District Court Denies Preliminary Injunction in a Case Challenging the Family Smoking Prevention and Tobacco Control Act

By Kurt R. Karst

The U.S. District Court for the Western District of Kentucky (Bowling Green Division) denied a Motion for Preliminary Injunction in a case concerning the Constitutionality of the recently enacted Family Smoking Prevention and Tobacco Control Act (“FSPTCA”). As we previously reported, five tobacco manufacturers (including R.J. Reynolds Tobacco Company, Lorillard Tobacco Company, and Commonwealth Brands, Inc.) and a retailer of tobacco products filed a Complaint in August alleging that certain FSPTCA provisions concerning Modified Risk Tobacco Products (“MRTP”) violate their First Amendment right to engage in commercial speech.

The MRTP provisions of the FSPTCA (FDC Act § 911) prohibit the introduction into interstate commerce of any tobacco product that is “sold or distributed for use to reduce harm or the risk of tobacco-related disease,” which means a product:

(i) the label, labeling, or advertising of which represents explicitly or implicitly that –

(I) the tobacco product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products;

(II) the tobacco product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or

(III) the tobacco product or its smoke does not contain or is free of a substance;

(ii) the label, labeling, or advertising of which uses the descriptors “light”, “mild”, or “low” or similar descriptors; or

(iii) the tobacco product manufacturer of which has taken any action directed to consumers through the media or otherwise, other than by means of the tobacco product's label, labeling, or advertising, after June 22, 2009, respecting the product that would be reasonably expected to result in consumers believing that the tobacco product or its smoke may present a lower risk of disease or is less harmful than one or more commercially marketed tobacco products, or presents a reduced exposure to, or does not contain or is free of, a substance or substances.

To market an MRTP, a company must first file an application with the Department of Health and Human Services Secretary. The application is made available for public comment and is referred to the Tobacco Products Scientific Advisory Committee for a recommendation. An MRTP application may be granted if it is determined that the applicant has demonstrated that “the product, as it is actually used by consumers, will (1) significantly reduce harm and risk of tobacco-related disease to individual tobacco users; and (2) benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.”

The Plaintiffs contended in their briefs (here, here, and here), among other things, that the MRTP provision is: (1) “a viewpoint-based restriction on core First Amendment speech . . . subject to strict scrutiny” which fails to pass review because “it is not necessary to serve the asserted interest;” (2) an unconstitutional prior restraint because it “lacks any of the constitutionally-mandated procedural safeguards that the Supreme Court requires of prior restraints under any level of scrutiny;” and (3) void for vagueness. FDA countered in its brief that “the statutory provisions regulating [MRTPs] do not restrict speech; they restrict the distribution of certain products without FDA review,” that strict scrutiny is inapplicable, and that even if the commercial speech test applies, “[t]he dangers of products sold or distributed as modified risk tobacco products that do not in fact reduce risk are so high that there is a compelling governmental interest in ensuring that statements about modified risk tobacco products are complete, accurate, and relate to the overall disease risk of the product” and the FSPTCA is narrowly tailored to advance that important governmental interest. (Eleven non-profit public health organizations and consumer advocacy groups, including the Campaign for Tobacco-Free Kids and the American Cancer Society, supported FDA’s position in an amicus brief.)

After assuming “for purposes of this preliminary injunction motion that the MRTP provision regulates speech and must satisfy the First Amendment,” the court stated that “it seems likely that its restrictions on speech are constitutionally permissible” using the familiar test for government regulation of commercial speech that was announced by the Supreme Court in Central Hudson Gas & Electric Corp. v. Public Service Commission, 447 U.S. 557 (1980). In particular, the court noted that the government has a substantial interest in protecting consumers from misleading tobacco industry claims about allegedly reduced risk tobacco products because of the “significant health risks associated with the use of tobacco products and the history of marketing ‘low tar’ and ‘light’ cigarettes, that the government adequately demonstrated that “the harms it recites are real” and that the FSPTCA’s MRTP provision will “alleviate [the harms] to a material degree,” and that there is “at least a reasonable fit between the means and ends of the MRTP regulatory scheme.”

After considering each of the factors for granting a preliminary injunction, the court ruled that such a remedy is unwarranted. The court did note, however, that the Plaintiffs have some likelihood of success on the theory that the MRTP provision operates as a prior restraint and lacks a reasonable time limit for 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. . . . 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. . . . 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.

On that basis, the court concluded that the first factor of the preliminary injunction analysis – i.e., whether the Plaintiffs have a strong likelihood of success on the merits – was not determinative and proceeded to analyze the other three preliminary injunction factors.

It is unclear whether the Plaintiffs in the case will appeal the ruling. There has been significant speculation that the U.S. Supreme Court will ultimately be asked to rule on the Constitutionality of the FSPTCA. Meanwhile, FDA continues to flex its new enforcement muscles granted to the Agency under the FSPTCA. Last week, FDA announced that it issued several Warning Letters to companies marketing illegal flavored cigarettes. FDA has also been sued by a cigar importer and distributor in connection with FDA statements regarding flavored cigarettes.