Showing posts with label drug regulation. Show all posts
Showing posts with label drug regulation. Show all posts

Monday, November 15, 2010

New Warning Labels for U.S. Cigarettes; Big Tobacco on the Rampage


Philip Morris Intl. sues Uruguay and Brazil.

Lots of developments on the nicotine front these days. On opposite ends of the news spectrum, so to speak, the Food and Drug Administration (FDA) announced plans to slap new and much more graphic warning stickers on cigarette packs--while elsewhere in the world, the world’s major tobacco companies got busy fighting tougher regulations on cigarette marketing. Meanwhile, the state of California has set limits on the marketing of e-cigarettes, disallowing companies from promoting the nicotine inhalers as “smoking-cessation devices.”

So let’s get busy. In the first significant change for cigarette advertising in 25 years, the FDA, freed by Congress last year to regulate tobacco products, will select nine new designs from among 36 contenders for new, far more graphic warning labels on cigarette packages. The new warning labels will begin appearing in about a year. To view the contenders, go to www.fda.gov/cigarettewarnings.

But will new, grisly images of dying smokers and rotted lungs really make a difference to the roughly one-quarter of adult Americans who still smoke?  “I am pleasantly shocked that [they are] doing this,” Stanton A. Glantz, a tobacco researcher at UC San Francisco, told the Los Angeles Times.  “There is no question but that strong graphic warning labels work,” he said. “Right now we have the weakest warning labels in the world. Now we will be right up there tied for the strongest.”

No so fast, counters John F.  Banzhaf, the executive director of Action on Smoking and Health and a George Washington University law professor. In the same L.A. Times article, Banzhaf said he was “quite disappointed,” stating that the agency “has done nothing more than exactly what Congress told them to do, and not one iota more.” So far, the FDA has banned advertising in magazines for young people, nixed the marketing ploy of handing out free samples on the street, and forbidden tobacco companies from marketing cigarettes by using the words “light” or “low-tar.”

Perhaps a more important result of Congressional approval of FDA oversight is that Medicare has now changed its rules to include smoking cessation products for covered beneficiaries. Previously, only people dying of lung disease were approved for smoking cessation products—a bit late in the disease cycle to do anybody much good.

According to a variety of estimates from government and research agencies, as many as half a million Americans die prematurely from smoking-related diseases. The Department of Health and Human Services has lately been stymied by a smoking rate of about 20%, basically unchanged since 2004. In 1965, about 42% of Americans smoked. The Department of Health and Human Services (HHS) has a stated goal of bringing smoking levels down to 12% by 2020.

That will not be an easy target to hit. And neither Congress nor the FDA nor HHS can count on anything amounting to cooperation from the cigarette giants. The New York Times, in an article by Duff Wilson, notes that worldwide cigarette sales rose 2% last year, as cigarette companies increasingly shift their marketing efforts toward a hunt for new customers in developing countries.  The aggressive nature of the worldwide cigarette marketing push was underscored this year when Philip Morris International sued the governments of Uruguay and Brazil, claiming that those countries had enacted tobacco regulations that were excessive and a threat to the company’s trademark and property rights.

Dr. Douglas Bettcher of the World Health Organization’s Tobacco Free Initiative accused the company of “using litigation to threaten low- and middle-income countries.” Philip Morris subsidiaries are also filing suits in Ireland and Norway over display advertising prohibitions. (Philip Morris USA, a separate division, is not involved in these lawsuits, and did not join with R.J. Reynolds and other tobacco companies in filing suit against the FDA last year.)

In the New York Times article, Wilson writes:

Companies like Philip Morris International and British American Tobacco are contesting limits on ads in Britain, bigger health warnings in South America and higher cigarette taxes in the Philippines and Mexico. They are also spending billions on lobbying and marketing campaigns in Africa and Asia, and in one case provided undisclosed financing for TV commercials in Australia.

As tobacco expert Dr. Cynthia Pomerleau points out on her blog, low smoking rates among women in the developing world make them a particularly tempting marketing target for the tobacco industry. Pomerleau, research professor emerita in the University of Michigan’s Department of Psychiatry, also reminds us that “the real goal here is not to remove health warnings altogether—health warnings have actually worked well for them by legitimizing the claim that if people choose to smoke, it’s not their fault—just to prevent them from dominating the package and actually becoming salient.”

It is important for the industry, says Pomerleau, to publicize “effects that can be achieved or problems that can be addressed by smoking.” In this respect, Pomerleau is concerned about the likelihood that the tobacco industry will seize upon the relationship between smoking and thinness as the wedge for sales campaigns aimed at women. “If it worked in the U.S., why not in Africa or Asia or South America?”

And finally, under a consent judgment worked out with California state Attorney General Jerry Brown, the Florida-based Smoking Everywhere company, a distributor of electronic cigarettes, has agreed not to target minors in its advertising, or to make claims that its products are safe alternatives to tobacco. The move comes shortly after the FDA announced plans to regulated battery-powered e-cigarettes as new drug delivery devices. Smoking Everywhere distributes e-cigarettes manufactured in China. The consent judgment also bars the company from selling its products in vending machines, and requires the products to contain warning labels about the dangers of nicotine.

And don’t forget: Thursday, November 18 marks the 35th annual Great American Smokeout.
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