Bbk Tobacco & Foods v. U.S. Food and Drug Admin.

• Decision Date: 09 December 2009
• Docket Number: No. CV 09-2111-PHX-JAT.,CV 09-2111-PHX-JAT.
• Citation: 672 F.Supp.2d 969
• Parties: BBK TOBACCO & FOODS, LLP, Plaintiff, v. (1) U.S. FOOD AND DRUG ADMINISTRATION; (2) Margaret A. Hamburg, Commissioner of the United States Food and Drug Administration; (3) U.S. Department of Health and Human Services; (4) Kathleen Sebelius, Secretary of the United States Department of Health and Human Services, Defendants.
• Court: U.S. District Court — District of Arizona

672 F.Supp.2d 969

BBK TOBACCO & FOODS, LLP, Plaintiff, v. (1) U.S. FOOD AND DRUG ADMINISTRATION; (2) Margaret A. Hamburg, Commissioner of the United States Food and Drug Administration; (3) U.S. Department of Health and Human Services; (4) Kathleen Sebelius, Secretary of the United States Department of Health and Human Services, Defendants.

No. CV 09-2111-PHX-JAT.

United States District Court, D. Arizona.

December 9, 2009.

COPYRIGHT MATERIAL OMITTED

Joel Eric Sannes, Lake & Cobb PLC, Tempe, AZ, Jonathan M. Weis, Mitchell S. Chaban, Levin Ginsburg, Chicago, AZ, for Plaintiff.

Daniel Kadane Crane-Hirsch, Office of Consumer Litigation, U.S. Justice Department, Washington, DC, for Defendants.

ORDER

JAMES A. TEILBORG, District Judge.

Pending before the Court is Plaintiff BBK Tobacco & Foods, LLP's ("BBK") Motion for Order to Show Cause re: Plaintiff's Motion for Temporary Restraining Order and Preliminary Injunction (Doc. # 12); BBK's Motion for Temporary Restraining Order and Preliminary Injunction (Doc. # 13); BBK's Motion for Summary Judgment (Doc. # 34); and Defendants U.S. Food and Drug Administration ("FDA"), Margaret A. Hamburg, U.S. Department of Health and Human Services, and Kathleen Sebelius (collectively "Defendants") Opposition to Plaintiff's Motion for Summary Judgment and Cross-Motion to Dismiss or in the Alternative for Summary Judgment (Doc. # 44). For the reasons that follow, the Court grants Defendants' motion based upon Federal Rules of Civil Procedure 12(b)(1) and denies all other pending motions.

BACKGROUND

The following facts are not in dispute. BBK is in the business of distributing, among other things, various brands and flavors of flavored rolling papers to retailers. BBK's flavored rolling papers are sold in separate packages apart from any tobacco product, and the flavored papers do not contain any tobacco. Nevertheless, BBK's flavored papers are intended to be used by customers who use the papers to make "roll-your-own tobacco" cigarettes in addition to use for "non-tobacco smokable herbs." (Doc. # 35 at p. 3, ¶ 6.)

On June 22, 2009, the President signed into law the Family Smoking Prevention and Tobacco Control Act ("Tobacco Act"), Pub.L. No. 111-31, 123 Stat. 1776 (codified at 21 U.S.C. § 387 et seq.). The Tobacco Act includes a "Special rule for cigarettes," wherein Congress prohibited cigarettes and their component parts from containing certain characterizing flavors:

Special rule for cigarettes

Beginning 3 months after June 22, 2009, a cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke.

21 U.S.C. § 387g(a)(1)(A). Among its express purposes, Congress sought to secure the FDA's "authority to address issues of particular concern to public health officials, especially the use of tobacco by young people and dependence on tobacco." 123 Stat. at 1781.

On September 14, the FDA issued a "Letter to Industry on Cigarettes Containing Certain Characterizing Flavors," wherein the FDA stated that the special rule for cigarettes "applies to all tobacco products that meet the definition of a `cigarette' in section 900(3) of the Act even if they are not labeled as `cigarettes' or are labeled as cigars or as some other product." (Doc. # 35-1 at p. 8.)

On September 22, the FDA posted "Form 3734" on its website related to "information regarding cigarettes with characterizing flavors." (Doc. # 35-1 at p. 18.) The FDA states in its Form 3734 that "[e]ffective September 22, 2009, cigarettes and their components, such as filters and papers, that contain certain characterizing flavors are considered adulterated under the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act." (Id.) Form 3734 asks the user to input, among other things: a description of the product type, whether cigarette, filter, or paper; the characterizing flavor; a description of the purchase; and a description of the store or internet information where the items were purchased or discovered. (Id.)

Also on September 22, the FDA issued a guidance document entitled "General Questions and Answers on the Ban of Cigarettes that Contain Certain Characterizing Flavors" ("Q & A Guidance Document"). (Doc. # 35-1 at p. 19.) The FDA included the following question and answer in its Q & A Guidance Document:

Does the special rule for cigarettes in section 907(a)(1)(A) of the FDCA, banning cigarettes containing an artificial or natural flavor that is a characterizing flavor, apply to rolling paper or filters intended for use in roll-your-own cigarettes?

Yes. The special rule for cigarettes in section 907(a)(1)(A) of the FDCA prohibits the component parts of a cigarette (including the filter or paper) from containing an artificial or natural flavor that is a characterizing flavor. Section 900(3) of the FDCA defines "cigarette" as a tobacco product that "meets the definition of the term `cigarette' under section 3(1) of the Federal Cigarette Labeling and Advertising Act," which states that a cigarette is any wrapped roll of tobacco. A consumer rolled, roll-your-own cigarette is a cigarette under section 900(3) because it is a wrapped roll of tobacco. Rolling paper or filters intended for use in roll-your-own cigarettes are component parts of a rolled, roll-your-own cigarette and therefore may not be flavored with a characterizing flavor.

(Id. at p. 23, question 4.) The FDA also included the following disclaimer in its Q & A Guidance Document: "This guidance document represents the [FDA's] current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public." (Id. at p. 21.)

In November 2009, the FDA issued a "Final guidance for Industry," concerning "Listing of Ingredients in Tobacco Products." ("Listing Guidance Document") (Plaintiff's trial ex. 11 at p. 1.) The FDA included the following statements in its Listing Guidance Document:

FDA intends to use the following definitions in implementing the ingredient listing requirements of section 904 of the act:

....

The term "tobacco product" ... is not limited to products containing tobacco, but also includes components, parts, and accessories of tobacco products, whether they are sold for further manufacturing or for consumer use. For example, tobacco, papers, and filters are tobacco products, whether they are sold to consumers for use with roll-your-own tobacco or are sold for further manufacturing into a product sold to a consumer, such as a cigarette.

(Id. at pp. 3-4.) The FDA included a similar disclaimer as is contained in its Q & A Guidance Document: "This guidance represents the [FDA's] current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public." (Id. at p. 2.)

In October 2009, BBK filed this present action seeking a declaration that its separately sold flavored rolling papers are not tobacco products under the Tobacco Act and, hence, Defendants have no authority to regulate separately sold flavored papers. BBK also seeks injunctive relief in the form of prohibiting Defendants from: issuing statements that separately sold flavored papers are prohibited by the Tobacco Act; promulgating rules or regulations to this effect; or taking any other adverse action towards BBK based upon flavored papers being prohibited by the Tobacco Act.

ANALYSIS

Both parties seek summary judgment under Rule 56. Defendants, however, also seek to dismiss BBK's action pursuant to Rules 12(b)(1) and 12(b)(6). Because subject matter jurisdiction is a threshold issue, the Court will first address Defendants' arguments under Rule 12(b)(1). See Orient v. Linus Pauling Inst. of Sci. & Med., 936 F.Supp. 704, 706 (D.Ariz.1996) ("Federal subject matter jurisdiction is a threshold issue that goes to the power of the court to hear the case....").

Subject Matter Jurisdiction

"The party asserting jurisdiction has the burden of proving all jurisdictional facts." Indus. Tectonics, Inc. v. Aero Alloy, 912 F.2d 1090, 1092 (9th Cir.1990) (citing McNutt v. Gen. Motors Acceptance Corp., 298 U.S. 178, 189, 56 S.Ct. 780, 80 L.Ed. 1135 (1936)). In effect, the Court presumes lack of jurisdiction until the plaintiff proves otherwise. Stock West, Inc. v. Confederated Tribes, 873 F.2d 1221, 1225 (9th Cir.1989). The defense of lack of subject matter jurisdiction may be raised at any time by the parties or the Court. See FED.R.CIV.P. 12(h)(3).

RIPENESS

Defendants argue that because they have not taken any enforcement action or any other final agency action with respect to flavored rolling papers, the doctrine of ripeness precludes this Court from exercising judicial review over BBK's claims. "Ripeness is a justiciability doctrine designed `to prevent the courts, through avoidance of premature adjudication, from entangling themselves in abstract disagreements over administrative policies, and also to protect the agencies from judicial interference until an administrative decision has been formalized and its effects felt in a concrete way by the challenging parties.'" Nat'l Park Hospitality Ass'n v. Dep't. of Interior, 538 U.S. 803, 807-08, 123 S.Ct. 2026, 155 L.Ed.2d 1017 (2003) (quoting Abbott Labs. v. Gardner, 387 U.S. 136, 148-49, 87 S.Ct. 1507, 18 L.Ed.2d 681 (1967), overruled on other grounds by Califano v. Sanders, 430 U.S. 99, 105, 97 S.Ct. 980, 51 L.Ed.2d 192 (1977)). Ripeness stems "both from Article III limitations on judicial power and from prudential reasons for refusing to exercise jurisdiction." Reno v. Catholic Social...