BBK Tobacco & Foods v. U.S. Food and Drug Administration
BBK Tobacco & Foods asked a court to declare that its flavored rolling papers, which are sold separately from cigarettes, are not subject to regulation as “tobacco products” under the Family Smoking Prevention and Tobacco Control Act (“the Act”). The court dismissed BBK’s request, finding that the Food and Drug Administration (FDA) had not yet taken action against the company and, therefore, the company’s claim was premature. The court noted that the FDA had issued a guidance document, which declared that rolling papers intended for use in roll-your-own cigarettes were subject to regulation under the Act. However, the court determined that the FDA’s guidance document could not be used for enforcement of the Act and did not represent a “final” action of the FDA.
BBK Tobacco & Foods v. U.S. Food and Drug Admin, 672 F.Supp.2d 969 (D.Ariz., 2009).
Tobacco companies or front groups may challenge any legislative or regulatory measure that affects their business interests. Unlike public interest litigation, these cases seek to weaken health measures. These cases frequently involve the industry proceeding against the government. For example, a group of restaurant owners challenging a smoke free law as unconstitutional.
Measures to regulate the marketing on tobacco packages. This includes both bans on false, misleading, deceptive packaging, as well as required health warnings on packaging.
(See FCTC Art. 11)
The court might consider procedural matters without touching the merits of the case. These might include: improper joinder, when third parties, such as Health NGOs or government officials, seek to become parties to the suit; lack of standing, where a plaintiff fails to meet the minimum requirements to bring suit; lack of personal jurisdiction, where the court does not have jurisdiction to rule over the defendant; or lack of subject matter jurisdiction, where the court does not have jurisdiction over the issue at suit.
A discussion on whether the regulations impose an undue burden on the tobacco industry. This argument may involve the costs of implementing regulatory measures.
Type of Tobacco Product
None
Limitations regarding the use of quotes The quotes provided here reflect statements from a specific decision. Accordingly, the International Legal Consortium (ILC) cannot guarantee that an appellate court has not reversed a lower court decision which may influence the applicability or influence of a given quote. All quotes have been selected based on the subjective evaluations undertaken by the ILC meaning that quotes provided here may not accurately or comprehensively represent a given court’s opinion or conclusion, as such quotes may have originally appeared alongside other negative opinions or accompanying facts. Further, some quotes are derived from unofficial English translations, which may alter their original meaning. We emphasize the need to review the original decision and related decisions before authoritatively relying on quotes. Using quotes provided here should not be construed as legal advice and is not intended to be a substitute for legal counsel on any subject matter in any jurisdiction. Please see the full limitations at https://www.tobaccocontrollaws.org/about.
"BBK argues that it should not be required to exhaust its available administrative remedies because doing so would cause BBK irreparable harm. Irreparable harm can be an exception to the requirement of administrative exhaustion. See Bd. of Trs. of Const. Laborers' Pension Trust for S. California v. M.M. Sundt Const. Co.,37 F.3d 1419, 1421 (9th Cir. 1994) ("Exceptions to exhaustion requirements are usually limited, and apply only in extraordinary circumstances, such as, when the arbitral process would be futile or would cause the plaintiff irreparable injury."). Notwithstanding, BBK has failed to demonstrate that requiring it to pursue its available administrative remedies would cause it irreparable harm. Again, the irreparable harm alleged by BBK primarily amounts to financial loss. Moreover, the Tobacco Act was signed into law in June 2009. Rather than pursue a citizen petition through the FDA, BBK decided to wait nearly four months and file an action directly with this Court. As described above, BBK's decision to discontinue the distribution of its products stems from its own decisions, not any final actions taken by the FDA. While BBK faces a threat of real financial loss, this alone does not relieve BBK from the requirement of pursuing its administrative remedies, especially after waiting idly for several months before taking action, and especially when such financial loss stems primarily from BBK's own volition. The Court does not discount Mr. Kesselman's past experiences with the criminal justice system and how such experiences affect his current decisions concerning BBK's continued distribution of flavored rolling papers in wake of the Tobacco Act. Nevertheless, BBK has failed to demonstrate that irreparable harm, to the extent it exists here, is resulting from the FDA's actions, and not the actions of BBK alone, such that BBK should not be compelled to exhaust its available administrative remedies."
Limitations regarding the use of quotes The quotes provided here reflect statements from a specific decision. Accordingly, the International Legal Consortium (ILC) cannot guarantee that an appellate court has not reversed a lower court decision which may influence the applicability or influence of a given quote. All quotes have been selected based on the subjective evaluations undertaken by the ILC meaning that quotes provided here may not accurately or comprehensively represent a given court’s opinion or conclusion, as such quotes may have originally appeared alongside other negative opinions or accompanying facts. Further, some quotes are derived from unofficial English translations, which may alter their original meaning. We emphasize the need to review the original decision and related decisions before authoritatively relying on quotes. Using quotes provided here should not be construed as legal advice and is not intended to be a substitute for legal counsel on any subject matter in any jurisdiction. Please see the full limitations at https://www.tobaccocontrollaws.org/about.
BBK Tobacco & Foods asked a court to declare that its flavored rolling papers, which are sold separately from cigarettes, are not subject to regulation as “tobacco products” under the Family Smoking Prevention and Tobacco Control Act (“the Act”). The court dismissed BBK’s request, finding that the Food and Drug Administration (FDA) had not yet taken action against the company and, therefore, the company’s claim was premature. The court noted that the FDA had issued a guidance document, which declared that rolling papers intended for use in roll-your-own cigarettes were subject to regulation under the Act. However, the court determined that the FDA’s guidance document could not be used for enforcement of the Act and did not represent a “final” action of the FDA.