Today, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would require health warnings on cigarette packages and advertising.  The warnings include color images depicting some of the lesser-known health risks of cigarette smoking.  This is FDA’s second attempt to require graphic warnings for cigarette packages and advertisements.

The Tobacco Control Act requires FDA to issue regulations requiring new warning labels specifically on cigarette packages and in advertisements.  In June 2011, FDA published a final rule requiring color graphics depicting the negative health consequences of smoking to accompany nine textual warning statements specified in the Tobacco Control Act.  However, the final rule was challenged in court by several tobacco companies.  In R.J. Reynolds Tobacco Co. v. Food & Drug Administration, 696 F.3d 1205 (D.C. Cir. 2012), the U.S. Court of Appeals of the District of Columbia held that the 2011 rule violated the First Amendment and remanded the rule back to FDA.

Based on the findings of a consumer research study conducted by FDA, the proposed new warnings would include the following statements:

  • 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 causes COPD, a lung disease that can be fatal.
  • 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.

Each of these warnings would accompany an image that depicts the health risk warned against.  The new cigarette health warnings would appear on cigarette packages and in advertisements, occupying the top 50% of the area of the front and rear panels of cigarette packages and at least 20% of the area at the top of cigarette advertisements.

FDA will accept comment on the proposed warnings until October 30, 2019.

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Husch Blackwell has experience advising tobacco manufacturers on FDA regulations, including regulations on tobacco labeling and warnings. Our FDA lawyers have the required scientific and technical backgrounds to assist companies with compliance. Contact Seth MailhotEmily Lyons or your Husch Blackwell attorney.