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FDA Issues Final Regulation for New Cigarette Health Warnings

The following is an update from the National Association of Tobacco Outlets (NATO) sourced through their March 18th online bulletin. Reposted with permission.

Yesterday, the U.S. Food and Drug Administration (FDA) issued a final rule or regulation to require new health warnings on cigarette packages, on cigarette cartons, and in cigarette advertisements to increase the public’s understanding of the health consequences of smoking. These new cigarette health warnings would consist of eleven text warning statements with each text warning accompanied by a photo-realistic color image.

The Family Smoking Prevention and Tobacco Control Act, the law that granted the FDA the authority to regulate tobacco products, directed the FDA to issue regulations requiring new textual warning statements accompanied by color graphics depicting the negative health consequences of smoking. The FDA first issued a new regulation in June of 2011 requiring text warnings and graphic pictures on cigarette packages, on cigarette cartons, and in cigarette advertisements. The cigarette manufacturers challenged the regulation in court on the grounds that the warnings violated the protection of free speech under the First Amendment to the U.S. Constitution. “Commercial speech” has been ruled by the U.S. Supreme Court to include product packaging and product advertising. On August 24, 2012, the United States Court of Appeals for the District of Columbia overturned the first FDA cigarette health warnings and sent the matter back to the FDA to create new warnings that comply with constitutional standards.

Health Warnings and Graphic Images: The new cigarette health warnings read as follows:

  • 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.

The graphic color images for each respective text health warning statement are shown below:

Package Size and Placement Requirements: The new cigarette health warnings would occupy at least the top 50 percent of the area of the front and rear panels of cigarette packages and at least 50% of the left side of the front and rear panels of cigarette cartons. The required warnings must appear directly on the package and must be clearly visible underneath any cellophane or other clear wrapping. The required warnings must be indelibly printed on or permanently affixed to cigarette packages and to cigarette cartons. That is, these required warnings cannot be printed or placed on a label which is then affixed to a clear outer wrapper that is likely to be removed to access the product within the package.

Advertisement Size and Placement Requirements: For print advertisements and other advertisements with a visual component (including advertisements on signs, retail displays, Internet website pages, social media web pages, digital platforms, mobile applications, and email correspondence), the required warnings must appear directly on the advertisement. In addition, required warnings must comprise at least 20 percent of the area of a cigarette advertisement in a conspicuous and prominent format and be positioned at the top of each advertisement within the trim area, if any.

The FDA regulation states that the requirement to print the required warnings on cigarette packages, on cigarette cartons, and in advertisements do not apply to manufacturers or distributors of cigarettes that do not manufacture, package, or import cigarettes for sale or distribution within the United States.

Rotation Requirements: The eleven text and color image warnings for cigarette packages and cigarette cartons must be randomly displayed in each 12-month period, in as equal a number of times as is possible on each brand of cigarettes and must be randomly distributed in all areas of the United States in which the product is marketed. These random display and distribution requirements must be a part of a cigarette manufacturer’s plan filed with the FDA, which the agency needs to approve. The required health warnings for advertisements must be rotated quarterly in alternating sequence in advertisements for each brand of cigarettes in accordance with an FDA-approved plan.

Requirements for Retailers: When the regulation goes into effect, retailers will need to comply with several requirements regarding the new cigarette health warnings. These retail requirements are as follows:

  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.
  1. 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.
  1. 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.
  1. 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.

Advertising Plans: The FDA strongly encourages entities to submit their cigarette health warning rotational plans as soon as possible and in any event within five months of March 18, 2020. The FDA states in the final regulation that the agency intends to issue a final guidance document with additional information and recommendations to assist manufacturers and retailers prepare and submit plans for the rotation of the cigarette health warnings. For retailer-generated advertising, the agency states that retailers may list “all brands” in their cigarette health warning rotational plan, which would cover future brands, so long as the plan provides for the same schedule for quarterly rotation of the required warnings for all brands.

Effective Date Information: The FDA was under a federal court order to finalize the second set of new cigarette health warnings by March 15, 2020. This does not mean that the new cigarette health warnings had to be printed on cigarette packages, on cigarette cartons, and in cigarette advertisements by March 15, 2020. Rather, the Family Smoking Prevention and Tobacco Control Act states that any new cigarette health warnings would go into effect 15 months after a FDA cigarette health warning regulation is finalized.

The following information regarding the effective date of the new cigarette health warnings is

being provided by the FDA:

  1. Beginning June 18, 2021, these new cigarette health warnings will be required to appear prominently on cigarette packages, on cigarette cartons, and in advertisements.
  1. Beginning 30 days after June 18, 2021, a manufacturer must not introduce into domestic commerce of the United States any cigarette product, irrespective of the date of manufacture, that does not conform to the final rule.
  1. As of the effective date, June 18, 2021, no manufacturer, distributor, or retailer of cigarettes may advertise or cause to be advertised within the United States any cigarette product unless the advertising complies with the final rule.
  1. As explained in the final rule, if a cigarette product was manufactured prior to June 18, 2021, and its package does not contain the new required health warnings, the product may be introduced into commerce in the United States for 30 days after June 18, 2021, the effective date of the final rule. After this 30-day period, manufacturers would not be permitted to introduce into domestic commerce any cigarette packages, irrespective of the date of manufacture, that do not conform with the new health warning requirements. While this limitation applies to only manufacturers, FDA believes that under the final rule, keeping products without the required warnings on the market for an extended period would not be in the interest of the public health.

Sell Through Period at Wholesale and Retail: According to the final rule, after June 18, 2021, distributors and retailers may continue to distribute and sell-off their remaining stock of cigarette products if the packaging does not include the new health warnings, but only if the product was manufactured before the effective date and introduced into domestic commerce by the manufacturer within 30 days after June 18, 2021. That is, there is no limitation on a sell-through period for either wholesalers or retailers provided that cigarettes without the new health warnings were manufactured before June 18, 2021 and sold to distributors or retailers within 30 days of June 18, 2021.