HEALTH GROUPS FILE SECOND LAWSUIT AGAINST THE US FDA

HEALTH GROUPS FILE SECOND LAWSUIT AGAINST THE US FDA

While the Biden Administration Delays the Rule on Menthol, Death Toll Rises Daily 

 WASHINGTON, DC – APRIL 2, 2024 – The African American Tobacco Control Leadership Council (AATCLC), Action on Smoking and Health (ASH), and the National Medical Association (NMA), represented by Christopher Leung of Leung Law PLLC, have filed a second lawsuit against the U.S. Food and Drug Administration (FDA) for the agency’s inaction on issuing a final rule banning menthol cigarettes. This lawsuit comes more than seven months after the FDA’s initial date for finalizing the new rule and follows the FDA’s 15-year delay in equitable policymaking.

 

“The relentless and racist tobacco industry targeting has killed too many members of the Black community,” said Carol McGruder, Co-Chair of the African American Tobacco Control Leadership Council. “If Black lives truly matter, then we must end the sale of menthol cigarettes and do it now!”

The Plaintiffs’ first lawsuit was filed on June 17, 2020. Since then, approximately 39,789 Americans have died from menthol cigarettes.


The initial complaint sought to compel the FDA to act on its earlier conclusions that removing menthol cigarettes from the marketplace would benefit public health. The lawsuit specifically asked the Court to compel the FDA’s determination on whether to add menthol to the list of prohibited characterizing flavors – a determination that the FDA delayed making for over 10 years. The joint lawsuit followed the 2013 Citizen Petition from the Public Health Law Center which called on the FDA to prohibit the sale of menthol cigarettes.


“We’re extremely disappointed to be forced to file this second lawsuit against the FDA in support of protecting Americans from menthol cigarettes,” said Laurent Huber, Executive Director of Action on Smoking and Health. “The FDA’s own research confirms that a menthol ban would save lives; there is no scientific reason to delay finalizing this rule.”


In 2011, the FDA’s own scientific advisory committee concluded that the “Removal of menthol cigarettes from the marketplace would benefit public health in the United States.”


As a result of the Plaintiffs’ first lawsuit, the FDA made the landmark determination to add menthol to the list of banned characterizing flavors in cigarettes. To begin that rulemaking process, the FDA issued a Notice of Proposed Rulemaking to ban the sale of menthol cigarettes in the marketplace. Given that success, the Plaintiffs voluntarily dismissed their initial lawsuit.


Today, three years later, the FDA has failed to take the final step to formally promulgate and publish the proposed rule. After setting an initial date of August 2023 to issue this rule, the FDA has unreasonably and unlawfully delayed this life-saving rule.

“As African American physicians, we are deeply disturbed at the continuing delays in FDA’s finalizing of the ban on menthol cigarettes,” said Dr. Yolanda Lawson, President of the National Medical Association. “Our patients, more than any other group, become disabled and die prematurely due to the continued use of these cigarettes,” she said.


The Biden Administration has fallen for disinformation and fearmongering by the tobacco industry. The industry is sowing doubt and confusion and taking advantage of real issues in our country and claiming that removing menthol will harm Black lives, when just the opposite is true. We remain disheartened to be forced to call on the Biden Administration to prioritize human life.

 

Attorney Christopher Leung stated, “FDA’s delay in issuing a final rule is harming public health. As the FDA’s own analysis found, banning menthol cigarettes will reduce youth smoking, increase successful quit-attempts among current people who smoke, and save hundreds of thousands of lives – as well as billions of dollars spent on treating smoking-related harms. It’s time for the FDA to act.”


Tobacco products kill when used as intended. Menthol cigarettes make initiation easier, addiction stronger, and quitting harder. A ban on menthol cigarettes would save 6,000 Black lives every year.

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