Route 291 Fuel Stop Inc. d/b/a 291 Fuel Stop, DAB TB7769 (2024)

INITIAL DECISION AND DEFAULT JUDGMENT

The Center for Tobacco Products (CTP) filed an Administrative Complaint (Complaint) against Respondent, Route 291 Fuel Stop Inc. d/b/a 291 Fuel Stop, that alleges facts and legal authority sufficient to justify the imposition of a civil money penalty of $638.  The Complaint alleges that Respondent impermissibly sold regulated tobacco products to persons under the legal age and failed to verify that purchasers were of sufficient age, thereby violating the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 301 et seq., and its implementing regulations, Cigarettes and Smokeless Tobacco, 21 C.F.R. pt. 1140.  CTP seeks a civil money penalty of $638.

During the course of these administrative proceedings, Respondent failed to comply with orders and procedures governing this proceeding and failed to defend its action, which interfered with the speedy, orderly, or fair conduct of this proceeding.  21 C.F.R. § 17.35(a).  Accordingly, pursuant to 21 C.F.R. § 17.35, I strike Respondent’s Answer and issue this decision of default judgment.

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I. Procedural History

On August 25, 2023, CTP served the Complaint on Respondent by United Parcel Service, pursuant to 21 C.F.R. §§ 17.5 and 17.7.  Respondent timely filed its Answer to CTP’s Complaint.  On October 3, 2023, I issued an Acknowledgement and Status Report Order (ASRO) that set requirements governing this proceeding, including deadlines for the parties’ filings and exchanges.  I warned that:

I may impose sanctions including, but not limited to, dismissal of the complaint or answer, if a party fails to comply with any order (including this order), fails to prosecute or defend its case, or engages in misconduct that interferes with the speedy, orderly, or fair conduct of the hearing.  21 C.F.R. § 17.35.

ASRO ¶ 21.

I ordered CTP to file its pre-hearing exchange by December 26, 2023, and Respondent to file its pre-hearing exchange by January 16, 2024.  ASRO ¶ 6(a), (b); see 21 C.F.R. § 17.25(a).  CTP timely filed its exchange including a pre-hearing brief and 21 proposed exhibits.  Respondent did not file its exchange as required.

On January 19, 2024, I issued an Order to Show Cause, in which I required Respondent to show cause for its failure to comply with my ASRO.  I indicated that Respondent appeared to have abandoned its request for hearing and provided Respondent until February 1, 2024, to respond.  I warned Respondent that:

. . . I will dismiss the hearing request and enter a default judgment in favor of CTP unless Respondent files its pre-hearing exchange by February 1, 2024.

Order to Show Cause (emphasis in original).

To date, Respondent has not filed its pre-hearing exchange as twice ordered or otherwise responded to my Order to Show Cause.  Indeed, Respondent has been silent since filing its Answer on September 12, 2023.

II. Striking Respondent’s Answer

I may sanction a party for:

(1) Failing to comply with an order, subpoena, rule, or procedure governing the proceeding;

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(2) Failing to prosecute or defend an action; or
(3) Engaging in other misconduct that interferes with the speedy, orderly, or fair conduct of the hearing.

21 C.F.R. § 17.35(a).

Here, Respondent failed to:

• Comply with my October 3, 2023 ASRO when it failed to file its pre-hearing exchange by January 16, 2024; and
• Comply with my January 19, 2024 Order to Show Cause when it failed to show cause for its failure to comply with my ASRO or file its pre-hearing exchange by February 1, 2024.

I find that Respondent failed to comply with orders and procedures governing this proceeding and failed to defend its action, which has interfered with the speedy, orderly, or fair conduct of this proceeding.  21 C.F.R. § 17.35(a).  I conclude that Respondent’s conduct establishes a basis for sanctions pursuant to 21 C.F.R. § 17.35, and that sanctions are warranted.

The harshness of the sanctions I impose must reasonably relate to the nature and severity of the misconduct or failure to comply.  21 C.F.R. § 17.35(b).  Here, Respondent repeatedly failed to comply with my orders, despite my warnings that its failure could result in sanctions.  ASRO ¶ 21; Order to Show Cause.  I explicitly warned Respondent that those sanctions would include “dismiss[ing] the hearing request and enter[ing] a default judgment in favor of CTP . . . .”  Order to Show Cause; see also ASRO ¶ 21.  Respondent also failed to defend its action, despite my order providing the opportunity.  Order to Show Cause.  Respondent’s repeated misconduct interfered with the speedy, orderly, or fair conduct of this proceeding.

I find that Respondent’s misconduct is sufficient to warrant striking its Answer and issuing a decision by default, without further proceedings.  21 C.F.R. § 17.35(b), (c)(3), (d), (e).  Accordingly, I strike Respondent’s Answer, and issue this Initial Decision and Default Judgment.  21 C.F.R. §§ 17.35, 17.11(a).

III. Default Decision

Striking Respondent’s Answer leaves the Complaint unanswered.  Therefore, I am required to issue an initial decision by default, provided that the Complaint is sufficient to justify a penalty.  21 C.F.R. § 17.11(a).  Pursuant to 21 C.F.R. § 17.11(a), I am required to “assume the facts alleged in the [C]omplaint to be true” and, if those facts establish liability under the Act, issue a default judgment and impose a civil money penalty.

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Accordingly, I must determine whether the allegations in the Complaint establish violations of the Act.

Specifically, CTP alleges the following facts in its Complaint:

• Respondent owns 291 Fuel Stop, an establishment that sells tobacco products and is located at 1398 Industrial Highway, Eddystone, Pennsylvania 19022.  The establishment previously served as Conoco but has been owned and operated by Route 291 Fuel Stop Inc. during the relevant timeframe.  Complaint ¶¶ 11-12.
• An FDA-commissioned inspector conducted an inspection of Respondent’s establishment on November 8, 2021, at approximately 1:38 PM, during which “a person younger than 21 years of age was able to purchase a package of two Garcia y Vega Game Blue cigars . . . .”  Additionally, “the underage purchaser’s age was not verified before the sale . . . .”  Complaint ¶ 15.
• On December 21, 2021, CTP issued a Warning Letter to Respondent regarding the November 8, 2021 inspection.  The letter explained that the inspector documented violations of federal law, and that the named violations were not necessarily intended to be an exhaustive list of all violations at the establishment.  The Warning Letter also stated that if Respondent failed to correct the violations, regulatory action by the FDA or a civil money penalty action could occur and that it is Respondent’s responsibility to comply with the law.  Complaint ¶¶ 15-16.
• An FDA-commissioned inspector conducted a subsequent inspection of Respondent’s establishment on June 10, 2023, at approximately 10:30 AM, during which “a person younger than 21 years of age was able to purchase a package of Newport Box 100s cigarettes . . . .”  Additionally, “the underage purchaser’s age was not verified before the sale . . . .”  Complaint ¶ 13.

These facts establish 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 distributed or offered for sale in any state in violation of regulations issued under section 906(d) of the Act.  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 also 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); see also 21 U.S.C. § 387f (note) (directing the Secretary to change references to persons younger than 18 to younger than 21, and to change the age verification requirements from individuals under the age of 26 to under the age of 30, in 21 C.F.R. subpart B of part 1140).  Under section 906(d)(5) of the Act, no retailer may sell regulated tobacco products to any person younger than 21 years of age and retailers must verify, by means of photographic identification containing a

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purchaser’s date of birth, that no regulated tobacco product purchasers are younger than 21 years of age.

Taking the above alleged facts as true, Respondent violated the prohibition against selling regulated tobacco products to persons younger than 21 years of age on November 8, 2021, and June 10, 2023.  Act § 906(d)(5).  On the same dates, Respondent also violated the requirement that retailers verify, by means of photo identification containing a purchaser’s date of birth, that no regulated tobacco product purchasers are younger than 21 years of age.¹  Act § 906(d)(5).  Therefore, Respondent’s actions constitute violations of law that merit a civil money penalty.

CTP has requested a civil money penalty of $638, which is a permissible penalty for three² violations of the regulations found at 21 C.F.R. pt. 1140 within a 24-month period.  21 C.F.R. § 17.2.  Therefore, I find that a civil money penalty of $638 is warranted and so order one imposed.

Endnotes

¹  I note that CTP cites 21 C.F.R. § 1140.14(a)(2)(i) and (b)(2)(i), which have not been updated to reflect the age change, for the identification violations alleged on November 8, 2021, and June 10, 2023.  See Complaint ¶¶ 13.b, 15.b.

²  Two violations were committed on November 8, 2021, and two on June 10, 2023.  In accordance with customary practice, CTP counted the violations identified during the November 8, 2021 inspection as a single violation, and the violations identified during the subsequent inspection individually.