Lystn, LLC v. Food and Drug Administration

          ORDER

          PHILIP A. BRIMMER CHIEF UNITED STATES DISTRICT JUDGE

         This matter is before the Court on Federal Defendants' Motion to Dismiss [Docket No. 64], ^[1] State Defendants' Motion to Dismiss Plaintiff's Complaint Under Fed.R.Civ.P. 12(b)(1) and 12(b)(6) [Docket No. 63],^[2] and Defendant Association of American Feed Control Officials' Motion to Dismiss [Docket No. 65]. Plaintiff raises claims under the Administrative Procedure Act (“APA”), 5 U.S.C. § 704, and contends that the Court has subject matter jurisdiction under 28 U.S.C. §§ 1331 and 1367. Docket No. 1 at 12.

         I. BACKGROUND

         Plaintiff is a pet food manufacturer that produces and sells raw pet food. Docket No. 1 at 18, ¶ 60. Due to its manufacturing process, plaintiff's products naturally contain certain microorganisms at scientifically detectable levels that plaintiff claims are not harmful to humans. Id., ¶ 61; id. at 19, ¶ 64. One type of microorganism that may be present in plaintiff's pet food products is Salmonella. Id. at 18, ¶ 61.

         In July 2013, the Food and Drug Administration (“FDA”) issued a final version of its Compliance Policy Guide (“CPG”) § 690.800, “Salmonella in Food for Animals.” See U.S. Food & Drug Ass'n, Guidance for FDA Staff: Compliance Policy Guide Sec. 690.800 Salmonella in Food for Animals (2013), https://www.fda.gov/media/86247/download; see also Docket No. 64-1. The CPG states that the “FDA considers an animal feed or pet food that may be injurious to health because it is contaminated with Salmonella to be adulterated under section 402(a)(1) of the [Food, Drug, and Cosmetic Act (“FDCA”)] (21 U.S.C. 342(a)(1)).” Docket No. 64-1 at 6. A food is “adulterated” under the FDCA if it “bears or contains any poisonous or deleterious substance which may render it injurious to health, ” but is not considered adulterated if the substance is not an added substance and “if the quantity of such substance in such food does not ordinarily render it injurious to health.” 21 U.S.C. § 342(a)(1). In the CPG, the FDA recommends that its staff members should consider the following risk-based criteria in deciding whether to recommend seizure or import refusal of a pet food, animal feed, or their ingredients on the basis that it is adulterated:

1. Salmonella is present in one or more subsamples of the pet food or pet food ingredient; and

2. The pet food or pet food ingredient will not be, or information is not available to determine whether the pet food or pet food ingredient will be, further processed with a heat treatment or other method during the commercial manufacturing or processing to eliminate the Salmonella.

3. The Salmonella is of any serotype.

Docket No. 64-1 at 7. The CDA has adopted a definition of “adulteration” that mirrors the FDA's CPG. Docket No. 1 at 14, ¶ 41. The Model Bill and Regulations of the Association of American Feed Control Officials^[3] (“AAFCO”) provide a similar definition. Id., ¶ 43. Plaintiff contends that the CPG, and the similar state definitions, is at odds with 21 U.S.C. § 342 and its provision that a naturally occurring substance will not render a product adulterated if the substance is in such quantity as to not render it injurious to health. Docket No. 1 at 29-30, ¶¶ 107-116.

         On April 11, 2018, a CDA inspector collected a sample of plaintiff's pet food from a pet store in Littleton, Colorado. Id. at 26, ¶ 93. The sample allegedly contained Salmonella and Listeria monocytogenes in an unspecified quantity. Id. at 27, ¶ 94. The CDA is “currently prosecuting” plaintiff in the Colorado Office of Administrative Courts (“COAC”) based on this sample. Id. at 12 n. 21. Plaintiff attributes such prosecution to the FDA, asserting that “[t]he FDA, through the CDA, has chosen to prosecute Plaintiff for alleged violations of the [CPG].” Id. at 15, ¶ 47. Specifically, plaintiff contends that the CDA acted “pursuant to interagency agreement(s) between Colorado and the FDA and the FDA's call to the states for sampling of raw products.” Id. at 26, ¶ 93.

         On January 9, 2019, the FDA issued a Public Warning Notice for plaintiff's A ANSWERS™ Straight Beef Formula for Dogs on the basis that the product represented a serious threat to human and animal health. Id. at 25, ¶ 90. The FDA issued the warning after plaintiff refused to conduct a voluntary recall of its product. Id. The public warning stated that “[f]ederal law requires all pet food to be free of pathogens, including Salmonella.” Id. at 26, ¶ 90. The FDA recommended that pet owners throw the product away and clean the areas in which the product was stored, as well as all items that may have come into contact with the product. Id., ¶ 91.

         Plaintiff sued the FDA, the AAFCO, the CDA, three CDA employees, and the United States Department of Health and Human Services on July 5, 2019. See generally Id. Plaintiff seeks a declaratory judgment that plaintiff was denied its due process rights and seeks an injunction (a) preventing the FDA and the AAFCO from applying or enforcing the CPG and (b) requiring them to suspend any pending related enforcement actions specific to the CPG. Id. at 34. Plaintiff also seeks to enjoin defendants from reintroducing similar compliance policy guides, from circumventing the APA, and from “creating artificial, false, and misleading appearances with respect to raw pet food products, safety, security, commodity, and currency (including removal of such from existing federal government websites and other means of publications).” Id.

         In addition, plaintiff requests that all claims and references of plaintiff distributing an adulterated product, and any other federal report or record related to the § 690.800 enforcement, “be expunged from all federal and state records.” Id.

         The federal defendants move to dismiss plaintiff's action on the basis that, among other reasons, the Court lacks subject matter jurisdiction over plaintiff's lawsuit. Docket No. 64 at 5, 9. The state defendants also argue that the Court lacks subject matter jurisdiction over this case. Docket No. 63 at 5. Finally, the AAFCO moves to dismiss the claims against it on the basis that the Court lacks personal jurisdiction over the association. Docket No. 65 at 3.

         II. LEGAL STANDARD - SUBJECT MATTER JURISDICTION

         Dismissal pursuant to Federal Rule of Civil Procedure 12(b)(1) is appropriate if the Court lacks subject matter jurisdiction over claims for relief asserted in the complaint. Merrill Lynch Bus. Fin. Servs., Inc. v. Nudell, 363 F.3d 1072, 1074 (10th Cir. 2004). Rule 12(b)(1) challenges are generally presented in one of two forms: “[t]he moving party may (1) facially attack the complaint's allegations as to the existence of subject matter jurisdiction, or (2) go beyond allegations contained in the complaint by presenting evidence to challenge the factual basis upon which subject matter jurisdiction rests.” Id. (quoting Maestas v. Lujan, 351 F.3d 1001, 1013 (10th Cir. 2003)). “In reviewing a facial attack on the complaint, a district court must accept the allegations in the complaint as true.” Holt v. United States, 46 F.3d 1000, 1002 (10th Cir. 1995). However, “[w]hen reviewing a factual attack on subject matter jurisdiction, a district court may not presume the truthfulness of the complaint's factual allegations.” Id. at 1003. “The substantive distinction between a facial attack and a factual attack is that in a facial attack the defendant contests the sufficiency of the complaint, while a factual attack challenges the existence in fact of federal subject matter jurisdiction.” LaLoup v. United States, 29 F.Supp.3d 530, 536 (E.D. Pa. 2014). “Because the jurisdiction of federal courts is limited, there is a presumption against our jurisdiction, and the party invoking federal jurisdiction bears the burden of proof.” Merida Delgado v. Gonzales, 428 F.3d 916, 919 (10th Cir. 2005) (citation omitted).

         III. ANALYSIS

         A. Federal Defendants

         The federal defendants argue that the Court lacks subject matter jurisdiction over plaintiff's claims because plaintiff seeks pre-enforcement review of an FDA enforcement action. Docket No. 64 at 5-6. “It has long been established that courts lack jurisdiction to enjoin FDA from initiating enforcement proceedings under the FDCA.” Cody Labs., Inc. v. Sebelius, 2010 WL 3119279, at *8 (D. Wyo. July 26, 2010) (citation omitted).

         The APA, on which plaintiff bases subject matter jurisdiction, provides that “[a]gency action[s] made reviewable by statute and final agency action[s] for which there is no other adequate remedy in a court are subject to judicial review.” 5 U.S.C. § 704. “A preliminary, procedural, or intermediate agency action or ruling not directly reviewable is subject to review on the review of the final agency action.” Id. Plaintiff “[has] the burden of identifying specific federal conduct and explaining how it is ‘final agency action.'” Colo. Farm Bureau Fed'n v. U.S. Forest Serv., 220 F.3d 1171, 1173 (10th Cir. 2000) (quotation omitted).

         In arguing that the Court lacks subject matter jurisdiction over this case, the federal defendants rely upon Ewing v. Mytinger & Casselberry, Inc., 339 U.S. 594 (1950). In Ewing, a distributor of nutritional supplements challenged the seizure by the FDA of its product under 21 U.S.C. § 334(a), which permitted seizures of misbranded articles where there was probable cause to believe that the misbranded article was dangerous to public health or that the labeling of the article was fraudulent. Id. at 595, 597.^[4] The statute permitted such seizures “when the Administrator has probable cause to believe from facts found, without hearing, by him or any officer or employee of the Agency that the misbranded article is dangerous to health, or that the labeling of the misbranded article is fraudulent, or would be in a material respect misleading to the injury or damage of the purchaser or customer.” Id. at 595-96 (quoting 21 U.S.C. § 334(a)). The Supreme Court held that the district court “had no jurisdiction to review the administrative determination of probable cause.” Id. at 600. Specifically, the Supreme Court stated that “[j]udicial review of this preliminary phase of the administrative procedure does not fit the statutory scheme nor serve the policy of the [FDCA].” Id. The Ewing Court noted that “Congress made numerous administrative determinations under the [FDCA] reviewable by the courts, ” but the administrative finding of probable cause was not one of them. Id.

         In arguing that it seeks not pre-enforcement review, but review of a final agency action, plaintiff relies upon Abbott Laboratories v. Gardner, 387 U.S. 136 (1967), abrogated on other grounds by Califano v. Sanders, 430 U.S. 99 (1977). In Abbott, the Supreme Court noted that, while Ewing was “quite clearly correct, ” it did not govern the case before it - a declaratory judgment action challenging an administrative regulation that had already been promulgated. Id. at 147. Specifically, the Supreme Court found that Ewing “bears no analogy to the promulgation, after formal procedures, of a rule that must be followed by an entire industry” and that to find otherwise “would immunize nearly all agency rulemaking activities from the coverage of the Administrative Procedure Act.” Id. “[O]nly upon a showing of clear and convincing evidence of a contrary legislative intent should the courts restrict access to judicial review.” Id. at 141 (quotations omitted). Plaintiff argues that its lawsuit is a challenge to a final FDA rule and, for this reason, Ewing does not apply. Docket No. 78 at 3.

         The Supreme Court has stated that, for an agency action to be considered “final, ” two conditions must be satisfied: “[f]irst, the action must mark the ‘consummation' of the agency's decision making process, ” and “second, the action must be one by which ‘rights or obligations have been determined, or from which legal consequences will flow.'” Bennett, 520 U.S. at 178 (quoting Chicago & S. Air Lines, Inc. v. Waterman S.S. Corp., 333 U.S. 103, 113 (1948) and Port of Boston Marine Terminal Ass'n v. Rederiaktiebolaget Transatlantic, 400 U.S. 62, 71 (1970)). A final agency action must “determine rights or obligations, or produce legal consequences.” Ass'n of Flight Attendants-CWA v. Huerta, 785 F.3d 710, 714 (D.C. Cir. 2015). “In litigation over guidance documents, the finality inquiry is often framed as the question of whether the challenged agency action is best understood as a non-binding action, like a policy statement or interpretive rule, or a binding legislative rule.” Id. at 716. A policy statement “explains how the agency will enforce a statute or regulation - in other words, how it will exercise its broad enforcement discretion . . . under some extant statute or rule, ” id. (internal quotation marks omitted), while an interpretive rule is “issued by an agency to advise the public of the agency's construction of the statutes and rules which it administers.” Id. (quoting Perez v. Mortg. Bankers Ass'n, 575 U.S. 92, 97 (2015)). A legislative rule “‘modifies or adds to a legal norm based on the agency's own authority' flowing from a congressional delegation to engage in supplementary lawmaking.” Id. at 717 (emphasis omitted) (quoting Syncor Int'l Corp. v. Shalala, 127 F.3d 90, 95 (D.C. Cir. 1997)). “The most important factor in differentiating between binding and nonbinding actions is ‘the actual legal effect (or lack thereof) of the agency action in question.'” Id. (quoting Nat'l Min. Ass'n v. McCarthy, 758 F.3d 243, 252 (D.C. Cir. 2014)).

         Plaintiff alleges that “the FDA has taken final agency action by promulgating [the CPG] and is enforcing that rule through a shadow regulation scheme to disguise their role in the actions taken against the Plaintiff.” Docket No. 78 at 3. Specifically, it argues that the FDA's action marks the consummation of its decision-making process because (1) the FDA took a definitive legal position regarding its statutory authority; (2) the CPG concerns a legal question of statutory interpretation; and (3) the CPG “burdens the Plaintiff directly because of ...