. “No you can’t claim that an FDA regulated cigarette is safer!” Apparently, yes you can. So why have we ruined the tenable integrity of the FDA anyway?

Philip Morris wrote this legislation. Other tobacco company lawyers cued up almost immediately to help dismantle the most potentially effective regulatory authority and thus far are successful. One can only imagine what the current Supreme Court will do for them as the suits creep upstream. What is not left to the imagination is that when all is said and done Philip Morris will have gotten almost everything it wanted without ever filing a brief.

FDA Litigation Begins

The first lawsuit challenging the limited authority of the FDA to regulate tobacco advertising was filed in U.S. District Court in Kentucky today. Their complaint is that restrictions on advertising are an infringement of First Amendment rights.

This intriguing distinction in the U.S. that places advertisements under speech doctrines rather than trade is fairly recent. In 1980 the court established the Central Hudson test for “commercial speech” that disallows First Amendment protection only if the advertisement is false or misleading or the government has a substantial, reasonable, interest in regulation. But it wasn’t until 2001 that Lorrilard vs. Reilly struck down Massachusetts restrictions on tobacco advertising saying the state did not prove that these restrictions would reduce underage smoking.

Today’s suit claims,that marketing aspects of the law, "severely restrict the few remaining channels we have to communicate with adult tobacco consumers."

My concern is not that tobacco companies will be allowed to communicate with adult tobacco consumers but that reinforcing the “adults only” cachet will enhance longstanding marketing strategies for attracting youth. The tobacco companies can’t lose.

The success or failure of this litigation will no doubt take years. In fact, this aspect of the new law is not scheduled to take effect for three years anyway. But already we are learning of the troubling nature of institutionalizing contemporary tobacco use under the auspices of the Food and Drug Administration. Note that Philip Morris, a leading collaborator on the bill, is letting the competitors initiate this litigation.

Harm redux/ FDA's limited authority

It is unfortunate to see ostensible tobacco prevention advocates carrying water for the tobacco companies under the banner of harm reduction. The term harm reduction was coined as a means of dealing in a compassionate manner with drug use and sexual behaviors that put one at risk of harm or disease. Needle exchanges and free condoms are tactics to protect individuals, and therefore the community, from the worst results of risk taking behaviors. Using the term in this manner there is no tacit approval, or disapproval, of the addiction but a means that an individual's behavior can reduce harm. The perversion of the concept toward tobacco is not behavior modification but product modification and hence implicit approval of nicotine addiction. Simply calling oneself smoke free does not address the real need to challenge the rogue capitalism behind the tobacco pandemic.

The linked article from Glantz, Barnes, and Eubanks is just about a must read for sincere tobacco free advocates. The question remains why so many public health advocates could support such poor, even detrimental, legislation. My first assumption is that while public health groups out of necessity must deal with tobacco related disease they are not primarily focused on what it takes to challenge tobacco.

My experience in tobacco prevention is minimal but an overwhelming awareness has been that not everyone who claims to be a tobacco free advocate is. This unfortunately includes everyone from ADH grantees, employees, and even major public health group lobbyists.

This sounds like an old saw to me now but I once heard Dr. Tom Houston remark that 100 years ago, when infectious disease was the leading cause of death, there were no transnational corporations challenging the public health. In 2006 Dr. Houston's words curiously came to fruition with a federal conviction for fraud and racketeering in U.S. versus Philip Morris. Philip Morris was the lone supporter among tobacco companies of the FDA's limited authority over tobacco. Be sure that it will not be alone in the inevitable litigation the tobacco industry will throw into the gears of curiously suspect legislation. Enjoy the article!

http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000118

FDA's first regulation for tobacco

Just a note that the FDA's limited authority to regulate tobacco has lasted for maybe 10 minutes and the first statement regarding tobacco involves nicotine cessation drugs and a suicide warning.  The tobacco industry kills 400,000 Americans annually and the first remarks the FDA can come up with say that meds to help you quit may make you want to die.

http://www.msnbc.msn.com/id/31685329/