Case 3:22-cv-05789 Document 1 Filed 10/18/22 Page 1 of 8
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`UNITED STATES DISTRICT COURT
`WESTERN DISTRICT OF WASHINGTON
`AT TACOMA
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`UNITED STATES OF AMERICA,
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`Case No.: ______________
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`COMPLAINT FOR PERMANENT
`INJUNCTION
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`Plaintiff,
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`vs.
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`SUPER VAPE’Z LLC, a corporation, and
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`MARCO HOFFMAN, HEYDEE HOFFMAN,
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`and JUDITH A. CRAMER,
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`Defendants.
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`Plaintiff, the United States of America, by its undersigned counsel, and on behalf of the
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`United States Food and Drug Administration (“FDA”), respectfully represents to this Court as
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`follows:
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`1.
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`This statutory injunction proceeding is brought under the Federal Food, Drug, and
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`Cosmetic Act (the “Act”), 21 U.S.C. § 332(a), to permanently enjoin Super Vape’z, LLC,
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`(“Super Vape’z” or “the company”), a corporation, and Marco Hoffman, Heydee Hoffman, and
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`Judith A. Cramer, individuals (collectively, “Defendants”) from violating 21 U.S.C. § 331(k), by
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`causing tobacco products, within the meaning of 21 U.S.C. § 321(rr), to become adulterated and
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`misbranded while they are held for sale after shipment of one or more of their components in
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`interstate commerce.
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`Page 1
`COMPLAINT FOR INJUCTIVE RELIEF
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`CONSUMER PROTECTION BRANCH
`U.S. DEPARTMENT OF JUSTICE
`P.O. BOX 386, WASHINGTON, DC 20044
`(202) 514-3097
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`Case 3:22-cv-05789 Document 1 Filed 10/18/22 Page 2 of 8
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`2.
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`Jurisdiction and Venue
`This Court has jurisdiction over the subject matter and all parties to this action under 28
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`U.S.C. §§ 1331, 1337, and 1345, and 21 U.S.C. § 332(a), and personal jurisdiction over all
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`parties.
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`3.
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`Venue in this district is proper under 28 U.S.C. § 1391(b) and (c).
`Defendants
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`4.
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`Defendant Super Vape’z is a Washington limited liability corporation whose registered
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`agent’s address is 10518 South Tacoma Way, Ste C., Lakewood, WA 98499, within the
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`jurisdiction of this court. The company has three locations from which it conducts its tobacco
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`product operations: 17520 Meridian E., Ste D, Puyallup, WA 98375; 10518 South Tacoma Way,
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`Ste C, Lakewood, WA 98499; and 20401 Mountain Highway E., Spanaway, WA 98387.
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`5.
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`Defendant Marco Hoffman is a co-owner of Super Vape’z and the company’s registered
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`agent. Mr. Hoffman is responsible for purchasing the company’s raw ingredients and materials
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`for shipment directly to the company’s Puyallup location.
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`6.
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`Defendant Heydee Hoffman is Marco Hoffman’s wife and the other co-owner of Super
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`Vape’z. She and Mr. Hoffman are the most responsible individuals at the company.
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`7.
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`Defendant Judith A. Cramer is the General Manager of Super Vape’z. She is in charge of
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`the company’s retail operations, including managing inventory and delivering e-liquid products
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`between the company’s locations. Defendant Cramer is the most responsible individual at the
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`company when Defendant Marco Hoffman is not present.
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`8.
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`Defendants Marco Hoffman, Heydee Hoffman, and Cramer have all taken actions to
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`further the company’s operations within the jurisdiction of this Court.
`Defendants’ Operations
`Defendants manufacture, sell, and distribute finished electronic nicotine delivery system
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`9.
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`(“ENDS”) products at and from their Puyallup facility. Defendants’ manufacturing activities
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`include mixing, bottling, and labeling their ENDS products. Defendants also sell their ENDS
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`Page 2
`COMPLAINT FOR INJUCTIVE RELIEF
`Case No.
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`CONSUMER PROTECTION BRANCH
`U.S. DEPARTMENT OF JUSTICE
`P.O. BOX 386, WASHINGTON, DC 20044
`(202) 514-3097
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`Case 3:22-cv-05789 Document 1 Filed 10/18/22 Page 3 of 8
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`products at their Lakewood and Spanaway facilities. Defendants sell and distribute their ENDS
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`products to individuals for personal consumption.
`Defendants’ ENDS Products Are Adulterated and Misbranded
`Defendants violate the Act by causing tobacco products to become adulterated and
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`10.
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`misbranded while they are held for sale after shipment of one or more of their components in
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`interstate commerce. 21 U.S.C. § 331(k).
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`Defendants’ ENDS Products Are Tobacco Products.
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`11.
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`The Act defines “tobacco product” at 21 U.S.C. § 321(rr) to include “any product made
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`or derived from tobacco, or containing nicotine from any source, that is intended for human
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`consumption, including any component, part, or accessory of a tobacco product.” A “tobacco
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`product” within the meaning of 21 U.S.C. § 321(rr) is generally subject to the requirements in 21
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`U.S.C. ch. 9, subch. IX. See 21 U.S.C. § 387a(b) (providing that such subchapter shall apply to
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`“all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and to any other
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`tobacco products that [FDA] by regulation deems to be subject to this subchapter”); 81 Fed. Reg.
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`28,974, 28,975 (May 10, 2016) (deeming all products meeting the definition of “tobacco
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`product” at 21 U.S.C. § 321(rr), except accessories of such newly deemed products, to be subject
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`to such subchapter).
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`12.
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`ENDS products generally meet the definition of “tobacco product” at 21 U.S.C. § 321(rr),
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`and include: “devices, components, and/or parts that deliver aerosolized e-liquid when inhaled.”
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`FDA, Guidance for Industry: Enforcement Priorities for Electronic Nicotine Delivery Systems
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`(ENDS) and Other Deemed Products on the Market Without Premarket Authorization
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`(Revised)* (Apr. 2020), 9–10, https://go.usa.gov/xuvn5. E liquids “are a type of ENDS product
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`and generally refer to liquid nicotine and nicotine-containing e-liquids (i.e., liquid nicotine
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`combined with colorings, flavorings, and/or other ingredients).” Id.
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`Page 3
`COMPLAINT FOR INJUCTIVE RELIEF
`Case No.
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`CONSUMER PROTECTION BRANCH
`U.S. DEPARTMENT OF JUSTICE
`P.O. BOX 386, WASHINGTON, DC 20044
`(202) 514-3097
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`Case 3:22-cv-05789 Document 1 Filed 10/18/22 Page 4 of 8
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`13.
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`Defendants’ ENDS products are made or derived from tobacco, or contain nicotine from
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`any source, and are intended for human consumption, and thus are “tobacco product[s]” within
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`the meaning of 21 U.S.C. § 321(rr).
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`Defendants’ ENDS Products Are New Tobacco Products.
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`14.
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`The Act defines “new tobacco product” at 21 U.S.C. § 387j(a)(1) to include “any tobacco
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`product . . . that was not commercially marketed in the United States as of February 15, 2007.”
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`15.
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`Defendants’ ENDS products were not commercially marketed in the United States as of
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`February 15, 2007, and thus are “new tobacco product[s]” within the meaning of 21 U.S.C. §
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`387j(a)(1).
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`Pathways to Market for New Tobacco Products.
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`16.
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`A new tobacco product may receive FDA marketing authorization through any one of
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`three pathways: (1) the premarket tobacco product application (“PMTA”) pathway under 21
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`U.S.C. § 387j, through which FDA reviews a PMTA and issues an order permitting marketing of
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`the new tobacco product (“MGO”) under 21 U.S.C. § 387j(c)(1)(A)(i) upon a finding that the
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`product is appropriate for the protection of the public health; (2) the substantial equivalence
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`(“SE”) pathway under 21 U.S.C. § 387j(a)(2)(A)(i), through which FDA reviews a report
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`submitted under 21 U.S.C. § 387e(j) (“SE report”) for the product and issues an order
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`determining, among other things, that it is substantially equivalent to a tobacco product
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`commercially marketed in the United States as of February 15, 2007, or a tobacco product
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`marketed after that date, but which FDA previously determined to be substantially equivalent
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`(“SE order”); or (3) the SE exemption pathway under 21 U.S.C. § 387j(a)(2)(A)(ii), through
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`which FDA reviews an exemption request submitted under 21 C.F.R. § 1107.1 and a report
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`submitted under 21 U.S.C. § 387e(j)(1) (“abbreviated report”) for the product, and issues a
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`“found-exempt” order pursuant to 21 U.S.C. § 387e(j)(3)(A).
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`17.
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`A new tobacco product that is required by 21 U.S.C. § 387j(a) to have premarket review
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`and does not have an MGO in effect under 21 U.S.C. § 387j(c)(1)(A)(i), is adulterated under 21
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`Page 4
`COMPLAINT FOR INJUCTIVE RELIEF
`Case No.
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`CONSUMER PROTECTION BRANCH
`U.S. DEPARTMENT OF JUSTICE
`P.O. BOX 386, WASHINGTON, DC 20044
`(202) 514-3097
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`Case 3:22-cv-05789 Document 1 Filed 10/18/22 Page 5 of 8
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`U.S.C. § 387b(6)(A). A new tobacco product is required by 21 U.S.C. § 387j(a) to have
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`premarket review, unless it has an SE order or found-exempt order in effect. See 21 U.S.C. §
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`387j(a)(2)(A).
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`18.
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`A new tobacco product for which a “notice or other information respecting it was not
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`provided as required” under the SE or SE exemption pathway, including an SE report or an
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`abbreviated report, is misbranded under 21 U.S.C. § 387c(a)(6).
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`Defendants’ ENDS Products Have Not Been Authorized by FDA
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`and Are Both Adulterated and Misbranded.
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`19.
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`Defendants’ ENDS products, as “new tobacco product[s]” within the meaning of 21
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`U.S.C. § 387j(a)(1), are required by 21 U.S.C. § 387j(a) to have premarket review, as they do not
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`have an SE order or found-exempt order in effect. Defendants’ ENDS products do not have an
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`MGO in effect under 21 U.S.C. § 387j(c)(1)(A)(i). Accordingly, Defendants’ ENDS products
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`are adulterated under 21 U.S.C. § 387b(6)(A).
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`20.
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`In addition, neither an SE report nor an abbreviated report has been submitted for any of
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`Defendants’ ENDS products. Accordingly, Defendants’ ENDS products are misbranded under
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`21 U.S.C. § 387c(a)(6).
`Defendants Engage in Interstate Commerce.
`Defendants hold their ENDS products for sale after shipment of their components in
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`21.
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`interstate commerce. Specifically, the flavors that Defendants use to make their ENDS products
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`come from California and the nicotine comes from Arizona.
`Defendants’ History of Violative Conduct.
`Defendants are aware that their practices violate the Act. FDA has warned Defendants
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`22.
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`about their violative conduct and explained that continued violations could lead to enforcement
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`action, including an injunction.
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`Page 5
`COMPLAINT FOR INJUCTIVE RELIEF
`Case No.
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`CONSUMER PROTECTION BRANCH
`U.S. DEPARTMENT OF JUSTICE
`P.O. BOX 386, WASHINGTON, DC 20044
`(202) 514-3097
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`Case 3:22-cv-05789 Document 1 Filed 10/18/22 Page 6 of 8
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`23.
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`An FDA inspection conducted at Defendants’ Puyallup facility on March 21, 2021,
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`revealed that the company was manufacturing and offering for sale new tobacco products that
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`lacked the required FDA authorization.
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`24.
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`FDA sent the company and Defendant Marco Hoffman a Warning Letter on April 5,
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`2021, informing them that they manufacture and offer for sale or distribution new tobacco
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`products that lack required FDA authorization. The Warning Letter identified one of their
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`products that was sold without the required marketing authorization, SUPER VAPE’Z Premium
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`E-liquid Apple Mango, 60ml 12mg, and explained that such product is adulterated under 21
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`U.S.C. § 387b(6)(A) and misbranded under 21 U.S.C. § 387c(a)(6). The Warning Letter further
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`stated that “the violations discussed in this letter do not necessarily constitute an exhaustive list.”
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`The Warning Letter also noted that the company is registered with FDA as a tobacco products
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`manufacturer with over 700 listed products and explained that it was their responsibility to
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`ensure that their tobacco products comply with the law and failure to address their Act violations
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`could lead to enforcement action, including an injunction.
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`25.
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`On April 12, 2021, FDA received a written response from Mr. Hoffman. He stated that
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`the company had “removed and discontinued the sale of . . . Apple Mango . . . on April 5, 2021.”
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`26.
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`On May 11, 2021, FDA responded and stated that the company had not adequately
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`addressed the violation identified in the Warning Letter.
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`27.
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`FDA and Mr. Hoffman had a teleconference on May 17, 2021, during which FDA
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`explained that Super Vape’z Apple Mango was only an example of an unauthorized new tobacco
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`product and that the Warning Letter applied to all of the company’s unauthorized new tobacco
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`products.
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`28.
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`On April 4-7, 2022, FDA conducted a follow-up inspection at Defendants’ Puyallup
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`facility and found that Defendants continue to manufacture, sell, and distribute new tobacco
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`products that lack required FDA authorization, in violation of the Act.
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`Page 6
`COMPLAINT FOR INJUCTIVE RELIEF
`Case No.
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`CONSUMER PROTECTION BRANCH
`U.S. DEPARTMENT OF JUSTICE
`P.O. BOX 386, WASHINGTON, DC 20044
`(202) 514-3097
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`Case 3:22-cv-05789 Document 1 Filed 10/18/22 Page 7 of 8
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`29.
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`Request for Relief
`Despite prior notifications, Defendants remain unable or unwilling to comply with the
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`Act. Unless restrained by this Court, Defendants will continue to violate the Act in the manner
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`set forth above.
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`WHEREFORE, Plaintiff respectfully requests that the Court:
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`I.
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`Permanently restrain and enjoin, under 21 U.S.C. § 332(a), Defendants, and each and all
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`of their directors, officers, agents, representatives, employees, attorneys, successors, assigns, and
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`any and all persons in active concert or participation with any of them, from doing or causing a
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`violation of 21 U.S.C. § 331(k), by causing tobacco products to become adulterated and
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`misbranded while they are held for sale after shipment of one or more of their components in
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`interstate commerce;
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`II.
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`Order that FDA be authorized pursuant to this injunction to inspect Defendants’ places of
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`business, and all records relating to the manufacture, sale, and distribution of tobacco products,
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`to ensure continuing compliance with the terms of the injunction, with the costs of such
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`inspections to be borne by Defendants at the rates prevailing at the time the inspections are
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`accomplished; and
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`III.
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`Award Plaintiff its costs incurred in pursuing this action, including the costs of
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`investigation to date, and such other equitable relief as the Court deems just and proper.
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`BRIAN M. BOYNTON
`Principal Deputy Assistant Attorney General
`Civil Division
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`ARUN G. RAO
`Deputy Assistant Attorney General
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`GUSTAV W. EYLER
`Director
`Consumer Protection Branch
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`Page 7
`COMPLAINT FOR INJUCTIVE RELIEF
`Case No.
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`Respectfully submitted,
`NICHOLAS W. BROWN
`United States Attorney
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` s/ Ashley C. Burns__________________
`ASHLEY C. BURNS
`Assistant United States Attorney
`United States Attorney’s Office
`Western District of Washington
`700 Stewart Street
`Suite 5220
`Seattle, WA 98101
`(206) 553-2637
`Ashley.Burns@usdoj.gov
`CONSUMER PROTECTION BRANCH
`U.S. DEPARTMENT OF JUSTICE
`P.O. BOX 386, WASHINGTON, DC 20044
`(202) 514-3097
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`Case 3:22-cv-05789 Document 1 Filed 10/18/22 Page 8 of 8
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`_s/ Christina Parascandola____________
`CHRISTINA PARASCANDOLA
`Senior Litigation Counsel
`JOSHUA BROWNING
`Trial Attorney
`Consumer Protection Branch
`United States Department of Justice
`P.O. Box 386
`Washington, DC 20044
`(202) 514-3097
`christina.parascandola@usdoj.gov
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`Of counsel:
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`MARK RAZA
`Chief Counsel
`United States Food and Drug
`Administration
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`PERHAM GORJI
`Deputy Chief Counsel for Litigation
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`JONATHAN SILBERMAN
`Associate Chief Counsel for Enforcement
`United States Department of
`Health and Human Services
`Office of the General Counsel
`Food and Drug Division
`10903 New Hampshire Avenue
`Silver Spring, MD 20993-0002
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`Page 8
`COMPLAINT FOR INJUCTIVE RELIEF
`Case No.
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`CONSUMER PROTECTION BRANCH
`U.S. DEPARTMENT OF JUSTICE
`P.O. BOX 386, WASHINGTON, DC 20044
`(202) 514-3097
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