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).

  • United States
  • Dec 9, 2009
  • U.S. District Court, D. Arizona
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Parties

Plaintiff BBK Tobacco & Foods, LLP

Defendant

  • Kathleen Sebelius, Secretary of the United States Department of Health and Human Services
  • Margaret A Hamburg, Commissioner of the United States Food and Drug Administration
  • U.S. Department of Health and Human Services
  • U.S. Food and Drug Administration

Legislation Cited

Related Documents

Type of Litigation

Tobacco Control Topics

Substantive Issues

Type of Tobacco Product

None

"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."