FDA Releases Final Regulation for New Cigarette Warning Labels

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FDA Releases Final Regulation for New Cigarette Warning Labels

As the nation deals with the global COVID-19 pandemic, the U.S. Food and Drug Administration has released a final rule that will bring about a big change to the cigarette sector of the tobacco industry–graphic warning labels are coming in 2021.

The Family Smoking Prevention and Tobacco Control Act granted the FDA the ability to regulate tobacco products. In June 2011, the FDA first introduced regulations that required text warnings and graphic pictures on cigarette packages, cigarette cartons and cigarette advertising. Cigarette manufacturers challenged the regulation on the grounds that the requirements violated their First Amendment rights, an argument other areas of the tobacco industry used when facing the threat of warning labels for products like cigars [read more here]. The U.S. Supreme Court ruled that “commercial speech,” a protected right under the First Amendment, and that it applied to product packaging and advertising. The first attempt by the FDA to institute graphic cigarette warnings was overturned in 2012 by the United States Court of Appeals for the District of Columbia in August 2012, forcing the FDA to reevaluate its plan to be in better alignment with constitutional standards.

Graphic warning labels have been a part of the global tobacco industry for some time now but until recently, those graphic labels have not been a part of cigarette products sold and distributed in the U.S. With this new final rule, cigarette packages and advertisements will be required to bear one of 11 new textural warning label statements and accompanying color graphics. The following warning statements will be required:

  • 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 cataracts, which can lead to blindness.

“FDA is taking this action to promote greater public understanding of the negative health consequences of cigarette smoking,” the FDA wrote in its final ruling.

The new rule goes into effect on Jane 18, 2021. The change in warning labels came about with the FDA determining that the public has misconceptions about the health risks caused by smoking and that the new textual warning statements focused on less-known health consequences of smoking paired with corresponding color graphics will promote a greater public understanding of the risks associated cigarette smoking. The FDA is hoping that the new cigarette health warnings will advance the government’s interest in promoting a greater public understanding of the negative health consequences of cigarette smoking.

The new rule extends to not just cigarette packages but cigarette advertisements as well. The new cigarette warnings must appear prominently on packages and in advertisements, occupying the top 50 percent of the area of the front and rear panels of cigarette packages and at least 20 percent of the area of the top of cigarette advertisements. In addition, the required warnings for cigarette packages must be rotated quarterly and tobacco manufacturers, distributors and retailers are all required to submit a plan for the random and equal display and distribution of the required warnings on packages the quarterly rotation in advertisements to the FDA–who must then approve the plan before a company can actually execute it.

Retailers will also be impacted by the new cigarette warning rules. The National Association of Tobacco Outlets (NATO) explained the new compliance requirements that retailers must carry out within their stores:

  1. Under the regulation, retailers typically would not be required to submit a cigarette plan for rotating the health warnings on cigarette packages and cigarette cartons, as long as the cigarette packaging: (1) contains a warning; (2) is supplied to the retailer by a license- or   permit-holding tobacco product manufacturer or distributor; and (3) is not altered by the retailer. A retailer would be in violation of the regulation if it obscures, covers up, or blocks the health warnings with a sticker or marker or shrinks the warnings when cigarettes are displayed for sale in a store. The FDA believes that most, if not all, retailers would fall under this scenario.
  2. A retailer that is also a manufacturer of cigarettes would need to submit a plan to the FDA for the rotation of the new health warnings on cigarette packages, on cigarette cartons, and in cigarette advertisements.
  3. If a retailer directs its own cigarette advertising or generates or creates its own cigarette advertisements, then that retailer would need to submit a plan to the FDA regarding the quarterly rotation of the new cigarette health warnings on the advertisements.
  4. A retailer would not be allowed to display in a location open to the public a cigarette
    advertisement that does not contain a health warning or that contains a warning that has been altered by the retailer such as by blocking, covering, or obscuring the health warning.

The following graphic color images for each respective text health warning statement are as follows (provided by NATO):

FDA | Graphic Warning Labels for Cigarette Packaging and Advertising 2020

“FDA developed the new cigarette health warnings included in the final rule through a science-based, iterative research process,” the agency wrote in the final rule. “The required warnings will promote greater public understanding of the negative health consequences of cigarette smoking.”

There is no limitation on a sell-through period for either wholesalers or retailers as long as the cigarettes without the new health warnings were made before June 18, 2021 and sold to distributors and/or retailers within 30 days of June 18, 2021.

You can read the final rule in its entirety here. For all the latest legislation and FDA news impacting the tobacco industry, click here.

Sources: Federal Register, National Association of Tobacco Outlets (NATO)