TVC Management Corp d/b/a The Vapor Chef, DAB TB8780 (2024)

INITIAL DECISION

The Center for Tobacco Products (CTP) seeks to impose a $19,192 civil money penalty (CMP) against TVC Management Corp d/b/a The Vapor Chef (Respondent) for impermissibly manufacturing, selling, and/or distributing new tobacco products that lacked the required premarketing authorization, thereby violating the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. §§ 301 et seq.

For the reasons discussed below, I find Respondent violated the Act as alleged by CTP and that a reduced CMP in the amount $11,515 is appropriate. 

I. Background and Procedural History

CTP began this matter by serving an Administrative Complaint (Complaint) on Respondent at 2014 Ford Road, Suite C, Bristol, Pennsylvania 19007 by United States Postal Service (USPS), and by filing a copy of the Complaint with the FDA’s Division of

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Dockets Management.  Civil Remedies Division (CRD) Docket (Dkt.) Entry Nos. 1 (Complaint), 1b (Delivery Notification).

On February 26, 2024, Respondent timely filed an Answer.  CRD Dkt. Entry No. 5 (Answer).  In its Answer, Respondent admits all of the allegations of liability made in CTP’s Complaint and states, as a defense, that it, “ceased manufacturing and all sales of products not compliant with the PMTA process.”  Answer at 2.  Respondent further states, “all members of the staff that made the poor decisions to sell nicotine salts have been terminated.  My staff was under the impression that nicotine salts did not fall under the control of the tobacco act.  I was in medical recovery at the time and was unaware of this decision.  Their ignorance may just close my door and take my only source of income . . . I personally apologize and can assure you that there will be no more infractions of the deeming regulations.”  Id.  In its Answer, Respondent also stated that the CMP sought by CTP was too high.  Id.

On February 27, 2024, I issued an Acknowledgment and Pre-Hearing Order (APHO) establishing procedural deadlines for this case.  CRD Dkt. Entry No. 6 (APHO).  On March 25, 2024, Respondent filed copies of invoices for tobacco products.  CRD Dkt. Entry Nos. 7-9.  On March 26, 2024, Respondent filed copies of its bank statements.  CRD Dkt. Entry Nos. 10-10b.  Respondent also filed a letter explaining the establishment’s financial hardships, and claiming Respondent’s owner did not personally receive CTP’s warning letter and believed that the products it was selling to be appropriate under the premarket tobacco applications (PMTAs) it applied for in the past.  CRD Dkt. Entry No. 11 (Respondent’s Letter #1).  Respondent filed a timely pre-hearing brief which included the letter.  CRD Dkt. Entry No. 12 (Informal Brief of Respondent).

On April 30, 2024, Respondent filed an additional letter explaining that its business will shut down after October 2024 and it has no way of paying the penalty CTP seeks to impose.  CRD Dkt. Entry No. 14 (Respondent’s Letter #2).  On the same date, Respondent also filed an excel spreadsheet which purports to show a list of Respondent’s employees.  CRD Dkt. Entry No. 15 (Employee List).  

On May 20, 2024, CTP timely submitted its pre-hearing exchange, consisting of its informal brief, list of proposed witnesses, and seven proposed exhibits.  See CRD Dkt. Entry Nos. 16-16h.  CTP’s exchange included the written testimony of three witnesses: 1) James Bowling, Deputy Division Director, Office of Compliance and Enforcement, FDA, CTP (CTP Ex. 1); 2) Elise Booth, Consumer Safety Officer, Office of Compliance and Enforcement, FDA, CTP (CTP Ex. 2); and 3) Dara D. Hackett, Regulatory Counsel, Office of Compliance and Enforcement, FDA, CTP (CTP Ex. 3).

On July 17, 2024, I conducted a pre-hearing conference (PHC).  During the PHC, we discussed the allegations in CTP’s Complaint, the issues to be decided, procedural history, proposed exhibits and witnesses, and the purpose of conducting a hearing in this

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case.  CRD Dkt. Entry No. 22 at 1 (Order Following PHC).  Respondent admitted liability for the allegations in CTP’s Complaint, did not object to CTP’s seven proposed exhibits and three proposed witnesses, and declined to cross examine any of CTP’s witnesses.  Id.  CTP raised issues with certain documents Respondent submitted.  Specifically, CTP argued that Respondent’s filings (CRD Dkt. Entry Nos. 11 and 14) contained witness statements that did not comply with the instructions listed in the APHO and the regulatory procedures outlined in 21 C.F.R. § 17.37.  Id. at 2.  CTP also objected to the manner in which Respondent presented its exhibits, arguing the exhibits did not comply with APHO and regulatory procedures.  Id.  I instructed CTP to file written objections to Respondent’s submissions.  Id.

During the PHC, the parties agreed that a hearing was not necessary and that I could decide this case on the written record.  Id.  Therefore, I established a final briefing schedule.  Id.

On August 5, 2024, CTP timely filed Complainant’s Objections to Respondent’s Exhibits and Motion to Exclude.  CRD Dkt. Entry No. 23 (Motion to Exclude).  Subsequently, on August 20, 2024, CTP submitted a notice indicating its waiver of a final brief.  CRD Dkt. Entry No. 24 (CTP Waiver of Final Brief).

On September 11, 2024, Respondent filed another letter further explaining its financial hardships and generally repeating contentions from its earlier letters.  CRD Dkt. Entry No. 26 (Respondent’s Letter #3).  On September 12, 2024, CTP filed Complainant’s Objections to Respondent’s Docket Entry 26 and Motion to Exclude.  CRD Dkt. Entry No. 27 (Motion to Exclude #2).

I will consider the full administrative record in deciding this case.  The administrative record contains the exhibits and other evidence admitted as well as all documents and requests filed in this proceeding.  21 C.F.R. § 17.41(b).

II. CTP’s Motions to Exclude Evidence are Denied

1. August 5, 2024 Motion to Exclude

On August 5, 2024, CTP filed Complainant’s Objections to Respondent’s Exhibits and Motion to Exclude.  CRD Dkt. Entry No. 23 (Motion to Exclude).  In its Motion, CTP moved to exclude Respondent’s exhibits because they were not properly submitted in accordance with applicable regulations or the APHO issued in this case.  Id.  CTP also moved to exclude Respondent’s exhibits because they are not relevant or material to the issues presented in this case.  Id.

According to the regulations, “At least 30 days before the hearing, or by such other time as is specified by the presiding officer, the parties shall exchange witness lists, copies of

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prior written statements of proposed witnesses, and copies of proposed hearing exhibits, including written testimony.”  21 C.F.R. § 17.25(a).  The regulations further state that, “Direct testimony shall be admitted in the form of a written declaration submitted under penalty of perjury.  Any such written declaration must be provided to all other parties along with the last known address of the witness.  Any prior written statements of witnesses proposed to testify at the hearing shall be exchanged as provided in § 17.25(a).”  21 C.F.R. § 17.37(b).  Also, “If a party objects to the proposed admission of evidence not exchanged in accordance with paragraph (a) of this section, the presiding officer will exclude such evidence if he or she determines that the failure to comply with paragraph (a) of this section should result in its exclusion.”  21 C.F.R. § 17.25(b)(1).  Further, the presiding officer shall determine the admissibility of evidence and shall exclude evidence that is not relevant or material.  21 C.F.R. § 17.39(a), (c).

Here, CTP argues that CRD Dkt. Entry Nos. 11 and 14 should be excluded because they are letters from Aras Azoulas, who was not identified by Respondent as a potential witness in the pre-hearing exchange materials, and neither letter was submitted in the form of a written declaration or signed by the witness under penalty of perjury.  Motion to Exclude at 3.  CTP also argues that the letters at Docket Entries 11 and 14 are not relevant or material to the issues presented in this case, specifically as to whether Respondent offered for sale on its website an ENDS product that lacked premarket authorization and then distributed such product through interstate commerce in violation of 21 U.S.C. §331(a), because Respondent has already admitted liability for this charge.  Id.  

However, while these documents are of minimal probative value with regard to Respondent’s liability, they are relevant and material for the purpose of presenting Respondent’s arguments for mitigation of the CMP proposed by CTP.  CTP will not be prejudiced by these submissions as it had ample time to review these documents prior to briefing and formulate CTP’s arguments in response to the statements Respondent makes in these submissions.  Moreover, as Respondent is appearing pro se, and is not familiar with applicable regulations including the requirements for written declarations, I find the ends of justice will be served if Respondent is given a fair opportunity to defend itself against CTP’s allegations.  21 C.F.R 17.19(b)(17).  Therefore, these documents are admitted to the record.

2. September 12, 2024 Motion to Exclude

On September 12, 2024, CTP filed Complainant’s Objections to Respondent’s Docket Entry 26 and Motion to Exclude.  CRD Dkt. Entry No. 27 (Motion to Exclude #2).  In its Motion, CTP moved to exclude Respondent’s submission (CRD Dkt. Entry No. 26) because the deadline to file final briefs was August 20, 2024, and Respondent submitted this filing on September 11, 2024.  Id. at 1.  As this filing is also a written statement from Aras Azoulas, CTP moves to exclude on grounds similar to its first Motion to Exclude,

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filed on August 5, 2024.  Id.  Specifically, CTP moves to exclude CRD Dkt. Entry No. 26 because it was not submitted in accordance with the regulations governing witness testimony, and because it is not relevant or material to the issues presented in this case, given that Respondent has already admitted liability.  Id. at 1-2.

As previously discussed, these documents are relevant and material for the purpose of Respondent presenting Respondent’s arguments for mitigation of the CMP sought by CTP.  I will note that CRD Dkt. Entry No. 26 repeats statements and arguments that were made in previous filings.  Thus, while this document has limited probative value, it is admitted to the record for the reasons discussed above. 

III. Issues

1. Whether Respondent introduced or delivered for introduction into interstate commerce an adulterated and misbranded tobacco product; specifically, a Pop-Nic Salt 30ml 3mg product, in violation of 21 U.S.C. § 331(a) on March 13, 2023; and, if so,
2. Whether the $19,192 civil money penalty is appropriate, considering any mitigating or aggravating factors that I find in this case.

IV. Findings of Fact and Conclusions of Law

CTP seeks to impose a CMP 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).

1. CTP has demonstrated by a preponderance of the evidence that Respondent introduced or delivered for introduction into interstate commerce an adulterated and misbranded tobacco product on March 13, 2023, in violation of the Act.

The Act prohibits the introduction or delivery for introduction into interstate commerce of 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 order or substantial

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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 that is required to have premarket review and does not have an MGO in effect under 21 U.S.C. § 387j(c)(1)(A)(i), is adulterated.  21 U.S.C. § 387b(6)(A).  A new tobacco product for which a “notice or other information respecting it was not provided as required” under the substantial equivalence or substantial equivalence exemption pathway is misbranded.  21 U.S.C. § 387c(a)(6).

CTP’s case against Respondent 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; Elise Booth, Consumer Safety Officer in the Division of Promotion, Advertising and Labeling in CTP’s Office of Compliance and Enforcement; and Dara D. Hackett, Regulatory Counsel in the Division of Promotion, Advertising and Labeling in CTP’s Office of Compliance and Enforcement.  CTP Exs. 1, 2 and 3.  Elise Booth testified that she conducted a controlled online purchase investigation of Respondent’s online establishment at the URL: https://thevaporchef.com, on March 13, 2023.  CTP. Ex. 2 at 2, ¶¶ 5-7.  See also CTP Exs. 4-5 (Elise Booth’s narrative report and an email order confirmation dated March 13, 2023).  Dara D. Hackett collected the evidence purchased during the investigation of Respondent’s online establishment and testified that on March 22, 2023, she collected the Pop-Nic Salt 30ml 3mg product that Respondent sold through its online establishment and processed the evidence at an FDA office in Silver Spring, Maryland.  CTP. Ex. 3 at 2, ¶¶ 6-8.  See also CTP Ex. 6 (photographs of the mailing package and the product).  James Bowling testified that the Pop-Nic Salt 30ml 3mg tobacco product observed and being offered for sale during the March 13, 2023, online inspection is manufactured by Respondent in Pennsylvania and Respondent does not 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 the Pop-Nic Salt 30ml 3mg product was not commercially marketed in the United States as of February 15, 2007 . . . that on March 13, 2023, the day on which FDA observed the Pop-Nic Salt 30ml 3mg product being offered for sale at The Vapor Chef, at URL: https://thevaporchef.com, there was no record of this product having an authorized FDA marketing granted order in effect under 21 U.S.C. § 387j(c)(1)(A)(i) . . . there was no record of this product having a substantial equivalence order in effect under 21 U.S.C. § 387j(a)(2)(A)(i), and the manufacturer of the Pop-Nic Salt 30ml 3mg product had not submitted a report requesting a substantial equivalence order under 21 U.S.C. §387e(j) . . . the Pop‑Nic Salt 30ml 3mg product 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 Pop-Nic Salt 30ml 3mg product had not submitted an abbreviated report requesting a found-exempt order for such product under 21 U.S.C. § 387e(j)(1).

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CTP Ex. 1, ¶¶ 10-12.

Respondent conceded the factual allegations in the Complaint during the PHC.  CRD Dkt. Entry No. 22 (Order Following PHC) at 1.  Moreover, Respondent has not disputed any of the statements made in the written direct testimony of CTP’s three witnesses.  Based on the uncontested testimony of James Bowling, Elise Booth, and Dara D. Hackett as well as the supporting evidence submitted by CTP, I find that the Pop-Nic Salt 30ml 3mg product sold during the controlled online purchase investigation of Respondent at the URL: https://thevaporchef.com, on March 13, 2023, traveled in interstate commerce when shipped by Respondent from Pennsylvania 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 Pop-Nic Salt 30ml 3mg product was adulterated because it lacked the required FDA marketing authorization and was 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 Pop-Nic Salt 30ml 3mg product was misbranded because there was no substantially equivalent determination as required by 21 U.S.C. § 387e(j).

2. Respondent has demonstrated, by a preponderance of the evidence, the existence of mitigating circumstances to support a reduced CMP.

I determined that Respondent violated the prohibition against introducing or delivering for introduction into interstate commerce an adulterated and misbranded tobacco product.  21 U.S.C. § 331(a).  Pursuant to 21 U.S.C. § 333(f)(9), Respondent is liable for a civil money penalty not to exceed the amounts listed in FDA’s CMP regulations at 21 C.F.R. § 17.2.  See also 45 C.F.R. § 102.3.

In its Complaint, CTP seeks to impose a CMP amount of $19,192 against Respondent.  CRD Dkt. Entry No. 1, ¶ 1 (Complaint).  In its Answer, Respondent contends that the CMP sought by CTP is too high because the fine will shut its company down.  Answer at 2.  Respondent also contends that the people who made the decision to sell nicotine salts were terminated.  Id.  Respondent explains that after Respondent’s owner fell ill, he needed to step away from the company and took years to recover.  Id.  Also, Respondent claims almost all employees were laid off because the establishment almost did not make payroll.  Id.  Respondent also asserts that no future incidents will occur now that the owner is out of the hospital, but it cannot afford to pay the fine.  Id.  Over the course of this proceeding, Respondent submitted several other statements and documents which argue that Respondent is unable to pay the fine CTP seeks, and a CMP of $19,192 will affect Respondent’s ability to continue to operate its business.  See CRD Dkt. Entry Nos. 10-12, 14-15, 26.  Respondent stated that “we will be shutting down completely as all our current products are not approved by the FDA” and “the fine should be dropped

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completely as I will have no way to pay if and there is almost no substantial saleable equipment or stock on shutdown of the company.”  CRD Dkt. Entry No. 14.  Most recently, on September 26, 2024, Respondent filed a statement indicating “[w]e have ceased any and all business since September 6th 2024.”  CRD Dkt. Entry No. 28.

When determining the appropriate amount of a CMP, I must consider any aggravating or mitigating circumstances 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 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).

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).  Respondent was in the business of manufacturing and selling highly regulated and dangerous products.  Respondent received a written warning dated August 26, 2022, that stated, “you manufacture and offer for sale or distribution to customers in the United States e-liquid products without a marketing authorization order, including: Miley Pearus, ROYGBIV Gum, and Unicorn Poop,” which was a prohibited act under 21 U.S.C. § 331(k).  CTP Ex. 7 at 2.  Yet, after receiving this warning that Respondent was in violation of federal law, Respondent continued to manufacture and sell tobacco products without a marketing authorization order, such as the Pop-Nic Salt 30ml 3mg product purchased at Respondent’s online establishment.  The inability of Respondent to comply with federal tobacco law is serious in nature and demands a proportional CMP amount.

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

In its pre-hearing brief, Respondent explains that it does not believe the penalty amount is fair and it will cause its company to shut down.  Informal Brief of Respondent at 7.  Respondent states it included three months of banks statements to show that “the business is running on fumes as it is.”  Id.  Respondent further explains that it laid off the entire staff except one employee when Respondent’s owner fell ill which left the one employee to handle the business.  Id.  Respondent also explains that its bank accounts were closed unexpectedly and it is missing money from switching banks.  Id.  Respondent explains that it lost money because it had to dispose of all the supplies and included invoices showing those losses.  Id. at 8.  Lastly, Respondent explains that it lost customers to other vendors who still sell salt nicotine and it is responsible for health insurance payments for its employees.  Id.  The bank account statements Respondent submitted are from January 2023, June 2023, and December 2023.  CRD Dkt. Entry Nos. 10, 10a, 10b.  The January

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2023 bank account statement shows a balance of $14,715.52.  CRD Dkt. Entry No. 10 at 1.  The June 2023 bank account statement shows a balance of $10,372.52.  CRD Dkt. Entry No. 10a at 1.  The December 2023 bank account statement shows a balance of $27,147.83.  CRD Dkt. Entry No. 10b.

CTP argues that Respondent’s bank account statements are insufficient alone to establish Respondent’s ability pay the $19,192 penalty.  See CRD Dkt. Entry No. 16 at 11 (Informal Brief of Complainant) (citing Joy and Evergreen Petro, Inc. d/b/a Sunoco, DAB No. CR4698, 2016 WL 8650385 at *2 (H.H.S. Sept. 6, 2016)).  CTP also argues that in order to establish inability to pay the penalty, Respondent should have provided 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.

Based on my review, the CMP that CTP seeks could affect Respondent’s ability to do business.  In Respondent’s December 2023 bank statement, it shows a balance of $27,147.83.  CRD Dkt. Entry No. 10b.  I find that a $19,192 deduction from Respondent’s business income is very significant for a small business and is a mitigating factor.  While Respondent did not provide financial documents or more bank statements from 2024, based on Respondent’s statements it can be reasoned that Respondent did not encounter a significant increase in business or revenue since December 2023 to the point where it would be in a more suitable position to pay the full fine.  In fact, Respondent contends that it has ceased doing any business or bringing in revenue.  See CRD Dkt. Entry Nos. 10-12, 14-15, 26, 28.  Also, CTP did not present 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 CMP.  Therefore, after considering all the evidence and documentation in the record, I find that Respondent’s contentions regarding the difficulty to repay the CMP that CTP seeks, due to its financial condition, to be sincere and credible, and the evidence persuasive on this issue.  Thus, I find a reduction in the CMP amount to be appropriate.

3. History of Prior Violations

There is no indication in the record of any prior violations of section 331(c) resulting in a CMP.  However, CTP argues that there is a history of prior violations because Respondent was notified in a warning letter that it was in violation of the Act by manufacturing, selling, and/or distributing new tobacco products that lacked the required premarketing authorization required under the Act.  Informal Brief of Complainant at 12 (citing CTP Ex. 7).  CTP also argues that Respondent continued to offer for sale new tobacco products that lacked the required premarket authorization or exemption and thus demonstrated an unwillingness or inability to comply with federal tobacco laws and

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regulations.  Id.  However, I disagree with CTP’s contentions that Respondent’s repeated violations in this case were based on an unwillingness or inability to comply with the law.

Respondent’s owner asserted in its pre-hearing brief that he did not receive a warning letter, and if he personally reviewed it, Respondent’s sales of products without premarket approval would have ceased immediately.  Informal Brief of Respondent at 8.  While CTP points to the warning letter as evidence of a prior violation (Informal Brief of Complainant at 10-11), there is no evidence of any prior violations resulting in a CMP.  Therefore, contrary to CTP’s arguments, I find the record does not demonstrate Respondent’s unwillingness or inability to comply with tobacco laws and regulations based on its history of violations.  Instead, I find that Respondent’s single violation is a mitigating factor and the CMP should be reduced accordingly.

4. Degree of Culpability

Based on my finding that Respondent committed the violation alleged in the Complaint, I hold the Respondent fully culpable for offering for sale new tobacco products that were adulterated and misbranded, in violation of the Act.  The Act places a heavy burden on retailers who choose to manufacture and sell tobacco products because of their highly dangerous and addictive nature.  See 21 U.S.C. § 387 note (Findings and Purpose).  Although I find Respondent took remedial action by stopping the sale of products which were not authorized by the FDA upon receipt of CTP’s complaint, Respondent is not absolved of its responsibility as a manufacturer and retailer of tobacco products.

5. Other Matters as Justice May Require

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

For these reasons, after considering the record evidence, applicable law, and mitigating circumstances in this case, and after full evaluation of the relevant factors, I find reducing the CMP that CTP seeks by forty percent is appropriate and impose a $11,515 penalty.  21 U.S.C. § 333(f)(5)(B); 21 C.F.R. § 17.45(b)(1)-(3).

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V. Conclusion

For these reasons set forth above, I impose a reduced civil money penalty against Respondent TVC Management Corp d/b/a The Vapor Chef in the amount of $11,515 for impermissibly manufacturing, selling, and/or distributing new tobacco products that lacked the required premarketing authorization.  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.