Drive Thru Vapors, LLC, DAB TB8280 (2024)

INITIAL DECISION

The Center for Tobacco Products (“CTP”), of the United States Food and Drug Administration (FDA), seeks a civil money penalty against Respondent, Drive Thru Vapors, LLC,¹ for failure to obtain the required premarket authorization for Respondent’s new tobacco products, in violation of 21 U.S.C. § 331(k) of the Federal Food, Drug, and Cosmetic Act (Act). Therefore, CTP seeks a $19,192 civil money penalty against Respondent.

For the reasons discussed below, I find that Respondent violated 21 U.S.C. § 331(k) of the Act, as alleged in the Complaint, and I conclude that a $19,192 civil money penalty against Respondent is appropriate.

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Background and Procedural History

CTP began this matter by serving an Administrative Complaint (Complaint) on Respondent at 6204 Denton Highway, Watauga, Texas 76148 by United Parcel Service (UPS), and by filing a copy of the Complaint with the FDA’s Division of Dockets Management. CRD Dkt. Entry Nos. 1, 1b.

On June 30, 2023, attorney Eric P. Gotting filed a Notice of Appearance on behalf of Respondent in this case. CRD Dkt. Entry No. 3. On July 5, 2023, Mr. Gotting filed a timely Request for Extension. CRD Dkt. Entry No. 4. On that same date, I issued an Order granting Respondent’s Request for Extension. CRD Dkt. Entry No. 5. On August 2, 2023, Mr. Gotting filed a Notice of Withdrawal as Counsel. CRD Dkt. Entry No. 7.

On August 4, 2024, attorney Jerad Wayne Najvar filed a Notice of Appearance on behalf of Respondent in this case. CRD Dkt. Entry No. 8. On August 9, 2023, Respondent, through counsel, filed its timely Answer. CRD Dkt. Entry No. 9 (Answer). In its Answer, Respondent asserts, as defenses, that CTP lacks the statutory authority necessary to seek a civil money penalty against Respondent in this case, and that CTP’s Complaint against Respondent is invalid because it was not signed by the required agent. Id. at 1-4. In its Answer, Respondent also objects to the amount of the civil money penalty sought by CTP. Id. at 4.

On August 14, 2023, I issued an Acknowledgment and Pre-Hearing Order (APHO) acknowledging receipt of Respondent’s Answer and establishing procedural deadlines in this case. CRD Dkt. Entry No. 10.

On September 15, 2023, CTP filed a Joint Status Report indicating that the parties had been unable to reach a settlement in this case. CRD Dkt. Entry No. 11.

On October 18, 2024, attorney Kyrsten L. Melander filed a Notice of Appearance on behalf of CTP and a Motion to Compel Discovery, asserting that Respondent had not responded to CTP’s discovery request. CRD Dkt. Entry Nos. 13, 13a, 13b, 15. On that same date, CTP also requested an extension of the pre-hearing exchange deadlines. CRD Dkt. Entry No. 14. On October 20, 2023, I issued an Order, which advised Respondent that it had until November 8, 2023, to file a response to CTP’s Motion to Compel Discovery. CRD Dkt. Entry No. 16 at 1-2.My Order also granted CTP’s Motion to Extend Deadlines. Id. at 2.

On November 8, 2023, Respondent filed its Response to CTP’s Motion to Compel Discovery (Response to MTC). CRD Dkt. Entry Nos. 17-18. In its Response to MTC, Respondent stated that:  

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Respondent was not ignoring the requests for production; there was a miscommunication about the response deadline. Respondent served written responses to CTP’s Requests for Production on November 8, 2023, and is affirmatively reaching out to counsel for CTP to discuss potential resolution of any disputes about the document requests and the case as a whole.

CRD Dkt. Entry No. 18 at 2.

On November 9, 2024, I issued an Order extending the parties’ pre-hearing exchange deadlines for an additional 30 days, in order to allow the parties time to determine whether Respondent’s responses were sufficient to satisfy CTP’s Request for Production of Documents. CRD Dkt. Entry No. 19.

On January 5, 2024, CTP timely filed its pre-hearing exchange, consisting of a Pre-hearing Brief (CTP Br.), a List of Proposed Witnesses and Exhibits, and 13 proposed exhibits (CTP Exhibits (Exs.) 1-13). CTP’s pre-hearing exchange included the written direct testimony of two proposed witnesses, CTP’s Senior Regulatory Counsel Loretta Chi (CTP Ex. 1), and Inspector Garrett Carter (CTP Ex. 2). CRD Dkt. Entry Nos. 20, 20a-20n.

On January 26, 2024, Respondent timely filed its pre-hearing exchange, consisting of a Pre-hearing Brief (R. Br.), including Respondent’s Addendum to Pre-Trial Brief of Respondent Drive Thru Vapors LLC (Addendum), and Respondent’s Witness List. CRD Dkt. Entry Nos. 21, 21a. In Respondent’s Witness List, Respondent indicates that its Pre‑hearing Brief contains the testimony of proposed witness Mr. Steve Green, the owner of Respondent’s establishment. See CRD Dkt. Entry No. 21a. In Respondent’s Pre‑hearing Brief, Respondent also moved for summary decision on the grounds stated in its Answer, and reproduced in its Addendum (Respondent’s Motion for Summary Decision). CRD Dkt. Entry 21 at 5, 9-13.

On February 9, 2024, CTP filed its Response to Respondent’s Motion for Summary Decision, arguing that Respondent’s Motion should be denied because material facts regarding the appropriateness of the proposed civil money penalty remain in dispute. CRD Dkt. Entry No. 25.

On March 20, 2024, I held a video prehearing conference call (PHC) in this case, and addressed a number of issues. See CRD Dkt. Entry No. 30 (Order Following Pre-Hearing Conference).

During the PHC, the parties agreed to amend the issues, as set forth in paragraph 5, subsection 1 of the APHO, in this case. See CRD Dkt. Entry No. 10 ¶ 5. Accordingly, the issues to be addressed in this proceeding were amended to:  1) whether Respondent violated 21 U.S.C. § 331(k) of the Act, as alleged in the

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Complaint; and, if so, 2) whether the civil money penalty sought by CTP is appropriate, considering any aggravating and mitigating factors. CRD Dkt. Entry No. 30 at 1-2. During the PHC, I explained that the purpose of a formal hearing is to allow for the cross-examination of any witnesses who have provided sworn testimony in their exchanges, and we also discussed the parties’ exchanges and proposed witnesses. Id. at 2. Respondent’s counsel advised that he did not intend to cross-exam CTP’s witnesses, Loretta Chi and Inspector Carter. However, Respondent’s counsel indicated that he would promptly give notice if, upon further review of the direct testimony of CTP’s proposed witness Loretta Chi, counsel then decided that he wanted to cross-examine Ms. Chi. Id.

During the PHC, I explained that, since Mr. Green’s written direct testimony was not included as a proposed exhibit as part of Respondent’s pre-hearing exchange, Respondent would need to demonstrate that exceptional circumstances justified its failure to timely exchange a complete witness list and that the addition would not substantially prejudice the opposing party, as set forth in paragraph 9 of the APHO and 21 C.F.R. §§ 17.25(a) and 17.37(b). Id. Further, I explained that, in the absence of such compliance, Mr. Green’s proposed testimony would not be admitted. Id. However, I did grant Respondent’s counsel leave to file a motion to admit the untimely filed written direct testimony of Mr. Green. Id. Additionally, in the event that any written direct testimony of Mr. Green was admitted, CTP’s counsel reserved the right to conduct cross-examination of Respondent’s Mr. Green. Id.

During the PHC, Respondent did not object to the admission of the direct testimony of CTP’s proposed witnesses, nor did Respondent object to the admission of CTP’s proposed exbibits. Id. Therefore, I admitted CTP Exhibits (Exs.) 1-13 into the administrative record. Id.

During the PHC, CTP’s pending Motion to Compel was discussed and, since Respondent had submitted responses to CTP’s Request for Production of Documents, I denied CTP’s Motion to Compel Discovery as moot. Id at 3.

Lastly, given that there are genuine issues as to material facts with regard to whether the civil money penalty amount sought by CTP in the Complaint is appropriate, I also denied Respondent’s Motion for Summary Decision during the PHC. Id.

In my March 22, 2024 Order Following Pre-Hearing Conference, the parties were instructed to notify me of their intent to cross-examine the opposing party’s witness(es) by April 16, 2024. Id. Also, if Respondent intended to file a motion for the admission of the untimely submitted written direct testimony of Mr. Green, Respondent was instructed do so by April 1, 2024, and if Respondent filed its

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motion, pursuant to 21 C.F.R. § 17.32(c), CTP’s response was due by April 16, 2024. Id. at 4.

On April 19, 2024, I issued an Order providing that, in the absence of a motion to supplement Respondent’s pre-hearing exchange with the untimely proposed written direct testimony of Mr. Steve Green, any direct testimony of Mr. Green shall remain excluded. CRD Dkt. No. 31 at 1. In addition, given that the Respondent has not indicated that it intends to cross-examine CTP’s witnesses, there is no reason to conduct a hearing in this matter. See CRD Dkt. Entry No. 10 ¶ 18.a. Thus, in an April 22, 2024 Order, I established a May 24, 2024 deadline for the parties to submit simultaneous final briefs in this case. CRD Dkt. Entry No. 33. at 2.

On May 24, 2024, CTP filed its timely final brief in this case. CRD Dkt. Entry No. 34. To date, Respondent has not filed a final brief. Accordingly, the record is now closed, and I am issuing a decision on the record in this case.

Issues

• Whether Respondent violated 21 U.S.C. § 331(k) of the Act, as alleged in the Complaint; and
• If so, whether the $19,192 civil money penalty sought by CTP is appropriate, considering any aggravating and mitigating factors.

Analysis, Findings of Facts and Conclusions of Law

In order to prevail, CTP must prove Respondent’s liability by a preponderance of the evidence. The U.S. Supreme Court has described the preponderance of the evidence standard as requiring that the trier-of-fact believe that the existence of a fact is more probable than not before finding in favor of the party that had the burden to persuade the judge of the fact’s existence. In re Winship, 397 U.S. 358, 371-72 (1970); Concrete Pipe and Prods. of Cal., Inc. v. Constr. Laborers, 508 U.S. 602, 622 (1993).

CTP has the burden to prove Respondent’s liability and appropriateness of the penalty by a preponderance of the evidence. 21 C.F.R. § 17.33(b). Respondent has the burden to prove any affirmative defenses and any mitigating factors likewise by a preponderance of the evidence. 21 C.F.R. § 17.33(c).

The Act prohibits adulterating or misbranding a regulated tobacco product. 21 U.S.C. § 331(k). Specifically, Title 21, United States Code, Section 331 reads:  

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The following acts and the causing thereof are prohibited:  (k) The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any act with respect to, a . . . tobacco product. . . if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded.

21 U.S.C. § 331(k).

A “new tobacco product” is defined as any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modification of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007. 21 U.S.C. § 387j(a)(1). A “new tobacco product” is exempt from this premarket authorization requirement only if the Secretary has issued a substantial equivalence report or a found exempt order for such product. 21 U.S.C. §§ 387j(a)(2)(A), 387e(j)(3)(A). The Secretary issued the regulations at 21 C.F.R. Parts 1140 under section 906(d) of the Act. 21 U.S.C. § 387a-1; see also; 81 Fed. Reg. 28,974 (May 10, 2016).

The FDA has the authority to seek civil money penalties from any person who violates any Act requirement that relates to tobacco products. 21 U.S.C. § 333(f)(9)(A). The term “person” is defined to include individuals, partnerships, corporations, and associations. 21 U.S.C. § 321(e). Manufacturers who violate a requirement of the Act that relates to tobacco products may incur a civil money penalty up to the maximum amounts provided for by law, currently $19,192 for each such violation, not to exceed $1,279,448 for all violations adjudicated in a single proceeding. 21 U.S.C. § 333(f)(9)(A); 21 C.F.R. § 17.2; 45 C.F.R. § 102.3.

I.     Violation of 21 U.S.C. § 331(k) of the Act

A. Respondent’s E-Liquid Tobacco Products

In its Complaint, CTP alleges that Respondent does business under the name of Drive Thru Vapors, LLC, located at 6204 Denton Highway, Watauga, Texas 76148. CRD Dkt. Entry No. 1 ¶ 14; see also CRD Dkt. Entry No. 20 at 3. In its Answer, Respondent did not specifically deny this allegation, therefore it is deemed admitted. See CRD Dkt. Entry No. 9; 21 C.F.R. § 17.9(b)(1). In its Complaint, CTP alleges that on March 18, 2023, Inspector Garrett Carter conducted an inspection at Respondent’s establishment located at 6204 Denton Highway, Watauga, Texas 76148. CRD Dkt. Entry No. 1 ¶ 17; see also CRD Dkt. Entry No. 20 at 2, CTP Ex. 2 ¶ 5. Respondent does not dispute that Inspector Carter conducted an inspection of Respondent’s establishment on March 18, 2023. See CRD Dkt. Entry Nos. 9, 21.

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CTP alleges that, after at least one component part was shipped in interstate commerce, Respondent manufactured tobacco products that did not possess the required premarket authorization under the law, causing them to become adulterated and misbranded tobacco products, while those products were held for sale in violation of 21 U.S.C. § 331(k). See CRD Dkt. Entry No. 1 at 5-6 ¶¶ 21‑23; CRD Dkt. Entry No. 20 at 2.

In its Pre-hearing Brief, Respondent admits that it offered new tobacco products for sale on March 18, 2023, that its new tobacco products were not commercially marketed in the United States as of February 15, 2007, and that there is no FDA marketing granting order (MGO) authorizing Respondent’s new tobacco products, nor have the products been found to be either substantially equivalent (SE) or otherwise exempt from the premarket authorization requirement. See CRD Dkt. Entry No. 21 at 2-5; see also Declaration (Decl.) of Loretta Chi, CTP Ex. 1 at 4-5 ¶¶ 11-13. In addition, during the March 18, 2023 inspection, Inspector Carter observed that Respondent’s establishment had e-liquid product[s] available for sale and observed an employee of the establishment manufacture an e-liquid product for a customer. See Decl. of Inspector Garrett Carter, CTP Ex. 2 at 2 ¶¶ 7‑8; March 2023 VIA Inspection Results Report, CTP Ex. 3 at 3 ¶¶ 23; March 2023 Photographs of E-Liquid Manufacturing Components, CTP Ex. 4; March 2023 Photographs of Strawberry Banana E-Liquid Manufacturing, CTP Ex. 6; March 2023 Photographs of E-Liquid Flavors Menu, CTP Ex. 7.

In its Pre-hearing Brief, Respondent argues that:  

the “new tobacco product” lacking an MGO to which CTP’s allegations pertain are Respondent’s finished e-liquids. Those e-liquids do not exist as “new tobacco products” until they are manufactured. They are not “held for sale” until they are manufactured. And once manufactured and “held for sale,” CTP alleges no obliteration or moderation of the labels nor that any other predicate “act” is performed upon them.

Respondent’s Pre-hearing Brief, CRD Dkt. Entry No. 21 at 10.

In essence, Respondent’s position is that there is no allegation that the finished e‑liquid products it manufactured are sold outside of Texas and the provisions of Section 331(k) do not apply to the component parts of the e-liquid products, even though they traveled in interstate commerce, because they are not “held for sale”. I would agree that there is no evidence to establish that Respondent’s e-liquid finished products traveled in interstate commerce. The issue for resolution then is whether the component parts (which, by definition, “includ[e] any component, part, or accessory of a tobacco product,” 31 U.S.C § 321 (rr)), after shipment in interstate commerce, are “held for sale.”

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The record is clear that the component parts observed and photographed during the inspection on March 18, 2023 traveled in interstate commerce. Respondent’s establishment is located in the State of Texas, and CTP has established that the components used to manufacture Respondent’s e-liquid tobacco products traveled in interstate commerce, stating that:  

Components of the e-liquid product[s] observed during the March 18, 2023 inspection were manufactured in California, Arizona, and Florida, which are outside of the state in which Respondent operates. See Chi Declaration, CTP Ex. 1 at 3, ¶¶ 7-9; March 2023 Photographs of E-Liquid Manufacturing Components, CTP Ex. 4. Thus, at least one component of Respondent’s e-liquid product[s] products traveled in interstate commerce prior to being held for sale by Respondent. The interstate commerce element in 21 U.S.C. § 331(k) is satisfied when a component of an FDA‑regulated product that is held for sale is shipped in interstate commerce. Baker v. United States, 932 F.2d 813, 816 (9th Cir. 1991) (holding that “wholly intrastate manufactures and sales of [products] are covered by 21 U.S.C. § 331(k) as long as an ingredient used in the final product travelled in interstate commerce”); see also United States v. Regenerative Scis., LLC, 741 F.3d 1314, 1320-21 (D.C. Cir. 2014) (citing Baker, 932 F.2d at 816, with approval).

CTP’s Pre-hearing Brief, CRD Dkt. Entry No. 20 at 5.

Thus, the question then becomes whether the components, such as the liquid nicotine, vegetable glycerin, and propylene glycol pictured in CTP Ex. 4 (“such article”) are “held for sale.” I conclude that they are. There is no reason to believe that Respondent purchased those items for any reason other than to sell smaller portions of those components in a finished product. All of the components pictured in CTP. Ex. 4 are being held for the purpose of selling a customized new tobacco product ordered by a customer. Further, Inspector Carter observed a customer of Respondent being sold “21mg nicotine 80/20 mix PG/VG 30,” which I am assuming is the propylene glycol and vegetable glycerin, with a dash of Strawberry Banana flavoring, apparently. See Decl. of Inspector Garrett Carter, CTP Ex. 2 at 2-3 ¶ 8. The product “for sale,” in essence, was merely smaller amounts of the components poured from the larger bottles seen in CTP Ex. 4 at 2, 4, 6. Therefore, it is difficult to view the larger components, that traveled in interstate commerce, as not being “held for sale” in this case.

Moreover, the Family Smoking Prevention and Tobacco Control Act states that, “[i]t is in the public interest for Congress to enact legislation that provides the Food and Drug Administration with the authority to regulate tobacco products.” The Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111‑31,

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§ 2(12), 123 Stat. 1776 (2009). The Act further states that, “[i]t is also essential that manufacturers, prior to marketing such products, be required to demonstrate that such products will meet a series of rigorous criteria, and will benefit the health of the population as a whole . . . .” Id. § 2(36), 123 Stat. 1776 (2009). Respondent’s interpretation of Section 331(k) of the Act is that it could market a new tobacco product without the “rigorous criteria” required by Congress, by narrowly defining “held for sale” to apply only to a finished product, which would appear to be inconsistent with the legislative purpose of this Act.

The Supreme Court has stated that:  

[t]he words of paragraph (k)[²] ‘while such article is held for sale after shipment in interstate commerce’ apparently were designed to fill this gap and to extend the Act’s coverage to every article that had gone through interstate commerce until it finally reached the ultimate consumer. Doubtless it was this purpose to insure federal protection until the very moment the articles passed into the hands of the consumer by way of an intrastate transaction that moved the House Committee on Interstate and Foreign Commerce to report on this section of the Act as follows: ‘In order to extend the protection of consumers contemplated by the law to the full extent constitutionally possible, paragraph (k) has been inserted prohibiting the changing of labels so as to misbrand articles held for sale after interstate shipment.’

United States v. Sullivan, 332 U.S. 689, 696-697 (1948).

It is not credible that Congress intended to allow an entity whose application to market a new tobacco product was not approved to then market that product anyway by purchasing the components necessary to create the finished product through interstate commerce and selling the finished product intrastate to the public. Such an interpretation is not consistent with the legislative purpose of the Act, nor judicial interpretation of those provisions, as noted above. As a result, I find that Respondent has violated the provisions of Section 331(k).

B. Misbranding and Adulteration

In its Pre-hearing Brief, Respondent argues that since it applied for an MGO through the premarket tobacco product application (PMTA) pathway, rather than applying for authorization through the SE pathway or the SE exemption pathway, its products would be “adulterated,” but not “misbranded.” See Respondent’s

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Pre‑hearing Brief, CRD Dkt. Entry No. 21 at 5, 10-11. However, as correctly stated in CTP’s final brief:  

the ALJ only needs to find that Respondent’s act resulted in the new tobacco products becoming either adulterated or misbranded in order to find Respondent liable for a civil money penalty.3 See 21 U.S.C. § 331(k) (“. . . if such act is done while such article is held for sale . . . and results in such article being adulterated or misbranded”) (emphasis added); cf. United States v. UCO Oil Co., 546 F. 2d 833, 838 (9th Cir. 1976) (“Once it is determined that the statute defines but a single offense, it becomes proper to charge the different means, denounced disjunctively in the statute, conjunctively in each count of the indictment. Proof of any one of the allegations will sustain a conviction”) (omitting internal citations).

CTP’s Final Brief, CRD Dkt. Entry No. 34 at 8.

As discussed above, I find that Respondent’s failure to obtain the required premarket authorization for its new tobacco products caused such new tobacco products to become adulterated and misbranded while they are held for sale after shipment of one or more of their components in interstate commerce, in violation of 21 U.S.C. § 331(k).

C. Signature of an Office of the Chief Counsel Attorney

In its Pre-hearing Brief, Respondent also argues that the Complaint is not valid because Respondent believes that the Complaint was not signed by an attorney within FDA’s Office of the Chief Counsel. See Respondent’s Pre-hearing Brief, CRD Dkt. Entry No. 21 at 11. However, I find Respondent’s argument to be entirely unsuccessful. CTP’s Complaint in this case was signed by Seth Heller, an attorney within FDA’s Office of the Chief Counsel. See Complaint, CRD Dkt. Entry 1, at 7. Therefore, CTP complied with 21 C.F.R. § 17.5(a).

I.     Civil Money Penalty

I have found that Respondent violated Section 331(k) of the Act. The FDA, and CTP, may seek civil money penalties from any person who violates the Act’s requirements as they relate to the sale of regulated tobacco products. 21 U.S.C. § 333(f)(9). In its Complaint, CTP sought to impose the maximum penalty amount of $19,192 against Respondent. See Complaint, CRD Dkt. Entry No 1 ¶¶ 1, 26. When determining the appropriate amount of a CMP, I must consider any aggravating or mitigating circumstance and the factors listed in the Act. 21 C.F.R. § 17.34(a)-(b). Specifically, I am required to take into account “the nature, circumstances, extent and gravity of the violations and, with respect to the violator, ability to pay, effect on ability to continue to

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do business, any history of prior such violations, the degree of culpability, and such other matters as justice may require.” 21 U.S.C. § 333(f)(5)(B); 21 C.F.R. § 17.45(b)(1)-(3) .Respondent must prove any mitigating factors by a preponderance of the evidence. 21 C.F.R. § 17.33(c).

A. Nature, Circumstances, Extent and Gravity of the Violations

As noted above, The Family Smoking Prevention and Tobacco Control Act was enacted for the purpose of authorizing regulation of tobacco products for the “protection of the public health.” 21 USC 387f(d). Respondent was in the business of manufacturing and selling this highly regulated and dangerous product. It received a written warning on July 7, 2022, that the “FDA has determined that you manufacture, sell, and/or distribute to customers in the United States Drive Thru Vapors, LLC Strawberry Yogurt e-liquid product without a marketing authorization order,” which was a prohibited act under 21 USC 331(k). CTP Ex. 8 at 2. Yet, after it received this warning that it was in violation of federal law, it continued to manufacture and sell this and other “new tobacco products.” The inability of Respondent to comply with federal tobacco law is serious in nature and demands a proportional CMP amount.

B. Respondent’s Ability to Pay and Effect on Ability to Do Business

In evaluating this factor, I have considered Respondent’s arguments that it expended 
“substantial expense” to submit a PMTA which was denied on a technical basis,³ the proposed CMP is excessive in light of Respondent’s status as a very small business with slim profits overall, and the e-liquids were only a very small percentage of Respondent’s overall business, estimated at 10%. See Respondent’s Pre-hearing Brief at 12-13. However, Respondent has not provided any evidence documenting the specifics of these arguments. As a result, I have no documentary evidence that supports Respondent’s allegations. Accordingly, I cannot find that Respondent has established an inability to pay.

In considering the effects of the CMP on Respondent’s ability to continue to do business, Respondent itself has indicated that the e-liquid products are a very small percentage of its business. See id. at 13. Therefore, there is no apparent reason why Respondent could not continue to do business with the remaining 90% of its products.

C. History of Prior Violations

There is no indication in the record of any prior violations of Section 331(k) resulting in a CMP. However, Respondent did receive a warning letter dated July 7, 2022, advising that it was in violation of federal law for manufacturing and selling a new tobacco product without marketing authorization. CTP Ex. 8. Thus, Respondent was on notice that it was in violation of section 331(k) but continued to manufacture and market its new tobacco products after this warning.

D. Degree of Culpability

As noted above, Respondent received written notice that it was in violation of federal law by manufacturing and selling “new tobacco products” without obtaining a marketing authorization order. See id. This notice was contained in the warning letter dated July 7, 2022, which contained the directive to “take prompt action to address any violations that are referenced above, as well as violations that are the same as or similar to the ones stated above and take any necessary actions to bring your tobacco products into compliance with the FD&C Act.” Id. at 2. Yet, Respondent continued to manufacture and sell these same products, without any apparent modification to its business practices or attempts to contact the FDA for information or assistance, until at least the time of the inspection on March 18, 2023. Thus, I must find that this degree of culpability does not merit a reduction in the CMP.

E. Additional Mitigating Factors

I find that the administrative record does not reflect any additional mitigating factors in this case.

F. Penalty

Based on the foregoing, I find that the $19,192 civil money penalty sought by CTP against Respondent is appropriate under 21 U.S.C. §§ 333(f)(5)(B) and 333(f)(9).

Conclusion

Pursuant to 21 C.F.R. § 17.45, I impose a civil money penalty of $19,192 against Respondent, Drive Thru Vapors, LLC, for failure to obtain the required premarket authorization for Respondent’s new tobacco products, in violation of 21 U.S.C. § 331(k) of the Act. Pursuant to 21 C.F.R. § 17.45(d), this decision becomes final and binding upon both parties after 30 days of the date of its issuance.

Endnotes

¹  I note that in the caption of all of the pleadings submitted by the parties, Respondent is referred to as “Drive Thru Vapors, LLC.” However, paragraph one of the Complaint refers to Respondent as “Drive Thru Vapors, LLC, d/b/a Drive Thru Vapors.” See Complaint, Civil Remedies Division (CRD) Docket (Dkt.) Entry No. 1¶ 1.

²  21 U.S.C. § 331(k).

³  Although not identified as such, I have considered this as an argument by Respondent that its attempt to obtain an MGO should be considered a mitigating factor. However, the fact that it continued to manufacture and market its products knowing it did not have authorization to do so does not mitigate the seriousness of the violation.