A Blunt Exercise of Power

Editors  Note:   The article  below  demonstrates  that  whatever one’s views are on smoking,  it is clear that FDA is going to resort to extreme measures  to regulate the tobacco industry.   To date CRE has covered the actions of  TPSAC;  the action described below was not reviewed by TPSAC.

In a like manner, whatever one’s views are on TPSAC,  it is the  body duly constituted to inject sound science into decision-making.  Menthol on its own  is a very significant issue;  however if future  FDA  actions are to be guided by the action described below,  now  it  is  even more  important   that the  TPSAC  review of  menthol  establish  the precedent  that the regulation of  the tobacco industry is to be science based.

Grisly FDA Tobacco Warnings Could Trip First Amendment Battle

R.J. Reynolds and Lorillard Will Fight Proposed Rules

By Rich Thomaselli
Published: November 11, 2010

NEW YORK (AdAge.com) — In a never-ending quest to rid the country of the ills of smoking, the government is proposing a series of grisly images — including a dead body in a morgue, a dying cancer patient and a rotting mouth — be included on all cigarette packaging beginning in late 2012.

 But while the Food and Drug Administration and the Department of Health and Human Services insist the shock value will serve as a deterrent to smoking and tobacco use, others aren’t so sure — and some even question the legality of enforcing the graphic warning labels on cigarette packs.

“It’s not surprising the FDA would do something like this,” said David L. Hudson, a scholar at the First Amendment Center, which has offices in Washington and Nashville, Tenn. “The FDA has had many First Amendment issues and now they’re taking it to another level with these images. First Amendment rights have been flagrantly infringed upon in this area for some time. I think there’s been a movement afoot to have people think that there’s a tobacco advertising exception to the First Amendment. There isn’t, and there shouldn’t be. It’s not illegal to smoke in this country.”

Then again, the First Amendment hasn’t done much to stop the continual march of restrictions imposed on tobacco marketing.

Biggest change in 25 years
Health and Human Services on Wednesday announced what it called “bolder health warnings on cigarette packages and advertisements” that represent the most significant change in cigarette ads in more than 25 years, and a strategy “that will help tobacco users quit and prevent children from starting.”

Editors Note:  Click on the photo to review the 36 images proposed by the FDA for public comment. 

The images, as proposed, would take up 50% of the space on a pack of cigarettes and be positioned at the top of the pack, with the brand name below. Philip Morris Co., the nation’s biggest cigarette manufacturer, issued a statement saying it has already “actively participated in the FDA’s rule-making and public comment processes and plans to do the same on this proposal.”

But a group of several other tobacco companies, including R.J. Reynolds and Lorillard, the country’s second- and third-largest cigarette manufacturers, have already filed suit challenging the legality of the larger and more graphic warnings, saying the warning labels will obscure the companies’ brand names.

“When the rule takes effect, the health consequences of smoking will be obvious every time someone picks up a pack of cigarettes,” FDA Commissioner Margaret A. Hamburg, M.D., said in a statement. “This is a concrete example of how FDA’s new responsibilities for tobacco-product regulation can benefit the public’s health.”

In a separate interview with the Associated Press, Ms. Hamburg said, “Some very explicit, almost gruesome pictures may be necessary.”

Not a quick fix
In the same AP story, however, Penn State marketing professor Marvin Goldberg cautioned that the startling images were “no silver bullet. Will this wipe out smoking? No, but it will put a dent in it.”


Since 1970, when cigarettes ads on TV were banned — technically Jan. 2, 1971, so that the tobacco companies could advertise one last time on the New Year’s Day college football bowl games — the average number of smokers has dropped from 40% of the American population to around 20%. But that 20% figure, representing about 46 million adults, hasn’t changed since 2004.

“The job of ending the tobacco epidemic cannot fall to a warning label alone,” said Dr. Jane L. Delgado, president and CEO of the National Alliance for Hispanic Health.

The government strategy includes a proposal issued by the FDA titled “Required Warnings for Cigarette Packages and Advertisements.” Specifically, the proposed rule details a requirement of the Family Smoking Prevention and Tobacco Control Act that calls for nine new, larger and more noticeable textual warning statements, as well as color graphic images depicting the negative health consequences of smoking to appear on cigarette packages and in cigarette advertisements.

But the “color graphic images” is a kind way of describing some fairly gruesome photos that show the consequences of smoking. One pictures a man holding a cigarette, with the smoke coming out of a hole in his throat. Another shows a healthy human lung next to a nicotine-damaged organ. Another shows a body in a coffin, and yet another even more graphic image shows a body in a morgue, with staples running down his torso, presumably from having just been autopsied.

It’s a bold move and, with accompanying text that includes phrases such as “Smoking can kill you” and “Cigarettes are addictive,” they are certainly starker than the Surgeon General’s warning.

But that’s what the FDA is going for. There are 36 images total; the FDA is taking public comment through Jan. 9 and then will pick nine of the photos to go on boxes by Oct. 22, 2012.

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