Syn Enterprise, Inc. d/b/a Mobil, DAB TB9072 (2025)

INITIAL DECISION

The Center for Tobacco Products (CTP) seeks to impose a $20,678 civil money penalty (CMP) against Respondent, Syn Enterprise, Inc. d/b/a Mobil.  CTP alleges that Respondent received in interstate commerce an electronic nicotine delivery system (ENDS) product that lacks the premarketing authorization required under the Federal Food, Drug, and Cosmetic Act (Act) and offered such product for sale, in violation of 21 U.S.C. § 331(c).  Therefore, CTP seeks a $20,678 CMP against Respondent.  For the reasons discussed below, I find that Respondent violated the Act as alleged by CTP, and that a CMP of $20,678 is appropriate. 

I.      Background

CTP began this matter by serving an Administrative Complaint on Respondent at 1315 Bartow Road, Lakeland, Florida 33801 by United Parcel Service (UPS), and by filing a copy of the Complaint with the Food and Drug Administration’s (FDA) Division of

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Dockets Management.  Civil Remedies Division (CRD) Docket (Dkt.) Entry Nos. 1 (Complaint), 1b (UPS Proof of Service). 

On May 7, 2024, Respondent emailed its Answer to CTP’s Complaint, a request for an e-file waiver, and a request for an extension to the Attorney Advisor assigned to this case.  See CRD Dkt. Entry No. 3 at 2.  The Attorney Advisor responded to Respondent’s email, providing information regarding the procedures for requesting an e-file waiver and providing the appropriate mailing addresses for Respondent to mail its filings.  Id. at 1.  On May 8, 2024, the Attorney Advisor uploaded all of the documents received via email from Respondent to the electronic case file in DAB ACTS, including Respondent’s Answer, request for an e-file waiver, and request for an extension.  See CRD Dkt. Entry Nos. 4-6.

On May 10, 2024, CRD received Respondent’s Answer via mail and contemporaneously uploaded the document to the electronic case file in DAB ACTS.  See CRD Dkt. Entry No. 7.  The Answer received by CRD in the mail on May 10, 2024 is the same document Respondent e-mailed to the Attorney Advisor assigned to this case on May 7, 2024.  Compare CRD Dkt. Entry Nos. 5, 7.

On May 15, 2024, a letter by the direction of Administrative Law Judge Benjamin Zeitlin, the ALJ previously assigned to this case, was issued, informing the parties that Respondent’s request for an e-file waiver had been granted, and that Respondent’s Answer was deemed properly and timely filed on May 8, 2024.  CRD Dkt. Entry No. 8.  On May 15, 2024, Judge Zeitlin also issued an Order rendering Respondent’s May 7, 2024 request for an extension of time to file an answer moot.  CRD Dkt. Entry No. 9.

On May 15, 2024, Judge Zeitlin issued an Acknowledgment and Pre-Hearing Order acknowledging receipt of Respondent’s Answer and establishing procedural deadlines for this case.  CRD Dkt. Entry No. 10 (APHO). 

On May 27, 2024, contrary to paragraph 2.a of Judge Zeitlin’s APHO, Respondent sent the Attorney Advisor assigned to this case an email including indiscernible images embedded in the body of the email, but no subject or text in the body of the email.  See CRD Dkt. Entry No. 11 at 2-15.  On May 30, 2024, the Attorney Advisor assigned to this case responded to Respondent’s email stating:

Good afternoon, Mr. Azam.

I will upload your email to the case file.  However, please note that paragraph 2.a of Judge Zeitlin’s Acknowledgment and Pre-Hearing Order states, in part,: “[n]o submissions will be accepted by email unless specifically authorized.”

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Id. at 1 (emphasis in original, underlining replaced by italics).

On June 5, 2024, a representative from Dockets Management forwarded to CRD, via email, a copy of Respondent’s pre-hearing exchange that was mailed by Respondent to the address for Dockets Management.  See CRD Dkt. Entry No. 12b.  On that same date, the Attorney Advisor assigned to this case uploaded Respondent’s pre-hearing exchange to the electronic case file in DAB ACTS.  See CRD Dkt. Entry Nos. 12-12a.  Respondent’s prematurely filed pre-hearing exchange consisted of its Pre-Hearing Brief of Respondent, and no proposed exhibits or proposed direct testimony of any witnesses.

On June 10, 2024, CTP filed a Joint Status Report indicating that the parties intended to engage in further settlement discussions and that CTP would notify the Departmental Appeals Board if the parties agreed to a settlement and Respondent fulfilled the terms of the settlement agreement.  CRD Dkt. Entry No. 13 at 1.

On July 31, 2024, CTP filed an Unopposed Motion to Extend Deadlines (Motion to Extend).  CRD Dkt. Entry No. 14.  On August 2, 2024, Judge Zeitlin issued an Order granting CTP’s Motion to Extend, extending the parties’ discovery and respective pre-hearing exchange deadlines by thirty (30) days.  See CRD Dkt. Entry No. 15.

On September 4, 2024, CTP timely filed its pre-hearing exchange consisting of its Informal Brief of Complainant, Complainant’s List of Proposed Witnesses and Exhibits, and seven proposed exhibits.  CRD Dkt. Entry Nos. 16-16h.  CTP’s exchange included the written direct testimony of two proposed witnesses: (1) James Bowling, Deputy Division Director for the Division of Enforcement and Manufacturing in the Office of Compliance and Enforcement, CTP, FDA, CTP Exhibit (Ex. 1); and (2) Stefania Sweet, FDA-commissioned officer in the state of Florida, CTP (Ex. 2).  CRD Dkt. Entry Nos. 16b-16c.

On October 11, 2024, this case was reassigned to me for adjudication.  See CRD Dkt. Entry No. 17.

On November 1, 2024, Mr. Joshua Davenport filed an Entry of Appearance on behalf of CTP.  CRD Dkt. Entry No. 19.  Subsequently, on November 19, 2024, Ms. Tara Boland filed an Entry of Appearance on behalf of CTP.  CRD Dkt. Entry No. 22.

On November 19, 2024, I conducted the pre-hearing conference (PHC).  During the PHC, I explained the issues before me, the parties’ respective burdens of proof, and we discussed the parties’ pre-hearing exchange submissions.  CRD Dkt. Entry No. 23 (Order Following PHC) at 1-3.  I asked Mr. Azam, Respondent’s authorized representative, if Respondent objected to the admission of CTP’s seven proposed exhibits into the record, and Mr. Azam stated that he did not object.  Id. at 2.  There being no objections, I admitted CTP Exs. 1-7 into the administrative record.  Respondent did not submit any

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proposed exhibits with its pre-hearing exchange.  During the PHC, given that Respondent is not represented by counsel, I explained that my decision in this case must be supported by the administrative record, and asked Mr. Azam if Respondent would like the opportunity to submit any evidentiary documents in the form of exhibits, although Respondent’s pre-hearing exchange deadline had passed.  See CRD Dkt. Entry No. 23 at 2-3.  Mr. Azam declined to submit any evidentiary documents in the form of exhibits for my consideration.  Id. at 3.

During the PHC, I explained the purpose of a hearing and asked Mr. Azam if Respondent intended to cross-examine CTP’s witnesses.  Id.  In response, Mr. Azam stated that Respondent did not intend to cross-examine CTP’s witnesses.  Id.  Thus, 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).

During the PHC, I also provided both parties with an opportunity to file final briefs or arguments in this case.  Both Respondent and CTP orally waived the opportunity to file a final brief.  Id.

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).

II.      Issues

1. Whether Respondent received in interstate commerce an ENDS product that lacks the premarketing authorization required under the Act, specifically an Elfbar Mango Peach Apricot ENDS product, and offered such product for sale on December 12, 2023, in violation of 21 U.S.C. § 331(c); and, if so,
2. Whether the $20,678 civil money penalty is appropriate, considering any mitigating or aggravating factors that I find in this case.  21 C.F.R. § 17.45.

III.     Findings of Fact and Conclusions of Law 

1. CTP has demonstrated by a preponderance of the evidence that the Respondent received an adulterated and misbranded ENDS product in interstate commerce and delivered or proffered such product for sale on December 12, 2023, in violation of the Act.

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).

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The Act prohibits the receipt in interstate commerce of any tobacco product that is adulterated or misbranded and the delivery or proffered delivery of any tobacco product that is adulterated or misbranded for pay or otherwise.  21 U.S.C. § 331(c); 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 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 respecting it was not provided as required” under the substantial equivalence or substantial equivalence pathway is misbranded.  21 U.S.C. §§ 387c(a)(6).  

CTP’s case against Respondent relies on the written direct testimony of Deputy Division Director James Bowling of the Division of Enforcement and Manufacturing in the Office of Compliance and Enforcement, CTP, FDA, and Inspector Stefania Sweet, FDA-commissioned officer in the state of Florida.  CTP Exs. 1 and 2.  Inspector Sweet testified that during the inspection on December 12, 2023, at approximately 6:45 PM, an Elfbar Mango Peach Apricot ENDS product was available for sale at Respondent’s establishment.  CTP. Ex. at 2, ¶¶ 4, 6.  See also CTP Exs. 3-6 (Inspector Sweet’s narrative report, inspection details, photographs and notice of inspection dated December 12, 2023).

Deputy Division Director Bowling testified that the ENDS product observed for sale during the December 12, 2023, inspection was manufactured in China, which is outside of the state in which Respondent operates.  CTP Ex. 1, ¶ 7.  Deputy Division Director Bowling further testified that he:

. . . can confirm that Elfbar Mango Peach Apricot ENDS products were not commercially marketed in the United States as of February 15, 2007 . . . . that on December 12, 2023, the day on which FDA observed the Elfbar Mango Peach Apricot ENDS product being offered for sale at Mobil, there was no record of this product having an 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 Elfbar Mango Peach Apricot ENDS product had not submitted a report requesting a substantial equivalence order under 21 U.S.C. § 387e(j). . . . the Elfbar Mango Peach

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Apricot ENDS 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 Elfbar Mango Peach Apricot ENDS product had not submitted an abbreviated report requesting a found-exempt order for such product under 21 U.S.C. § 387e(j)(1). 

CTP Ex. 1, ¶¶ 12-14.

In its Answer, Respondent admitted the allegations set forth in the Complaint, and thus conceded the factual allegations raised therein.  See CRD Dkt. Entry Nos. 5 at 5, 7 at 3.  In its Answer, Respondent asserts a defense, specifically, Respondent states:

[The Inspector] [f]ound 2 pack[s] facing towards [the] cashier[,] not facing [the] customer[,] which was to be trashed[,] but [Respondent] forgot to do it.  If you see the picture, you will find lot[s] of other pack[s] of vape[s].  Genuine mistake. . . .

CRD Dkt. Entry Nos. 5 at 4, 7 at 4. 

At the PHC, Respondent reiterated its admission of liability, as set forth in its Answer, but contested the proposed $20,678 CMP as being too high.  See CRD Dkt. Entry No. 23 at 2.

Respondent has not disputed any of the statements made by Inspector Sweet or Deputy Division Director Bowling, and Respondent does not deny that Elfbar Mango Peach Apricot ENDS product observed by Inspector Sweet on December 12, 2023 was at its establishment and being proffered for sale.  Further, the photograph submitted by CTP of Respondent’s product display cabinet clearing shows that the Elfbar Mango Peach Apricot ENDS product was being displayed and offered for purchase, along with Respondent’s other products.  See CTP Ex. 5 at 7.  Therefore, the defense asserted by Respondent has no merit, and fails to absolve Respondent of its liability.  Therefore, Respondent’s actions constitute violations of law that merit a CMP.    

2. Respondent has not demonstrated by a preponderance of the evidence mitigating circumstances to support a reduced CMP.

I have determined that Respondent violated the prohibition against receiving and offering for sale a new tobacco product that was adulterated and misbranded.  21 U.S.C. § 331(c).  Pursuant to 21 U.S.C. § 333(f)(9), Respondent Mobil is liable for a civil money penalty not to exceed the amounts listed in the FDA’s CMP regulations at 21 C.F.R. § 17.2; see also 45 C.F.R. § 102.3.

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In its Complaint, CTP seeks to impose a CMP amount of $20,678 against Respondent.  CRD Dkt. Entry No. 1 ¶ 1. 

When determining the appropriate amount of a CMP, 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).  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).

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

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. 16 at 8 (Informal Brief of Complainant).  CTP specifically refers to a Warning Letter it issued to Respondent on August 8, 2023, citing Respondent for offering for sale tobacco products, specifically Elfbar Sakura Grape and Elfbar Rainbow Candy ENDS products that lacked the required marketing authorization.  Id.; CTP Ex. 7 at 1.  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 violation indicated in this letter may not be a complete list of violations at the establishment.”  CRD Dkt. Entry No. 16 at 9; CTP Ex. 7 at 3.  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.  CRD Dkt. Entry No. 16 at 9; CTP Ex. 7 at 3.

In its Answer, Respondent asserts that the ENDS products observed by Inspector Sweet were to be trashed, but Respondent forgot to do so.  See CRD Dkt. Entry Nos. 5 at 4, 7 at 4.  Respondent further asserts that it made a genuine mistake.  Id.  Although Respondent’s honesty is commendable, such an oversight or mistake with regard to a regulated tobacco product is indeed serious.  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 U.S.C. § 387f(d).  There is no dispute that the Respondent was in the business of selling a highly regulated and dangerous product.  See 21 U.S.C. § 387 note.  Further, the administrative record does not show that Respondent made a meaningful effort to come into compliance with the law after receiving the August 8, 2023 Warning Letter.  Thus, Respondent’s violation warrants a significant penalty.

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

In its Answer and Informal Brief of Respondent, Respondent contends that the CMP sought by CTP is too high.  CRD Dkt. Entry Nos. 5 at 4, 7 at 4, 12 at 6.  Respondent specifically states: that it can only afford to pay $50 a month for four months, that Respondent could not afford to retain counsel to assist it with this matter, and that the penalty will have a negative impact on Respondent’s ability to continue to do business.  CRD Dkt. Entry Nos. 5 at 3-4, 7 at 4-5, 12 at 6.  According to CTP’s Informal Brief of Complainant:

In response to CTP’s Request for Production of Documents, Respondent sent its January through April 2024 Profit and Loss Statement, as well as its 2023 US Income Tax Return for an S Corporation that demonstrates that Respondent’s Establishment operated at profit for 2023.

CRD Dkt. Entry No. 16 at 9-10.

However, after being afforded multiple opportunities to do so, Respondent has not submitted any evidence in the form of exhibits or written direct testimony sworn under penalty of perjury to substantiate its claims regarding its financial hardship.  See CRD Dkt. Entry Nos. 10 ¶¶ 6-10, 23 at 2-3.

In addition, CTP argues that Respondent’s January through April 2024 Profit and Loss Statement as well as its 2023 S Corporation Income Tax Return are insufficient alone to establish Respondent’s ability to pay the $20,678 penalty.  See CRD Dkt. Entry No. 16 at 10 (citing Joy and Evergreen Petro, Inc. d/b/a Sunoco, DAB No. CR 4698, 2016 WL 8650385 at *2 (H.H.S. 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. 

In a recent case, the Board explained that:

Although Respondent argues on appeal that the CMP “would severely impact [its] ability to continue operations and maintain employment for [its] staff,” Respondent provided no evidence to support that assertion.  NA at 1.  Respondent presented no profit and loss statements, or any other financial data, demonstrating an inability to pay the CMP or that the CMP would “severely impact” Respondent’s ability to continue its business.

Smokers Haven 3 LLC d/b/a Smoker’s Haven, DAB No. 3164 at 6 (2024).

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Here, in the absence of evidence in the administrative record, I am unable to meaningfully evaluate Respondent’s ability to pay the proposed CMP.  Further, without such evidence, I am also unable to meaningfully evaluate the potentially negative effect that imposition of the proposed CMP may have on Respondent’s ability to continue to do business.

3. History of Prior Violations

There is no indication in the record of any prior violations of Section 331(c) that were adjudicated and resulted in the imposition of a civil money penalty. 

4. Degree of Culpability

Based on my finding that Respondent committed the violation alleged in the Complaint, I hold 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 sell tobacco products because of their highly dangerous and addictive nature.  See 21 U.S.C. § 387 note (Findings and Purpose).  

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).  However, based on the evidence in the record, I find that the proposed penalty amount of $20,678 is appropriate and that there are no mitigating circumstances.

For these reasons, after considering the evidence in the record, applicable law, and aggravating and mitigating circumstances in this case, I find that a CMP amount of $20,678 is appropriate under 21 U.S.C. §§ 333(f)(5)(B), (f)(5)(C), and (f)(9).

IV.    Conclusion

I impose a civil money penalty against Respondent, Syn Enterprise, Inc. d/b/a Mobil, in the amount of $20,678 for receiving in interstate commerce an ENDS product that lacks the premarketing authorization required under the Act and offering such product for sale.  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.