Lystn, LLCv. Food and Drug Administration et al
AMENDED ORDER by Chief Judge Philip A. Brimmer on 9/14/2020. ORDERED that Federal Defendants' Motion to Dismiss [Docket No. 64] is GRANTED. ORDERED that State Defendants' Motion to Dismiss Plaintiff's Complaint Un der Fed. R. Civ. P. 12(b)(1) and 12(b)(6) [Docket No. 63] is GRANTED. ORDERED that Defendant Association of American Feed Control Officials' Motion to Dismiss [Docket No. 65] is DENIED AS MOOT. ORDERED that Plaintiff& #039;s Motion for Discovery in Aid of Jurisdiction [Docket No. 62] is DENIED. ORDERED that Plaintiff's Second Motion for Discovery in Aid of Jurisdiction [Docket No. 70] is DENIED. ORDERED that Plaintiff's Motion to Amend Complaint Solely to IncorporateClaims Under Federal Advisory Committee Act (("FACA"), 5 U.S.C. app. 2 §§ 1-16)[Docket No. 106] is DENIED. ORDERED that Plaintiff's Combined Motion and Memorandum for Inj unctive Relief Pursuant to F.R.C.P. 65(a)(2) [Docket No. 12] is DENIED AS MOOT. ORDERED that Next Generation Pet Food Manufacturers Association, Inc.'s Motion to Intervene [Docket No. 86] is DENIED AS MOOT. ORDERED that Weston A. Price Foundation's Motion to Intervene [Docket No. 100] is DENIED AS MOOT. ORDERED that plaintiff's complaint is DISMISSED without prejudice. ORDERED that this case is closed. (sphil, )
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLORADO
Chief Judge Philip A. Brimmer
Civil Action No. 19-cv-01943-PAB-KLM
LYSTN, LLC, d/b/a AnswersTM Pet Food,
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,
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
“Federal defendants” refers to the Food and Drug Administration and the
United States Department of Health and Human Services.
“State defendants” refers to the Colorado Department of Agriculture (“CDA”)
and to the three individual defendants, who are CDA employees.
that 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 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 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 Administrative
The AAFCO is a private, “voluntary membership association of local, state and
federal agencies charged by law to regulate the sale and distribution of animal feeds.”
Docket No. 1 at 3. Plaintiff alleges that the AAFCO is a “quasi-legislative enterprise
created by local, state, federal, and international regulators to define and establish
regulations for pet food and feed ingredients, in addition to setting standards for
nutritional adequacy.” Id. at 10, ¶ 28. “Most states in the U.S. have adopted the Model
Bill and Regulations established by AAFCO. While participation and membership in
AAFCO is voluntary, if a state agency wishes to receive monies from the FDA, [it] must
agree to enforce the FDA’s policies and procedures in full.” Id.
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 suffi ciency 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).
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)
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
The Attorney General had also instituted eleven “libel suits” against the
distributor based on the FDA’s finding of probable cause, which the distributor also
challenged. Id. at 596-99.
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 how the FDA engages [in] this type of shadow
regulation.” Id. at 6-7 (citing Am. Acad. of Pediatrics v. FDA, 379 F. Supp. 3d 461, 489
(D. Md. 2019)).
The Court finds that the CPG is not a final agency action. On its face, this policy
guide simply provides information to staff members concerning how to interpret 21
U.S.C. § 342 for the purpose of determining whether further administrative proceedings
are necessary. The CPG provides that FDA employees “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.” Docket No. 64-1 at 7 (emphasis added). The
Tenth Circuit has “specifically held that an agency action is not final – and thus not
reviewable – if it serves to ‘initiate further proceedings’ necessary for a final
determination of the parties’ rights.” Potash Ass’n of N. M. v. U.S. Dep’t of Interior, 367
F. App’x 960, 964 (10th Cir. 2010) (unpublished). While plaintiff argues that the
contents of the guidance, not the agency’s label, dictates “whether statutory notice-andcomment demands apply,” see Docket No. 78 at 5 (quoting Azar v. Allina Health
Servs.,139 S. Ct. 1804, 1812 (2019)), the substance of the CPG provides guidance
only and does not create any legal right. “[T]he FDA’s guidance documents do not
provide any legal basis from which the FDA can institute civil or criminal legal
proceedings.” BBK Tobacco & Foods, LLP v. FDA, 672 F. Supp. 2d 969, 975 (D. Ariz.
2009); see also 21 U.S.C. § 371(h)(1)(A) (“[G]uidance documents . . . shall not create
or confer any rights for or on any person.”). The FDA, moreover, derives no
enforcement authority from the CPG. See Docket No. 64-1 (the CPG). Instead, the
FDA’s enforcement power stems from 21 U.S.C. § 334. See Merrell Dow Pharm. Inc. v.
Thompson, 478 U.S. 804, 830 (1986) (“Congress has provided the FDA with a wideranging arsenal of weapons to combat violations of the FDCA, including authority to
obtain an ex parte court order for the seizure of goods subject to the Act, see 21 U.S.C.
§ 334, authority to initiate proceedings in a federal district court to enjoin continuing
violations of the FDCA, see § 332, and authority to request a United States Attorney to
bring criminal proceedings against violators, see § 333.”).
Plaintiff relies on its claim that the FDA has enforced the CPG through “public
health warnings, punitive inspections, and through . . . the [CDA].” Docket No. 78 at 8.
In particular, plaintiff states that, after plaintiff refused to conduct a voluntary recall of
one of its products, “the FDA issued a Public Warning Notice for A+ ANSWERS™
Straight Beef Formula for Dogs stating [it] was doing so because the product
represents a serious threat to human and animal health and is adulterated under the
[FDCA].” Docket No. 1 at 25, ¶ 90. 5 Moreover, it alleges that, “pursuant to an
interagency agreement(s) between Colorado and the FDA and the FDA’s call to the
states for sampling of raw products, an inspector working for the Colorado Department
of Agriculture collected a sample of raw pet food manufactured by the Plaintiff [from] a
pet store located in Littleton, CO.” Id. at 26, ¶ 93.
However, “[c]ourts have consistently held . . . that the issuance of a warning
Plaintiff alleges that this action was based upon a sample of its pet food taken
by the state of Nebraska. Id. at 25, ¶ 90.
letter by FDA does not constitute final agency action ripe for judicial review.” Cody
Labs., 2010 WL 3119279, at *11; see also Biotics Research Corp. v. Heckler, 710 F.2d
1375, 1377 (9th Cir. 1983) (“[T]he type of informal letter issued by the FDA . . . does
not constitute the kind of formal or final agency action the Supreme Court had in
mind.”) (citation omitted). At best, the issuance of a warning letter “indicate[s] a
readiness on the part of the FDA to initiate enforcement procedures.” Biotics, 710 F.2d
at 1378. Such an action, however, “do[es] not commit the FDA to enforcement action.”
Moreover, to the extent that plaintiff alleges that the CDA’s prosecution of
plaintiff is a thinly-veiled enforcement attempt by the FDA, this argument is without
merit. Plaintiff claims that the CPG “is being enforced against the Plaintiffs through . . .
punitive inspections and through the FDA’s enforcement agent, the [CDA].” Docket
No. 78 at 8. Plaintiff appears to argue that the CPG constitutes a final agency action
because, according to plaintiff, other defendant entities are indirectly enforcing the
CPG – which plaintiff refers to as “shadow regulation.” See Docket No. 1 at 24, ¶ 87.
For example, plaintiff claims that “the FDA – through AAFCO, compels state regulatory
agencies to enforce [its guidelines] in exchange for a piece of roughly $11,100,000.00
in FDA funding,” id. at 13, ¶ 39, and that the “CDA . . . funded by the FDA, pulled
Plaintiff’s products from the shelves of one of its Colorado retail stores selling Plaintiff’s
products.” Id. at 11, ¶ 33.
The Court finds that plaintiff has failed to sufficiently plead facts to plausibly
support its “shadow regulation” allegations. For example, while plaintiff claims that “the
FDA enlisted the CDA to pull product from shelves to be tested by [its] state laboratory
and slandered the Plaintiff’s products,” the example it gives of such action is conduct
performed by the state of Nebraska, not the CDA or AAFCO. See Docket No. 1 at 2425, ¶ 89. Further, while plaintiff alleges that “[t]he FDA, through the CDA has chosen to
prosecute Plaintiff,” see Docket No. 1 at 15, ¶ 47, plaintiff fails to allege in its complaint
any facts supporting its claim that the CDA’s state prosecution of plaintiff was at the
behest of the FDA or was a condition to the CDA receiving federal funding. See
generally Docket No. 1. A complaint must allege enough factual matter that, taken as
true, makes the plaintiff’s “claim to relief . . . plausible on its face.” Khalik v. United Air
Lines, 671 F.3d 1188, 1190 (10th Cir. 2012) (citing Bell Atl. Corp. v. Twombly, 550 U.S.
544, 570 (2007)). “[W]here the well-pleaded facts do not permit the court to infer more
than the mere possibility of misconduct, the complaint has alleged – but has not shown
– that the pleader is entitled to relief.” Ashcroft v. Iqbal, 556 U.S. 662, 679 (2009). “[A]
court need not accept conclusory allegations.” McGettigan v. Di Mare, 173 F. Supp. 3d
1114, 1121 (D. Colo. 2016) (citing Moffett v. Halliburton Energy Servs., Inc., 291 F.3d
1227, 1232 (10th Cir. 2002)).
Even if plaintiff had set forth sufficient facts to plausibly support the existence of
“shadow regulation,” the FDA’s alleged act – through itself or through another entity –
of either collecting or inducing another entity to collect samples from plaintiff’s pet food
does not allege final agency action. The initiation of an investigation does “not
consummate the type of decisionmaking process envisioned by the Supreme Court in
Abbott Laboratories and Standard Oil as final agency action.” Mobil Expl. & Producing
U.S., Inc. v. Dep’t of Interior, 180 F.3d 1192, 1198 (10th Cir. 1999). Various courts
have held that investigatory processes similar to those at issue here are not final
agency actions. See id. (collecting cases). In sum, plaintiff has failed to allege specific
actions taken by the FDA that would constitute the “consummation” of the agency’s
decision-making process. The Court finds that plaintiff’s allegations do not “identify
specific federal conduct and explain how it is ‘final agency action.’” Colo. Farm
Bureau, 220 F.3d at 1173. Because plaintiff seeks review of a non-final agency action,
the Court does not have subject matter jurisdiction over plaintiff’s claims against the
federal defendants. As a result, the Court will grant the federal defendants’ motion to
B. State Defendants and the AAFCO
The state defendants argue that the Court does not have subject matter
jurisdiction over plaintiff’s claims against them because plaintiff’s claims do not arise
under federal law. Docket No. 63 at 6. The AAFCO has joined in the state defendants’
argument. Docket No. 65 at 1 n.2. Specifically, they argue that the APA cannot be
Even if the Court had jurisdiction to consider plaintiff’s challenge to the CPG,
its request for injunctive relief is improper. Plaintiff asks the Court to enjoin the FDA
from conducting an enforcement action in this matter and to “suspend any pending
related enforcement actions specific to the application of [the CPG].” Docket No. 1 at
34. “[T]he law is well-settled that the district courts lack jurisdiction to enjoin
enforcement proceedings brought pursuant to the FDCA.” Genendo Pharm. N.V. v.
Thompson, 308 F. Supp. 2d 881, 882 (N.D. Ill. 2003). In essence, plaintiff’s lawsuit is
an attempt to test its defense – that Salmonella is a naturally occurring substance that
cannot render its pet food adulterated – at the pre-enforcement stages. But “[w]hether
an enforcement action is simply contemplated or has already been filed, those subject
to enforcement action may not file an anticipatory challenge; they must raise any
defenses they have in the enforcement action itself.” Cody Labs., 2010 WL 3119279,
used to review state agency decisions and that the APA does not create a private
cause of action against state agencies. Docket No. 63 at 6. Plaintiff responds that its
claims arise under federal law because the state entities have consented to be sued in
federal court. Docket No. 79 at 5-6.
The APA provides for judicial review of “[a]gency action[s] made reviewable by
statute and final agency action[s] for which there is no other adequate remedy in a
court.” 5 U.S.C. § 704. “Agency” is defined as “each authority of the Government of
the United States, whether or not it is within or subject to review by another agency.” 5
U.S.C. § 701(b)(1). As such, “the APA does not apply to state agencies” and an entity
intending to challenge a state agency action “must seek relief under the state
administrative procedures act.” Felmlee v. Oklahoma, 2014 WL 5592399, at *2 (N.D.
Okla. Nov. 3, 2014), aff’d, 620 F. App’x 648, 652-53 (10th Cir. 2015) (unpublished)
(finding that plaintiff “ha[d] not alleged any cognizable . . . APA claim against” the stateagency and state-employee defendants); see also Town of Portsmouth v. Lewis, 813
F.3d 54, 64 (1st Cir. 2016) (stating that the APA “only provides for review of federal
agency action” and “does not provide a right of action against a state agency.”).
Plaintiff cites Zeppelin v. Federal Highway Administration, 293 F. Supp. 3d 1267
(D. Colo. 2017), and Ross v. Federal Highway Administration, 162 F.3d 1046 (10th Cir.
1998), arguing that “state agencies are subject to the APA when they consent to be the
vehicle of a Federal agency’s action.” Docket No. 79 at 5. The Court finds these cases
inapplicable here. In Ross, the Tenth Circuit determined that a state’s highway
construction project was a “major federal action” requiring state compliance with the
National Environmental Policy Act (“NEPA”) where the state received federal funding
and in which federal participation was lengthy. 163 F.3d at 1053. The court noted that
“[t]he state of Kansas and Douglas County chose to develop this trafficway in
conjunction with the federal government as a federal-aid highway project and
proceeded in that manner for more than ten years before attempting to ‘defederalize’ a
portion of the project.” Id. at 1055. The court affirmed the district court’s injunction
against the state agency from taking further action on the project without conducting
further environmental review. Id. at 1050, 1055.
The issue in Zeppelin – also a NEPA case – was whether the court could enjoin
the Colorado Department of Transportation (“CDOT”) from sending money to the City of
Denver to assist it in rebuilding a highway. 293 F. Supp. 3d at 1270, 1283. Relying on
Ross, the court determined that it had the authority to enjoin the non-federal entity on
the basis that CDOT had consented to the court’s jurisdiction, “given CDOT’s thorough,
long-standing, and active consent to federal involvement, and its request for federal
funds.” Id. at 1285. “CDOT therefore has effectively conceded that it must obey the
dictates of this Court with respect to NEPA and the APA.” Id.
The Court is unpersuaded by plaintiff’s reliance on Ross and Zeppelin. Both
cases involved judicial review under NEPA, and no court has adopted plaintiff’s theory
outside of this context. Plaintiff has made no argument explaining why the Court
should expand the holdings in these cases to permit judicial review of a state agency
action outside of the NEPA context. Moreover, even if the Court were to follow
Zeppelin’s analysis, plaintiff has not demonstrated that the CDA has sufficient federal
connections to render it subject to the Court’s jurisdiction. In Zeppelin, the court
concluded that, “in the Tenth Circuit[,] a non-federal entity may be enjoined in an APA
case under a consent theory – the state or local government took federal money and
participated in a federal process, so it may fairly be subjected to federal requirements –
but such consent is not in all cases irrevocable.” 293 F. Supp. 2d at 1284. The court
compared two cases – Ross, in which “federal involvement [in the state agency action]
was pervasive and long-standing,” and Village of Los Ranchos de Albuquerque v.
Barnhart, 906 F.3d 1477 (10th Cir. 1990), where “there was comparatively little federal
involvement (although the municipality certainly took federal money).” Id. “Somewhere
in between those two poles, a non-federal entity’s participation with the federal
government becomes irrevocable consent to federal statutory requirements, such as
NEPA, which is enforceable through the APA.” Id.
The Court finds that plaintiff’s allegations are insufficient to find consent to
federal statutory requirements. Plaintiff alleges that the “AAFCO and its state
government members, at the behest of the FDA, using FDA monies and directives, . . .
acted in concert and/or coordination with the FDA to sample and debase Plaintiff’s
products . . . within the State of Colorado.” Docket No. 1 at 11, ¶ 31. Plaintiff asserts
that the CDA “is an active participating member of AAFCO who – funded by the FDA,
pulled Plaintiff’s products from the shelves of one of its Colorado retail stores . . . after
what is believed will be proved the CDA’s mishandling Plaintiff’s products.” Id., ¶ 33;
see also id. at 24, ¶ 89. Additional allegations include plaintiff’s statement that,
“[a]rmed with their policy guidance and cooperating states that adopt AAFCO’s very
different definition of adulteration, the FDA attempts to compel Plaintiff to recall its
products, to justify [its] public shaming of Plaintiff for allegedly distributing adulterated
foods, and to conduct frequent punitive inspections of the Plaintiff’s manufacturing and
other operational facilities,” id. at 14-15, ¶ 44, and that the FDA “is actually using
AAFCO and participating member states to apply a zero-tolerance Salmonella standard
to raw pet food” and that the FDA, “through its regulating State agency . . . threatens
criminal and/or monetary punitive action” when manufacturers refuse to comply with its
recall requests. Id. at 24, ¶¶ 86-87. Finally, plaintiff contends that, “pursuant to an
interagency agreement(s) between Colorado and the FDA . . ., an inspector working for
the [CDA] collected a sample of raw pet food manufactured by the Plaintiff,” id. at 26,
¶ 93, – a decision plaintiff alleges was “orchestrated and directed by the FDA and its
agent AAFCO.” Id. at 27, ¶ 98. Plaintiff asserts that the CDA’s prosecution of plaintiff
comes “at the direction of the FDA.” Id. at 29, ¶ 103.
These allegations are insufficient for the Court to find that it has subject matter
jurisdiction over the state entities in this case. Plaintiff alleges that the CDA, in
prosecuting plaintiff, is acting at the behest of the FDA. See id. But plaintiff alleges no
facts supporting this allegation, and the Court need not accept conclusory allegations.
See Hackford v. Babbitt, 14 F.3d 1457, 1465 (10th Cir. 1994) (stating that the court is
“not bound by conclusory allegations, unwarranted inferences, or legal conclusions”).
And while the state defendants admit that the CDA “receives some federal funding for
its optional compliance with the [Animal Feed Regulatory Program Standards],” Docket
No. 90 at 3, the receipt of federal funding does not provide the Court subject matter
jurisdiction over state agencies under the APA. See Merryfield v. Disability Rights Ctr.
of Kan., 439 F. App’x 677, 679 (10th Cir. 2011) (unpublished) (holding that the receipt
of federal funds does not render a state agency a federal agency for APA purposes).
The Court finds that plaintiff has failed to meet its burden of demonstrating that the
Court has subject matter jurisdiction over the claims against the state defendants. See
Merida Delgado, 428 F.3d at 919 (“[T]he party invoking federal jurisdiction bears the
burden of proof.”).7
C. Motions for Jurisdictional Discovery
Plaintiff has also filed two motions for discovery in aid of jurisdiction. Docket No.
62; Docket No. 70. In its first motion, plaintiff states that it “desires not only to produce
2,600 documents [it] believe[s] firmly establish the proof of final agency action but also
to get the un-redacted versions thereof directly from the Defendants themselves.”
Docket No. 62 at 8, ¶ 19. In its second motion, plaintiff requests leave to depose Scott
Ziehr, the co-administrator of the CDA’s Feed Program. Docket No. 70 at 3, ¶ 2. It
argues that deposing Mr. Ziehr “would clear up the factual dispute about whether or not
[the Court] has jurisdiction to hear the Plaintiff’s complaint,” id., because it would reveal
The AAFCO has filed a motion to dismiss based on a lack of personal
jurisdiction and for failure to state a claim. See Docket No. 65. The APA does not
permit actions against private parties. See Midland Farms, LLC v. U.S. Dept. of Agric.,
35 F. Supp. 3d 1056, 1062 (D.S.D. 2014) (“The APA is not an independent source of
jurisdiction, . . . nor does it provide a private right of action against a private party.”)
(citations omitted); Window Sys., Inc. v. Manchester Mem’l Hosp., 424 F. Supp. 331,
336 (D. Conn. 1976) (“[T]he APA is not applicable to suits between private parties.”).
Accordingly, the Court finds that it lacks subject matter jurisdiction over this case to the
extent that plaintiff raises claims against the AAFCO. Accordingly, Court does not
reach the AAFCO’s arguments and will deny its motion as moot.
“the Federalization of the CDA and its prosecution of the Plaintiff.” Id. at 8, ¶ 23.
“When a defendant moves to dismiss for lack of jurisdiction, either party should
be allowed discovery on the factual issues raised by that motion.” Sizova v. Nat’l Inst.
of Standards & Tech., 282 F.3d 1320, 1326 (10th Cir. 2002) (citation omitted). “In
determining whether to allow jurisdiction discovery[,] however, the trial court ‘is vested
with broad discretion.’” Grynberg v. Ivanhoe Energy, Inc., 666 F. Supp. 2d 1218, 1227
(D. Colo. 2009) (quotation omitted). An abuse of discretion occurs upon the denial of
jurisdictional discovery “if the denial results in prejudice to a litigant.” Sizova, 282 F.3d
at 1326. “Prejudice is present where pertinent facts bearing on the question of
jurisdiction are controverted . . . or where a more satisfactory showing of the facts is
necessary.” Id. (quotation and citation omitted). A district court will not abuse its
discretion in denying a request for jurisdictional discovery where there is a “very low
probability that the lack of discovery affected the outcome of th[e] case.” Magpul
Indus., Corp. v. Blue Force Gear, Inc., No. 14-cv-01470-RBJ, 2014 WL 6845851, at *2
(D. Colo. Dec. 4, 2014) (quoting Bell Helicopter Textron, Inc. v. Heliqwest Int’l, Ltd., 385
F.3d 1291, 1299 (10th Cir. 2004)).
Plaintiff has failed to present a sufficient factual predicate to support its
argument that subject matter jurisdiction can be established through additional
discovery. In its first motion, plaintiff seeks leave to serve an interrogatory and request
for production on defendant, seeking the identification of “ALL documents . . . reflecting
in any way communication by and among the Defendants, their agents, employees, or
the like – or any combination thereof, regarding Plaintiff, its products, and/or any
officer, employee, or agent thereof.” Docket No. 62-1 at 18. Plaintiff also seeks the
production of “[a]ll documents identified above.” Id. Plaintiff argues that it “merely
seeks the materials demonstrating[,]  unquestionably, the cooperation by and among
defendants to enforce this ‘non-binding’ policy against Plaintiff with impunity,
throughout the country, and with significant deleterious effects to Plaintiff and others in
its industry.” Docket No. 62 at 11, ¶ 29. But plaintiff raises no allegations of facts or
evidence that it believes its wide-reaching discovery request would reveal. See Docket
No. 62; see also First Magnus Fin. Corp. v. Star Equity Funding, 2007 WL 635312, at
*10 (D. Kan. Feb. 27, 2007) (denying jurisdictional discovery where plaintiff “ha[d] not
stated any facts that it believe[d] jurisdictional discovery would likely reveal”). A party
“may not use discovery as a fishing expedition.” Anthony v. United States, 667 F.2d
870, 880 (10th Cir. 1981).
Further, plaintiff has not argued in its first discovery motion that it is prejudiced
by the denial of jurisdictional discovery. See Docket No. 62. Plaintiff states that
“prejudice occurs where – as herein: ‘pertinent facts bearing on the question of
jurisdiction are controverted,’” Docket No. 62 at 7-8, ¶ 18 (quoting Sizova, 282 F.3d at
1326), but sets forth no argument demonstrating facts in dispute that would render the
denial of additional discovery prejudicial. Instead, plaintiff states that it is in possession
of “2,600 documents [that] firmly establish the proof of a final agency action.” Id. at 8, ¶
19. If, as plaintiff contends, the documents in its possession “firmly establish” a final
agency action, it is unclear to the Court why additional discovery is necessary to
establish the Court’s subject matter jurisdiction or how plaintiff could be prejudiced by
the denial of additional discovery. As such, plaintiff has failed to demonstrate that it is
entitled to additional jurisdictional discovery.
In its second motion, plaintiff seeks to depose Mr. Ziehr on the basis that such
deposition will uncover the fact that the FDA, CDA, and AAFCO have worked in concert
to enforce the CPG. See, e.g., Docket No. 70 at 8, ¶¶ 23-24. However, plaintiff
violated the Local Rules by failing to confer with defendants before filing this second
motion in aid of jurisdictional discovery. “Before filing a motion, counsel for the moving
party . . . shall confer or make reasonable good faith efforts to confer with any opposing
counsel or unrepresented party to resolve any disputed matter. The moving party shall
describe in the motion, or in a certificate attached to the motion, the specific efforts to
fulfill this duty.” D.C.COLO.LCivR 7.1(a). This rule “mandates that the Court not
consider any motion, other than a motion under Fed. R. Civ. P. 12 or 56, unless”
counsel has conferred with the opposing party. Ballard v. Tritos, Inc., No. 10-cv-02757PAB-KMT, 2010 WL 5559544, at *1 (D. Colo. Dec. 30, 2010).
Even if plaintiff had complied with the Local Rules, its motion for additional
jurisdictional discovery is without merit. Plaintiff argues that “[t]wo new important
facts . . . were drawn out [from] two [CDA] employees during depositions for the State
prosecution that indicate that the Defendants’ denials of concerted action between the
FDA, AAFCO, and the [CDA] are false.” Docket No. 70 at 4, ¶ 5. Specifically, plaintiff
states that a CDA employee testified that the CDA’s biochemistry lab receives federal
funding from the FDA that is contingent on following the FDA and AAFCO’s Animal
Feed Regulatory Program Standards. Id., ¶ 7. Further, plaintiff claims that a CDA
inspector who took the sample of plaintiff’s pet food testified that Mr. Ziehr told him to
inspect plaintiff’s food “because of a ‘recall,’” but there was no recall of plaintiff’s pet
food at the time of the sampling. Id. at 5, ¶ 10-11.8 Plaintiff asserts that this was a
“cover-up [of] Federal involvement in the request.” Id. at 3, ¶ 13. Plaintiff seeks to
depose Mr. Ziehr “to obtain facts regarding the Federalization of the CDA and its
prosecution of the Plaintiff.” Id. at 8, ¶ 23.
Plaintiff provides no support, beyond its bare allegations, that Mr. Ziehr’s
directive to the CDA inspector to sample plaintiff’s pet food was at the behest of the
FDA. This is insufficient to demonstrate that additional jurisdictional discovery is
warranted. See First Magnus Fin. Corp., 2007 WL 635312, at *10 (jurisdictional
discovery not required when movant has not stated any facts it believes jurisdictional
discovery will reveal). Given the Court’s noted deficiencies in plaintiff’s complaint – i.e.,
the lack of plausible allegations that the state prosecution was initiated at the directive
of the FDA – additional discovery would not change the Court’s conclusion that it lacks
subject matter jurisdiction over this case. The Court will deny plaintiff’s second motion
for jurisdictional discovery. See Bell Helicopter, 385 F.3d at 1298-99 (holding that the
district court did not abuse its discretion in denying jurisdictional discovery where there
was a “very low probability that the lack of discovery affected the outcome of the case”).
D. Motion to Amend the Complaint
On November 12, 2019, plaintiff filed Plaintiff’s Application for a Temporary
Plaintiff does not provide the Court with the transcripts from these depositions.
See Docket No. 70.
Restraining Order and/or Preliminary Injunction [Docket No. 104]. Plaintiff sought
either a temporary restraining order or a preliminary injunction (1) “[r]equiring
[d]efendants to comply with Section 10 of [the Federal Advisory Committee Act
(“FACA”)] – opening their meetings and committees to the public”; and (2) “[r]equiring
[d]efendants to comply with the non-discretionary duties of Section 5 of FACA to ensure
fair, balanced, and equal representation of ALL pet food manufacturers and their
positions, including, but not limited to, natural pet food manufacturers and their trade
groups.” Docket No. 104 at 14. The Court denied the motion on November 14, 2019.
Docket No. 105. The Court’s denial was based on the fact that plaintiff’s complaint did
not raise a claim under FACA and “contain[ed] no allegations relevant to the relief
plaintiff [sought] in its injunctive relief motion.” Id. at 3; see also Alley v. Aurora Loan
Servs. LLC, No. 10-cv-02163-REB-CBS, 2011 WL 3799035, at *14 (D. Colo. July 21,
2011), report and recommendation adopted by 2011 WL 3799585 (“[T]o obtain
preliminary injunctive relief, the moving party bears the burden of establishing, a[m]ong
other elements, that he or she has a likelihood of success on the merits of the
underlying claims.” (emphasis added)) (citation omitted). The Court also rejected
plaintiff’s request to “graft” its new allegations into its complaint, noting that plaintiff had
failed to file a motion to amend its complaint under Rule 15 of the Federal Rules of Civil
Procedure and could not move for amendment in its motion for injunctive relief. Docket
No. 105 at 5.
On November 15, 2019, plaintiff filed Plaintiff’s Motion to Amend Complaint
Solely to Incorporate Claims Under Federal Advisory Committee Act ((“FACA”), 5
U.S.C. app. 2 §§ 1-16) [Docket No. 106]. Plaintiff asserts that it “has revised its
operative Complaint herein to include its claims for FACA which only first accrued on
November 5, 2019.” Docket No. 106 at 3, ¶ 8. Plaintiff asserts that its amendment will
not prejudice defendant or delay these proceedings because it “intentionally avoided”
making any changes to the complaint “other than inserting its claims under FACA,” so
that the amendment will “not disturb and/or otherwise derail the Court’s considerations
of the motions to dismiss.” Id., ¶ 11.
“Rule 15(a) provides that leave to amend ‘shall be freely given when justice so
requires.’” Frank v. U.S. West, 3 F.3d 1357, 1365 (10th Cir. 1993). “The liberal
granting of motions for leave to amend reflects the basic policy that pleadings should
enable a claim to be heard on its merits.” Calderon v. Kansas Dep’t of Soc. and
Rehab. Servs., 181 F.3d 1180, 1186 (10th Cir. 1999); see also Minter v. Prime Equip.
Co., 451 F.3d 1196, 1204 (10th Cir. 2006) (“The purpose of the rule is to provide
litigants ‘the maximum opportunity for each claim to be decided on its merits rather than
on procedural niceties.’” (citation omitted)).
The Court has discretion to grant a party leave to amend its pleadings. Foman
v. Davis, 371 U.S. 178, 182 (1962). “Refusing leave to amend is generally only justified
upon a showing of undue delay, undue prejudice to the opposing party, bad faith or
dilatory motive, failure to cure deficiencies by amendments previously allowed, or
futility of amendment.” Frank, 3 F.3d at 1365 (citation omitted). “The non-moving party
bears the burden of showing that the proposed amendment is sought in bad faith, that it
is futile, or that it would cause substantial prejudice, undue delay or injustice.” Corp.
Stock Transfer, Inc. v. AE Biofuels, Inc., 663 F. Supp. 2d 1056, 1061 (D. Colo. 2009)
A court may also “on just terms, permit a party to serve a supplemental pleading
setting out any transaction, occurrence, or event that happened after the date of the
pleading to be supplemented.” Fed. R. Civ. P. 15(d). Courts apply the same standard
when deciding whether to permit a party to supplement a pleading under Rule 15(d) as
they do for amendment of a pleading under Rule 15(a)(2). See Sw. Nurseries, LLC v.
Florists Mut. Ins., Inc., 266 F. Supp. 2d 1253, 1256 (D. Colo. 2003).
The Court finds that the motion should be denied. First, unrelated to Rule
15(a)’s requirements, it does not appear that plaintiff adequately complied with
D.C.COLO.LCivR 7.1(a), and may have misrepresented what happened in connection
with the attempted conferral. Plaintiff states in its Rule 7.1(a) certification that it
contacted defendants by e-mail and by sending them a redlined version of the
proposed supplemental complaint, and that “Defendants remained mute.” Docket No.
106 at 1-2, ¶¶ 1-3. AAFCO asserts, however, that all three defendants emailed
plaintiff’s counsel the day before the motion was filed to oppose the amendment, and
that paintiff therefore “blatantly misrepresented the facts.” Docket No. 114 at 1-2; see
also Docket No. 110 at 1 (stating that “counsel for the Federal Defendants responded
to Plaintiff’s counsel’s first email within a few hours, opposing amendment of the
complaint”). The federal defendants also state that, fewer than twenty-four hours after
plaintiff’s counsel sent a redlined version of the proposed complaint to defendants, and
before counsel had an opportunity to consider the proposed amendment and to consult
with their client, plaintiff’s counsel filed the motion to amend. Docket No. 110 at 1. The
Court finds that plaintiff’s counsel merely informed defendants that plaintiff planned to
file a motion, and there is no indication that any actual conferral took place. This
violates the requirements of Rule 7.1(a) that the “the parties must hold a conference,
possibly through the exchange of correspondence but preferably through person-toperson telephone calls or face-to-face meetings, and must compare views and attempt
to reach an agreement, including by compromise if appropriate.” Hoelzel v. First Select
Corp., 214 F.R.D. 634, 636 (D. Colo. 2003) (quotations omitted). The motion to amend
is thus subject to denial for plaintiff’s violation of Rule 7.1(a).
Moreover, the Court finds that, notwithstanding plaintiff’s Local Rule violation, its
motion should be denied on the merits. “The principal factors which are considered in
connection with the offer of an amendment are, first, whether it will cause delay and,
second, whether the adversary will suffer prejudice.” R.E.B. Inc. v. Ralston Purina Co.,
525 F.2d 749, 752 (10th Cir. 1975). The Court finds that the proposed supplement to
add the FACA claim will cause both delay and prejudice, and will also impact efficiency
and judicial economy.
The FACA claim is distinct from and unrelated to the APA claim asserted in the
original complaint. See Docket No. 1. Indeed, in denying the TRO motion, the Court
stated that the motion for a temporary restraining order, Docket No. 104, “is not
reasonably related to, and seeks relief that is wholly separate from, the relief sought in
its complaint.” Docket No. 105 at 4-5. The Court further noted plaintiff’s
acknowledgment of the fact “that the relief it now seeks is not of the same character as
the relief it seeks in its underlying complaint.” Id. at 5. Courts have held that
supplementation of a complaint should be denied when the new claim is unrelated to
the initial action. See Planned Parenthood of S. Ariz. v. Neely, 130 F.3d 400, 402 (9th
Cir. 1997); Clervrain v. United States, 2019 WL 130288, at *1 (D. Kan. Jan. 8, 2019);
see also Minter, 451 F.3d at 1208 (stating that prejudice “occurs when the amended
claims arise out of a subject matter different from what was set forth in the complaint
and raise significant new factual issues”). The Court has, in this order, determined that
it does not have subject matter jurisdiction over this case and has dismissed plaintiff’s
APA claims. To allow the plaintiff to add wholly unrelated claims to its complaint at this
point in the proceedings would be unduly prejudicial to defendants, who have each filed
meritorious motions to dismiss for lack of subject matter jurisdiction. From the
foregoing, the Court finds that allowing plaintiff to file a supplemental complaint adding
the FACA claim would prejudice defendants and impact the interests of efficiency and
judicial economy. Moreover, plaintiff does not explain why justice would be served by
granting the amendment. Denial of the motion thus appears to be warranted. See 6A
Charles Alan Wright & Arthur R. Miller, Fed. Prac. & Proc. § 1506 at 271 (3d. ed. 2010)
(“[W]hen the matters alleged in a supplemental pleading have no relation to the claim
originally set forth and joinder will not promote judicial economy or the speedy
disposition of the dispute between the parties, refusal to allow the supplemental
pleading is entirely justified.”).9
As the Court has found that the motion to amend [Docket No. 106] should be
denied on grounds of undue delay, prejudice, and the other factors discussed herein, it
has not addressed the futility argument.
Because the Court finds that it lacks subject matter jurisdiction over plaintiff’s
claims, and finds that justice does not require amendment of plaintiff’s claim, this matter
will be dismissed in its entirety.
Wherefore, it is
ORDERED that Federal Defendants’ Motion to Dismiss [Docket No. 64] is
GRANTED. It is further
ORDERED that State Defendants’ Motion to Dismiss Plaintiff’s Complaint Under
Fed. R. Civ. P. 12(b)(1) and 12(b)(6) [Docket No. 63] is GRANTED. It is further
ORDERED that Defendant Association of American Feed Control Officials’
Motion to Dismiss [Docket No. 65] is DENIED AS MOOT. It is further
ORDERED that Plaintiff’s Motion for Discovery in Aid of Jurisdiction [Docket No.
62] is DENIED. It is further
ORDERED that Plaintiff’s Second Motion for Discovery in Aid of Jurisdiction
[Docket No. 70] is DENIED. It is further
ORDERED that Plaintiff’s Motion to Amend Complaint Solely to Incorporate
Claims Under Federal Advisory Committee Act ((“FACA”), 5 U.S.C. app. 2 §§ 1-16)
[Docket No. 106] is DENIED. It is further
ORDERED that Plaintiff’s Combined Motion and Memorandum for Injunctive
Relief Pursuant to F.R.C.P. 65(a)(2) [Docket No. 12] is DENIED AS MOOT. It is further
ORDERED that Next Generation Pet Food Manufacturers Association, Inc.’s
Motion to Intervene [Docket No. 86] is DENIED AS MOOT. It is further
ORDERED that Weston A. Price Foundation’s Motion to Intervene [Docket No.
100] is DENIED AS MOOT. It is further
ORDERED that plaintiff’s complaint is dismissed without prejudice.
ORDERED that this case is closed.
DATED September 14, 2020.
BY THE COURT:
PHILIP A. BRIMMER
Chief United States District Judge
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