Grand River Enterprises Six Nations v. Knudsen

District Court, D. Montana·Decided July 17, 2023·No. 6:23-cv-00048·Unknown

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MONTANA HELENA DIVISION

GRAND RIVER ENTERPRISES SIX

NATIONS, LTD.,

Plaintiff. CV-23-48-H-BMM

ORDER vs.

AUSTEN KNUDSEN, in his official capacity, Attorney General of the State of Montana,

Defendant. INTRODUCTION Grand River Enterprises Six Nations, LTD., (“GRE”) has moved for a Temporary Restraining Order against Montana Attorney General Austin Knudsen (the “Attorney General”). (Doc. 6.) GRE seeks to enjoin the Attorney General from implementing a recent decision to impose a ban on the wholesale shipment and distribution of GRE products within Montana and to remove GRE from a state- maintained list of approved tobacco product manufacturers. (Doc. 7.) The Court held a hearing in this matter on July 14, 2023. (Doc. 18.) The Court will deny GRE’s request for a temporary restraining order for the following reasons. BACKGROUND Montana law requires the Attorney General to maintain a directory (the “Montana Tobacco Directory”) of tobacco products sold in the state. The Montana

Tobacco Directory lists “all tobacco product manufacturers that have provided current and accurate certifications conforming to [specific requirements] and all brand families that are listed in the certifications.” Mont. Code Ann. § 16-11-504.

Montana has established a process for each tobacco product manufacturer to obtain the annual certification that allows its products’ sale within the state. Mont. Code Ann. § 16-11-503. Tobacco product manufacturers must complete the certification and remain included in the Montana Tobacco Directory to sell their products.

The annual certification process commences in April of each year. Tobacco product manufacturers must certify that their brand styles “are intended to be sold in the United States” and that they will “immediately notify the [Attorney General] . .

. if any information in th[e] Certification changes.” (Doc. 8-2 at 3.) The law directs the Attorney General to monitor each tobacco product manufacturer’s compliance with the certification process and remove from the Montana Tobacco Directory tobacco product manufacturers who fail to comply with certification requirements.

Mont. Code Ann. § 16-11-504(4). Montana law prohibits the sale of a manufacturer’s tobacco products if that manufacturer is not included in the Montana Tobacco Directory: “it is unlawful for any person to . . . sell, offer for sale, or possess

for sale in this state cigarettes of a tobacco product manufacturer or brand family not included in the [Montana Tobacco Directory].” Mont. Code Ann § 16-11-505. GRE operates as a tobacco product manufacturer. This dispute centers on the certification,

or lack thereof, of eight out of the more than thirty types of GRE tobacco products listed on the Montana Tobacco Directory. (Doc. 7 at 3.) GRE claims that it has complied with Montana law and that it and its products have remained listed on the

Montana Tobacco Directory for more than ten years. (Id.) The Court now will provide additional background regarding GRE’s participation in the Montana tobacco market and the Attorney General’s unique oversight of GRE’s operations. GRE participates in the Montana tobacco market

pursuant to an Assurance of Voluntary Compliance agreement (“AVC”) it entered with the State in 2012. (Doc. 8-1.) The State does not require compliance agreements for each cigarette manufacturer operating in Montana: GRE entered the AVC with

the State following several alleged violations of the laws regulating tobacco product manufacturers. (Id. at 3.) GRE sought, in other words, to “come into compliance with the laws of the State of Montana and to be listed on the [Montana Tobacco Directory] as a non-participating manufacturer whose cigarettes are approved for

sale in the State of Montana.” (Id. at 3.) The AVC requires GRE to comply with specific terms to sell its products in Montana. (Id.) The AVC’s mandates include that GRE comply with “all local, state,

and federal laws,” and the AVC provides that “failure to abide by any terms of this AVC is grounds for the immediate removal of [GRE] from the Montana [Tobacco] Directory.” (Id. at 4.) The AVC, as relevant here, also submits the parties to Montana

state district court for enforcement actions: “The Montana First Judicial District Court, Lewis and Clark County, shall retain jurisdiction over the subject matter of this AVC and over [GRE] for purposes of enforcement.” (Id.) The AVC finally states

that “[t]he parties acknowledge and agree that this AVC is voluntarily entered into by the parties as a result of arm’s-length negotiations and that the parties each had the opportunity to review this matter with counsel prior to executing this AVC.” (Id. at 5.)

GRE asserts that it received a letter from the Attorney General on May 9, 2022, raising a limited issue with GRE’s 2022 certification. (Doc. 7 at 3.) The Attorney General’s letter asserted that GRE had requested in 2020 that the Food and

Drug Administration (“FDA”) withdraw eight brand styles from a specific product review process the FDA had implemented pursuant to the Food Drug and Cosmetic Act (“FDCA.”) (Id. at 3-4); (Doc. 8-2.) The FDA’s review process ensures that tobacco products sold in the United States are unadulterated. Products that do not

complete the review are considered adulterated and misbranded, and federal law does not allow their sale in the United States. (Doc. 8-9 at 30.) The Attorney General alleged that GRE had withdrawn the eight brand styles

from FDA review in January 2020, and, as a result, the FDA in February 2021 had deemed them adulterated and prohibited GRE from selling, marketing, or distributing these eight styles. (Doc. 8-2); (Doc. 8-9 at 8, 30.) The Attorney General

further alleged that GRE knowingly had included these eight brand styles in its 2020 and 2021 Montana Tobacco Directory certifications despite the FDA’s determination that the products were adulterated. The Attorney General viewed

GRE’s conduct as violating state and federal law. (Doc. 8-2 at 2-4.) The Attorney General’s letter informed GRE that the eight products would be removed from the Montana Tobacco Directory and that the Attorney General considered the removal an “enforcement action.” (Doc. 7 at 3); (Doc. 8-2 at 4.)

GRE responded to this letter on May 26, 2022. (Doc. 7 at 3.) GRE confirmed to the Attorney General that, in January 2020, it had requested that the FDA withdraw the eight brand styles from review. (Id. at 3-4.) GRE asserted in its letter

to the Attorney General that it did not object to removing the eight brand styles from the 2022 Montana Tobacco Directory. The 2022 Montana Tobacco Directory included all of GRE’s products except for the eight brand styles referenced in GRE’s and the Attorney General’s letters. (Id. at 4.)

The Attorney General sent a letter to GRE on June 14, 2023, informing it that the Attorney General had sent all Montana wholesalers a “Notice of Intent to Remove,” notifying Montana wholesalers that they were prohibited from selling

GRE products if the products were shipped to wholesalers after June 14, 2023. (Id. at 4); (Doc. 8-9 at 1.) The letter also informed GRE that the Attorney General would remove all of GRE’s products from the Montana Tobacco Directory on July 14,

2023. (Doc. 7 at 4); (Doc. 8-9 at 1-3.) The Attorney General cited the AVC agreement to support the enforcement action. (Doc. 8-9 at 1.) GRE claims that the Attorney General imposed this ban with

immediate effect and offered no prior notice or opportunity to be heard. (Doc.

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Grand River Enterprises Six Nations v. Knudsen, (D. Mont. 2023).

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