Trees Vape Supply, LLC d/b/a Tea Time E-liquid Co., DAB TB9013 (2025)

INITIAL DECISION

The Center for Tobacco Products (CTP) seeks to impose a $19,192 civil money penalty against Respondent Trees Vape Supply, LLC d/b/a Tea Time E-liquid Co. CTP alleges that Respondent introduced into interstate commerce e-liquid products that lack the premarketing authorization required under the Federal Food, Drug, and Cosmetic Act (Act) in violation of 21 U.S.C. § 331(a). Therefore, CTP seeks a $19,192 civil money penalty against Respondent. For the reasons discussed below, I find that Respondent violated the Act as alleged by CTP, and that a reduced civil money penalty of $15,192 is appropriate.

I.    Background

CTP began this matter by serving an Administrative Complaint on Respondent at 114 White Oak Avenue, Plainville, Connecticut 06062 by United Parcel Service (UPS), and by filing a copy of the Complaint with the Food and Drug Administration’s (FDA) Division of Dockets Management. Civil Remedies Division (CRD) Docket (Dkt.) Entry Nos. 1 (Complaint), 1b (UPS Tracking Proof of Service).

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On April 16, 2024, Respondent registered for the Departmental Appeals Board (DAB) E- filing system and filed a timely request for an extension of time within which to file an answer. CRD Dkt. Entry No. 3. On April 17, 2024, I issued an Order Granting Motion for Extension. CRD Dkt. Entry No. 4. On May 16, 2024, Respondent filed its timely Answer, denying all of the allegations set forth in CTP’s Complaint, asserting its defenses, and disputing the appropriateness of the civil money penalty sought by CTP stating it should not pay a civil money penalty. CRD Dkt. Entry No. 5.

On May 21, 2024, I issued an Acknowledgment and Pre-Hearing Order (APHO) acknowledging receipt of Respondent’s Answer and establishing procedural deadlines for this case. CRD Dkt. Entry No. 9 (APHO).

On June 20, 2024, Respondent prematurely filed its pre-hearing exchange consisting of the Pre-Hearing Brief of Respondent, and three exhibits. CRD Dkt. Entry Nos. 8 - 11; see CRD Dkt. Entry No. 17 at 2.

On July 20, 2024, Respondent filed three additional exhibits in response to CTP’s request to produce documents which included a letter responding to CTP’s request to produce documents, a 2024 Sales to Date file, and a 2023 1099-K tax document. Id.; CRD Dkt. Entry Nos. 12, 12a, and 12b.

On August 12, 2024, CTP timely filed its pre-hearing exchange consisting of an Informal Brief of Complainant, Complainant’s List of Proposed Witnesses and Exhibits, and eight proposed exhibits. CRD Dkt. Entry Nos. 13-13k. CTP’s exchange included the written direct testimony of three proposed witnesses: 1.) James Bowling, Deputy Division Director for the Division of Enforcement and Manufacturing in the Office of Compliance and Enforcement, CTP Exhibit (Ex.) 1, 2.) Eric Harvey, Regulatory Counsel for the Office of Compliance and Enforcement, CTP Ex. 2, and 3.) Dara D. Hackett, Regulatory Counsel for the Office of Compliance and Enforcement, CTP Ex. 3. CRD Dkt. Entry Nos. 13b-13d.

On August 19, 2024, Respondent filed a statement and a copy of its 2023 Tax Return in response to CTP’s letter stating it did not provide sufficient evidence to prove its unable to pay the civil money penalty. CRD Dkt. Entry Nos. 14, 14a.

On October 2, 2024, I conducted a telephone pre-hearing conference (PHC) with the parties. During the PHC, I explained the issues before me and the parties’ respective burdens of proof, discussed the parties’ pre-hearing exchange submissions and explained the purpose of a hearing. CRD Dkt. Entry No. 17. There being no objections to either parties’ documentary evidence, I admitted CTP Exs. 1-8 and Respondents Exs. 1-8 into the record and both parties waived their rights to a hearing. CRD Dkt. Entry No. 17 at 2. Accordingly, having found a hearing to be unecessary, I explained to the parties that I will decide this case based on the written administrative record. Id.; 21 C.F.R. § 17.45(a).

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My October 7, 2024, Summary Order of PHC and Order Establishing Deadlines for Final Briefs, provided a November 4, 2024, deadline for the parties to file simultaneous final briefs. CRD Dkt. Entry No. 17 at 3. Respondent did not file a final brief, as permitted. On October 31, 2024, CTP filed its Notice of Waiver of Final Brief. CRD Dkt. Entry No. 18.

The administrative record is now complete and closed, and this matter is ready for a decision. I will consider the full administrative record in deciding this case. 21 C.F.R. §§ 17.41(b), 45(a). I will now decide this case based on the evidence in the administrative record.

II.    Issues

1. Whether Respondent introduced in interstate commerce e-liquid products that lack the premarketing authorization required under the Act, specifically Tea Time E- liquid Co. Peach Mango Tea and Tea Time E-liquid Co. Raspberry Limeaid Tea e- liquid products on November 29, 2023, in violation of 21 U.S.C. § 331(a);
2. Whether any affirmative defenses are meritorious; and
3. If Respondent is liable for penalties or assessments, whether the $19,192 civil money penalty is appropriate, considering any mitigating or aggravating factors that I find in this case. 21 C.F.R. § 17.45.

III.   Applicable Law

In 2009, Congress enacted the Family Smoking Prevention and Tobacco Control Act (TCA) to regulate tobacco products. 21 U.S.C. §§ 387 et seq. The Act prohibits the introduction or delivery for introduction into interstate commerce or cause the introduction or delivery for introduction into interstate commerce, any tobacco product that is adulterated or misbranded. 21 U.S.C. § 331(a); see also 21 U.S.C. § 321(b). Premarket authorization from the FDA is required for all “new tobacco products.” 21 U.S.C. § 387j(a)(2)(A).

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 required to have premarket review with a Marketing Granted Order (MGO) unless it has a substantial equivalence or substantial equivalence exemption order (found-exempt order) in effect for such product. 21 U.S.C. §§ 387j(a)(2)(A), 387e(j)(3)(A). A new tobacco product is adulterated if it has not obtained the required premarket authorization. 21 U.S.C. § 387b(6)(A). A new tobacco product for which a “notice or other information

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respecting it was not provided as required” under the substantial equivalence or substantial equivalence pathway is misbranded. 21 U.S.C. §§ 387c(a)(6).

Under the Act, a tobacco product is adulterated if it has not obtained the required premarket authorization. 21 U.S.C. § 387b(6)(A). Thus, when a manufacturer does not submit a PMTA for its ENDS products, or when a manufacturer submits a PMTA for its ENDS products and receives a denial order, the products are being adulterated. 21 U.S.C. § 387b(6)(A). The adulterated and misbranded ENDS products in turn violate the Act. The Act prohibits the receipt in interstate commerce of any tobacco product that is adulterated or misbranded and the delivery or proffered delivery thereof for pay or otherwise. 21 U.S.C. § 331(c). The FDA may seek a civil money penalty from “any person who violates a requirement of this chapter which relates to tobacco products.” 21 U.S.C. § 333(f)(9)(A) (2012). Penalties are set by 21 U.S.C. § 333 note and 21 C.F.R.
§ 17.2.

IV.    Findings of Fact and Conclusions of Law

1. CTP has demonstrated by a preponderance of the evidence that Respondent introduced adulterated and misbranded e-liquid products in interstate commerce on November 29, 2023, in violation of the Act.

To prevail, CTP has the burden of proving the Respondent’s liability and the appropriateness of any civil money penalty, whereas the Respondent has the burden of proving any affirmative defenses and mitigating factors. 21 C.F.R. § 17.33 (b)-(c). As the presiding officer, I do not have the authority to find Federal Statues or regulations invalid. 21 C.F.R § 17.19(c). CTP seeks to impose a civil money penalty against Respondent pursuant to the authority conferred by the Act and implementing regulations at Part 21 of the Code of Federal Regulations. CTP has the burden to prove the Respondent’s liability and the appropriateness of the penalty by a preponderance of the evidence. 21 C.F.R. § 17.33(b).

In its case against Respondent, CTP relies on the written direct testimony of James Bowling, Deputy Division Director for the Division of Enforcement and Manufacturing, in CTP’s Office of Compliance and Enforcement; Eric Harvey and Dara D. Hackett, Regulatory Counsels for the Division of Promotion, Advertising and Labeling in CTP’s Office of Compliance and Enforcement. CTP Exs. 1-3.

Eric Harvey testified that on November 29, 2023, at approximately 10:48 AM, during the controlled online purchase inspection of Tea Time E-Liquid Co., at the URL: www.teatimeliquid.com, under Controlled Purchase Assignment Number 10, he observed, supervised, and collected evidence that Undercover Purchaser A was able to purchase the Tea Time E-liquid Co. Peach Mango Tea and Tea Time E-liquid Co. Raspberry Limeaid Tea e-liquid products available for sale at Respondent’s online

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establishment. CTP Ex. at 2, ¶¶ 5, 7; see also CTP Exs. 4, 5 (Inspector Harvey’s declaration, screenshot online purchase confirmation, and November 2023 narrative report).

Dara D. Hackett testified that on December 6, 2023, she processed evidence “from a controlled online purchase” during the November 29, 2023, investigation of Respondent’s online establishment. CTP Ex. 3 at 3, ¶6 (Dara D. Hackett’s declaration). Specifically, she testified that on December 6, 2023, she collected the Tea Time E-liquid Co. Peach Mango Tea and Tea Time E-liquid Co. Raspberry Limeaid Tea e-liquid products that Respondent sold at its online establishment on November 29, 2023, to Undercover Purchaser A and processed the evidence at an FDA office in Silver Spring, Maryland. Id. ¶¶ 5, 7. See also CTP Ex. 6 (Photographs of products during the evidence collection process for Controlled Purchase Assignment Number 10).

Deputy Director Bowling testified that the Tea Time E-liquid Co. Peach Mango Tea and Tea Time E-liquid Co. Raspberry Limeaid Tea e-liquid products observed and sold during the November 29, 2023, online inspection were manufactured in California, and neither the manufacturer nor Respondent have any registered tobacco production facilities in the state of Maryland. CTP Ex. 1, ¶¶ 7-8. Deputy Director Bowling further testified that he:

. . . can confirm that Tea Time E-liquid Co. Peach Mango Tea and Tea Time E-liquid Co. Raspberry Limeaid Tea e-liquid products were not commercially marketed in the United States as of February 15, 2007 . . . . that on November 29, 2023, the day on which FDA observed Tea Time E- liquid Co. Peach Mango Tea and Tea Time E-liquid Co. Raspberry Limeaid Tea e-liquid products being offered for sale at Tea Time E-liquid Co., at the URL: www.teatimeliquid.com, there was no record of these products having an FDA marketing granted order in effect under 21 U.S.C. § 387j(c)(1)(A)(i)          there was no record of these products having a substantial equivalence order in effect under 21 U.S.C. § 387j(a)(2)(A)(i), … and the manufacturer of the Tea Time E-liquid Co. Peach Mango Tea and Tea Time E-liquid Co. Raspberry Limeaid Tea e-liquid products had not submitted a report requesting a substantial equivalence order under 21 U.S.C. § 387e(j).   the Tea Time E-liquid Co. Peach Mango Tea and Tea Time E-liquid Co. Raspberry Limeaid Tea e-liquid products did not have a found-exempt order in effect under 21 U.S.C. § 387e(j)(3)(A) (SE pathway under 21 U.S.C. § 387j(a)(2)(A)(ii)), and that the manufacturer of the Tea Time E-liquid Co. Peach Mango Tea and Tea Time E-liquid Co. Raspberry Limeaid Tea e-liquid products had not submitted an abbreviated report requesting a found-exempt order for such products under 21 U.S.C. § 387e(j)(1).

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CTP Ex. 1, ¶¶ 3-5.

In its Answer, Respondent denied the allegations set forth in the Complaint, and thus opposed the factual allegations raised therein, and rejected owning any penalty amount. CRD Dkt. Entry No. 5. In its Pre-Hearing Brief of Respondent, Respondent denied selling tobacco products but stated that it sells e-liquid products that contain synthetic nicotine, thus all its products are exempt from the premarket authorization requirement. CRD Dkt. Entry No. 8. Further, at the PHC, Respondent stated that it made changes to its website and product offerings in anticipation of pursuing a settlement. See CRD Dkt. Entry No. 17 at 2.

Respondent did not dispute any of the statements made in the written direct testimony of CTP’s three witnesses. Instead, Respondent argues that the FDA inspector, from a May 2021 inspection visit allegedly stated that since Respondent’s products contained synthetic nicotine, “they are not classified as tobacco products and currently do not fall under any FDA regulation.” Id. at 3-6. However, Respondent countered its own argument in its response to CTP’s September 2022 Warning Letter, when Respondent stated, “I understand that back in May 2022 the FDA was granted regulation over synthetic nicotine products. I was told a few weeks after this announcement that any companies that use synthetic nicotine in their products must submit a PMTA.” CRD Dkt. Entry No. 13k at 1. Respondent has demonstrated by its own admission, that it was aware since 2022, that its e-liquid products were under FDA’s regulation and required premarket authorization. Moreover, in the Warning Letter, CTP frequently stated that e- liquid products are tobacco products. CTP Ex. 7 at 1. Also, in the Warning Letter, CTP stated:

To the extent that your products are made with non-tobacco nicotine, please be aware that, on March 15, 2022, the President signed legislation to amend the FD&C Act to extend FDA’s jurisdiction to products “containing nicotine from any source,” not just nicotine derived from tobacco. See Consolidated Appropriations Act, 2022, Public Law 117-103, Division P, Title I, Subtitle B. Specifically, this legislation expanded the definition of “tobacco product” under section 201(rr) of the FD&C Act (21 U.S.C. § 321(rr)) to include products containing nicotine from any source. Tobacco products, including e‑liquid products containing nicotine from any source, must be in compliance with the FD&C Act and its implementing regulations. For more information, please see https://www.fda.gov/tobacco- products/ctp-newsroom/requirements-products-made-non- tobacco-nicotine-take-effect-april-14

CTP Ex. 7 at 1.

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As stated above, Respondent does not dispute any of the statements made by Deputy Director Bowling, Eric Harvey, or Dara D. Hackett. Specifically, Respondent does not deny that the Tea Time E-liquid Co. Peach Mango Tea and Tea Time E-liquid Co. Raspberry Limeaid Tea e-liquid products observed by Dara D. Hackett was held for sale on its online establishment and introduced into interstate commerce after Respondent mailed the products in question from Connecticut to Maryland. Thus, Respondent’s arguments are unpersuasive in its attempt to deny any liability.

Tobacco products are highly dangerous and addictive products and, as such, are heavily regulated. 21 U.S.C. § 387 note. Retailers that choose to distribute tobacco products have the burden to assure they sell such products in compliance with the law. Based on the uncontested testimony of James Bowling, Eric Harvey, and Dara D. Hackett as well as the supporting evidence submitted by CTP, I find that the Tea Time E-liquid Co. Peach Mango Tea and Tea Time E-liquid Co. Raspberry Limeaid Tea e-liquid products sold during the controlled online purchase investigation of Respondent at the URL: www.teatimeliquid.com, on November 29, 2023, traveled in interstate commerce when shipped by Respondent from California to an FDA office in Silver Spring, Maryland. See 21 U.S.C. § 331(c); see also United States v. Sullivan, 332 U.S. 689, 696 (1948), 92 L. Ed. 297, 303 (holding that the Act applies “to articles from the moment of their introduction into interstate commerce all the way to the moment of their delivery to the ultimate consumer”). I also find that the Tea Time E-liquid Co. Peach Mango Tea and Tea Time E-liquid Co. Raspberry Limeaid Tea e-liquid products were adulterated because these products lacked the required FDA marketing authorization and were not exempt from this requirement. 21 U.S.C. §§ 387j(a)(2)(A), 387e(j)(3)(A). Finally, under 21 U.S.C. § 387c(a)(6), the Tea Time E-liquid Co. Peach Mango Tea and Tea Time E-liquid Co. Raspberry Limeaid Tea e-liquid products were misbranded because there was no substantially equivalent determination as required by 21 U.S.C. § 387e(j).
Therefore, Respondent’s actions constitute violations of law that merit a civil money penalty.

2. Respondent has demonstrated by a preponderance of the evidence mitigating circumstances to support a reduced civil money penalty.

I have determined that Respondent violated the prohibition against introducing into interstate commerce tobacco products that were adulterated and misbranded. 21 U.S.C. § 331(a). Pursuant to 21 U.S.C. § 333(f)(9), Respondent Tea Time E-liquid Co. is liable for a civil money penalty not to exceed the amounts listed in the FDA’s civil money penalty regulations at 21 C.F.R. § 17.2; see also 45 C.F.R. § 102.3.

When determining the appropriate amount of a civil money, I am required to consider any “circumstances that mitigate or aggravate the violation” and “the factors identified in the statute under which the penalty is assessed . . . .” 21 C.F.R. §§ 17.34(a); 17.34(b).

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Specifically, I must consider “the nature, circumstances, extent and gravity of the violations and, with respect to the violator, ability to pay, effect on ability to continue to 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).

CTP seeks to impose a civil money amount of $19,192 against Respondent. CRD Dkt. Entry No. 1, ¶ 1. In Respondent’s Answer, Pre-Hearing Brief, and responses to CTP, Respondent maintained that the civil money sought by CTP should be cleared. CRD Dkt. Entry Nos. 5, 8, 12, and 14. Respondent specifically states: that it cannot afford to pay the civil money penalty and doing so would bankrupt it; the co-packing facility used complies with FDA regulations; it cannot afford legal assistance to handle this matter; it does not market to children; once notified of the unauthorized tobacco products, it immediately reached out to FDA, CTP; and that it was told that it could continue to sell its e-liquid products by an FDA investigator, Devon Jenkins, in May 2021 because its products were made with synthetic nicotine and did not require PMTA, and Respondent had no other complaints and was in full compliance with FDA for years. Id.

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

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) was enacted for the purpose of authorizing regulation of tobacco products for the “protection of the public health.” 21 U.S.C. § 387f(d). CTP contends that Respondent’s violations are serious in nature as they contravene the FDA’s efforts to protect the public health from the multitude of adverse health effects associated with tobacco use. CRD Dkt. Entry No. 13 at 10 (Informal Brief of Complainant). CTP specifically refers to the September 9, 2022, Warning Letter it issued to Respondent, citing Respondent for manufacturing, and offering for sale or distributing new tobacco products, specifically Peach Mango Tea, Raspberry Limeaid Tea, and Mixed Berry Tea that lacked the required marketing authorization. Id.; CTP Ex. 7 at 1-2. CTP states that the Warning Letter notified Respondent that future violations may lead to enforcement action, including, but not limited to, civil money penalties, seizure, and/or injunction by FDA and advised Respondent that “[t]he violations discussed in this letter do not necessarily constitute an exhaustive list.” CTP Ex. 7 at 2; CRD Dkt. Entry No. 13 at 9. Finally, CTP states the Warning Letter referred the Respondent to an FDA website, which included information to help tobacco retailers understand and comply with FDA tobacco laws and regulations. Id. at 10-11; Id. at 1-2.

In its Pre-Hearing Brief, Respondent asserts that it does not sell tobacco products because its products contain synthetic nicotine.” CRD Dkt. Entry No. 8 at 3. Further, in an exhibit submitted along with its Pre-Hearing Brief, Respondent admits to receiving the September 2022, Warning Letter but states it believed it was sent by mistake since it never heard back from FDA, CTP after reaching out in October 2022. R. Ex. 3.

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However, on September 30, 2022, Respondent sent a response to the September 9, 2022, Warning Letter stating that it provides “hundreds of customers” with its e-liquid products and that it was aware, shortly after the regulation change was made, that companies selling products containing synthetic nicotine are required to submit a PMTA. CRD Dkt. Entry No. 13k. Respondent alluded to helping its customers by continuing to offer and sell e-liquid products because if not “more than 90% of [its] customers would go back to smoking cigarettes. Id. at 2. In support of Respondent’s claim, Respondent cited a statement Dr. Brian King, Director of CTP, made in an American Press interview, “I'm fully aware of the misperceptions that are out there and aren't consistent with the known science. We do know that e-cigarettes, as a general class, have markedly less risk than a combustible cigarette product.” See CRD Dkt. Entry No. 13k at 2 quoting Matthew Perrone, Insider Q&A: FDA official on vaping’s “promise or peril” AP News (2022), https://apnews.com/article/science-health-public-tobacco-industry-regulation- 6af0d635d7859bab914cc249ef43b6e2 (last visited Nov 14, 2024).

Respondent’s familiarity with topics concerning tobacco products and its acknowledgment that it received e-liquid products, informs me that Respondent is aware of the seriousness concerning tobacco regulations. If Respondent accessed the materials provided by CTP, it would have known that e-liquid products are treated like tobacco products for regulation purposes. Therefore, Respondent’s claims regarding its uncertainty with the law, misunderstanding of the Warning Letter, and waiting for FDA, CTP to contact it, are not valid affirmative defenses that can relieve Respondent of its liability. It is Respondent’s obligation to understand the laws that impact the products it sells and distributes.

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

In its Answer, Respondent argues that it does not “owe” the civil money penalty sought by CTP because it does not believe it is “responsible for this action taken by the FDA[],” and that Respondent “is not in any position financially to pay a $20,000 fine. We have not even reached $20,000 in sales this year.” CRD Dkt. Entry No. 5. In its Pre-Hearing Brief, Respondent claims that “the civil money penalty is not appropriate. . . it would bankrupt [Respondent’s] company,” and that Respondent “ha[d] no previous violations and ha[d] fully cooperated with the FDA throughout the years.” CRD Dkt. Entry No. 8 at 6. In Mr. Bowers’ affidavit, Mr. Bowers states that the civil money penalty sought by CTP “would hurt [his] business.” R. Ex. 1 at 3. Respondent also submitted, as supplemental documents, a copy of its Year-to-Date Sales (YTD sales) for January 1, 2024, to June 20, 2024, a copy of its 2023 1099-K, and a copy of its 2023 Tax Return. See CRD Dkt. Entry Nos. 12a, 12b, and 14a. According to Respondent’s Year to Date Sales (YTD sales), as of June 20, 2024, Respondent’s store revenue was $20,195.51. CRD Dkt. Entry No. 12a. In Respondent’s letter, filed on July 20, 2024, responding to CTP’s request for production of documents, Respondent states, “I only sell my e-liquids on my website.” CRD Dkt. Entry No. 12 at 1.

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CTP argues that these documents are insufficient alone to establish Respondent’s ability to pay the $19,192 penalty. See CRD Dkt. Entry No. 13 at 11-12 (citing Joy and Evergreen Petro, Inc. d/b/a Sunoco, DAB No. CR4698, at 2 (Sept. 6, 2016). CTP further argues that in order to establish inability to pay the penalty, Respondent should have provided additional evidence as to its business assets, such as, “proof as to its cash reserves, its credit worthiness, or other potential sources of capital, all of which are highly relevant to the issue of ability to pay a penalty.” Id. CTP also maintains, “Respondent may continue to sell authorized tobacco products and other products at the establishment.” CRD Dkt. Entry No. 13 at 12.

Based on my review of the evidence, the civil money penalty that CTP seeks can affect Respondent’s ability to pay the civil money penalty. Mr. Bowers’ statement regarding the harm that the full $19,192 civil money penalty will cause his business is supported by Respondent’s statements that its inventory consisting of only e-liquid products. CRD Dkt. Entry No. 12 at 1. I find that a $19,192 deduction from Respondent’s stated business income is significant even as an online retailer with limited overhead. I consider as a mitigating factor that the penalty CTP is seeking represents close to 100% of Respondent’s 2024 revenue for the first half of half of the calendar year from e-liquid products sales. Also, CTP did not provide any evidence regarding Respondent’s current financial position, Respondent’s ability to pay the penalty, or Respondent’s ability to continue to do business which could weigh in favor of imposing the maximum $19,192 civil money penalty. However, Respondent’s exhibits and financial statements demonstrate that a $19,192 civil money penalty would result in a significantly negative effect on Respondent’s ability to do business and is, therefore constitutes a mitigating factor.

3. History of Prior Violations

There is no indication in the record of any prior violations of section 331(a) of the Act resulting in a civil money penalty. CTP notes, however, that Respondent previously received a Warning Letter notifying it that it violated the law. CTP further notes that notwithstanding this warning, Respondent continued to introduce into interstate commerce e-liquid products that lacked the required premarket authorization, which shows an unwillingness or inability to comply with the law. CRD Dkt. Entry No. 13 at 10-12. CTP, therefore, proffers Respondent’s repeated violations support a penalty of $19,192. Id. at 12.

I agree with CTP that the Warning Letter demonstrates an alleged prior violation and that Respondent was warned against providing e-liquid products on its website without a pre- marketing authorization order. CTP Ex. 7 at 2. Specifically, Respondent was warned about it offering for sale its Peach Mango Tea, Raspberry Limeaid Tea, and Mixed Berry Tea products. CTP Ex. 7 at 2. Yet, over a year after receiving the Warning Letter, Respondent continued to provide the same Peach Mango Tea and Raspberry Limeaid Tea

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e-liquid products on its online establishment and continued introducing these products into interstate commerce. CRD Dkt. Entry No. 1 at 4.

5. Degree of Culpability

Based on my finding that Respondent committed the violation alleged in the Complaint, I hold Respondent fully culpable for introducing into interstate commerce e-liquid products that were adulterated and misbranded, in violation of the Act. The Act places a heavy burden on retailers who choose to sell e-liquid products because of their highly dangerous and addictive nature. See 21 U.S.C. § 387 note (Findings and Purpose). Respondent argues that e-liquid products are not as dangerous and addictive as cigarettes; however, this does not negate the inherent dangerous e-liquid products still present. Although I find Respondent’s account of events to be understandable, its explanations for why it did not comply do not absolve Respondent of its responsibility as a retailer of e-liquid products. Further, Respondent’s claim that an FDA employee informed it in 2021 that it was allowed to sell e-liquid products is refuted by Respondent’s own admission that “back in March of 2022, the FDA was granted regulation over synthetic nicotine products. I was told a few weeks after this announcement that any companies that use synthetic nicotine in their products must submit a PMTA.” CRD Dkt. Entry No. 13k at 1. Respondent’s admission shows that Respondent was aware that the products it was introducing into interstate commerce required approval, but between March 2022 to November 29, 2023, Respondent did not take any active steps to prevent future violations. Respondent repeatedly states that it called, emailed, and mailed letters to FDA, CTP but does not state that it filed or attempted to file an application, visited the websites provided in the Warning Letter, or took any other meaningful steps to show that it was actively trying to comply with the new regulations. Based on the record, Respondent did not remove any of the products from its online establishment nor forgo introducing the e-liquid products into interstate commerce.

6. Other Matters as Justice May Require

The Act gives me discretion to consider any other evidence or arguments to mitigate the amount of the civil money penalty. 21 U.S.C. § 333(f)(5)(B). Based on the evidence in the record, I find the proposed penalty amount of $19,192 will place a significant financial strain on Respondent. However, having found Respondent violated the law, to ensure that justice is served, the civil money penalty should ensure future compliance with the Act and tobacco regulations.

For these reasons, after considering the evidence in the record, applicable law, and aggravating and mitigating circumstances in this case, I find that a penalty amount of $15,192 is appropriate under 21 U.S.C. §§ 333(f)(5)(B), (f)(5)(C), and (f)(9).

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V.    Conclusion

I impose a reduced civil money penalty against Respondent Trees Vape Supply, LLC d/b/a Tea Time E-Liquid Co., in the amount of $15,192 for introducing into interstate commerce e-liquid products that lack the premarketing authorization required under the Act. Pursuant to 21 C.F.R. §§ 17.11(b), 17.45(d), this decision becomes final and binding upon both parties after 30 days of the date of its issuance.