Male smoking cigarette

Graphic warnings weighed to emphasize smoking’s health effects, including blindness

Graphic, photo-realistic warning labels could confront the public face-to-face with some lesser known but serious health consequences of smoking-including blindness-as the AOA weighs in on the first significant update to cigarette packaging in over three decades.

In August, the U.S. Food and Drug Administration (FDA) issued a proposed rule to require new warnings on cigarette packaging and tobacco advertisements with an aim of promoting "greater public understanding of the negative health consequences of smoking," the agency noted. The labels, 13 in all, depict "unsettling images" of blackened lungs, neck cancer, gangrenous toes, bloody urine and a pair of eye conditions-age-related macular degeneration (AMD) and cataracts-alongside stark warning messages.

Once finalized, the rule would require these health warnings to be prominently displayed on cigarette packaging and advertisements, occupying the top half, front and back, of packages and at least 20% of the top area on advertisements. Consumers would begin noticing the changes as soon as 15 months after the final rule is issued.

"Cigarette packages and advertisements can serve as an important channel for communicating health information to broad audiences that include both smokers and nonsmokers," notes Mitch Zeller, J.D., director of the FDA's Center for Tobacco Products, in a news release. "In fact, daily smokers potentially see warnings on cigarette packages more than 5,100 times per year, and all members of the public, including adolescents, are exposed to cigarette advertisements in print and digital media, as well as in and around stores where cigarettes are sold."

Originally mandated by the Family Smoking Prevention and Tobacco Control Act of 2009, the warning labels were first presented in a 2011 FDA rule that tobacco companies eventually blocked in court. This time, the FDA says the warning labels more closely depict the "factual dangers" of smoking.

In this latest iteration, the FDA selected the warnings through consumer research that identified smoking-related health concerns that were both new and informative when compared with current Surgeon General's warnings on packaging and advertisements, developed in 1984. Among these, AMD and cataracts were identified, given Americans' comparative obliviousness with the association between smoking and blindness as compared with other countries, worldwide.

Given the degree of public and stakeholder interest in the proposed rule, the FDA opened a public comment period through Oct. 15 to hear feedback on the newly proposed warning labels. For its part, the AOA strongly supports the inclusion of vision loss among the 13 proposed warnings and provided input to help further enhance such messaging.

AOA supports warning labels, offers suggestions

In comments to FDA Acting Commissioner Norman Sharpless, M.D., the AOA applauds the proposed rule and calls the warning labels a necessary next step to improve the visual health outcomes of the public. Building upon findings of the 2014 Surgeon General's report, The Health Consequences of Smoking: 50 Years of Progress, which confirmed the causal relationship between cigarette smoking and AMD, the AOA reiterated not only the public health benefit of communicating these eye health risks but also the potential for resonance among the public.

Vision loss consistently ranks among Americans' greatest health fears, even more so than loss of hearing, memory, speech or even a limb, while the total U.S. economic burden of vision loss and blindness tops $139 billion. As such, doctors of optometry have long been committed to educating patients about the dangers tobacco use poses to eye health; the FDA's proposal reaffirms existing chairside consultation.

"The loss of vision from smoking is entirely preventable," the letter reads, signed by AOA President Barbara L. Horn, O.D. "We applaud FDA's efforts to reduce the number of people who are visually impaired due to their lack of education surrounding the less-known adverse effects of smoking. AOA and its members stand ready to support this rule in any way we can and will remain actively involved in ensuring patient education and understanding of these important health issues."

Additionally, the AOA offered suggestions for greater impact with warning labels concerning AMD, cataracts and diabetes. For instance, the FDA's current warning label for AMD depicts a black male receiving an intravitreal injection. The AOA suggested changes to better reflect gender and racial considerations, i.e., depicting a woman-considering 65% of AMD cases are in women-or depicting a Hispanic individual-given that this ethnic group is likely to see a six-fold rise in expected AMD cases by 2050. The AOA also suggested replacing the proposed AMD graphic by instead highlighting the apparent vision toll of AMD as opposed to unintentionally creating fear over a necessary medical intervention.

Following similar reasoning, the AOA suggested the FDA consider a woman for the graphic illustrating cataracts, while in the case of smoking and diabetes, the AOA emphasized how diabetes is a leading cause of vision loss among Americans, ages 20 to 74. Lastly, the AOA recommended including the national quit hotline, 1-800-QUIT-NOW, on cigarette packaging and advertisements.

Smoking and eye health

Despite 50-plus years of literature concerning the adverse health effects of smoking, public awareness of these risks remains varied. That's especially true when it comes to smoking's effect on eye health. In fact, as few as 9.5% of U.S. smokers believed that smoking could cause blindness, per a 2011 Optometry study. However, contrast that with Australia where nearly 47% of smokers knew the harm. So, why the difference?

Australia's National Tobacco Campaign, launched in 1997, included print and television ads linking smoking with "loss of eyesight" via AMD. Research indicated commercials concerning the smoking and AMD association were "more efficient in generating Quitline (cessation hotline) calls than other ads that contained information about tar in smoker's lungs." Moreover, the message was delivered in a "dramatic manner" with depictions of burst blood vessels in the retina, as well as graphic warning labels emblazoned on cigarette packaging.

Dan Bintz, O.D., AOA Health Promotions Committee member, acknowledges the significant differences in public health awareness about smoking's ill effects from country to country. All told, some 120 countries have already adopted the kinds of graphic warnings the FDA now proposes. But, still, the FDA's proposed labeling is comparatively mundane with countries, such as Canada, depicting images of cancerous tongues, rotting teeth and emaciated cancer patients.

"Although this FDA-proposed rule seems like a big step, many countries have had even larger warnings with more graphic images for several years," Dr. Bintz says. "The messages are still quite watered down and there is a complete lack of new labels and images specifically for smokeless tobacco."

Nonetheless, the proposed rule is a step in the right direction, Dr. Bintz says. As a practitioner who's committed to educating his patients about smoking's effect on their health, Dr. Bintz notes every bit of reinforcement-be it from packaging to chairside consultation-helps chip away at this public health issue.

"As in the care of our patients with diabetes, the issue of tobacco use has allowed optometry to be heard as a health care profession, advocating for prevention of diseases and promoting healthier lifestyles," he says.

Want information about how to consult patients on smoking? Access these AOA and federal resources:

September 10, 2019

comments powered by Disqus