Warning Shot: Behind the Warning Label Delay

How cigar associations won a stay on the FDA’s warning label requirements.


In addition, although Judge Mehta stated that neither the law nor the posture of the case allowed him to act on the matter, he made an overt gesture to the plaintiffs, wondering why they had not challenged the FDA’s refusal to stay the implementation of the health warning requirements during the ANPRM process, stating that the court cannot “remedy a perceived wrong unless it is presented for consideration.”

In turn, plaintiffs acted with due haste in filing an injunction with the court for a stay of the health warning requirements going into effect until after their appeal was heard before the District of Columbia Circuit. In turn, echoing the verbiage in Judge Mehta’s ruling on the parties’ motions for summary judgment, the injunction was granted and the health warning requirements stayed until 60 days after adjudication of the plaintiffs’ appeal. [Note: Subsequent to this articles’ submission, the FDA has clarified that hookah tobacco and shisha (i.e. waterpipe tobacco) are not considered “pipe tobacco” per the FDA’s Deeming Regulations. Therefore, waterpipe tobacco products are not subject to the injunction issued and thus must bear the required health warning statements on their packaging and advertising as of August 10, 2018.]

Though such an act is a victory for members of the industry and temporarily alleviates the burden of having to meet the Aug. 10 deadline, the industry should not rest on its laurels but remain ever vigilant in navigating this regulatory landscape.

This story first appeared in the September/October 2018 issue of Tobacco Business magazine. Members of the tobacco industry are eligible for a complimentary subscription to our magazine. Click here for details.

Andrew Schmidt is associate counsel at Kretek International.