UNITED STATES OF AMERICA
BEFORE THE DEPARTMENTAL APPEALS BOARD
CIVIL REMEDIES DIVISION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

In the Case of:
Center for Tobacco Products,
Complainant,
v.
P. Lura LLC
d/b/a Shell / C-Store,
Respondent.

)
)
)
)
)
)
)
)
)
)
)
)
)

ADMINISTRATIVE COMPLAINT
FOR CIVIL MONEY PENALTY
FDA Docket No. FDA-2019-H-2252
CRD Docket No. T-19-2870

INTRODUCTION
1.

The Center for Tobacco Products (CTP), Food and Drug Administration (FDA),
United States Department of Health and Human Services, seeks a civil money
penalty (CMP) in the amount of $570 from P. Lura LLC, d/b/a Shell / C-Store
(Respondent) for violating FDA’s tobacco regulations promulgated under Section
906(d) of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 387f(d))
at least three times within a twenty-four month period.
LEGAL AUTHORITY

2.

FDA has the authority to seek a civil money penalty from any person who
violates a requirement of the Act related to tobacco products. 21 U.S.C.
§ 333(f)(9).

3.

The Act prohibits the misbranding of a tobacco product while such product is held
for sale after shipment of the product or its components in interstate commerce.

 21 U.S.C. § 331(k). A tobacco product is deemed to be misbranded if it is sold or
distributed in violation of regulations issued under Section 906(d) of the Act (21
U.S.C. § 387f(d)). 21 U.S.C. § 387c(a)(7)(B); 21 C.F.R. § 1140.1(b). Such
regulations include those codified at 21 C.F.R. Part 1140, which were issued
under Section 906(d) of the Act to impose restrictions on the sale and distribution
of and access to tobacco products.
4.

As of August 8, 2016, pursuant to 21 U.S.C. § 387a, FDA deemed additional
products meeting the definition of a tobacco product, except accessories to these
newly deemed products, to be subject to regulation under the Act. These
products include, but are not limited to, electronic nicotine delivery systems
(including e-cigarettes), e-liquids, cigars, and pipe tobacco. See Final Rule,
Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and
Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco
Control Act; Restrictions on the Sale and Distribution of Tobacco Products and
Required Warning Statements for Tobacco Products, 81 Fed. Reg. 28,974 (May
10, 2016), available at https://federalregister.gov/a/2016-10685 (hereafter
"Deeming Regulation").

5.

The Deeming Regulation amended the regulations codified at 21 C.F.R. Part
1140 to define the term "covered tobacco product" to mean "any tobacco product
deemed to be subject to the [Act] under 1100.2 of this chapter, but excludes any
component or part that is not made or derived from tobacco," see 21 C.F.R.
§ 1140.3, and to extend the Part 1140 restrictions on sale and distribution of and
access to tobacco products to "covered tobacco products," see 21 C.F.R.

2

 § 1140.1(a) (defining the Part 1140 regulations as "set[ting] out the restrictions
under the [Act] on the sale, distribution, and use of cigarettes, smokeless
tobacco, and covered tobacco products."). Therefore, selling or distributing a
tobacco product, including a "covered tobacco product," in violation of these
regulations causes that tobacco product to be misbranded. 21 U.S.C.
§ 387c(a)(7)(B).
6.

Retailers who have violated regulations promulgated under Section 906(d) of the
Act (21 U.S.C. §387f(d)) may incur a civil money penalty up to the maximum
amounts set forth in a schedule found in the Family Smoking Prevention and
Tobacco Control Act (TCA), Pub. L. No. 111-31, 123 Stat. 1776 (2009),
§ 103(q)(2)(A)(i) (codified at 21 U.S.C. § 333 note). See 21 C.F.R. § 17.2,
referencing 45 C.F.R. § 102.3 (setting forth, among other things, the current CMP
amounts, adjusted for inflation, for 2 or more violations). The current amounts
are available at http://www.fda.gov/TobaccoProducts/
GuidanceComplianceRegulatoryInformation/ucm232109.htm#civilmoneypenalty.
CURRENT ALLEGATIONS

7.

Respondent owns an establishment that does business under the name Shell /
C-Store and is located at 3000 North Belt Line Road, Irving, TX 75062.

8.

Respondent’s establishment receives tobacco products in interstate commerce,
including JUUL Classic Menthol e-liquid products and VUSE Berry e-liquid
products, and holds them for sale after shipment in interstate commerce.

3

 9.

On February 16, 2019, an FDA-commissioned inspector conducted an inspection
of Shell / C-Store. During this inspection, Respondent committed the following
violations:
a. Selling covered tobacco products to a minor, in violation of 21 C.F.R.
§ 1140.14(b)(1). Specifically, a person younger than 18 years of age was
able to purchase a JUUL Classic Menthol e-liquid product on February 16,
2019, at approximately 12:55 PM; and
b. Failing to verify the age of a person purchasing covered tobacco products by
means of photographic identification containing the bearer’s date of birth, as
required by 21 C.F.R. § 1140.14(b)(2)(i). Specifically, the minor’s
identification was not verified before the sale, as detailed above, on February
16, 2019, at approximately 12:55 PM.

10.

On February 19, 2019, CTP issued a Notice of Compliance Check Inspection to
Respondent’s establishment, stating that an inspection had been conducted on
February 16, 2019, and that during this inspection, a minor was able to enter the
establishment and purchase a regulated tobacco product at approximately
12:55 PM. This Notice stated that other potential violations of federal tobacco
law may have been observed, and further stated that if, after review, CTP
determined that there was a violation of federal law, the establishment may
receive further notification from FDA.

11.

On June 8, 2018, Respondent committed the following violations:
a. Selling covered tobacco products to a minor, in violation of 21 C.F.R.
§ 1140.14(b)(1). Specifically, a person younger than 18 years of age was

4

 able to purchase a VUSE Berry e-liquid product on June 8, 2018, at
approximately 2:28 PM; and
b. Failing to verify the age of a person purchasing covered tobacco products by
means of photographic identification containing the bearer’s date of birth, as
required by 21 C.F.R. § 1140.14(b)(2)(i). Specifically, the minor’s
identification was not verified before the sale, as detailed above, on June 8,
2018, at approximately 2:28 PM.
12.

On August 9, 2018, CTP issued a Warning Letter to Shell / C-Store, notifying
Respondent that FDA had documented the violations set forth in Paragraph 11.
UPS records show that the Warning Letter was received on August 10, 2018.
The Warning Letter stated that failure to correct the violations may result in a civil
money penalty action, or other regulatory action by FDA. The Warning Letter
also stated that it was the responsibility of Shell / C-Store to ensure compliance
with the law and that the letter was not intended as an exhaustive list of
violations. Additionally, on June 12, 2018, CTP issued a Notice of Compliance
Check Inspection to Respondent’s establishment, stating that an inspection had
been conducted on June 8, 2018, and that during this inspection, a minor was
able to enter the establishment and purchase a regulated tobacco product at
approximately 2:28 PM. This Notice stated that other potential violations of
federal tobacco law may have been observed and further stated that if, after
review, CTP determined that there was a violation of federal law, the
establishment may receive further notification from the FDA regarding the
violations.

5

 RESPONDING TO COMPLAINT
13.

Respondent must respond to this Complaint. The cover letter provides
information on options for responding. Respondent has the right to request a
hearing by filing an Answer within 30 days after service of the Complaint. 21
C.F.R. § 17.9. The Answer will be deemed to be a request for a hearing, unless
the Answer states otherwise. Failure to file an Answer within 30 days after
service of the Complaint may result in a default order imposing the proposed civil
money penalty. 21 C.F.R. § 17.11. The Answer must be filed with the
Departmental Appeals Board, Civil Remedies Division, 330 Independence Ave.,
S.W., Cohen Building, Room G-644 (MS 6132), ATTN: FDA CMP, Washington,
D.C. 20201. The Answer must include both the FDA Docket Number and CRD
Docket Number which are found at the top of this document.

14.

Respondent has the right, but is not required to retain counsel for representation.

6

 REQUEST FOR RELIEF
15.

CTP respectfully requests that an order assessing a civil money penalty against
Respondent in the amount of $570 be entered for three of Respondent’s
violations within a twenty-four month period.

DATED: May 13, 2019

Respectfully submitted,

/s/
Ann Simoneau
Attorney for Complainant
Food and Drug Administration
Center for Tobacco Products
Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Phone: (877) 287-1373
Fax: (301) 595-1438
CTP-CMP@fda.hhs.gov

7