RED TAPE or BOTTOM LINE? –

Aug. 24, 2022 – In its latest request for postponement, the plaintiffs made the same or similar arguments for postponement as in previous requests, which include:

• The rule would cause the plaintiffs irreparable harm, including substantial compliance costs.
• The plaintiffs would need to redesign packaging, modify the printing process, purchase and engrave printing cylinders, print compliant packages, and redesign, modify, and replace point-of-sale advertisements at hundreds of thousands of retailers.
• The actions required to comply would cost millions of dollars and thousands of employee hours, which the plaintiffs would not be able to recover or obtain reimbursement from the government if they prevail.

The FDA strongly encourages companies to submit cigarette plans as soon as possible, but no later than December 7, 2022. Practically, however, the rule has now been postponed eight times, with the possibility of further delay. While companies should be prepared to submit plans to the FDA and comply with the rule when required to do so, it is also prudent to focus on enforceable requirements, such as the FDA’s current warning statements and filing cigarette rotational health warning plans with the Federal Trade Commission.

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