LYSTN, LLC v. Food & Drug Admin.
| Decision Date | 14 September 2020 |
| Docket Number | Civil Action No. 19-cv-01943-PAB-KLM |
| Parties | LYSTN, LLC, d/b/a Answers™ Pet Food, Plaintiff, v. FOOD AND DRUG ADMINISTRATION, ASSOCIATION OF AMERICAN FEED CONTROL OFFICIALS, COLORADO DEPARTMENT OF AGRICULTURE, KATE GREENBERG, individually, and officially in her capacity as Commissioner of the Colorado Department of Agriculture, LAUREL HAMLING, individually, and officially in her capacity as Feed Program Administrator for the Colorado Department of Agriculture, SCOTT ZIEHR, individually, and officially in his capacity as Feed Program Regulatory Administrator for the Colorado Department of Agriculture, and UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, Defendants. |
| Court | U.S. District Court — District of Colorado |
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 contendsthat the Court has subject matter jurisdiction under 28 U.S.C. §§ 1331 and 1367. Docket No. 1 at 12.
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 torecommend seizure or import refusal of a pet food, animal feed, or their ingredients on the basis that it is adulterated:
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 Officials3 ("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 AdministrativeCourts ("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 theAPA, 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.
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 theallegations 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).
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 directlyreviewable 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...
To continue reading
Request your trial