Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Center for Tobacco Products,
Tasbeeh Petroleum Inc.
d/b/a Mobil Mart,
Docket No. T-20-1892
FDA Docket No. FDA-2020-R-0733
Decision No. TB5285
The Center for Tobacco Products (“CTP”), of the United States Food and Drug Administration (“FDA”), seeks to impose against Respondent, Tasbeeh Petroleum Inc. d/b/a Mobil Mart, a No-Tobacco-Sale Order (“NTSO”) for a period of 30 consecutive days for eight repeated violations of the Federal Food, Drug, and Cosmetic Act (“Act”), 21 U.S.C. § 301 et seq., and its implementing regulations, 21 C.F.R. pt. 1140, within a 36-month period. CTP alleges that Mobil Mart violated the Act by impermissibly selling covered tobacco products to minors and failing to verify, by means of photo identification containing a date of birth, that purchasers were 18 years of age or older. Therefore, CTP seeks to impose an NTSO for a 30 consecutive day period against Respondent Mobil Mart for eight violations of the Act within a 36-month period. For the reasons set forth in this decision, I find Respondent liable for the violations alleged in the complaint but conclude that reducing the NTSO against Respondent from a period of 30 consecutive days to 20 consecutive days is appropriate.
CTP began this matter by serving an administrative complaint on Respondent, Tasbeeh Petroleum Inc., d/b/a Mobil Mart, at 8810 West State Road 84, Davie, Florida 33324, and by filing a copy of the complaint with the FDA’s Division of Dockets Management.
Respondent timely filed an answer to CTP’s complaint; however, Respondent did not specifically deny the allegations. Answer ¶ 3. On March 19, 2020, I issued an Acknowledgment and Pre-Hearing Order (“APHO”) that set out the deadlines for the parties’ submissions in this case, and included informal briefs for the parties to complete and submit.
On March 29, 2020, CTP served Requests for Production of Documents (“RFP”) on Respondent. In a letter dated April 16, 2020, Respondent filed a motion requesting an extension of 30 days to respond to CTP’s RFP. On April 23, 2020, I issued an order giving CTP until April 30, 2020 to respond to Respondent’s motion. I also extended Respondent’s deadline to respond to CTP’s request for production of documents to May 11, 2020.
On April 30, 2020, CTP filed its Response to Respondent’s Motion to Extend Deadlines (Response). CTP stated that it did not oppose Respondent’s motion and requested that all the deadlines be extended by 30 days. On May 1, 2020, I issued an order extending all the APHO deadlines.
On June 8, 2020, CTP filed a Motion to Compel Discovery asserting that Respondent did not respond to its discovery request as required by my APHO and regulations. Dkt. Entry No. 12. On June 8, 2020, CTP also filed a Motion to Extend Deadlines.
On June 10, 2020, I issued an Order extending the parties’ pre-hearing exchange deadlines and set a deadline for June 26, 2020 for Respondent to respond to CTP’s Motion to Compel Discovery. On June 30, 2020, Respondent submitted a letter with nine (9) attachments. On September 4, 2020, CTP timely filed its pre-hearing exchange, containing a pre-hearing brief (CTP Br.) and 15 proposed exhibits (CTP Exs. 1-15), including the written direct testimony of one witness, FDA-commissioned Inspector Krystle Kirkland-Mobley (CTP Ex. 8).
On September 10, 2020, a letter by my direction was issued, giving both parties until September 21, 2020 to advise whether the discovery issues had been resolved and if not, to identify what specifically was still an issue or unresolved. On September 24, 2020, CTP filed an Updated Status Report, stating that “there are no outstanding discovery issues.” Later that same day, Respondent filed a response stating they are unable to provide any additional evidence at this time.
On September 24, 2020, Respondent also submitted a document captioned “Motion to Court for Appearance.” Respondent attached three (3) documents; two of which were labeled Exhibit A and Exhibit B and will be referred to as Exhibit 1 and Exhibit 2 respectively. Respondent did not propose any witnesses. No other evidence was submitted by Respondent prior to the September 28, 2020 deadline for submission of evidence.
On October 1, 2020, I issued an Order rendering CTP’s Motion to Compel Discovery moot. On October 1, 2020, I also issued an Order scheduling a telephone pre-hearing conference for October 15, 2020. CTP was present for the pre-hearing conference. Respondent did not appear for the pre-hearing conference. On October 15, 2020, I issued an Order to Show Cause giving Respondent until October 26, 2020 to show cause for its failure to appear at the scheduled pre-hearing conference. On November 19, 2020, I issued an Order Scheduling Telephone Hearing setting a hearing for December 10, 2020. On December 8, 2020, Respondent submitted a document stating that its accountant would provide representation during the hearing.
On December 10, 2020, I conducted a hearing for the purpose of cross-examination and for the admission of the parties’ proffered exhibits. Counsel for CTP appeared with its witness, and several observers from CTP. Respondent and its representative, Mr. Zersis Minocher, appeared as well. Respondent’s representative cross-examined Inspector Krystle Kirkland-Mobley. See Hearing Transcript (Tr.) at 18-22. CTP’s counsel declined redirect examination of Inspector Kirkland-Mobley. Id. at 27.
During the hearing, I received into evidence CTP’s Exs. 1-15, absent objection and Respondent’s Exhibit 1-2, letters and filed submissions, absent objection. Tr. at 11.
On January 8, 2021, I informed the parties that the Court had received the transcript of the hearing, and set the deadline of March 10, 2021, for the parties’ post-hearing brief submissions. Neither CTP nor Respondent filed a post-hearing brief by the established deadlines.
- Whether Respondent repeatedly violated 21 U.S.C. § 331, specifically 21 C.F.R. § 1140.14(b)(1) and 1140.14(b)(2)(i) for eight repeated violations within a 36-month period.
- Whether an NTSO of 30 consecutive days’ duration is an appropriate remedy.
III. Analysis, Findings of Facts and Conclusions of Law
CTP seeks to impose an NTSO against Respondent pursuant to the authority conferred by the Act, as amended by the Family Smoking Prevention and Tobacco Control Act (TCA) and implementing regulations at Part 21 of the Code of Federal Regulations. See TCA, Pub. L. No. 111-31 (June 22, 2009). The Act prohibits the misbranding of tobacco products while they are held for sale after shipment in interstate commerce. 21 U.S.C. § 331(k). A tobacco product is misbranded if distributed or offered for sale in any state in violation of regulations issued under section 387f(d) of the Act. 21 U.S.C. § 387c(a)(7)(B).
The FDA and its agency, CTP, may seek the imposition of remedies against any person who violates the Act’s requirements as they relate to the sale of tobacco products. 21 U.S.C. § 333(f)(9). CTP may seek to impose an NTSO when it finds “that a person has committed repeated violations of restrictions promulgated under section 387f(d) . . . at a particular retail outlet . . ..” 21 U.S.C. § 333(f)(8). “Repeated violations” is defined as “at least 5 violations of particular requirements over a 36-month period at a particular retail outlet that constitute a repeated violation. . ..” TCA § 103(q)(1)(a).
The regulations provide that no retailer may sell covered tobacco products to any person younger than 18 years of age. 21 C.F.R. § 1140.14(b)(1). The regulations also require that retailers verify, by means of photographic identification containing a purchaser’s date of birth, that no covered tobacco product purchasers are younger than 18 years of age. 21 C.F.R. § 1140.14(b)(2)(i).
1. Prior Violations
This case constitutes the fourth action CTP has brought against Respondent for violating the Act’s requirements. CTP Exs. 1, 3, 5; Complaint ¶¶ 8-11; see CRD Docket Numbers T-18-1514, T-18-3323; T-19-1490. The previous actions alleged Respondent sold covered tobacco to a minor on July 29, 20171
, February 18, 2018, June 30, 2018, and November 24, 2018, in violation of 21 C.F.R. § 1140.14(b)(1). The prior actions further alleged that, on the same dates, Respondent also failed to verify photographic identification of the covered tobacco product purchaser in violation of 21 C.F.R.
The first two actions resulted in settlement and concluded after Respondent admitted to violating the regulations as alleged and paid an agreed upon penalty. CTP Exs. 2, 4. In both settlements, Respondent expressly waived its right to contest these violations in
subsequent actions. Id. The third action resulted in an Initial Decision and Default Judgment and concluded Respondent was liable for the November 24, 2018 violations. CTP Ex. 6. Respondent did not contest the judgment within the allotted timeframe. Thus, these violations are now administratively final.
2. Current Violations
I now turn to whether the remaining allegations in the complaint are true, and, if so, whether Respondent’s actions constitute a violation of law. 21 C.F.R. § 17.45(b). Specifically, I must determine whether on June 19, 2019, at approximately 6:35 PM, Respondent sold a Black & Mild cigar to a person younger than 18 years of age in violation of 21 C.F.R. § 1140.14(b)(1) and failed to verify the age of the covered tobacco purchaser, in violation of 21 C.F.R. § 1140.14(b)(2)(i).
CTP has the burden of proving Respondent’s liability by a preponderance of the evidence. 21 C.F.R. § 17.33(b). It is Respondent’s burden to prove any affirmative defenses also by a preponderance of the evidence. 21 C.F.R. § 17.33(c). As detailed below, I find that based on the evidence of record, it is more likely than not that, on the date and time in question, Respondent sold a covered tobacco product to a minor in violation of 21 C.F.R. § 1140.14(b)(1) and failed to verify the age of the covered tobacco purchaser, in violation of 21 C.F.R. § 1140.14(b)(2)(i).
CTP premises its case on the testimony of Inspector Kirkland-Mobley, who conducted the inspection at issue, and supported by corroborating evidence including contemporaneous notes and photographs. CTP Exs. 8-13. Inspector Kirkland-Mobley is an FDA-commissioned officer with the state of Florida, whose duties include determining whether retailers comply with the age and photo identification requirements relating to the sale of tobacco products. CTP Ex. 8. Inspector Kirkland-Mobley testified that she conducted such an inspection of Respondent’s establishment on June 19, 2019, at approximately 6:35 PM, during which she observed a minor enter the establishment, without tobacco products, and return with a tobacco product in hand. Id. at 2-3.
Inspector Kirkland-Mobley testified that, prior to the inspection at issue, she verified that the minor carried true and accurate photographic identification that included the minor’s true date of birth. Id. at 2. Inspector Kirkland-Mobley also verified that the minor did not have any tobacco products in the minor’s possession. Id. at 2-3. Inspector Kirkland-Mobley testified that she parked her car near Respondent’s establishment, where she remained in the car, and the minor exited the vehicle. Id. at 3. The inspector testified that she had an unobstructed view where she watched the minor enter Respondent’s establishment and later exit Respondent’s establishment with something in the minor’s hand. Id. Inspector Kirkland-Mobley testified that the minor immediately returned to the car and handed her a cigar product, which she identified as a Black and Mild cigar. Id. Inspector Kirkland-Mobley immediately labeled the Black and Mild cigar as evidence,
photographed the package, and processed the evidence in accordance with standard procedures. Id. Inspector Kirkland-Mobley also contemporaneously recorded the inspection in the FDA’s Tobacco Inspection Management System (TIMS) and created a Narrative Report. Id. CTP corroborated Inspector Kirkland-Mobley’s testimony by offering as evidence photographs that the inspector made of the Black and Mild cigar on the date and time in question. CTP Exs. 12-13. CTP further corroborated Inspector Kirkland-Mobley’s account by submitting a copy of her contemporaneously recorded TIMS report and Narrative Report. CTP Exs. 9-10.
I found Inspector Kirkland-Mobley’s testimony to be credible and believable and supported by contemporaneous records and photographic evidence. CTP Exs. 8-13.
Respondent asserts that it did it did not have an employee working as a cashier who met the description detailed in the inspector’s narrative report. Answer at 1-2; see CTP Ex. 9 at 1-2. In a letter date June 30, 2020, Respondent asserts “We did not have a male by the following description working at our store: Black/dark brown hair & mustache & beard” as described in the inspector’s narrative report. Dkt. Entry No. 17 ¶ 2; see CTP Ex. 9 at 1-2. Respondent submits that a person who does not match the inspector’s description “handles the cash register at this store.” While it seems implausible that only one person is responsible for the cash register during all the hours that the establishment is open, Respondent provided no evidence to support this assertion. Dkt. Entry No. 17. Respondent’s assertion is self-serving and unsupported by the record and I do not find it compelling on this issue. Moreover, even if Respondent did not employ a cashier that met such a description, I would not find the alleged variance determinative as to whether Respondent sold a covered tobacco product to a minor on the date in question.
Respondent also implies that a sale may not have taken place. Specifically, Respondent takes issue with the photographs, stating that CTP did not provide direct evidence of the purchase, only a photo of the outside of the store and a photo of the cigar in a bag but none of the alleged transaction taking place or a photograph of the receipt indicating that the cigar was sold from the establishment. Tr. at 12. Respondent, during cross-examination, stated, “Maybe the kid had the product in his pocket.” Id. at 20. In her narrative report, Inspector Kirkland-Mobley documented that she confirmed that the minor did not have tobacco products prior to the start of the inspection by securing the minor’s belongings in the vehicle prior to the start of the inspection, asking the minor to turn out the minor’s pockets, and asking the minor directly. CTP Ex. 8 at 1-2, CTP Ex. 9. The inspector credibly testified that she watched the minor enter Respondent’s establishment and exit Respondent’s establishment with something in the minor’s hand. CTP Ex. 8 at 3. The minor immediately returned to the vehicle and handed the inspector a cigar. Id. It is reasonable to conclude that the minor was successful in his/her attempt and did indeed purchase the tobacco product, rather than procuring it by any other means from Respondent’s establishment. I find that the minor did just that.
Respondent also suggests that CTP did not have the correct establishment. In a letter dated June 30, 2020, Respondent asked CTP to provide “a receipt of our store and a photograph of our clerk selling the products to the underage offender.” Then, on September 24, 2020, Respondent filed another letter asserting that it reviewed the camera footage and “could not find the person matching your description. New footage automatically starts recording over the old footage after 14 days…” Respondent also renewed its request for CTP to provide camera footage and a receipt of the purchase. Yet, Inspector Kirkland-Mobley confirmed that she was present at the Respondent’s establishment at the time of the alleged violations. Her testimony corroborates the photographs taken and establishes that that she conducted a follow-up UB compliance check inspection at Mobile Mart, located at 8810 West State Road 84, Davie, FL 33324. CTP Ex. 8 at 7. This is the same address on each letter submitted by Respondent. Once again, the record does not contain any admissible evidence to rebut Inspector Kirkland-Mobley’s presence at the Respondent’s establishment on June 19, 2019.
CTP has the burden of proving Respondent’s liability by a preponderance of the evidence. 21 C.F.R. § 17.33. After considering the evidence of record, I find that CTP has provided sufficient evidence, which Respondent has failed to successfully rebut, that Respondent sold covered tobacco product to a minor and failed to verify the age of the covered tobacco purchaser on June 19, 2019, at approximately 6:35 PM, in violation of 21 C.F.R. § 1140.14(b)(1) and 21 C.F.R. § 1140.14(b)(2)(i).
The facts as outlined above, establish that Respondent’s actions constitute a violation of law and I conclude that Respondent is liable under the Act.
CTP may seek an NTSO when it finds five or more repeated violations of the applicable regulations over a 36-month period. 21 U.S.C. § 333(f)(8); TCA § 103(q)(1)(a); see Food & Drug Admin., Civil Money Penalties & No-Tobacco-Sale Orders For Tobacco Retailers: Guidance for Industry, 5-6 (Dec. 2016), (December 2016 Guidance), available at http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM252955.pdf (last visited Sept. 23, 2020).
In the present NTSO action, CTP counted repeated violations that occurred within the 36-month period that included February 18, 2018 to June 19, 2019. Respondent originally violated 21 C.F.R. § 1140.14(b)(1), the proscription against selling covered tobacco to a minor, on July 29, 2017. Respondent then repeated that violation on February 18, 2018, June 30, 2018, November 24, 2018, and June 19, 2019. Respondent originally violated 21 C.F.R. § 1140.14(b)(2), the requirement to verify through photographic identification that no covered tobacco product purchaser is under the age of 18, on July 29, 2017. Respondent then repeated that violation on February 18, 2018, June 30, 2018, November
24, 2018, and June 19, 2019. Accordingly, Respondent has repeatedly violated the regulatory requirements at least eight times within a 36-month period.
I now turn to whether a 30-day NTSO is appropriate in this case.
1. Determining Appropriate Length of NTSO
When determining the appropriate duration of an NTSO, 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). Further, when determining whether to “compromise, modify, or terminate” an NTSO, I must “consider whether the retailer has taken effective steps to prevent violations of the minimum age requirements for the sale of tobacco products.” TCA § 103(q)(1)(G), (F)(i)-(iv). These steps include:
(i) adopting and enforcing a written policy against sales to minors;
(ii) informing its employees of all applicable laws;
(iii) establishing disciplinary sanctions for employee noncompliance; and
(iv) requiring its employees to verify age by way of photographic identification or electronic scanning device[.]
TCA § 103(q)(1)(G), (F)(i)-(iv); see also December 2016 Guidance at 11; Food & Drug Admin., Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order, 3- 4 (Aug. 2015), (FDA Guidance), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/determination-period-covered-no-tobacco-sale-order-and-compliance-order (last visited Sept. 23, 2020); Kuma H. Mamie d/b/a 7-Eleven Store 22921A, DAB No. 2877, at 7 (2018); Station Management Consultants Inc. d/b/a Sunoco, DAB No. 2996, at 2-3, 6-7 (2020).
CTP policy guidelines establish 30 calendar days as the maximum NTSO duration CTP will seek for a retailer’s first NTSO. See FDA Guidance at 4.
In this case, CTP seeks the maximum NTSO duration of 30 calendar days.
a. Nature, Circumstances, Extent and Gravity of the Violations
Respondent has failed to comply with the Act and its implementing regulations on more than three occasions and committed at least eight repeated violations within a 36-month period. Each violation was serious because it contravened federal laws enacted to protect minors from adverse health effects associated with tobacco use. The repeated inability of
Respondent to comply with federal tobacco regulations is serious in nature and an NTSO is necessary and appropriate to protect the public health.
b. Respondent’s Ability to Pay
I will not need to consider whether or not Respondent has the ability to pay since it is not relevant in determining an NTSO.
c. Effect on Ability to Continue to do Business
Respondent has not provided any evidence with regard to its ability or inability to operate from the imposition of an NTSO. As a result, there is no evidence in the written record to establish an inability to maintain business.
d. History of Prior Violations
As noted previously, Respondent has been the subject of three prior civil money penalty actions. The current action is the first NTSO action against Respondent for repeated violations of the Act and its implementing regulations. Respondent has repeatedly violated the law despite the imposition of escalating civil money penalties against it. Between February 18, 2018 and June 19, 2019, Respondent sold a covered tobacco product to a minor on eight occasions. On each of those occasions, Respondent also failed to verify by means of photographic identification containing a purchaser’s date of birth, that no covered tobacco product purchasers were younger than 18 years of age. Respondent has demonstrated that it is either unable or unwilling to comply with the federal tobacco regulations, which calls for a more severe penalty.
e. Degree of Culpability
I find Respondent fully culpable for all violations of the Act and its implementing regulations within a 36-month period.
f. Other Matters as Justice May Require
Sales of tobacco products to minors are unlawful because younger individuals are more susceptible to making decisions that will endanger their lives down the road. Retailers who choose to sell such a highly dangerous and addictive product bear a heavy burden to ensure that they make their sales in compliance with law.
Following the most recent violation, Respondent installed software on the cash register that requires a scan of a driver’s license to proceed with a purchase of tobacco. Dkt. Entry No. 5. Answer ¶ 2. Respondent submitted photographs of the new software. Id. at 4-11. The Respondent asserts that it also required all its employees to participate in a 15-
day training. However, this claim is not supported by the record. Respondent did not present any admissible evidence to corroborate its claims or to demonstrate that it has an approved training program that complies with standards developed by the Food and Drug Administration. 21 U.S.C. § 333 note; see also 45 C.F.R. § 102.3. It is important that Respondent attempted to take steps that are effective in preventing violations of the minimum age requirements for the sale of tobacco products. See TCA § 103(q)(1)(G), (F)(i)-(iv).
Overall, I find that Respondent took corrective actions that I may consider as a mitigating factors.
Consequently, I conclude that a reduction in the NTSO period is appropriate.
2. Appropriate Penalty
Based on the foregoing reasoning, I conclude that an NTSO for a period of 20 consecutive days is appropriate to deter Respondent from continuing to violate federal law but enable Respondent an opportunity to conduct its business is compliance with the law. 21 U.S.C. §§ 333(f)(5)(B); TCA § 103(q)(1)(G); 21 C.F.R. § 17.34; FDA Guidance at 3-4.
Pursuant to 21 C.F.R. § 17.45, I enter judgment in the form of a No-Tobacco-Sale Order for a period of 20 consecutive days against Respondent, Tasbeeh Petroleum Inc. d/b/a Mobil Mart, for at least eight repeated violations of the Act, 21 U.S.C. § 301 et. seq., and its implementing regulations, 21 C.F.R. part 1140, within a 36-month period. Pursuant to 21 C.F.R. § 17.45(d), this order becomes final and binding upon both parties after 30 days of the date of its issuance.
Margaret G. Brakebusch Administrative Law Judge
1. Respondent’s original violations occurred on July 29, 2017.
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