The Center

Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Center for Tobacco Products,
Complainant
v.
Azon Liquors Inc.,

Respondent.

Docket No. C-13-828

FDA Docket No. FDA-2013-H-0642
Decision No. CR2863

Date: July 19, 2013

INITIAL DECISION AND DEFAULT JUDGMENT

‘or Tobacco Products (CTP) filed an administrative complaint (Complaint)

against Respondent, Azon Liquors Inc., that alleges facts and legal authority sufficient to

justify impo:

sing a $500 civil money penalty. Respondent did not timely answer the

Complaint, nor did Respondent request an extension of time within which to file an
answer. Therefore, I enter a default judgment against Respondent and assess a civil

money penal

ty of $500.

CTP began this case by filing a copy of the Complaint with the Food and Drug
Administration’s (FDA) Division of Dockets Management and serving the Complaint on

Respondent.
unlawfully s
tobacco pro

The Complaint alleges that, on two separate occasions, Respondent
old a tobacco product to a minor and failed to verify that the purchaser of the
uct was of sufficient age, thereby violating the Federal Food, Drug, and

Cosmetic Act (Act), codified at 21 U.S.C. §§ 301-399d, and its implementing regulations
found at 21 C.F.R. Part 1140. CTP seeks a civil monetary penalty of $500 for these

violations.
On June 3, 2013, CTP served the Complaint on Respondent by United Parcel Service,
pursuant to 21 C.F.R. §§ 17.5 and 17.7. In the Complaint and accompanying cover letter,
CTP explained that, within 30 days, Respondent should pay the penalty, file an answer,
or request an extension of time within which to file an answer. CTP warned Respondent
that, if it failed to take one of these actions within 30 days, an Administrative Law Judge
could issue an initial decision by default ordering Respondent to pay the full amount of
the proposed penalty, pursuant to 21 C.F.R. § 17.11.

Respondent has not filed an answer within the time provided by regulation or timely
requested an extension. Pursuant to 21 C.F.R. § 17.11(a), 1am required to “assume the
facts alleged in the complaint to be true[] and, if such facts establish liability under [the
Act],” issue an initial decision by default and impose a civil monetary penalty.
Accordingly, I must determine whether the allegations in the Complaint establish
violations of the Act.

Specifically, CTP alleges that:

e Respondent owns Azon Liquors, an establishment that sells tobacco products and
is located at 384 Walnut Street Extension, Agawam, Massachusetts 01001.
Complaint 3.

e¢ On April 29, 2012, an FDA-commissioned inspector observed two violations at
Azon Liquors. First, “a person younger than 18 years of age was able to purchase
a package of Marlboro cigarettes . . . at approximately 12:56 PM ET[.]” The
inspector also noted that “the minor’s identification was not verified before the
[April 29, 2012,] sale... .” Complaint § 10.

e “[OJn June 21, 2012, CTP issued a Warning Letter to Azon Liquors.” The letter
informed Respondent of the violations the FDA-commissioned inspector had
observed on April 29, 2012, and explained that the FDA could initiate a civil
money penalty or other regulatory action if Respondent failed to correct the
violations. Moreover, CTP explained that the Warning Letter was not intended to
provide an exhaustive list of violations and that Azon Liquors was responsible for
complying with the law. Complaint § 10.

e Respondent’s President, Michael W. Beaudry, responded in writing to the
Warning Letter on Respondent’s behalf on June 25, 2012. Mr. Beaudry explained
that, during trainings and meetings, “employees are reminded to check
identification for customers who look under the age of forty.” Moreover, Mr.
Beaudry indicated that “[h]e also instructed his staff to check identification
regularly to prevent future violations.” Complaint 11.
e On October 16, 2012, CTP acknowledged that it had received Respondent’s
response. CTP also reminded Respondent that it had a continuing duty to comply
with the law. Complaint § 11.

e During a following inspection, FDA-commissioned inspectors documented two
additional violations. “Specifically, a person younger than 18 years of age was
able to purchase a package of Marlboro cigarettes on November 10, 2012, at
approximately 12:08 PM ET[.]” And, “the minor’s identification was not verified
before the [November 10, 2012,] sale... .” Complaint ¥ 1.

Taking these facts as true, I must find, pursuant to 21 C.F.R. § 17.11(a), that Respondent
is liable 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, codified at 21 U.S.C. § 387f(d). 21 U.S.C. §
387c(a)(7)(B); 21 C.F.R § 1140.1(b). Those regulations prohibit the sale of “cigarettes or
smokeless tobacco to any person younger than 18 years of age[.]” 21 C.F.R. §
1140.14(a). Those regulations also require a retailer to “verify by means of photographic
identification containing the bearer’s date of birth that no person purchasing the [tobacco]
product is younger than 18 years of age[.]” 21 C.F.R. § 1140.14(b)(1).

Here, Respondent violated 21 C.F.R. § 1140.14(a) and (b)(1) on two separate occasions.
First, on April 29, 2012, Respondent unlawfully sold a tobacco product to a minor
without verifying that the purchaser was not younger than 18 years of age, in violation of
21 C.F.R. § 1140.14(a) and (b)(1). Then, on November 10, 2012, Respondent again sold
a tobacco product to a minor without verifying that the minor was of sufficient age.
Therefore, Respondent’s actions and omissions on two separation occasions at the same
retail outlet constitute violations of law for which a civil money penalty is merited.

The regulations require me to impose a civil money penalty in the amount that is either
the maximum provided for by law or the amount sought in the Complaint, whichever is
smaller. 21 C.F.R. § 17.11(a). Respondent has committed its fourth violation within a
24-month period, the maximum penalty for which is $2000. 21 C.F.R. § 17.2. CTP,
however, has requested a civil money penalty in the amount of $500, which is the
maximum penalty for the third violation committed within a 24-month period. Therefore,
l impose a civil money penalty in the amount of $500.

/s/
Steven T. Kessel
Administrative Law Judge