Federal Court Denies Request for Injunction Against Modified Risk Provisions of FDA Tobacco Law, But Suggests These Provisions are Unconstitutional

Last week, a U.S. District Court in Kentucky denied the tobacco companies' request for an injunction against the modified risk tobacco product (MRTP) provisions of the FDA tobacco law. This does not throw out the tobacco companies' (i.e., the plaintiffs') complaint about these provisions, but it does mean that these provisions will remain in force pending the outcome of the case.

While anti-smoking groups painted this as a huge victory against Big Tobacco, a close reading of the actual court decision reveals that the Court actually indicates the high probability that the modified risk provisions of the law are unconstitutional because they represent an unconstitutional prior restraint on tobacco company speech, by virtue of the law's failure to put a time limit on the FDA's review of requests to market modified risk products.

As the United States District Court decision explains:

"the Plaintiffs argue that the MRTP provision is an unconstitutional prior restraint. To a limited extent, the Court agrees. By requiring applicants to submit “proposed advertising and labeling” and “sample product labels and labelling” with their applications to market modified risk tobacco products, 21 U.S.C. § 387k(d)(1), (5), the MRTP provision operates as a prior restraint by holding that speech captive and effectively “compel[ling] [Plaintiffs’] silence” until the FDA completes its review." ...

"Under the MRTP provision, tobacco manufacturers must submit not only the would-be modified risk product but any “proposed advertising and labeling” and “sample product labels and labelling” to the FDA for review. 21 U.S.C. § 387k(d)(1), (5). Thus, any such proposed speech about a modified risk tobacco product is effectively silenced until the FDA issues a decision. Because this is so, the reasonable time limit safeguard is necessary to satisfy the “principle that the freedoms of expression must be ringed about with adequate bulwarks.” Bantam Books, Inc. v. Sullivan, 372 U.S. 58, 66 (1963). At this point, such a time limit is missing. While Congress has charged the FDA with “establish[ing] a reasonable timetable for the Secretary to review an application under this section,” it has given the FDA two years to come up with one. 21 U.S.C. § 387k(k)(F). The Court thinks it likely that this two-year delay is unconstitutional given that certain portions of the MRTP provision have been in effect since June 22, 2009."

The Rest of the Story

The District Court clearly believes that the modified risk tobacco products provision of the FDA tobacco law is unconstitutional because it represents an impermissible prior restraint on tobacco company speech regarding these products. It is an impermissible prior restraint because there is no time limit to safeguard against an undue interference with the freedom of speech.

I should emphasize that this is one of the challenged provisions of the law that I thought was least likely to succeed. The provisions which I think are most likely to be found unconstitutional are the advertising restrictions, particularly the ban on cigarette advertising within 1000 feet of schools, and the restriction on truthful speech of companies regarding the fact that the FDA regulates and approves tobacco products and that cigarette companies are in compliance with strict FDA standards.

Now it appears that there is a chance that this 3rd provision of the law may also be found unconstitutional, at least as to the absence of a time limit on the FDA's consideration of modified risk tobacco product applications.

Either way, it is clear that the anti-smoking groups are deceiving themselves by thinking that the FDA law is not without constitutional problems. And they are deceiving their constituents and the public by asserting that the full range of advertising and speech restrictions in the law are going to see the light of day.