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FDA to Impose Graphical Warnings on all Cigarette Packs for Public Awareness

The U.S. Food and Drug Administration (FDA) has passed a new rule that compels all cigarette making companies to add graphical warnings on cigarette packings and all advertisements. These warnings could be textual, photo-realistically graphical or both, explaining the severe health complications of smoking i.e. developmental problems, heart diseases, diabetes, blood pressure, and many others.

FDA is a federal agency constituted within the Department of Health and Human Services of the US. It safeguards the health of all citizens by taking control over medicines, drugs, vaccines, devices and biological products.

Mitch Zeller is the director at the Center for Tobacco Products, U.S. FDA. Mitch says that; “The 11 finalized cigarette health warnings represent the most significant change to cigarette labels in more than 35 years and will considerably increase public awareness of lesser-known, but serious negative health consequences of cigarette smoking,”

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He further adds; “Research shows that the current warnings on cigarettes, which have not changed since 1984, have become virtually invisible to both smokers and nonsmokers, in part because of their small size, location and lack of an image. Additionally, research shows substantial gaps remain in the public’s knowledge of the harms of cigarette smoking, and smokers have misinformation about cigarettes and their negative health effects. The new cigarette health warnings complement other critical FDA actions, including outreach campaigns targeted to both adults and youth, to educate the public about the dangers associated with using cigarettes, as well as other tobacco products.”

With an effect from June 2021, all the new cigarette packs would be available with warnings about potential health damages. The same applies to advertisements for these cigarettes. FDA has advised using the upper 50% of the area and rear panels on a typical cigarette box to be covered with these warnings. As to the agency, 20% of the area from top in an advertisement should display the warnings.

Once these new guidelines are adopted, all packs and advertisements of cigarettes would display potential health damages of smoking to the user. The purpose of adding graphical images is to make sure that the buyer pays attention to what could smoking cause to his health. In case he can’t read or understand the written statement, the pictorial warning could still be understandable.

FDA already outlines this in a rule proposed in 2019. For now, the agency is following a more scientific approach to evaluate and impose health-based warnings. These warnings depict the severe health complications that are probably not known to the common public.

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Many people don’t even know that smoking could cause a health problem for them. For example, many of smokers are found to have an extremely high probability of bladder cancer. It is 4 times more than a normal person and was never observed before. The research also explains that smoking is the leading cause behind 5000 annual deaths by bladder cancer only in the US. Yet common people don’t believe that smoking could give them cancer.

This proposed rule suggested adding 13 warnings, which the FDA considered and chose 11 warnings as final. Based on the FDA’s consumer research data, these rules are finalized to be added to cigarette packs and advertisements.

FDA has also announced a complete guidance plan along with this final rule. It is called “Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide” for industries on how to comply with FDA’s new rule.



Areeba Hussain

The author is a fulltime medical and healthcare writer. She graduated in Medical Microbiology and Immunology with distinction. Her areas of prime interest are medicine, medical technology, disease awareness, and research analysis. Twitter @Areeba94789300

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