The 2009 Family Smoking Prevention and Tobacco Control Act directed FDA to issue a rule requiring state-of-the-art graphic warning labels on cigarette packages. FDA issued such a rule, but the tobacco companies sued and blocked the original warnings in court in 2013.
As expected, the tobacco companies sued, asking a Trump-appointed federal judge in Texas to throw out the new warnings.
Rather than ruling on the case, the judge has entered six orders postponing the effective date while he considers motions from the tobacco companies and FDA for summary judgment. (A summary judgement is issued when the issue is solely one of law, independent of the specific facts in the case.) His recent order put off a decision until April 9, 2023, over three years after FDA issued to new warning label rule and nearly two years after the warning labels were supposed to start running.
The first such order, entered in May of 2020, was with the government’s consent and was due to COVID. All the others have been over the government’s objection. Not making a decision has effectively granted tobacco’s request for a preliminary injunction against the warning labels without actually having to demonstrate that the requirements to issue a preliminary injunction have been met.
In particular, a preliminary injunction is granted when the requesting party (in this case, the plaintiff tobacco companies) is highly likely to be successful in a trial on the merits and there is a substantial likelihood of irreparable harm unless the injunction is granted. Given that Congress explicitly directed FDA to issue to warning label rule and how careful FDA was in issuing the new rule based on their earlier loss in court on the original warning labels, one would think FDA was likely to prevail this time around.
Health advocates expect this judge will strike down the FDA rule requiring the warning labels, but the FDA (and health advocates) cannot take any additional legal action — appeal to a higher court — until he actually rules.
As noted above, by sitting on the decision, the judge has effectively blocked the warning labels without having to go to the trouble — or risk of reversal on appeal — of actually issuing a decision.
While this is very frustrating, it does reinforce the value of states and localities taking action to fill the FDA void on things where they can, most notably by prohibiting the sale of all flavored tobacco products.