Case 6:22-cv-00429-JCB Document 1 Filed 11/03/22 Page 1 of 19 PageID #: 1
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`UNITED STATES DISTRICT COURT
`EASTERN DISTRICT OF TEXAS
`Tyler Division
`
`Case No.
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`))))))))))))))))))))))))))
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`)
`)
`
`MAGELLAN TECHNOLOGY, INC.;
` 2225 Kenmore Avenue, Suite 110
` Buffalo, New York 14207,
`
` and
`
`VAPOR TRAIN 2 LLC;
` 3500 McCann Road
` Longview, Texas 75605,
`
`Plaintiffs,
`
`v.
`
`U.S. FOOD AND DRUG ADMINISTRATION;
`ROBERT M. CALIFF, M.D., Commissioner for
`Food and Drugs;
` 10903 New Hampshire Avenue
` Silver Spring, Maryland 20903,
`
`U.S. DEPARTMENT OF HEALTH AND
`HUMAN SERVICES;
`XAVIER BECERRA, Secretary of Health and
`Human Services;
` 200 Independence Avenue, S.W.
` Washington, D.C. 20201,
`
`Defendants.
`
`VERIFIED COMPLAINT
`(TEMPORARY RESTRAINING ORDER AND PRELIMINARY INJUNCTION
`REQUESTED)
`
`Plaintiffs Magellan Technology, Inc. (“Magellan”) and Vapor Train 2 LLC (“Vapor
`
`Train”), for their Verified Complaint against the United States Food and Drug Administration,
`
`Robert M. Califf, M.D., Commissioner for Food and Drugs (collectively, “FDA”), the United
`
`States Department of Health and Human Services, and Xavier Becerra, Secretary of the
`
`Department of Health and Human Services (collectively, “HHS”), hereby state as follows:
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`1
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`

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`Case 6:22-cv-00429-JCB Document 1 Filed 11/03/22 Page 2 of 19 PageID #: 2
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`NATURE OF THE ACTION
`
`1.
`
`Through this action, Plaintiffs seek a declaratory judgment that FDA has violated
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`the Administrative Procedure Act by issuing a Refuse to Accept (“RTA”) order for twelve bundled
`
`Premarket Tobacco Product Applications (“PMTAs”) that Magellan submitted for various
`
`electronic nicotine delivery system products it markets.
`
`2.
`
`Plaintiffs contend that FDA acted arbitrarily, capriciously, and otherwise not in
`
`accordance with applicable law in issuing the RTA order because the agency (i) invoked
`
`regulations governing PMTA acceptance that do not apply to Magellan’s PMTA and (ii) failed to
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`consider timely amendments containing required content that Magellan properly submitted but
`
`which FDA failed to link to the corresponding applications because of its own failure to issue
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`Submission Tracking Numbers (“STNs”) to Magellan for the underlying applications.
`
`3.
`
`Plaintiffs seek (i) a temporary restraining order and preliminary injunction staying
`
`the RTA order pending the outcome of this action; and (ii) a final judgment setting aside the RTA
`
`order and remanding to FDA for further review of Magellan’s PMTAs.
`
`THE PARTIES
`
`4.
`
`Plaintiff Magellan Technology, Inc., is a corporation headquartered in Buffalo,
`
`New York. Magellan distributes ENDS products nationwide, including in this district. Magellan
`
`is the master distributor of all Hyde- and JUNO-branded ENDS products. Through its scientific
`
`advisors, on May 12 and 13, 2022, Magellan submitted twelve bundled applications for marketing
`
`authorization for a range of Hyde- and JUNO-branded ENDS products to FDA.
`
`5.
`
` Plaintiff Vapor Train 2 LLC is a Texas limited liability company headquartered
`
`and with two retail stores in Longview, Texas. Until FDA issued the RTA order, Vapor Train
`
`
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`2
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`

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`Case 6:22-cv-00429-JCB Document 1 Filed 11/03/22 Page 3 of 19 PageID #: 3
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`purchased Hyde-branded ENDS products from Magellan and sold them to consumers at retail
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`through its two stores.
`
`6.
`
`Defendant United States Food and Drug Administration is a division of Defendant
`
`Department of Health and Human Services (“HHS”). The headquarters and principal place of
`
`business of FDA is 10903 New Hampshire Avenue, Silver Spring, Maryland 20903. The
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`headquarters and principal place of business of HHS is 200 Independence Avenue, S.W.,
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`Washington, D.C. 20201. Defendant Robert M. Califf, M.D., is the Commissioner of the Food and
`
`Drug Administration and is sued in his official capacity. Defendant Xavier Becerra is the Secretary
`
`of Health and Human Services and is sued in his official capacity.
`
`JURISDICTION AND VENUE
`
`7.
`
`This Court has subject matter jurisdiction pursuant to 28 U.S.C. § 1331. This Court
`
`has the authority to grant the declaratory relief requested by Plaintiffs pursuant to 28 U.S.C. §§
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`2201 and 2202. The Court also has the authority to hold unlawful and set aside FDA’s actions
`
`pursuant to 5 U.S.C. §§ 702 and 706 and to grant temporary and preliminary injunctive relief
`
`pursuant to 5 U.S.C. § 705.
`
`8.
`
`This Court has personal jurisdiction over Defendants FDA, HHS, Commissioner
`
`Califf, and Secretary Becerra in their official capacities, as each is an agency or official of the
`
`United States Government.
`
`9.
`
`Venue is proper in this district pursuant to 28 U.S.C. § 1391(e) as the district
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`wherein Plaintiff Vapor Train 2 LLC resides.
`
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`3
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`FACTS
`
`A.
`
`
`
`ENDS Products are “Tobacco Products” under the Tobacco Control Act
`
`10.
`
`Electronic nicotine delivery system (“ENDS”) products are regulated by FDA as
`
`“tobacco products” under the Tobacco Control Act (“TCA”), 21 U.S.C. §§ 387, et seq., because
`
`they “contain[] nicotine from any source” and are “intended for human consumption.” 21 U.S.C.
`
`§ 321(rr)(1). As such, they are subject to the requirements of Subchapter IX of the Federal Food,
`
`Drug and Cosmetic Act (“FDCA”).
`
`
`
`11.
`
`Section 910 of the FDCA, 21 U.S.C. § 387j, requires that any tobacco product that
`
`was not commercially marketed as of February 15, 2007, receive a marketing order from FDA
`
`prior to being commercially marketed in the United States.
`
`
`
`12.
`
`Prior to April 15, 2022, ENDS products containing nicotine that was synthetically
`
`manufactured or otherwise not derived from tobacco plants did not qualify as “tobacco products”
`
`and were not subject to Section 910’s premarket authorization requirements because the statutory
`
`definition of a “tobacco product” extended only to products “made or derived from tobacco that
`
`[are] intended for human consumption, including any component, part, or accessory of a tobacco
`
`product.” 21 U.S.C. § 321(rr) (2009). However, the Consolidated Appropriations Act, 2022, Pub.
`
`L. 117-103, 136 Stat. 49, Division P, Title I, Subtitle B, §111(a) expanded the statutory definition
`
`to include products containing nicotine “from any source” effective April 15, 2022.
`
`
`
`13.
`
`As a result, manufacturers and distributors of ENDS products were required to
`
`submit premarket tobacco applications for these synthetic nicotine products. If they submitted
`
`PMTAs by May 14, 2022, they would not be in violation of the Section 910’s marketing
`
`authorization requirement during the 60-day period up through July 13, 2022. See id. at § 111(d).
`
`
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`4
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`B.
`
`
`
`FDA has Historically Extended Enforcement Discretion to ENDS Products with
`Timely Submitted and Pending PMTAs
`
`14. May 14, 2022, was not the first time that manufacturers and distributors of ENDS
`
`products were required to submit PMTAs for their products in order to keep them on store shelves.
`
`15. When the Tobacco Control Act was first enacted in 2009, its requirements
`
`originally applied only to cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless
`
`tobacco. 21 U.S.C. § 387a(b). The TCA’s requirements would only apply to other products
`
`meeting the statutory definition of a “tobacco product” if FDA “by regulation deems” such
`
`products to be “tobacco products.” Id.
`
`16.
`
`Through its so-called “Deeming Rule,” 81 Fed. Reg. 28974 (May 10, 2016)
`
`(codified at 21 C.F.R. § 1143.1), FDA deemed ENDS products containing nicotine derived from
`
`tobacco plants to be tobacco products.
`
`17.
`
`However, because thousands, if not millions, of ENDS products were already
`
`commercially marketed in the United States, in the Deeming Rule’s preamble, FDA introduced a
`
`discretionary enforcement policy that allowed for delayed compliance periods for ENDS products.
`
`See 81 Fed. Reg. at 29009-15.
`
`18.
`
`Under this discretionary enforcement policy, PMTA submissions were originally
`
`required to be filed in 24 months, or by August 8, 2018. 81 Fed. Reg. at 28977-78, 29011. Tobacco
`
`products, including ENDS products, already on the U.S. market would not be subject to FDA
`
`enforcement action in the meantime or while a timely submitted PMTA was pending FDA review.
`
`Id.
`
`
`
`19.
`
`FDA’s deadline for the filing of PMTAs under its discretionary enforcement policy,
`
`however, changed multiple times over the succeeding years, and these changes resulted in
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`
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`5
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`significant litigation. See Vapor Technology Ass’n v. FDA, 977 F.3d 496, 497-502 (6th Cir. 2020)
`
`(summarizing history of litigation surrounding PMTA submission deadline).
`
`20.
`
`Ultimately, to comply with an order from the United States District Court for the
`
`District of Maryland,1 FDA specified that ENDS products for which a PMTA was submitted by
`
`September 9, 2020, could continue to be commercially marketed for a period of up to one year
`
`after September 9, 2020, provided that the PMTA remained pending and FDA had taken no
`
`adverse action on the application.2
`
`21.
`
`Even after September 9, 2021, however, FDA has continued to exercise
`
`enforcement discretion to allow the continued marketing of ENDS products containing tobacco-
`
`derived nicotine for which timely submitted PMTAs are still pending or, in certain cases, where
`
`FDA originally issued a marketing denial order on the PMTA, but then either administratively
`
`stayed or retracted the marketing denial order. See, e.g., Turning Point Brands, Inc. v. FDA, No.
`
`21-3855, ECF No. 19, p. 9-10 (6th Cir. Oct. 8, 2021); My Vape Order, Inc. v. FDA, No. 21-71302,
`
`ECF No. 45, p. 2 (9th Cir. Dec. 30, 2021); Juul Labs, Inc. v. FDA, No. 22-1123, Doc. # 1953737
`
`(D.C. Cir. July 6, 2022).
`
`22. With respect to ENDS products containing non-tobacco-derived nicotine, prior to
`
`July 13, 2022, FDA publicly indicated that it would utilize the same approach, with ENDS
`
`products that are the subject of pending applications “subject to enforcement at FDA’s discretion.”
`
`See Nicholas Florko, Stat News, FDA appears to hold off on crackdown on synthetic nicotine
`
`products, despite calls from Congress (July 8, 2022).
`
`
`1 See April 22, 2020 Order in American Academy of Pediatrics v. FDA, No. 8:18-cv-00883-PWG
`(D. Md.).
`2 U.S. Food & Drug Admin., Guidance for Industry, Enforcement Priorities for Electronic Nicotine
`Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket
`Authorization (Revised), at 27-28 (Apr. 2020), https://www.fda.gov/media/133880/download.
`
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`6
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`23.
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`To date, to the knowledge of Petitioners, FDA has not issued a Warning Letter to
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`any manufacturer or importer of an ENDS product regarding a product for which a timely filed
`
`PMTA remains pending.
`
`C.
`
`
`
`
`Regulations and Forms Governing FDA’s Premarket Tobacco Product Application
`Requirements
`
`24.
`
`In June 2019, FDA issued its final guidance on PMTAs for ENDS products. FDA,
`
`Guidance for Industry, Premarket Tobacco Applications for Electronic Nicotine Delivery Systems
`
`(June 2019), https://bit.ly/2XZlEah.
`
`25.
`
`In September 2019, FDA issued a proposed rule governing PMTAs. Premarket
`
`Tobacco Product Applications
`
`and Recordkeeping Requirements, Proposed Rule,
`
`https://bit.ly/2m5c2g8.
`
`26.
`
`FDA published its final PMTA Rule setting out the requirements for a PMTA and
`
`the procedures for FDA’s review of such applications in the Federal Register on October 4, 2022.
`
`Premarket Tobacco Product Applications and Recordkeeping Requirements, Final Rule, 86 Fed.
`
`Reg. 55300 (Oct. 4, 2020), https://bit.ly/3Dt3d57.
`
`27.
`
`In March 2020, FDA included in the reopening of the comment period on the
`
`proposed PMTA rule the potential for adding a new Form 4057b to the PMTA submission
`
`requirements. See 85 Fed. Reg. 13840, 13840-41 (Mar. 10, 2020).
`
`28.
`
`The purpose of the form was for submitting PMTAs that contained multiple ENDS
`
`products in a single “bundled” submission. Id. at 13841.
`
`29.
`
`The Office of Management and Budget (“OMB”) granted its approval to FDA’s
`
`inclusion of the amended Form 4057b in its PMTA forms. Office of Management and Budget,
`
`Premarket Tobacco Product Applications and Recordkeeping Requirements, ICR 202003-0910-
`
`008; https://bit.ly/3f9qcsv.
`
`
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`7
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`

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`30.
`
`On April 13, 2022, two days before the expanded definition of “tobacco products”
`
`established by the Consolidated Appropriations Act, 2022, took effect, FDA sought emergency
`
`authority from OMB to amend Form 4057b, and on April 14, 2022, OMB granted emergency
`
`authorization for FDA to use the amended Form 4057b. Office of Management and Budget,
`
`Premarket Tobacco Product Applications and Recordkeeping Requirements, ICR 202204-0910-
`
`012; https://bit.ly/3sv5YMY.
`
`31.
`
`FDA did not publish the amended Form 4057b on its website where potential
`
`applicants could access it until April 28, 2022. FDA, Premarket Tobacco Product Applications,
`
`https://bit.ly/3Dapi7h.
`
`32.
`
`FDA failed to publish notice of the amendment in the Federal Register until May
`
`16, 2022, two days after the PMTA submission deadline for the newly defined “tobacco products.”
`
`87 Fed. Reg. 29749 (May 16, 2022).
`
`33.
`
`FDA’s regulations require that applicants submit their PMTAs electronically. See
`
`21 C.F.R. § 1114.49(a). This may be done either through FDA’s Center for Tobacco Products
`
`electronic submission portal, or “CTP Portal,” or FDA’s separate agency-wide “Electronic
`
`Submissions Gateway,” although FDA’s website recommends submitting PMTAs through the
`
`CTP Portal due to better functionality.3
`
`D. Magellan’s PMTAs
`
`34.
`
`On May 12 and 13, 2022, Magellan, through its scientific advisors, timely
`
`submitted eleven separate bundled PMTAs for Juno and Hyde-branded ENDS products containing
`
`non-tobacco-derived nicotine.
`
`
`3 See https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/premarket-
`tobacco-product-applications.
`
`
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`8
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`35. Most of the bundled PMTAs were submitted on Magellan’s behalf by SKYTE
`
`Testing Services Guangdong Co., Ltd. (“SKYTE”) through its CTP Portal account.
`
`36.
`
`One of the bundled PMTAs was submitted by Magellan’s other scientific advisor,
`
`Accorto Regulatory Solutions, LLC (“Accorto”) through its Electronic Submissions Gateway
`
`account.
`
`37.
`
`For each of the submissions by SKYTE, the CTP Portal failed to generate a
`
`Submission Tracking Number (“STN”) for each submission.
`
`38.
`
`FDA never issued any correspondence or notice to Magellan providing STNs for
`
`the bundled PMTAs submitted by SKYTE through the CTP Portal.
`
`39.
`
`It was only after Magellan later received the Refuse to Accept order (discussed in
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`further detail below) on October 6, 2022, that it learned that the STN numbers assigned to the
`
`SKYTE bundled applications were PM0005370; PM0005438; PM0005442; PM0005480;
`
`PM0005508; PM0005514; PM0005521; PM0006321; and PM0006322.
`
`40.
`
`However, for
`
`the bundled PMTA Accorto submitted FDA’s Electronic
`
`Submissions Gateway, the Electronic Submissions Gateway generated an STN after the
`
`submission was uploaded, and that PMTA was assigned STN PM0005595.
`
`41.
`
`FDA’s practice and regulations governing PMTAs allow applicants to submit
`
`amendments prior to FDA issuing a refuse to accept order. See 21 C.F.R. §§ 1114.9.
`
`42.
`
`On August 18, 2022, SKYTE uploaded supplemental amendments for each of the
`
`bundled PMTAs it had originally submitted on May 12 and 13, 2022.
`
`43.
`
`Because the CTP Portal failed to generate an STN number for each of the original
`
`bundled applications, when SKYTE sought to submit amendments for the applications, it did not
`
`have an STN that it could list either in the CTP Portal or on the Form 4057a that was part of the
`
`
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`9
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`supplemental amendment to identify the original application to which the amendment was to be
`
`linked.
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`44.
`
`Despite FDA’s CTP Portal failing to provide STNs for Magellan’s PMTAs,
`
`SKYTE provided identifying information for each of the amendments so FDA could link them to
`
`the prior submissions.
`
`45.
`
`Like the initial bundled applications themselves, each supplemental amendment
`
`submitted on August 18, 2022, identified in the zipped file name itself the particular ENDS device
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`to which the amendment related.
`
`46.
`
`The amendments submitted by SKYTE on August 18, 2022, contained a completed
`
`Form 4057a, as well as a Form 4057 and a Form 4057b for each of the bundled submissions. The
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`“Submission Summary” section on page 7 of 14 of these Forms 4057a stated that the purpose of
`
`the supplemental submissions was to supply Forms 4057 and 4057b for each bundled submission.
`
`47.
`
`As part of its PMTAs, Magellan submitted a substantial number of dual language
`
`documents provided by the manufacturer of the subject ENDS products that include content in
`
`both English and Mandarin Chinese.
`
`48.
`
`These dual language documents include documents related to the manufacturer’s
`
`processes for manufacturing and maintaining quality control over the subject ENDS products,
`
`including specifications, protocols, and standard operating procedures.
`
`49.
`
`These dual language documents did not result from the translation of original
`
`Mandarin Chinese-language documents into English. Rather, they are original dual language
`
`documents that are kept and maintained in the ordinary course of business by the manufacturer as
`
`a dual language document, not as a document that is only in Mandarin Chinese.
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`10
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`50.
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`The manufacturer maintains these design and production documents in both
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`languages in the normal course of its business specifically because they are for an American
`
`customer, Magellan, and the manufacturer knows that they will be required for FDA’s review.
`
`Indeed, the manufacturer maintains many similar dual language documents for its own branded
`
`ENDS products for which it has sought premarket authorization from FDA.
`
`E.
`
`FDA’s Refuse to Accept Order
`
`51.
`
`On October 6, 2022, FDA issued a Refuse to Accept order to Magellan for its ENDS
`
`products in the bundled PMTAs assigned STNs: PM0005337; PM0005370; PM0005438;
`
`PM0005442; PM0005480; PM0005508; PM0005514; PM0005521; PM0006321; PM0006322;
`
`and PM0005595. A copy of the RTA order with confidential manufacturer information redacted
`
`is attached hereto as Exhibit A.
`
`52.
`
`The RTA order was the first notice Magellan received from FDA regarding any
`
`purported deficiency in any of its bundled PMTAs.
`
`53.
`
`For each of the PMTAs submitted by SKYTE, FDA determined that the
`
`submissions failed to include FDA Form 4057b–Premarket Tobacco Product Application Product
`
`Grouping Spreadsheet as required by 21 C.F.R. § 1105.10(a)(6) and 21 C.F.R. § 1114.7(b).
`
`54.
`
`FDA also found the SKYTE submissions deficient for failing to include a
`
`certification statement signed by an authorized representative as required by 21 C.F.R. §
`
`1114.7(a)(11) and 21 C.F.R. § 1114.7(m).
`
`55.
`
`The certification statement, however, was found in the Forms 4057 that Skyte
`
`uploaded through the CTP Portal as part of the amendments on August 18, 2022.
`
`
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`11
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`56.
`
`The RTA order noted that “although you submitted additional submissions which
`
`may have been intended to amend your applications,” the submissions “did not specify the STNs
`
`assigned to the original submission within FDA form 4057a” in violation of 21 C.F.R. § 1114.9.
`
`57.
`
`The RTA order states that “although your submission(s) may include the required
`
`content for a PMTA, they lack these necessary elements to accurately identify the purpose of the
`
`submission as well as the applications, products, and content which is being amended.”
`
`58.
`
`A review of Appendix B to the RTA order, listing amendments and additional
`
`submissions received by FDA for Magellan, suggests that FDA erroneously found nine of
`
`SKYTE’s supplemental submissions from August 18, 2022, to be lacking Form 4057a-Premarket
`
`Tobacco Product Application Amendment and General Correspondence Submission.
`
`59.
`
`The RTA order also states that the bundled PMTAs assigned STNs PM0005337
`
`and PM0005595 contained portions that were not in English and “[w]hile they contain[ed] the
`
`original language version alongside an English translation of those portions, they do not include a
`
`signed statement by an authorized representative of the manufacturer certifying that the English
`
`language translation is complete and accurate, and a brief statement of the qualifications of the
`
`person that made the translation certification statement as required by 21 C.F.R. 1114.7(b)(1).”
`
`60.
`
`The RTA order itself states in bold that Magellan “cannot introduce or deliver for
`
`introduction” any of the ENDS products subject to the RTA order “into interstate commerce in the
`
`United States” and that doing so would be a violation of the FDCA and could result in enforcement
`
`action by FDA.
`
`61.
`
`Penalties for selling unauthorized ENDS products can include both substantial civil
`
`penalties and criminal prosecution. 21 U.S.C. §§ 331, 333.
`
`
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`12
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`62.
`
`Simply resubmitting the bundled PMTAs would not provide an adequate remedy
`
`for Magellan because, to Magellan’s understanding, FDA will not consider exercising enforcement
`
`discretion as to any non-tobacco-derived nicotine ENDS products unless the corresponding
`
`PMTAs were submitted by May 14, 2022, and remain pending.
`
`F.
`
`
`
`The MDO Threatens Magellan and Vapor Train’s Businesses
`
`63.
`
`As a result of the RTA order, Vapor Train has stopped selling Magellan’s Hyde-
`
`branded ENDS products and does not plan to purchase more of the products for so long as the
`
`RTA order remains in effect.
`
`64.
`
`Vapor Train has a number of customers that regularly purchase the Hyde products
`
`subject to the RTA order from it, as well as other products, and expects that it may lose those
`
`customers’ business as a result of the RTA order.
`
`65.
`
`At the time the RTA order issued, Magellan had sold the Hyde and Juno products
`
`at issue to over 4,500 retailers nationwide.
`
`66. Magellan had already spent over $1 million on the PMTAs at the time the RTA
`
`order issued and plans to spend over $10 million on the PMTAs in total.
`
`67. Magellan’s Hyde and Juno products subject to the RTA order compete with
`
`numerous other ENDS products that either have received marketing authorization from FDA or,
`
`while they also lack marketing authorization from FDA, are not subject to FDA enforcement
`
`because the PMTAs submitted by the manufacturers of those products are still pending or, if FDA
`
`has issued a marketing denial order on the application, the agency has administratively stayed or
`
`retracted the marketing denial order and is re-reviewing the application.
`
`68.
`
`The RTA order means that Magellan thus stands to lose substantial sales to the
`
`manufacturers and distributors of these products in the highly competitive ENDS industry.
`
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`13
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`Case 6:22-cv-00429-JCB Document 1 Filed 11/03/22 Page 14 of 19 PageID #: 14
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`69.
`
`Even if the RTA order is stayed at a later date, because other ENDS manufacturers
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`and distributors have not received RTA orders or other adverse actions and FDA continues to
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`exercise enforcement discretion as to their products, Magellan will lose market share to them, as
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`well as associated customer goodwill.
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`COUNT I
`(Declaratory Judgment that Defendants Violated the Administrative Procedure Act)
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`
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`70.
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`Plaintiffs incorporate herein by reference the allegations set forth in paragraphs 1
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`through 69, above.
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`71.
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`As a federal agency, FDA is subject to the requirements of the Administrative
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`Procedure Act, including the prohibition against agency action that is “arbitrary, capricious, an
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`abuse of discretion, or otherwise not in accordance with law.” 5 U.S.C. § 706(2).
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`
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`72.
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`FDA’s RTA order is a “final agency action” for which there is no other adequate
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`remedy in a court. See 5 U.S.C. § 704. On November 1, 2022, the United States Court of Appeals
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`for the Fifth Circuit held that RTA orders are not directly reviewable by it under Section 912 of
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`the FDCA, 21 U.S.C. § 387l. See Nov. 1, 2022 Order in Boomtown Vapor, LLC v. FDA, Case No.
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`22-60467 (5th Cir. 2022).
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`
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`73.
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`FDA acted arbitrarily, capriciously, and otherwise not in accordance with law in
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`issuing the RTA order to Magellan.
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`
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`74.
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`FDA acted arbitrarily, capriciously, and otherwise not in accordance with law by
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`issuing the RTA order on the ground that Magellan’s applications assigned STNs PM0005337 and
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`PM0005595 lacked translation certification statements as required by 21 C.F.R. § 1114.7(b)(1)
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`when such translation certification statements were unnecessary because the documents at issue
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`were original dual language documents that were already in English and so were not “[d]ocuments
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`
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`14
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`

`

`Case 6:22-cv-00429-JCB Document 1 Filed 11/03/22 Page 15 of 19 PageID #: 15
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`that have been translated from another language into English” as specified in 21 C.F.R. §
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`1114.7(b)(1).
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`
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`75.
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`FDA acted arbitrarily, capriciously, and otherwise not in accordance with law by
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`issuing the RTA order on the ground that Magellan’s applications assigned STNs PM0005337;
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`PM0005370; PM0005438; PM0005442; PM0005480; PM0005508; PM0005514; PM0005521;
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`PM0006321; and PM0006322 failed to include FDA Form 4057b—Premarket Tobacco Product
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`Application Product Grouping Spreadsheet as required by 21 C.F.R. § 1105.10(a)(6) and 21 C.F.R.
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`§ 1114.7(b) because Magellan, through its scientific advisor, submitted timely amendments that
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`contained FDA Form 4057b for each such application prior to the issuance of the RTA order.
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`
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`76.
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`FDA acted arbitrarily, capriciously, and otherwise not in accordance with law by
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`issuing the RTA order on the ground that Magellan’s applications assigned STNs PM0005370;
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`PM0005438; PM0005442; PM0005480; PM0005508; PM0005514; PM0005521; PM0006321;
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`and PM0006322 failed to include a certification statement signed by an authorized representative
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`as required by 21 C.F.R. § 1114.7(a)(11) and 21 C.F.R. § 1114.7(m) because the certification
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`statements were found in the Forms 4057 that were submitted as timely amendments on August
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`18, 2022, before FDA issued the RTA order dated October 6, 2022.
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`
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`77.
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`FDA acted arbitrarily, capriciously, and otherwise not in accordance with law by
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`failing to consider Magellan’s timely amendments submitted on August 18, 2022, on the grounds
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`that the amendments did not include or reference the Submission Tracking Numbers assigned to
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`the original bundled applications to which the amendments related when FDA itself failed to assign
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`the original bundled applications corresponding Submission Tracking Numbers. FDA similarly
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`acted arbitrarily, capriciously, and otherwise not in accordance with law by issuing the RTA order
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`on the basis that Magellan’s amendments dated August 18, 2022, did not specify the STNs
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`
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`15
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`

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`Case 6:22-cv-00429-JCB Document 1 Filed 11/03/22 Page 16 of 19 PageID #: 16
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`assigned to the corresponding original submission within the Forms 4057a in violation 21 C.F.R.
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`§ 1114.9 and that the amendments “lack the necessary elements to accurately identify the purpose
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`of the submission as well as the applications, products, and contents which is being amended.”
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`
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`78.
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`An actionable controversy of a justiciable nature exists between Plaintiffs and
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`Defendants regarding whether FDA’s aforementioned conduct constitutes a violation of the
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`Administrative Procedure At.
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`
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`79.
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`As a direct and immediate result of FDA’s actions in violation of the requirements
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`of the Administrative Procedure Act, Magellan and Vapor Train are suffering ongoing and
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`irreparable harm in that the RTA order prohibits Plaintiffs from introducing or delivering
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`Magellan’s subject ENDS products into interstate commerce. If the RTA order were stayed or
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`vacated, Vapor Train and Magellan could return to the status quo ante of continuing to market the
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`ENDS products under an exercise of FDA’s enforcement discretion while the PMTAs remained
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`under FDA review. See Wages & White Lion Investments, LLC v. FDA, 16 F.4th 1130, 1143-44
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`(5th Cir. 2021).
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`
`
`WHEREFORE, Plaintiffs Magellan Technology, Inc. and Vapor Train 2 LLC request a
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`temporary, preliminary, and permanent injunction and a declaratory judgment:
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`
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`A.
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` Declaring that FDA acted arbitrarily, capriciously, and not in accordance with law
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`in issuing the RTA order to Magellan;
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`
`
`
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`B.
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`C.
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`Temporarily and preliminarily staying the RTA order for the duration of this action;
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`Setting aside FDA’s RTA order and remanding the issue back to FDA for further
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`review of Magellan’s PMTA in accordance with law;
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`
`
`D.
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`Awarding Plaintiffs’ their reasonable attorneys’ fees, costs, and expenses under 28
`
`U.S.C. § 2412 and other applicable authority; and
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`
`
`16
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`

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`Case 6:22-cv-00429-JCB Document 1 Filed 11/03/22 Page 17 of 19 PageID #: 17
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`E.
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`Granting such other and further relief as is necessary and appropriate.
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` Respectfully submitted,
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`
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`Dated: November 3, 2022
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`
`
`
`
` By: /s/ G. Blake Thompson
` G. Blake Thompson
` State Bar No. 24042033
` Blake@TheMannFirm.com
` Andy Tindel
` State Bar No. 20054500
` atindel@andytindel.com
` MANN | TINDEL | THOMPSON
`
`
`
`
`
` 112 E. Line Street, Suite 304
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`
`
`
`
` Tyler, Texas 75702
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`
`
`
`
` Tel: 903.596.0900
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`
`
`
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` Fax: 903.596.0909
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`
`
`
`
`
`
`
`
` Eric N. Heyer (pro hac vice motion to be filed)
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`
`
`
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` Joseph A. Smith (pro hac vice motion to be filed)
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`
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`
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` Krupa A. Patel (pro hac vice motion to be filed)
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`
`
`
`
` THOMPSON HINE LLP
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`
`
`
`
` 1919 M Street, NW, Suite 700
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`
`
`
`
` Washington, DC 20036
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`
`
`
`
` Phone: 202.331.8800
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`
`
`
`
` Fax: 202.331.8330
`
`
`
`
`
` eric.heyer@thompsonhine.com
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`
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`
`
` joe.smith@thompsonhine.com
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` Counsel for Plaintiffs Magellan Technology, Inc.
`and Vapor Train 2 LLC
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`17
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`

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`Case 6:22-cv-00429-JCB Document 1 Filed 11/03/22 Page 18 of 19 PageID #: 18
`Case 6:22-cv-00429-JCB Document1 Filed 11/03/22 Page 18 of 19 PagelD #: 18
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`VERIFICATION
`
`I verify under penalty of perjury that the facts set forth in the foregoing complaint, other
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`than those facts relating to Vapor Train 2 LLC, which Omar Dawud 1sseparately verifying, are
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`true and correct to the best of my information, knowledge, and belief.
`
`
`
`Chief Strategy Officer
`Magellan Technology,Inc.
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`18
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`

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`Case 6:22-cv-00429-JCB Document 1 Filed 11/03/22 Page 19 of 19 PageID #: 19
`Case 6:22-cv-00429-JCB Document1 Filed 11/03/22 Page 19 of 19 PagelD #: 19
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`VERIFICATION
`
`
`
`
`
`-mvinformation, knowledge, and belief.
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`I verify underpenalty ofperjurythat the facts set forth in the foregoing complaintrelating
`to Vapor Train 2 LLCaretrue andcorrect to the best of my information, knowledge, and be
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`
`
`Cyn ee ee
`
`
`FZ a
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`ge,
`
`Omar Dawud
`Member
`VaporTrain 2 LLC
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`