Cigarette Manufacturers Challenge FDA Cigarette Health Warnings

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Cigarette Manufacturers Challenge FDA Cigarette Health Warnings

The following article was submitted by the National Association of Tobacco Outlets (NATO)

On May 6, 2020, Philip Morris USA Inc. and Sherman Group Holdings, LLC filed a lawsuit in Federal District Court for the District of Columbia against the U.S. Food and Drug Administration seeking to invalidate both the FDA’s recently issued rule for new text and
graphic cigarette health warnings on cigarette packages, cigarette cartons, and cigarette advertisements and the requirement under the Family Smoking Prevention and Tobacco Control Act that the FDA promulgate such graphic health warnings.

This is the second federal lawsuit to be filed against the FDA seeking to invalidate the new graphic cigarette health warnings. The other lawsuit was filed in April of this year against the FDA by R.J. Reynolds Tobacco Company, Santa Fe Natural Tobacco Company, ITG Brands, Liggett Group and five tobacco retailers.

Background: Based on decisions issued by the U.S. Supreme Court, the First Amendment to the U.S. Constitution protects free speech, which includes “commercial speech” or advertising since advertising is how manufacturers and retailers “speak” to the general public. The First Amendment free speech protections have been applied specifically to tobacco products.

The Family Smoking Prevention and Tobacco Control Act, the law that granted the FDA the authority to regulate tobacco products, directs the FDA to issue regulations requiring new text and color graphic health warnings depicting the negative health consequences of cigarette smoking. The FDA issued a rule in June of 2011 requiring nine text warnings and graphic pictures to be printed on cigarette packages, cigarette cartons, and cigarette advertisements.

Several cigarette manufacturers challenged this first text and graphic cigarette health warning rule in court on the grounds that the warnings violated the free speech protections under the First Amendment to the U.S. Constitution. On August 24, 2012, the U.S. Circuit Court of Appeals for the District of Columbia overturned the first FDA cigarette health warnings as violating the First Amendment and sent the matter back to the FDA to create new warnings that comply with constitutional standards.

On March 17, 2020, the FDA issued a rule requiring eleven new health warnings on cigarette packages, cigarette cartons, and cigarette advertisements. These new cigarette health warnings consist of eleven text warning statements accompanied by a photo-realistic graphic color image. The new health warnings are shown at the end of this article.

Legal Claims Against the New FDA Cigarette Health Warnings: The lawsuit filed by Philip Morris USA Inc. and Sherman Group Holdings LLC against the FDA has seven different claims, including the following key claims:

  1. The new rule requiring eleven different text/graphic cigarette health warnings to appear on cigarette packages, cigarette cartons, and cigarette advertisements violates the First
    Amendment to the U.S. Constitution.
  2. The Family Smoking Prevention and Tobacco Control Act’s requirement that the FDA issue a rule requiring text and graphic cigarette health warnings violates the First Amendment to the U.S. Constitution.
  3. The FDA violated the Administrative Procedures Act.
  4. The FDA violated the Family Smoking Prevention and Tobacco Control Act by adopting a rule with eleven new graphic and text warnings when the law only allows for nine such warnings.

First Amendment Claim on the FDA Rule: This claim argues that the new graphic cigarette warnings would force manufacturers to convey the government’s anti-smoking message “through shocking and inflammatory warnings aimed at eliciting negative emotional responses rather than informing consumers.” In addition, the requirement that the text and graphic warnings cover the top 50% of the front and back of each cigarette package, the left 50% of the front and back panels of cigarette cartons, and the top 20% of cigarette advertisements is more extensive that necessary to support the FDA’s newly stated government interest of educating consumers about the lesser known health risks of cigarette smoking. Moreover, the graphics are misleading because they depict “extreme and unlikely conditions and treats conditions of differing severity as if they were equal.”

First Amendment Claim Against Family Smoking Prevention and Tobacco Control Act: With the 2012 court decision that held the text and graphic cigarette health warnings were unconstitutional and the new warnings also raising the same First Amendment free speech issues, there is an underlying problem with the Family Smoking Prevention and Tobacco Control Act itself. Specifically, Congress did not include any findings or justification in the provisions of the Family Smoking Prevention and Tobacco Control Act itself regarding the need to impose such a burden on the free speech rights of cigarette manufacturers. Moreover, the size and placement requirements of the graphic warnings as specified in the Family Smoking Prevention and Tobacco Control Act unduly burden the manufacturer’s right to advertise their lawful products.