Manufacturers now have until Oct. 16, 2021, to comply,
Image courtesy of the U.S. Food & Drug Administration
WASHINGTON — A Texas court postponed the date new cigarette health warnings will be required by the U.S. Food and Drug Administration (FDA).
Winston-Salem, N.J.-based R.J. Reynolds Tobacco Co., along with several other manufacturers and five retailers, and the FDA jointly asked the court on May 6 for a 120-day extension of the effective date of the warnings because of the disruptive effects of the COVID-19 outbreak on manufactures, retailers and the FDA.
Cigarette manufacturers have until Oct. 16, 2021, to comply with the new rule–which has been challenged by several lawsuits. The new warnings previously were required before June 18, 2021.
“[The] FDA remains fully committed to the rule and would not agree to postpone its effective date but for the extraordinary disruptions caused by the COVID-19 pandemic,” the administration said in a statement.
On March 17, the FDA issued the rule requiring 11 new health warnings on cigarette packs, cartons and ads, consisting of text warning statements and graphic color images.
R.J. Reynolds, along with other manufacturers and retailers, filed a lawsuit in the Eastern District of Texas on April 3 to invalidate the FDA’s rule and Congress’s requirement that the FDA mandate the warnings. New York-based Philip Morris USA Inc. and Sherman Group Holdings LLC, owned by Richmond, Va.-based Altria Group, Inc., filed a lawsuit in the District of Columbia against the FDA seeking the same resolution.
The U.S. District Court for the Eastern District of Texas granted on May 8 a joint motion to postpone the warning deadline by 120 days, the FDA said. Any obligation to comply with a deadline tied to the new date is also postponed, according to the FDA.
“The FDA strongly encourages entities to submit cigarette plans as soon as possible, and in any event by Dec. 16, 2020,” it said in the statement. “Early submission will facilitate timely FDA review of plans prior to the effective date of the required warnings, encourage dialogue with entities regarding any implementation concerns, and provide time to consider proposals by entities in a timely manner.”
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