Tobacco Industry: USA Package Warnings
U.S. government changes course on graphic cigarette warnings
Mar 20, 2013
By David Ingram
(Reuters) – The U.S. government has dropped its push for cigarette labels to carry images of diseased lungs and other graphic health warnings, and will craft new anti-smoking ads that do not run afoul of free speech rights.
In a letter to Republican House Speaker John Boehner last Friday, Attorney General Eric Holder said that the Food and Drug Administration would go back to the drawing board to develop the ads, as required by legislation passed by Congress in 2009.
Half the space on the front and back of each cigarette pack must be taken up by anti-smoking warnings and a large share of other printed ads should have similar discouraging messages, according to the legislation.
Cigarette manufacturers, however, sued to prevent the ads from appearing on the packaging for their products, saying such a move would curtail free speech rights. In August, a federal court struck down the requirement as unconstitutional.
The Justice Department was facing a deadline on whether to ask the U.S. Supreme Court to review that ruling.
“The Department of Justice in this case has vigorously defended the constitutionality of the graphic warnings,”
Holder wrote in the letter notifying Boehner, who is a smoker. Holder said the deadline for an appeal prompted the new approach.
Many other nations have for years used graphic images to try to deter smokers.
The FDA has argued that the images of rotting teeth and diseased lungs are accurate and necessary to warn consumers – especially teenagers – about the risks of smoking.
On Tuesday, the FDA used a blog posting to say the agency “will undertake research to support a new rulemaking consistent with the (2009) Tobacco Control Act.” (Additional reporting by Toni Clarke; Editing by Paul Simao)
Appeals Court Agrees That the FDA’s Graphic Cigarette Warning Labels Are Unconstitutional
Aug. 27, 2012
Jacob Sullum
On Friday the U.S. Court of Appeals for the D.C. Circuit ruled that graphic cigarette warning labels proposed by the Food and Drug Administration (FDA) violate the First Amendment.
The court concluded that the labels, which would occupy half of each cigarette pack’s front and back panels as well as one-fifth of each cigarette ad, go well beyond the “purely factual and uncontroversial” disclosures that the Supreme Court has said the government may require to prevent “deception of consumers.
” Instead, Judge Janice Rogers Brown wrote for the two-judge majority, the labels “are primarily intended to evoke an emotional response,” thereby encouraging smokers to quit and deterring nonsmokers from picking up the habit. This anti-smoking message, she said,
“raises novel questions about the scope of the government’s authority to force the manufacturer of a product to go beyond making purely factual and accurate commercial disclosures and undermine its own economic interest…How much leeway should this Court grant the government when it seeks to compel a product’s manufacturer to convey the state’s subjective—and perhaps even ideological—view that consumers should reject this otherwise legal, but disfavored, product?”
Assuming that “such compulsion is constitutionally permissible,” Brown said, it still must satisfy the test established by the Supreme Court for regulation of commercial speech: It must be narrowly tailored to serve a substantial government interest.
“The First Amendment requires the government not only to state a substantial interest justifying a regulation on commercial speech,” Brown noted, “but also to show that its regulation directly advances that goal.” Yet the FDA “has not provided a shred of evidence—much less the ‘substantial evidence’ required by the [Administrative Procedure Act]—showing that the graphic warnings will ‘directly advance’ its interest in reducing the number of Americans who smoke.
” Although the FDA “makes much of the ‘international consensus’ surrounding the effectiveness of large graphic warnings,” it “offers no evidence showing that such warnings have directly caused a material decrease in smoking rates in any of the countries that now require them.”
The Family Smoking Prevention and Tobacco Control Act of 2009 required the FDA to create the new warnings, which feature disturbing images such as diseased lungs, an autopsied cadaver, a crying baby, and a man smoking through a hole in his throat, along with the phone number for the National Cancer Institute’s “Network of Tobacco Cessation Quitlines.
” The D.C. Circuit was reviewing a decision by U.S. District Judge Richard Leon, who reached similar conclusions last February, although he applied “strict scrutiny” to the warnings instead of the “intermediate scrutiny” the appeals court deemed appropriate.
In March the U.S. Court of Appeals for the 6th Circuit upheld the statutory requirement for new warning labels, although it did not address the designs picked by the FDA.
Tobacco Groups Win Challenge to FDA Cigarette Label Rule
Aug 24, 2012
By Tom Schoenberg
Tobacco companies defeated a U.S. law forcing cigarette packaging and advertisements to display images such as diseased lungs, persuading a federal appeals court that the requirements violate their free speech rights.
In a 2-1 decision, the U.S. Court of Appeals in Washington today ruled that Food and Drug Administration regulations mandating visual-image warnings of smoking’s health risks, along with the telephone number 1-800-QUIT-NOW, are “unabashed attempts to evoke emotion” and “browbeat consumers” to stop buying the companies’ products.
“These inflammatory images and the provocatively named hotline cannot rationally be viewed as pure attempts to convey information to consumers,” U.S. Circuit Judge Janice Rogers Brown wrote in her majority opinion.
Commonwealth Brands Inc., Liggett Group LLC and Santa Fe Natural Tobacco Co.
Sued the FDA last year, claiming the mandates for cigarette packages, cartons and advertising, passed as part of the Family Smoking Prevention and Control Act, violated the First Amendment.
The companies said in court papers that complying with the requirements would cost them a total of about $20 million. The mandate, scheduled to go into effect next month, was put on hold by a lower-court judge while the appeals court considered its legality.
Selected Images
The government argued in court papers that nine images selected by the agency to be placed on packages and advertisements are true depictions required by Congress in the law to show the negative health consequences of smoking.
The graphics were supposed to cover the top half of the front and back of cigarette packages and 20 percent of print advertisements. The FDA estimated the visual warnings would help lower the smoking rate by about 0.212 percentage points, according to the lower court judge who also ruled against the FDA.
Jennifer Haliski, an FDA spokeswoman, said the agency doesn’t comment “on possible, pending or ongoing litigation.”
The Campaign for Tobacco-Free Kids, an anti-smoking group, urged the government to appeal the ruling, noting that a federal appeals court Cincinnati upheld the packaging requirements in March.
“The split decisions make it likely the U.S. Supreme Court will settle the issue,” the group said in an e-mailed statement.
Charcoal Warnings
During a Feb. 1 hearing before U.S. District Judge Richard Leon, Mark Stern, a Justice Department lawyer, compared the FDA’s proposed cigarette warnings to those on charcoal that advise people to not use it indoors, noting that 28 people a year die from carbon monoxide poisoning from using charcoal inside their homes.
With cigarettes, there are 440,000 deaths, Stern said.
“It’s very unusual to sell a product that when used as intended will kill you,” Stern said.
He said that the image of a man with cigarette smoke coming out of a tracheotomy hole in his throat conveys addictiveness.
Brown said the image could be misinterpreted to suggest that the procedure is a common consequence of smoking.
In a dissent, U.S. Circuit Judge Judith Rogers said Brown’s opinion applied the wrong level of First Amendment scrutiny and disregarded the tobacco companies’ history of deceptive advertising.
Noel Francisco, a lawyer for R.J. Reynolds, a unit of Reynolds American Inc. (RAI), argued that “the purpose of the warnings is not to inform, but to scare consumers into adopting the government’s course of action.” He said during the February hearing that the government was using “threats and fear” to motivate people to stop using a lawful product.
‘Smoking Rates’
FDA “failed to present any data” showing that the proposed graphic warnings “will accomplish the agency’s stated objective of reducing smoking rates,” Brown said in the opinion.
“The First Amendment requires the government not only to state a substantial interest justifying a regulation on commercial speech, but also to show that its regulation directly advances that goal,” she said in the ruling.
On Aug. 15, the High Court of Australia upheld that country’s requirement that cigarettes be sold in uniform packages barring display of company trademarks.
New Zealand and the U.K. are among countries whose governments have indicated interest in implementing similar legislation, which takes effect in Australia Dec. 1.
The case is R.J. Reynolds Tobacco Co. v. U.S. Food and Drug Administration, 11-5332, U.S. Court of Appeals for the District of Columbia (Washington).
The Smoke Report Video: The Death Penalty for Smoking?
April 14, 2012
Those graphic cigarette ads the FDA tried to push on tobacco companies recently had a day in court.
Watch
A Deep Breath For Free Speech
Nov 13, 2011 By Jeff Jacoby
THE FOOD AND DRUG ADMINISTRATION announced last year that harsh new labels, large and graphic, would soon have to cover half of the front and back of all cigarette packages and at least 20 percent of the space in all tobacco advertising.
Included in each label would be a blunt warning — “Smoking can kill you,” for example, or “Tobacco smoke can harm your children” — plus a hard-hitting color image.
Among the grisly pictures approved by the Food and Drug Administration: ravaged lungs; a corpse with an autopsy scar down its chest; a man smoking through a tracheotomy hole in his throat; a diseased mouth with discolored teeth and cancerous lesions; and a woman sobbing with grief.
Displayed on every image as well would be the toll-free number of the FDA’s smoking quit line, 1-800-QUIT-NOW.
The explicit labels, which Congress authorized in the Family Smoking Prevention and Tobacco Control Act of 2009, were supposed to be in place by next September. Last week, US District Judge Richard Leon wisely said no.
The FDA’s gruesome new labels are not designed to provide consumers with useful information about the hazards of smoking. After 45 years of mandatory Surgeon General’s warnings, every non-comatose American knows perfectly well that cigarettes are a noxious health risk.
That’s why the share of Americans who are occasional smokers has fallen to an all-time low of 19.3 percent, or less than 1 in 5 — a far cry from the more than 42 percent who were smokers in 1965. No one, not even Big Tobacco, disputes Washington’s right to require cigarette makers to disclose pertinent facts about their product’s dangers. Those disclosures, it’s clear, have been effective.
So why the shrill new labels? Not to inform Americans, but to indoctrinate them. To “grab people by the lapels,” as NPR put it last summer, “and be the visual equivalent of someone yelling: ‘Stop smoking!'”
Indeed, the FDA released a video describing the required new labels as “bold and powerful messages,” and FDA Commissioner Margaret Hamburg told reporters that with the new warnings in place, “every single pack of cigarettes in our country will in effect become a mini-billboard.
” At a White House press briefing, Health and Human Services Secretary Kathleen Sebelius said that the new regulations would amount to “rebranding” cigarette packs, transforming them to convey the message that “smoking is gross.”
But “smoking is gross” is opinion, not fact. Millions of Americans — including me — may share that opinion, but under the Constitution the government has no power to compel anyone to express it. Requiring vendors to post accurate information, the First Amendment allows; forcing them to promote the FDA’s anti-tobacco ideology, it forbids.
“The line between the constitutionally permissible dissemination of factual information and the impermissible expropriation of a company’s advertising space for Government advocacy can be frustratingly blurry,” acknowledged Judge Leon. But “here — where these emotion-provoking images are coupled with text [exhorting] consumers to call the phone number ‘1-800-QUIT’ — the line seems quite clear.”
In a memorable 1977 decision, the US Supreme Court ruled in favor of New Hampshire resident George Maynard, who had covered up the state motto “Live Free or Die” on his automobile license plates. Under the Constitution, the court held in Wooley v. Maynard, he could not be punished for doing so. Americans cannot be made to “use their private property as a ‘mobile billboard’ for the State’s ideological message.”
So in gloating that her agency’s strident new warnings were intended to convert every pack of cigarettes into an anti-smoking “mini-billboard,” the FDA commissioner was — presumably inadvertently — articulating precisely the goal that Wooley disallows.
Time and again the courts have made clear that compelled speech is as repugnant to the Bill of Rights as prohibited speech. Reasonable people can disagree over the point at which prudent consumer or public-health protections turn into patronizing nanny-state officiousness.
They can disagree over whether urging Americans not to smoke — or not to eat junk food or watch violent movies or drink too much wine — is a wise use of government influence, time, and money.
But even the wisest policy must be constitutional. The FDA can rent billboards from sea to shining sea and fill them with the ghastliest smoking-is-gross messages it can dream up. What it cannot do is order tobacco companies to use their own products — their own lawful products — to advertise the government’s anti-smoking agenda. If the First Amendment means anything, surely it means that.
Judge blocks graphic cigarette label images
Companies have challenged the rule as unconstitutional because they argue it compels speech
11/7/2011
U.S. District Judge Richard Leon ruled that it is likely the cigarette makers will succeed in a lawsuit to block the requirement.
The Justice Department argued that the images, coupled with written warnings, were designed to communicate the dangers to youngsters and adults. The FDA declined to comment on the judge’s ruling.
Congress instructed the FDA to require the labels, following the lead of the Canadian regulations that require similarly graphic images on cigarette packs.
07/24/2011
Don’t worry, you always have the opportunity to make comments at the bottom of the page. Yeah, your opinion matters, too.
Big Brother gets really ugly
New cigarette labels are enough to make you ill
June 26, 2011
It’s not unusual for the federal government to provoke widespread retching among its citizens, but it rarely does so intentionally. The new warning labels required on cigarette packs, however, have that goal. Designed to evoke disgust with smoking, they may also induce revulsion at excessive uses of power.

FDA unfairly maligns tobacco plant with graphic new cigarette warning labels
June 23, 2011
FDA hypocrisy
The Attack on Dignity and Moral Autonomy: The Case of Cigarettes
Jun 27, 2011
By Mario Rizzo
The latest in the paternalistic actions of the federal government are a kind of reductio ad absurdum. At least this is how it might have seemed ten or fifteen years ago if someone would have said that cigarette-pack health warnings would become graphic pictures designed to horrify the public into not smoking.
What is especially interesting about this development is the subtle change in arguments over the years about the purpose of government interference in this area.
1.In the beginning we had the Surgeon General’s Report simply warning people about the health consequences of cigarette smoking. Of course people realized that cigarette smoking was harmful even before the 1962 report.
2.Then we had fairly general warnings about “hazards” to health. In fact, at first it was simply said that smoking may be hazardous to one’s health.
3.Warnings evolved to include mention of specific illnesses.
All of this is the provision of information, although with the warnings on the package itself the idea was to remind people at the moment of purchase.
Why was it perceived by some that the provision of information, even at the moment of sale, is not sufficient? Why must we move to dramatic presentation of low-probability events? (Most people who smoke do not turn out as the photographs suggest, and many people who do not smoke will have breathing tubes, feeding tubes and nasty medical procedures sometime before they die.)
There are two answers to this question. The first is the “scholarly” answer.? Behavioral economists tell us that many people exhibit “optimism bias.” This is the cognitive attribute in which the person simultaneously realizes that the probability of, say, getting ill from tobacco smoking is p but that this population frequency does not apply to him.
It does not apply to him for “magical reasons.” He has good luck and so forth. So the probability of getting ill is for him (significantly?) less than p.
In view of this, some behavioral economists have suggested that policy makers use another cognitive bias – “availability bias” – to offset the optimism bias.
Availability bias refers to the exaggerated fear and estimate of the probability of harm when one is confronted with, say, a plane accident or instance of terrorism. After a plane accident many people think that the probability of dying in a plane crash is much higher than a cool statistical analysis would suggest.
So now let us put the two biases together and construct a policy. Telling people that smoking is dangerous – even providing people with statistics – is not enough. They will still think that their personal good luck will save them. So we must use their availability bias. We must make the images of a horrible death so available to their minds that they are jolted out of their optimism bias.
But wait. There is evidence that smokers already think that the probability of death and illness from smoking is higher than it really is. So it is unclear what optimism bias does here. Perhaps it just offsets it? In addition, how scary should the advertising campaigns be? Theoretically, they should just be scary enough to offset the optimism bias.
Thus we need to know the effective personal probability the individual places on disease from smoking and the degree to which the scary graphic offsets that.? Bottom line: We do not have this information nor are we likely to get it soon.
The second answer follows from the practical irrelevance of the first.? The campaign of scary pictures, scenarios and the like, will be deemed successful only when cigarette smoking is reduced to an extremely low level. The “optimum” is not well-informed decisionmaking by morally autonomous agents.? It is doing what the paternalist thinks you should be doing or not doing. Case closed.
So the whole campaign is an insult to the dignity of the individual. It is an attack on the older principle of informed choice. It does not respect individual moral autonomy.? It is an example of the sickness of modern American society.
Cigarette Health Warnings
06/22/2011
Beginning September 2012, FDA will require larger, more prominent cigarette health warnings on all cigarette packaging and advertisements in the United States.? These warnings mark the first change in cigarette warnings in more than 25 years and are a significant advancement in communicating the dangers of smoking.
View Final Warnings
The final set of cigarette health warnings contains nine different text warnings and accompanying color graphics to
•?increase awareness of the specific health risks associated with smoking, such as death, addiction, lung disease, cancer, stroke and heart disease;
•?encourage smokers to quit; and
•?empower youth to say no to tobacco.
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HURT: No ifs, ands or butts: FDA warning photos faked
June 21, 2011
By Charles Hurt,The Washington Times
And you paid for them.
The Black Pig Lung Hoax
It was an outright bald-faced lie.
“Pankiw described the centerpiece of his anti-smoking display as the diseased lung of a 150-pound man who smoked for 15 years. Actually, it was a pig’s lung shot full of various carcinogens on purpose, but, Pankiw said later, his lesson was made stronger by not passing along that tidbit of truth.”
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International Smokers Rights Conference
Caesars Palace, Las Vegas
June 27-29, 2005
Read what was presented by The Smoker’s Club in 2005.
Listen to Luc Martial saying that Canada forgot to check the facts on their new cigarette packs! They had to look around after the packs came out to find any doctor who would sign off on the facts with no checking.