Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Center for Tobacco Products,
(FDA No. FDA-2018-H-1326)

Complainant
v.

R and R Family, Inc.
d/b/a Riverfront Liquor Shoppe,

Respondent.
Docket No. T-18-1799
Decision No. TB3482

Date: January 28, 2019

INITIAL DECISION

I sustain in part the determination of the Center for Tobacco Products (CTP) of the
United States Food and Drug Administration (FDA) to impose a civil money penalty
against Respondent, R and R Family, Inc. d/b/a Riverfront Liquor Shoppe, for five
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.
Specifically, Respondent violated the Act by impermissibly selling cigarettes to minors
on May 2, 2015, May 11, 2016, and March 11, 2018. On the same dates, Respondent
also violated the requirement that retailers verify, by means of photo identification
containing the bearer's date of birth, that no cigarette purchaser is younger than 18 years
of age. However, I conclude that reducing the civil money penalty from $5,591 to $1,118
is appropriate.
I. Background

CTP began this matter by serving an administrative complaint seeking a $5,591 civil
money penalty on Respondent, at 25110 Grand River Avenue, Redford, Michigan 48240,
and by filing a copy of the complaint with the FDA Division of Dockets Management.
Respondent timely answered CTP’s complaint, denying the allegations.

The parties filed pre-hearing exchanges and exhibits. CTP filed a pre-hearing brief
(CTP Br.) and 14 exhibits (CTP Exs. 1-14), including the written direct testimony of two
witnesses (CTP Exs. 4, 6). Respondent filed a pre-hearing brief (R. Br.; see electronic
case filing (ECF) 7), and two exhibits I identify as R. Ex. A (see ECF 3a), and R. Ex. B
(see ECF 9a).! Following my extension of the pre-hearing exchange schedule,
Respondent filed nine exhibits” (R. Exs. 1-9; see ECF 14-14h), including the written
direct testimony of two witnesses (R. Exs. 1, 9).

On September 13, 2018, I conducted a hearing for the purpose of cross-examination and
for the admission of the parties’ proffered exhibits. During the hearing, I received into
evidence CTP Exs. 1-14 absent objection (Tr. at 13), R. Exs. 1-9 over objection (Tr. at
22), and R. Exs. A-B (Tr. at 53) absent objection. See Tr. at 6-22, 53 (identifying
exhibits, addressing objections, and ruling on admission).> Respondent cross-examined
CTP’s witness, Justin Bishop, an FDA-commissioned inspector. CTP cross-examined
Respondent’s witness, Rafid Jammoa, owner of Respondent’s establishment, and Jalal
Kattoula, manager of Respondent’s establishment. The parties filed post-hearing briefs
(CTP Post-Hrg. Br.; R. Post-Hrg. Br.).

Il. Issues

(1) Whether Respondent sold cigarettes to a minor and failed to verify the age
of the purchaser by means of photographic identification containing the
bearer's date of birth on March 11, 2018, in violation of 21 C.F.R.

§ 1140.14(a)(1) and (a)(2)(i); and if so,

' The hearing transcript erroneously identified the exhibit at ECF 9a as “Respondent
Exhibit D.” Transcript (Tr.) at 11. I correct line nine of the transcript to read as follows:
“that as Respondent Exhibit B.” Tr. at 11. I note that page 25 of the transcript correctly
identifies ECF 9a as Respondent’s Exhibit B.

2 Respondent submitted a document titled “Informal Brief of Respondent,” which
contained the sworn written direct testimony of Rafid Jammoa. | identified and admitted
this submission as Respondent’s Exhibit 9. See Tr. at 17-22.

3 In discussions of Respondent’s written declaration, the transcript erroneously
transcribed “misstatement” rather than “statement.” Tr. at 20. I correct line two of the
transcript to read as follows: “presented, and you also included the statement to.” Tr. at
20.
(2) Whether the civil money penalty amount of $5,591 that CTP seeks is
appropriate.

Ill. Analysis, Findings of Fact, and Conclusions of Law
A. Violations

CTP determined 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. 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). FDA and its
agency, CTP, may seek civil money penalties from any person who violates the Act’s
requirements as they relate to the sale of tobacco products. 21 U.S.C. § 331(f)(9).

The sale of tobacco products to an individual who is under the age of 18 is a violation of
implementing regulations. 21 C.F.R. § 1140.14(a)(1). The failure to verify, by means of
photo identification containing the bearer's date of birth, that no cigarette purchaser is
younger than 18 years of age is also a violation of implementing regulations. 21 C.F.R.

§ 1140.14(a)(2)(i).

Prior violations

This is the second civil money penalty action against Respondent. Complaint at 4;
CTP Ex. 2. The prior complaint charged Respondent with:

(1) | Selling cigarettes to a minor on May 2, 2015, and May 11, 2016, in
violation of 21 C.F.R. § 1140.14(a)(1); and

(2) Failing to verify the age of the purchaser by means of photographic
identification on the same dates, in violation of 21 C.F.R.
§ 1140.14(a)(2)(i).

CTP Ex. 2; Complaint at 4. The previous action resulted in settlement and concluded
after Respondent admitted to three violations‘ of regulations and paid the agreed upon
penalty. Complaint at 4; CTP Ex. 3. In settling the prior complaint, Respondent
expressly waived its right to contest these violations in subsequent actions. CTP Ex. 3.
These violations are now administratively final.

4 Tn accordance with FDA guidance, CTP counted the violations observed at the initial
inspection as a single violation, and the violations observed at subsequent inspections as
separate individual violations. See Orton Motor, Inc. d/b/a Orton’s Bagley v. U.S. Dep’t
of Health & Human Servs., No. 16-1299 (D.C. Cir. Mar. 20, 2018).
Current violations at issue

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 March 11, 2018, at approximately 4:08 PM,
Respondent:

(1) Sold cigarettes to a minor in violation of 21 C.F.R. § 1140.14(a)(1); and

(2) Failed to verify the age of the purchaser by means of photographic
identification containing the bearer's date of birth, in violation of 21 C.F.R.
§ 1140.14(a)(2)(i).

CTP has the burden to prove 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 I detail below, I find that
based on the evidence of record, it is more likely than not that Respondent sold cigarettes
to a minor and failed to verify photographic identification of the purchaser on March 11,
2018, in violation of 21 C.F.R. § 1140.14(a)(1) and (a)(2)(i).

CTP asserts that on March 11, 2018, at approximately 4:08 PM, Respondent sold
cigarettes to a minor and failed to verify the age of the purchaser by means of
photographic identification containing the bearer's date of birth. Complaint at 3.

CTP’s case against Respondent rests on the testimony of Inspector Bishop supported by
corroborating evidence including contemporaneous notes and photographs. CTP Exs. 4-
11. Inspector Bishop is an FDA-commissioned officer for the state of Michigan whose
duties include determining whether retail outlets unlawfully sell tobacco products to
minors or fail to comply with the photo identification requirements relating to the sale of
tobacco products. CTP Ex. 6 at 1-2. Inspector Bishop’s inspections entail accompanying
and providing direct field oversite to minors who attempt to purchase tobacco products
from retail establishments such as the one operated by Respondent. Jd. Inspector Bishop
testified that he conducted such an inspection of Respondent’s establishment on March
11, 2018, at approximately 4:08 PM. CTP Ex. 6 at 2-3.

Inspector Bishop testified that on March 11, 2018, he went to Respondent’s establishment
accompanied by a minor. CTP Ex. 6 at 2-3. He verified that the minor had no tobacco
products in the minor’s possession prior to entering the establishment but that the minor
possessed true and accurate photographic identification showing the minor’s actual date
of birth. /d. at 2. Inspector Bishop entered Respondent’s establishment following the
minor, and took up a position from which he had an unobstructed view of Respondent’s
sales counter and the minor. /d. at 3. He watched the minor purchase a package of
cigarettes and observed the clerk fail to check the minor’s identification. Jd.
Inspector Bishop testified that after the purchase, he and the minor exited the
establishment, and returned to the vehicle where the minor immediately gave him the
pack of cigarettes. CTP Ex. 6 at 3. Inspector Bishop labeled the cigarettes as evidence,
photographed all of the panels of the package, and processed the evidence in accordance
with standard procedures. Jd. Shortly after the inspection, Inspector Bishop recorded the
inspection in the FDA’s Tobacco Inspection Management System and created a Narrative
Report. Id.

CTP corroborated Inspector Bishop’s testimony by offering as evidence photographs that
Inspector Bishop took of the cigarettes that the minor purchased on the date in question.
CTP Exs. 10-11. CTP also submitted the Tobacco Inspection Management System
inspection detail and the Narrative Report Inspector Bishop created contemporaneously
with the inspection. CTP Exs. 8-9.

Rafid Jammoa is Respondent’s owner and representative in this matter.> Mr. Jammoa
stated that he and his manager, Jalal Kattoula, were the only two clerks on duty that day.
Neither Mr. Jammoa nor Mr. Kattoula recall selling tobacco products to a minor.

R. Post-Hrg. Br. at 3; R. Ex. 1 at 1.

Specifically, Mr. Jammoa testified that he does not know whether he or his staff sold the
tobacco product to the minor. Tr. at 40. Mr. Jammoa stated:

... [If 1 ask myself, if I sell to a minor, I'll say no, because I
don't remember what happened and I wish I had the video
cameras that record more than four days or seven days in a
month, I wish. I just wanted to know what I did is right, [or]
what I did is wrong. And [if] I did that. That's the whole
point of this whole case. That's what I'm trying to figure out,
what I did.

Id.

After the hearing, Mr. Jammoa asserted “I’m not trying to deny something I have done or
I’m not trying to run away from a penalty but in fact I just don’t know if this ever
happened or not.” R. Post-Hrg. Br. at 3. Mr. Jammoa stated, “Your Honor, I wish I had
better surveillance cameras to go back and check if the violations really occurred at my
location.” Jd. He emphasized, “. . . we don’t sell to minors willingly, so it’s very hard
for my employees and I to remember and admit something unknown to us.” Jd.

5 The transcript erroneously identified Mr. Jammoa as “Rafid Jammoa, Esq.” Tr. at 2.
I correct the record to reflect that Mr. Jammoa appeared pro se on behalf of Respondent.
Respondent’s manager, Jalal Kattoula, testified similarly. “I don’t recall or remember
selling tobacco products to a minor or anybody else that looks under the age of 30.
... Rafid Jammoa and I were the only ones in the store that day. I’m really good at

checking [identifications] of customers that

minor and failed to verify the identification
shirk his responsibilities. However, he also
sufficient evidence to show that his establis|

surveillance cameras, no cash register recei

he did not know how much the minor paid

look under the age of 30 when they attempt

to buy tobacco products.” R. Ex. 1 at 1; see Tr. at 43.

Mr. Jammoa admits that he does not know whether he or his manager sold cigarettes to a

of the purchaser, and he does not attempt to
believes that CTP has not submitted
ment made the illegal sale. R. Post-Hrg. Br.

at 3. Mr. Jammoa testified: “Now, if they ask me, is there evidence of you now to prove
to me that I sold to a minor, I will say, no, too, because the only evidence that you -- or
the pack of cigarettes, which they can get from everywhere in the state. I'm not the only
one who sells Marlboro ....” Tr. at 40. Respondent stated: “[T]here was no

pt of the transaction, and no price for the

merchandise the minor purchased.” R. Post-Hrg. Br. at 3. Respondent submitted cash
register receipts that do not show a cigarette sale on March 11, 2018, at approximately
4:08 PM. R. Ex. 6 at 9-10. Respondent takes exception to the Inspector’s testimony that

for the cigarettes, but estimated “right around

$7.” R. Post-Hrg. Br. at 3; Tr. at 26. Respondent explained: “The price is important to
me, so I can determine if the pack of Marlboro cigarettes came out of my store.” R. Post-

Hrg. Br. at 3.

Respondent takes issue with what he descri

bes as unfair inspection procedures as CTP’s

policy. Specifically, Respondent takes exception to CTP’s policy to not notify the
establishment at the time of the asserted violation. R. Post-Hrg. Br. at 2-4. Respondent
expressed frustration at not being able to determine if and how the violations occurred,

and accordingly whether to take responsibi

ity or to deny the allegations. R. Post-Hrg.

Br. at 2-5; Tr. at 36, 40. However, how CTP conducts its inspections is not at issue

before me.

At issue before me is whether the allegations in the complaint are true, and, if so, whether
these actions constitute a violation of law. 21 C.F.R. § 17.45. I must determine whether
— based on a preponderance of the evidence legal standard — Respondent sold cigarettes

to a minor and failed to verify the purchaser’s identification on March 11, 2018.

21 CFR. § 17.33.

I found Mr. Jammoa extraordinarily credible. He testified truthfully, honestly, and

accurately, even when it was against his interests. I found his testimony markedly sincere

and of authentic character. His statements were consistent, earnest, and believable.

I find that Mr. Jammoa testified credibly that he did not know whether his establishment

sold cigarettes to a minor on March 11, 201

8. Lam persuaded that he does not know. I
also find that Inspector Bishop testified credibly that on March 11, 2018, he watched a
minor purchase a package of cigarettes from Respondent’s establishment and observed
the clerk fail to check the minor’s identification. I am persuaded that his account of what
he observed is truthful and accurate.

The testimony of Inspector Bishop supported by corroborating evidence (CTP Exs. 4-11)
is sufficient to establish that it is more likely than not that on March 11, 2018, at
approximately 4:08 PM, Respondent’s establishment sold cigarettes to a minor and failed
to verify the age of the purchaser by means of photographic identification containing the
bearer's date of birth in violation of 21 C.F.R. § 1140.14(a)(1) and (a)(2)(i). 21 C.F.R.

§ 17.33(b). I do not find Respondent’s evidence sufficient to merit an affirmative defense
to negate liability. 21 C.F.R. § 17.33(c).

Accordingly, I find that the facts as outlined above establish Respondent’s liability under
the Act.

B. Civil Money Penalty

I have found that Respondent committed five violations of the Act and its implementing
regulations within a 36-month period. The FDA, and its CTP, may seek civil money
penalties from any person who violates the Act’s requirements as they relate to the sale of
tobacco products. 21 U.S.C. § 333 (f)(9). In its Complaint, CTP sought to impose the
maximum penalty amount, $5,591, against Respondent. Complaint § 1. Accordingly, I
now turn to whether a $5,591 civil money penalty is appropriate.

i. Determining Amount of Civil Money Penalty

When determining the amount of a civil money penalty, I am required to take into
account “the nature, circumstances, extent, and gravity of the violation or 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); see also 21 C.F.R. § 17.34.

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

Respondent has failed to comply with the Act and its implementing regulations five times
over a three-year period. Specifically, on, May 2, 2015, May 11, 2016, and March 11,
2018, Respondent sold cigarettes to a minor and failed to verify photographic
identification of the purchaser. Each violation was serious because it contravened federal
laws enacted to protect minors from the adverse health effects associated with tobacco
use. The repeated inability of Respondent to comply with federal tobacco regulations is
serious in nature and the civil money penalty amount should be set accordingly.
2. Respondent’s Ability to Pay and Effect on Respondent’s
Ability to Continue to Do Business

Respondent argues that it does not have the ability to pay the penalty amount and that
such a penalty would adversely affect Respondent’s ability to continue to do business.
Respondent provided very little documentary evidence to support this assertion. R. Ex. 7.
However, Mr. Jammoa testified under penalty of perjury to this assertion. R. Ex. 9 at 10.
Specifically, Mr. Jammoa testified that “[t]he penalty amount will have a negative impact
on my business and myself.” Jd. Mr. Jammoa testified that his “business is slow and
barely making it through.” Jd. He attested, “I don’t have this much money... .” Jd. As
I have detailed, I found Mr. Jammoa’s testimony to be distinctly credible, and again, I
believe him. I conclude Mr. Jammoa’s credible assertion is sufficient to support a finding
of a reduction in penalty on this basis.

3. History of Prior Violations

Respondent previously violated three regulations over a two-year period. Specifically,
Respondent sold cigarettes to a minor and failed to verify the purchaser’s identification
on May 2, 2015, and May 11, 2016. Respondent’s continued inability to comply with the
federal tobacco regulations, as this is Respondent’s second CMP, calls for an increased
penalty in this instance.

4. Degree of Culpability

Based on my finding that Respondent committed the most recent violations in the current
complaint, I hold it responsible for five violations of the Act and its implementing
regulations.

5. 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
assure that they make their sales in compliance with law.

I believe that Respondent understands this. Mr. Jammoa’s testimony, including his
demeanor and inflection, showed that he recognized the seriousness of the offense and
was authentically troubled that it may have occurred. See Tr. at 40. Even after the
hearing, Mr. Jammoa stated that the allegation has made him “seriously mentally and
emotional sick.” R. Post-Hrg. Br. at 4. He states:

... this past 7 months have been really hard on me, this case
is driving me crazy. When I go to sleep I think about it, it is
in my thoughts when I eat, I am always thinking about it and
it won’t leave me alone.

R. Post-Hrg. Br. at 4. It is apparent that Respondent takes allegations of such violations
very seriously. It is clear that Mr. Jammoa is deeply troubled that either he or his
manager may have mistakenly sold cigarettes to a minor.

Respondent has taken additional steps to mitigate the chance of additional violations.
Mr. Jammoa states that he takes these violations very seriously and implemented stricter
policies. Answer at 4. For instance, he states that he is carding every tobacco product
customer, even if that customer appears over 30 years old. R. Post-Hrg. Br. at 4.
Respondent also expressed interest in additional resources to prevent any future
occurrence.® Throughout the course of this administrative proceeding, I have been
impressed with Mr. Jammoa’s effort to comply with judicial directives and to follow
rules and procedures that are unfamiliar to him. I believe that he intends to institute
sufficient prevention measures to avoid further unlawful sales.

I have found the testimony on Respondent’s behalf to be extraordinarily credible and the
statements truthful and made in earnest. Respondent understands the gravity of its
actions when it sold - whether intentionally or not - tobacco products to minors and failed
to verify the identification of the purchasers. I believe that Respondent has been
significantly impacted by this matter and will take all necessary measures to prevent a
reoccurrence. Accordingly, I do not think that a $5,591 penalty is necessary or
appropriate in this case. I conclude that a reduced civil money penalty is appropriate.

ii. Appropriate Penalty
Based on the foregoing reasoning, I find a penalty amount of $1,118 to be appropriate

under 21 U.S.C. § 333(£)(5)(B) and (£)(9).

Conclusion

Pursuant to 21 C.F.R. § 17.45, I enter judgment in the amount of $1,118 against
Respondent, R and R Family, Inc. d/b/a Riverfront Liquor Shoppe, for five violations of

© Respondent may review the materials available at_https:/Avww.fda.gov/Tobacco
Products/GuidanceComplianceRegulatoryInformation/Retail/default.htm, including
access to free age verification calendars and other materials though CTP’s “This is Our
Watch” program as well as links to an “FDA Age Calculator” smartphone app.

10

the Act, 21 U.S.C. § 301 et seq., and its implementing regulations, 21 C.F.R. pt. 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.

/s/
Margaret G. Brakebusch
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division

Center for Tobacco Products,
(FDA No. FDA-2018-H-2113)

Complainant
v.

The Deters Company
d/b/a Blue Pantry,

Respondent.
Docket No. T-18-2408
Decision No. TB3426
Date: January 11, 2019
INITIAL DECISION AND DEFAULT JUDGMENT

The Center for Tobacco Products (CTP) began this matter by serving an administrative
complaint on Respondent, The Deters Company d/b/a Blue Pantry, at 7230 Turfway
Road, Florence, Kentucky 41042, and by filing a copy of the complaint with the Food
and Drug Administration’s (FDA) Division of Dockets Management. The complaint
alleges that Blue Pantry impermissibly sold covered tobacco products to a minor and
failed to verify, by means of photo identification containing a date of birth, that the
purchaser was 18 years of age or older, thereby violating 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. The complaint also alleges that Respondent previously sold covered tobacco
products to minors and failed to verify, by means of photo identification containing a date
of birth, that the purchasers were 18 years of age or older. The complaint further alleges
that Respondent Blue Pantry previously admitted to three violations of regulations found
at 21 C.F.R. pt. 1140 and, therefore, CTP seeks to impose a $5,591 civil money penalty
against Respondent Blue Pantry.

During the hearing process, Respondent failed to comply with two judicial directions
regarding CTP’s discovery request. I therefore strike Respondent’s answer and issue this
decision of default judgment.
I. Background

As provided for in 21 C.F.R. §§ 17.5 and 17.7, on June 6, 2018, CTP served the
complaint on Respondent Blue Pantry by United Parcel Service. Respondent timely filed
an answer, in which, Respondent admitted the allegations in the complaint but requested
a reduced penalty amount.

On September 4, 2018, I issued an Acknowledgment and Pre-hearing Order (APHO)
acknowledging receipt of Respondent’s answer and setting forth case procedures and
deadlines. The APHO contained a provision that set out instructions regarding a party's
request for production of documents. That provision states, in part, that a party had until
October 12, 2018, to request that the other party provide copies of documents relevant to
this case. The APHO also stated that, pursuant to 21 C.F.R. § 17.23(a), a party receiving
such a request must provide the requested documents no later than 30 days after the
request has been made. The parties were warned that failure to comply with any order
including the APHO may result in sanctions.

On November 9, 2018, CTP filed a Motion to Compel Discovery stating that it served its
request for production of documents (RFP) on Respondent on September 24, 2018. CTP
further stated that it did not receive a response from Respondent regarding its RFP, and
requested that I issue an order requiring Respondent to comply. Respondent did not file a
response to CTP’s Motion to Compel Discovery. Therefore, on November 29, 2018, I
granted CTP’s Motion to Compel Discovery and ordered Respondent to comply with
CTP’s RFP by December 14, 2018. I warned Respondent that failure to comply with my
order may result in sanctions, including the issuance of an Initial Decision and Default
Judgment finding Respondent liable for the violations listed in the complaint and
imposing a civil money penalty.

On December 19, 2018, CTP filed a Status Report and Motion to Impose Sanctions
stating that Respondent has not produced any documents as ordered. CTP requested I
strike Respondent’s answer, and issue an initial decision and default judgment imposing a
civil money penalty against Respondent. In a December 20, 2018 letter issued by my
direction, Respondent was given until January 3, 2019 to file a response to CTP’s Motion
to Impose Sanctions. To date, Respondent has not responded to the Motion to Impose
Sanctions or to the December 20, 2018 letter.

Therefore, pursuant to 21 C.F.R. § 17.35, 1am granting CTP’s Motion to Impose
Sanctions, and striking Respondent’s answer for failing to comply with two separate
judicial directions. Specifically, Respondent failed to comply with my September 4,
2018 APHO and Respondent failed to comply with my November 29, 2018 order
requiring it to comply with CTP’s RFP. Additionally, Respondent failed to respond to
CTP’s Motion to Impose Sanctions or the December 20, 2018 letter. This repeated
conduct is sufficiently egregious to warrant striking Respondent’s answer and issuing an
initial decision by default.

I. Default Decision

Striking Respondent’s answer leaves the complaint unanswered. Pursuant to 21 C.F.R.
§ 17.11, Lassume that the facts alleged in the complaint (but not its conclusory
statements) are true. Specifically:

e On July 28, 2017, CTP initiated a previous civil money penalty action, CRD
Docket Number T-17-5488, FDA Docket Number FDA-2017-H-4448, against
Respondent for three! violations of 21 C.F.R. pt. 1140 within a twenty-four month
period. CTP alleged those violations to have occurred at Respondent’s business
establishment, 7230 Turfway Road, Florence, Kentucky 41042, on February 7,
2017, and May 21, 2017;

e The previous action concluded when Respondent admitted the allegations
contained in the complaint issued by CTP, and paid the agreed upon monetary
penalty in settlement of that claim. Further, “Respondent expressly waived its
right to contest such violations in subsequent actions”;

e At approximately 7:38 p.m. on April 24, 2018, at Respondent’s business
establishment, 7230 Turfway Road, Florence, Kentucky 41042, an
FDA-commissioned inspector documented Respondent’s staff selling a package of
two Swisher Sweets Grape cigars to a person younger than 18 years of age. The
inspector also documented that staff failed to verify, by means of photographic
identification containing a date of birth, that the purchaser was 18 years of age or
older.

These facts establish Respondent Blue Pantry’s liability under the Act. The Act prohibits
misbranding of a tobacco product. 21 U.S.C. § 331(k). A tobacco product is misbranded
if sold or distributed in violation of regulations issued under section 906(d) of the Act.

21 U.S.C. § 387f(d); see 21 U.S.C. § 387c(a)(7)(B); 21 C.F.R. § 1140.1(b). The
Secretary of the U.S. Department of Health and Human Services issued the regulations at
21 C.F.R. pt. 1140 under section 906(d) of the Act. 21 U.S.C. § 387a-1; see 21 U.S.C.

§ 387f(d)(1); 75 Fed. Reg. 13,225, 13,229 (Mar. 19, 2010); 81 Fed. Reg. 28,974, 28,975-
76 (May 10, 2016). Under 21 C.F.R. § 1140.14(b)(1), no retailer may sell covered
tobacco products to any person younger than 18 years of age. Under 21 C.F.R.

' Two violations were documented on February 7, 2017, and two on May 21, 2017. In
accordance with customary practice, CTP counted the violations at the initial inspection
as a single violation, and all subsequent violations as separate individual violations.
§ 1140.14(b)(2)(), retailers must 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.

Under 21 C.F.R. § 17.2, a $5,591 civil money penalty is permissible for five violations of
the regulations found at 21 C.F.R. pt. 1140

Order

For these reasons, I enter default judgment in the amount of $5,591 against Respondent
The Deters Company d/b/a Blue Pantry. Pursuant to 21 C.F.R. § 17.11(b), this order
becomes final and binding upon both parties after 30 days of the date of its issuance.

/s/
Margaret G. Brakebusch
Administrative Law Judge