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FDA Proposes New Health Warnings for Cigarette Packages and Advertisements

by Suhani Kamdar

On August 15, 2019, the FDA published a new rule, “Required Warnings for Cigarette Packages and Advertisements,” requiring thirteen health warnings and accompanying graphic images to be displayed prominently on cigarette packages and advertisements on a rotational basis.  The rule, which would impact retailers who advertise cigarettes as well as suppliers, requires the display of photo-realistic images depicting the negative health consequences of smoking and marks the FDA’s second effort to implement such warnings under the Tobacco Control Act of 2009.

Several tobacco companies successfully challenged the FDA’s 2011 final rule requiring new health warnings and color graphics on cigarette packages, with the U.S. Court of Appeals for the District of Columbia holding that the rule violated the First Amendment.  The court, examining images such as a smoker with rotting teeth and diseased lungs as well as an individual with a hole in his throat and a cigarette in hand, held that the manufacturer was forced to go beyond making purely factual and accurate commercial disclosures and was compelled to undermine its own economic interest by turning every pack of cigarettes in the country into a “mini billboard for the government’s anti-smoking message[.]”

The FDA explains that the recently proposed health warnings are based on extensive research and describes them as factually accurate, with the images corresponding closely to the text warning statements.  Although industry insiders anticipate a similar challenge to these warnings once the rule is finalized, the FDA had little choice but to issue the proposed rule now.  After several public health groups filed a lawsuit to require the FDA to fulfill its obligations under the Tobacco Control Act to issue new warnings, a Massachusetts District Judge ordered the FDA to publish the new proposed rule by August 2019 and issue a final rule in March 2020.  Comments on the proposed rule will be accepted through October 15, 2019.

Proposed New Warnings

The thirteen proposed warnings for cigarette packages and advertisements cover various health conditions and describe how smoking impacts the body.  The required graphic images to be paired with the warning text include, for example, depictions of a blackened lung, a bulging tumor on a woman’s neck, an underweight infant on a scale, and a chest incision scar indicating heart surgery.  The warning statements and images are available through the FDA website.

The warning statements include:

  • WARNING: Tobacco smoke can harm your children.
  • WARNING: Tobacco smoke causes fatal lung disease in nonsmokers.
  • WARNING: Smoking causes head and neck cancer.
  • WARNING: Smoking causes bladder cancer, which can lead to bloody urine.
  • WARNING: Smoking during pregnancy stunts fetal growth.
  • WARNING: Smoking can cause heart disease and strokes by clogging arteries.
  • WARNING: Smoking reduces blood flow, which can cause erectile dysfunction.
  • WARNING: Smoking reduces blood flow to the limbs, which can require amputation.
  • WARNING: Smoking causes type 2 diabetes, which raises blood sugar.
  • WARNING: Smoking causes age-related macular degeneration, which can lead to blindness.
  • WARNING: Smoking causes cataracts, which can lead to blindness.
  • WARNING: Smoking causes COPD, a lung disease that can be fatal.


This last statement regarding COPD must be paired with two alternative images, resulting in a total of thirteen warnings.

Under the proposed rule, the warnings must occupy the top 50% of the front and rear panels on cigarette packages and at least 20% of the area of the top of a cigarette advertisement.


Random Display and Rotational Warnings

Just as the FDA has mandated for cigar warnings, it would require the proposed warnings for cigarette packages to be randomly displayed in a 12-month period, in as equal a number of times as is possible, and to be randomly distributed within the U.S.  The random display must comply with an approved plan submitted by the manufacturer, distributor, or retailer to the FDA.

The required warnings for advertisements would have to be rotated quarterly in alternating sequence for each brand of cigarettes, also according to a plan submitted to and approved by the FDA.


Retailer Liability

With respect to warnings on cigarette packages, retailers would not face liability as long as they sell or offer for sale cigarettes in packaging that (i) contains a warning; (ii) is supplied to the retailer by a licensed manufacturer or distributor; and (iii) is not altered by the retailer in any material way.

Retailers who direct advertising would have to comply with the warnings requirement for advertisements, including submission of a warning plan.  In addition, any retailer who, in a location open to the public, displays an advertisement that fails to contain a warning, or which has been altered by the retailer in a material way, would face liability.


How We Can Help Your Company

Rogers Joseph O’Donnell specializes in working with its corporate clients on compliance with regulatory and environmental laws that impact their business.  For compliance advice or defense of claims, attorneys Renee D. Wasserman, Alexis J. Morris, Suhani Kamdar, and Alecia Cotton are available to assist.

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