B. Bliss, LLC d/b/a Citgo, DAB TB8274 (2024)

I sustain the determination of the Center for Tobacco Products (“CTP”) of the United States Food and Drug Administration (“FDA”) to impose a civil money penalty of $638 against Respondent, B. Bliss, LLC d/b/a Citgo (Respondent). The evidence establishes that Respondent committed three violations of law and implementing regulations in a 24-month period by unlawfully selling tobacco products and failing to check the identification of underage individuals.

I. Background

Respondent requested a hearing to challenge CTP’s determination. I held a hearing on April 10, 2024, at which I afforded Respondent the opportunity to cross-examine Colleen Mencl, an inspector working on behalf of CTP. A transcript (Tr.) was made of the hearing. I received into evidence exhibits from CTP that are identified as CTP Ex. 1 – CTP Ex. 19, and from Respondent that are identified as

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R. Ex. A – R. Ex. C. Both CTP and Respondent filed pre-hearing briefs and post-hearing briefs.

II. Issues, Findings of Fact and Conclusions of Law

1. Issues

The issues are whether Respondent violated regulations governing the sale of tobacco products to underage purchasers and whether a civil money penalty of $638 is reasonable.

2. Findings of Fact and Conclusions of Law

This is a case that is brought pursuant to Section 906(d)(5) of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 387f(d)(5) and implementing regulations at 21 C.F.R. Part 1140. The Act and regulations prohibit the sale of tobacco products to individuals who are under the age of 21 and make unlawful the failure to verify the age of a person purchasing tobacco products by photographic identification containing the bearer’s date of birth. 21 U.S.C.
§ 387f(d)(5); 21 C.F.R. § 1140.14(b)(2)(i).¹

A retailer who unlawfully sells tobacco products causes its tobacco products to become misbranded. 21 U.S.C. § 387c(a)(7)(B). The Act prohibits committing an act that causes tobacco products to be misbranded while they are held for sale after shipment in interstate commerce. 21 U.S.C. § 331(k).

1. Noncompliance

There is no dispute in this case that Respondent sells tobacco products, that are in interstate commerce, to the general public. What is in dispute are CTP’s allegations that Respondent unlawfully sold tobacco products on February 9, 2022, and May 1, 2023, and that Respondent unlawfully failed to verify the age of the underage purchasers of tobacco products on those dates.

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I find CTP’s allegations to be supported by the weight of the evidence.

Colleen Mencl, is an FDA-commissioned officer with the state of Michigan whose duties include determining whether retailers comply with the age and photo identification requirements relating to the sale of regulated tobacco products. CRD Docket (Dkt.) Entry No. 14e at 1-2 (CTP Ex. 4 at 1-2). Inspector Mencl’s inspections entail accompanying trained underage purchasers who attempt to purchase tobacco products from retail establishments such as the one operated by Respondent. Id.

Inspector Mencl, in her direct testimony, testified that she went to Respondent’s establishment on two occasions, on February 9, 2022, and on May 1, 2023. CRD Dkt. Entry No. 14e at 2-5 (CTP Ex. 4 at 2-5). On each occasion, a trained underage purchaser accompanied her. Id. Inspector Mencl averred that on each occasion she verified that the underage purchaser was carrying only a valid federal or state-issued photographic identification. Before each inspection, Inspector Mencl confirmed that the underage purchasers were not in possession of tobacco products. Inspector Mencl testified that at each inspection, she entered Respondent’s establishment moments after the underage purchaser and was positioned in a clear, unobstructed view of the sales counter and the underage purchaser. On each occasion, she watched the underage purchaser purchase a covered tobacco product directly from an employee without presenting identification to the employee. Inspector Mencl notes that the employee did not provide a receipt to the underage purchaser during either inspection. Immediately after leaving the Respondent’s establishment, both the underage purchaser and Inspector Mencl entered the vehicle, and the package of cigars² were placed in a secure location until Inspector Mencl could label and photograph them. Id. at 3-4.

CTP corroborated Inspector Mencl’s testimony by offering as evidence photographs that Inspector Mencl made of the underage purchasers’ identification and the cigars that the underage purchasers bought on the dates in question. CRD Dkt. Entry Nos. 14j-l, 14o-q (CTP Ex. 9-11, 14-16). CTP also submitted narrative reports by Inspector Mencl created contemporaneously with each inspection. CRD Dkt. Entry Nos. CTP 14f, 14h (CTP Exs. 5, 7).

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Respondent offered no tangible evidence to rebut Inspector Mencl’s testimony. In its’ Post-Hearing Brief, Respondent expounds on its argument during the hearing, that the discrepancy with the handwritten dates on the evidence bags and the TIMS report are enough to dismiss the case. CRD Dkt. Entry Nos. 14, 27, 31 (CTP Ex. 10, Tr. at 6-9; R’s Post-Hearing Brief at 1-3). Respondent acknowledges that when it cross-examined Inspector Mencl, she stated writing “2/8/2022” was an error and she meant to write “2/9/2022.” Id. Respondent argued that this error “raises the doubt that the inspection and subsequent steps taken to report the inspection was either performed carelessly or not performed as per report.” CRD Dkt. Entry No. 31 (R. Post-Hearing Brief at 2). I must note, that during Inspector Mencl cross-examination, she explained that the TIMS database cannot be accessed a day before an inspection. CRD Dkt. Entry No. 27 (Tr. at 10). Thus, the TIMS report could only be created on the actual date the inspection took place, which would mean the inspection of Respondent’s establishment occurred on February 9, 2022.

Respondent also argues that “Swisher Sweet Cigarillos is one of the most widely sold tobacco products in the market” but failed to provide any video footage to show that the sale to the underage purchases did not occur at its establishment at the alleged time and date noted in the complaint. CRD Dkt. Entry No. 31 (R’s Post-Hearing Brief at 3). Respondent contends that the popularity of the tobacco product coupled with CTP not having a receipt/proof of purchase, proves that there is room for doubt as to whether the underage purchasers could have concealed tobacco products prior to entering the store. Id. Again, Respondent offered no evidence to counter Inspector Mencl’s narrative report, that the undercover purchasers’ belongings were kept in the vehicle and their pockets were checked prior to entering the establishment on February 9, 2022, and May 1, 2023. CRD Dkt. Entry No.14f (CTP. Ex. 5 at 1). That testimony, plus the corroborating evidence, leads to the inference that the underage purchasers could only have obtained cigars by purchasing them at Respondent’s business establishment.

Respondent also questioned the Inspector Mencl’s descriptions of Respondent’s clerks. CRD Dkt. Entry Nos. 27, 31 (Tr. at 10-12; R. Post-Hearing Brief at 2-3). During the hearing, Respondent stated that on February 9, 2022, and May 1, 2023, the establishment had only two employees, a husband and a wife. CRD Dkt. Entry No. 27 (Tr. at 14-15). Respondent disputes the descriptions given by CTP of the employees that made the sale to the underage purchasers. CRD Dkt. Entry Nos. 27, 31 (Tr. at 10-12; R. Post-Hearing Brief at 2-3). Respondent stated her husband does not have a mustache and she does not have light hair and does not wear glasses as described in the Inspector’s reports. See CRD Dkt. Entry Nos. 14i, 14r (CTP Exs. 8, 17).

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I find no basis to conclude that any of Respondent’s allegations are credible. Instead, I find evidence to support CTP’s position. The contemporaneous narratives describe Respondent’s clerk as being an adult male with black/dark brown hair and a mustache for the February 9, 2022 inspection. CRD Dkt. Entry No. 14f at 1 (CTP Ex. 5 at 1), and as being an adult female with light brown hair and glasses for the May 1, 2023 inspection was present at 12:16 pm EDT. CRD Dkt. Entry No. 14h at 1 (CTP Ex. 7 at 1). CTP provided the various definitions of what constitutes as a mustache to which include “a few sparse hairs” or “a 5’ o’clock shadow.” CRD Dkt. Entry Nos. 30 (CTP’s Post-Hearing Brief at p. 4 ft. 3.). When Respondent was under examination, CTP asked for the hours each employee maintains in a day. Respondent replied that she usually works from 6:00 am to about 1:00 / 2:00 pm and her husband usually works from around 2:00 pm until 10:00 pm. CRD Dkt. Entry No. 27 (Tr. at 15-16). Respondent already testified that she works until 1:00 pm or 2:00pm. Respondent, in her own words, places her vehicle at the establishment at the time and date of the May 1, 2023 inspection by acknowledging her vehicle was parked in the lot when the photo was taken. CRD Dkt. Entry No. 31 (R. Post-Hearing Brief at 2-3). Further, Respondent has established that the business had two employees on both inspection dates and now, under oath, stating that she works at the establishment daily at the time of inspection, there is an abundance of proof to support Inspector Mencl’s testimony. Respondent’s assertion that it does not employ a clerk that meets the description provided by the inspector is unsupported by any evidence of record.

I do not find that Respondent offered evidence that either directly rebuts Inspector Mencl’s testimony or undermines that testimony’s credibility. Contrary, it contradicts Respondent’s arguments. Respondent affirms that it was “oblivious” to the February 9, 2022 inspection, even after receiving a warning letter on March 17, 2022, because Respondent was not “notified in-person” and did not believe FDA documents via mail are “legit”. CRD Dkt. Entry Nos. 15, 31 (Respondent’s Informal Brief at 2; R. Post-Hearing Brief at 3-4).

Instead, Respondent provided images of tobacco retailer training materials, photos of what appears to be “We Scan IDs” signage at its establishment, a photo of a register with ID check software with a date of January 1, 2024, along with post-inspection letters from 2018 and 2019 showing successful compliance with local decoy operations involving underage purchasers attempting to purchase alcohol or tobacco products. CRD Dkt. Entry Nos. 15, 16 (R. Ex. A, B, C).

Yet, Respondent has established, with its own evidence, that decoy operations, similar to the ones conducted by Inspector Mencl on February 9, 2022, and May 1, 2023, have taken place at Respondent’s establishment numerous times. CRD Dkt. Entry No. 16 (R. Ex. C). It appears, after each decoy operation, Respondent received a letter summarizing what took place during the decoy operation and the

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evaluation. Id. Thus, when Respondent received CTP’s warning letter, Respondent should not have been “oblivious” but should have taken CTP’s warning letter seriously as it has done in the past. Regardless, Respondent acknowledges that it was given notice by CTP prior to the May 1, 2023 inspection. CRD Dkt. Entry No. 31 (R. Post-Hearing Brief at 3). Respondent stated in its brief, that it received the warning letter on March 17, 2022, which provided Respondent ample time to retrain its staff and ensure that its establishment complied with the tobacco regulations. Id. Once again, Respondent did not offer persuasive evidence. Regardless of whether Respondent thought the warning letter had merit, the Respondent is still responsible for ensuring it complies with all tobacco regulations.

The prevailing issue with Respondent’s arguments are that Respondent did not provide any persuasive evidence. Without such evidence, I cannot question the credibility of CTP’s complaint, which is supported by CTP’s evidence.

2. Remedy

CTP predicated its remedy determination on at least three violations of the Act and regulations committed by the Respondent during a 24-month period. As explained above, the weight of the evidence supports the allegations of two violations (unlawful sale of a tobacco product to an underage purchaser and failure to verify the purchaser’s age by photo identification prior to the sale) committed on February 9, 2022, and May 1, 2023.

On August 16, 2023, CTP filed an administrative complaint alleging that on February 9, 2022, Respondent unlawfully sold a tobacco product to an underage purchaser and failed to verify the purchaser’s age by photographic identification. CTP alleged additionally that on May 1, 2023, Respondent unlawfully sold a tobacco product to an underage purchaser and failed to verify the purchaser’s age by photographic identification. CTP determined to impose a civil money penalty based on these instances of noncompliance.

The FDA (and CTP) may impose civil money penalties against any individual or entity that violates the Act’s requirements governing sale of tobacco products. 21 U.S.C. § 333 (f)(9). Civil money penalty amounts are governed by regulations 45 C.F.R. Part 102. The maximum penalty in for committing three violations³ in a 24-month period is $638. 45 C.F.R. § 102.3, the amount that CTP determined to impose in this case.

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I have considered the circumstances of Respondent’s noncompliance. They amply justify the penalty that CTP determined to impose.

I take notice that tobacco products are highly addictive. The costs of tobacco addiction are both personal and social: personal in that the addicted individual may suffer both from devastating health issues, and social, in the collective consequence of tobacco-related illness is a substantial burden on our health care system and on related services.

Selling tobacco products to underage individuals – individuals who may lack the judgment skills of more mature persons – exposes them to the prospect of lifelong addiction and all the hardship and costs that come with that. Any sale of a tobacco product to an underage individual is thus a serious violation of law.
CTP determined to impose a civil money penalty against Respondent of $638. The proposed penalty is the maximum allowed by law. 21 C.F.R. § 17.2. I find the amount to be reasonable given the circumstances of this case. Respondent sold tobacco products – a dangerous and highly addictive substance – to an underage purchaser on more than one occasion. Furthermore, it sold tobacco products unlawfully and failed to check the underage purchasers’ identification after CTP had warned it explicitly not to do so. That establishes a high level of culpability on Respondent’s part.

Finally, I note that Respondent has not offered any evidence to show that it lacks the wherewithal to pay the penalty amount.

Endnotes

¹  On December 20, 2019, the Act was amended by the Further Consolidated Appropriations Act, 2020, Pub. L. No. 116–94, § 603(a)-(b), to raise the federal minimum age for sale of tobacco products to 21, and directed the Secretary of the U.S. Department of Health and Human Services (Secretary) to “update all references to persons younger than 18 years of age in subpart B of part 1140 of title 21, Code of Federal Regulations, and to update the relevant age verification requirements under such part 1140 to require age verification for individuals under the age of 30.” 21 U.S.C. § 387f (note).

²  CTP’s complaint refers to the tobacco products allegedly sold to underage purchasers on February 9, 2022, and May 1, 2023, as “Swisher Sweets Classic cigars”, while in both CTP’s Post-Hearing Brief and Respondent’s Post Hearing Brief, the tobacco products are referred to as “Swisher Sweets cigarillos.” These two names are interchangeable and are referring to the tobacco products purchased during both inspections. See Complaint 4-5; CRD Dkt. Entry Nos. 14k,14p (CTP Exs. 10, 15); CRD Dkt. Entry Nos. 30-31 (CTP’s Post-Hearing Brief; R.’s Post-Hearing Brief).

³  Under current FDA (and CTP) policy, the alleged violations described count as three violations for purposes of computing the civil money penalty in the instant case.