FDA issues graphic cigarette labels

Three of nine new warn­ing labels cig­a­rette mak­ers will have to use by the fall of 2012. In the most sig­nif­i­cant change to U.S. cig­a­rette packs in 25 years, the FDA’s the new warn­ing labels depict in graphic detail the neg­a­tive health effects of tobacco use. (Cour­tesy | U.S. Food and Drug Administration)

(Cour­tesy | U.S. Food and Drug Administration)

(Cour­tesy | U.S. Food and Drug Administration)

MICHAEL FELBERBAUM

AP Tobacco Writer

RICHMOND, Va. — Rot­ting teeth. Dis­eased lungs. A corpse of a smoker.

Nine new warn­ing labels fea­tur­ing graphic images that con­vey the dan­gers of smok­ing will be required by the Food and Drug Admin­is­tra­tion to be on U.S. cig­a­rette packs by 2012. Other images include a man with a tra­cheotomy smok­ing and a mother hold­ing a baby with smoke swirling around them. The labels will include phrases like “Smok­ing can kill you” and “Cig­a­rettes cause cancer.”

The labels, which the FDA released Tues­day, are a part of the most sig­nif­i­cant change to U.S. cig­a­rette packs in 25 years. They’re aimed at curb­ing tobacco use, which is respon­si­ble for about 443,000 deaths in the U.S. a year.

The labels will take up the top half — both front and back — of a pack of cig­a­rettes and each will include a national quit smok­ing hot­line num­ber. Warn­ing labels also must appear in adver­tise­ments and con­sti­tute 20 per­cent of an ad. Cig­a­rette mak­ers have until the fall of 2012 to comply.

“These kind of graphic warn­ing labels strengthen the under­stand­ing of peo­ple about the health risks of smok­ing,” FDA Com­mis­sioner Mar­garet Ham­burg said in an inter­view with The Asso­ci­ated Press. “We clearly have to renew a national con­ver­sa­tion around these issues and enhance awareness.”

Man­dates to intro­duce new graphic warn­ing labels were part of a law passed in 2009 that, for the first time, gave the fed­eral gov­ern­ment author­ity to reg­u­late tobacco, includ­ing set­ting guide­lines for mar­ket­ing and label­ing, ban­ning cer­tain prod­ucts and lim­it­ing nico­tine. The announce­ment fol­lows reviews of sci­en­tific lit­er­a­ture, pub­lic com­ments and results from an FDA-contracted study of 36 labels pro­posed last November.

The legal­ity of the new labels is part of a pend­ing fed­eral law­suit filed by Winston-Salem, N.C.-based Reynolds Amer­i­can Inc., par­ent com­pany of America’s second-largest cig­a­rette maker, R.J. Reynolds; No. 3 cig­a­rette maker, Greens­boro, N.C.-based Loril­lard Inc.; and others.

Tobacco mak­ers in the law­suit have argued the warn­ings would rel­e­gate the com­pa­nies’ brands to the bot­tom half of the cig­a­rette pack­ag­ing, mak­ing them “dif­fi­cult, if not impos­si­ble, to see.”

A spokesman for Rich­mond, Va.-based Altria Group Inc., par­ent com­pany of the nation’s largest cig­a­rette maker, Philip Mor­ris USA, said the com­pany was look­ing at the final labels but would not com­ment further.

In recent years, more than 30 coun­tries or juris­dic­tions have intro­duced labels sim­i­lar to those being intro­duced by the FDA. The U.S. first man­dated the use of warn­ing labels stat­ing “Cig­a­rettes may be haz­ardous to your health” in 1965. Cur­rent warn­ing labels — a small box with black and white text — were put on cig­a­rette packs in the mid-1980s.

The FDA says the new labels will “clearly and effec­tively con­vey the health risks of smok­ing” aimed at encour­ag­ing cur­rent smok­ers to quit and dis­cour­ag­ing non­smok­ers and youth from start­ing to use cigarettes.

“These labels are frank, hon­est and pow­er­ful depic­tions of the health risks of smok­ing,” Health and Human Ser­vices Sec­re­tary Kath­leen Sebe­lius said in a statement.

Amer­i­can Can­cer Soci­ety CEO John R. Sef­frin applauded the new labels in a state­ment, say­ing they have the poten­tial to “encour­age adults to give up their deadly addic­tion to cig­a­rettes and deter chil­dren from start­ing in the first place.”

The new labels come as the share of Amer­i­cans who smoke has fallen dra­mat­i­cally since 1970, from nearly 40 per­cent to about 20 per­cent. The rate has stalled since about 2004. About 46 mil­lion adults in the U.S. smoke cigarettes.

It’s unclear why declines in smok­ing have stalled. Some experts have cited tobacco com­pany dis­count coupons on cig­a­rettes or lack of fund­ing for pro­grams to dis­cour­age smok­ing or to help smok­ers quit.

While it is impos­si­ble to say how many peo­ple quit because of the labels, var­i­ous stud­ies sug­gest the labels do spur peo­ple to quit. The new labels offer the oppor­tu­nity for a pack-a-day smoker to see graphic warn­ings on the dan­gers of cig­a­rettes more than 7,000 times per year.

The FDA esti­mates the new labels will reduce the num­ber of smok­ers by 213,000 in 2013, with smaller addi­tional reduc­tions through 2031.

Tobacco use costs the U.S. econ­omy nearly $200 bil­lion annu­ally in med­ical costs and lost pro­duc­tiv­ity, the FDA said. Tobacco com­pa­nies spend about $12.5 bil­lion annu­ally on cig­a­rette adver­tis­ing and pro­mo­tion, accord­ing to the lat­est data from the Fed­eral Trade Commission.

The World Health Orga­ni­za­tion said in a sur­vey done in coun­tries with graphic warn­ing labels that a major­ity of smok­ers noticed the warn­ings and more than 25 per­cent said the warn­ings led them to con­sider quitting.

While some have voiced con­cerns over the hard-hitting nature of some of the labels, those con­cerns should be trumped by the government’s respon­si­bil­ity to warn peo­ple about the dan­gers of smok­ing, said David Ham­mond, a health behav­ior researcher at the Uni­ver­sity of Water­loo in Canada, who worked with the firm design­ing the labels for the FDA.

“This isn’t about doing what’s pleas­ant for peo­ple. It’s about ful­fill­ing the government’s man­date if they’re going to allow these things to be sold,” Ham­mond said. “What’s both­er­ing peo­ple is the risk asso­ci­ated with their behav­ior, not the warn­ings themselves.”

In places like Canada, Ham­mond said smok­ers offended by some of the images on cig­a­rettes packs there started ask­ing for dif­fer­ent packs when they received ones with cer­tain gory images, or used a case to cover them up. But smok­ers said those warn­ings still had an effect on them.

Canada intro­duced sim­i­lar warn­ing labels in 2000. Since then, its smok­ing rates have declined from about 26 per­cent to about 20 per­cent. How much the warn­ings con­tributed to the decline is unclear because the coun­try also imple­mented other tobacco con­trol efforts.

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