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Photos of weak, breathless children, heart surgery scars, and bloody urine may soon be displayed on every cigarette pack in every store in the U.S. The last day for public comment on the new U.S. Food and Drug Association (FDA) rules is Nov. 27.
"With these new proposed cigarette health warnings, we have an enormous public health opportunity to increase the public's understanding of the full scope of serious negative health consequences of cigarette smoking," said FDA Commissioner Ned Sharpless, MD, in August. "Given that tobacco use is still the leading cause of preventable disease and death in the U.S., there's a lot at stake to ensure the public understands these risks."
The FDA will take into account public comments from individuals, tobacco companies, anti-smoking organizations, health-related non-governmental organizations, and other stakeholders to create the text of its final rule requiring the graphic photos on cigarette packs.
"Following a lawsuit filed by several public health groups, a judge issued an order in March directing the agency to publish the proposed rule by August 2019 and issue a final rule in March 2020," an FDA spokesperson said in an email to MedicineNet. "The warnings would be required to appear on packages and in advertisements 15 months after a final rule is issued."
Research cited by the FDA has shown these kinds of photos deter smoking more effectively than the text warnings the FDA has required for decades. Similar images appear on cigarettes in Europe and in other countries, but U.S. tobacco giant RJ Reynolds in 2012 led a class action lawsuit to kill earlier efforts to require more graphic photos. The judge agreed that the earlier proposed rule violated the First Amendment rights of the tobacco companies.
But FDA officials think the current draft regulation and revamped photos will stand up to further First Amendment challenges.
"The FDA believes the proposed warnings would survive judicial scrutiny because they advance the substantial government interest of promoting greater public understanding of the negative health consequences of smoking and are factual, accurate, and not unduly burdensome," according to an email from the FDA. "Importantly, the agency developed a science-based, iterative research process for developing new cigarette health warnings in the proposed rule and underwent extensive legal, scientific, and regulatory analyses."
Look for new packaging early in 2021 at the latest.
What Are the Problems Caused by Smoking?
Smoking is an addiction. Tobacco contains nicotine, a drug that is addictive. The nicotine, therefore, makes it very difficult (although not impossible) to quit. In fact, since the U.S. Surgeon General's 1964 report on the dangers of smoking, millions of Americans have quit. Still, approximately 484,000 deaths occur in the U.S. each year from smoking-related illnesses. This represents almost 1 out of every 5 deaths.
The reason for these deaths, Dr. Stöppler said, is that smoking greatly increases the risk of getting lung cancer, heart attack, chronic lung disease, stroke, and many other cancers. Smokers die an average of 10 years earlier than nonsmokers. Smoking is the most preventable cause of death. In addition, smoking is perhaps the most preventable cause of breathing (respiratory) diseases within the USA, Dr. Stöppler said.
Smoking harms not just the smoker, but also family members, coworkers, and others who breathe the smoker's cigarette smoke, called secondhand smoke or passive smoke, Dr. Stöppler said. Among infants up to 18 months of age, secondhand smoke is associated with as many as 300,000 cases of chronic bronchitis and pneumonia each year. In addition, secondhand smoke from a parent's cigarette increases a child's chances for middle ear problems, causes coughing and wheezing, worsens asthma, and increases an infant's risk of dying from sudden infant death syndrome (SIDS), Dr. Stöppler said.
Smoking is also harmful to the unborn fetus, explains Dr. Stöppler. If a pregnant woman smokes, her fetus is at an increased risk of miscarriage, early delivery (prematurity), stillbirth, infant death, and low birth weight. In fact, it has been estimated that if all women quit smoking during pregnancy, about 4,000 new babies would not die each year, Dr. Stöppler said.
Exposure to passive smoke can also cause cancer. Research has shown that non-smokers who reside with a smoker have a 24% increase in risk for developing lung cancer when compared with other non-smokers, Dr. Stöppler said. An estimated 3,000 lung cancer deaths occur each year in the U.S. that are attributable to passive smoking, and an estimated 49,000 deaths each year in total from all smoking-related conditions occur as a result of secondhand smoke.
Secondhand smoke also increases the risk of stroke and heart disease. If both parents smoke, a teenager is more than twice as likely to smoke as a teenager whose parents are both nonsmokers. Even in households where only one parent smokes, young people are more likely to start smoking, Dr. Stöppler said.
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