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                              Community Mini Market 1 Inc. d/b/a Community Mini Market, DAB TB5208 (2020)
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Community Mini Market 1 Inc. d/b/a Community Mini Market, DAB TB5208 (2020)








  
  
    

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





Center for Tobacco Products,
	Complainant,
v.
Community Mini Market 1 Inc.
	d/b/a Community Mini Market,
	Respondent.
Docket No. T-20-1311FDA Docket No. FDA-2020-H-0065Decision No. TB5208August 5, 2020

        
              
    

      INITIAL DECISION AND DEFAULT JUDGMENT
The Center for Tobacco Products (CTP) began this matter by serving an administrative complaint (Complaint) on Respondent, Community Mini Market 1 Inc. d/b/a Community Mini Market, at 1801 Georges Lane, Philadelphia, Pennsylvania 19131, and by filing a copy of the Complaint with the Civil Remedies Division (CRD) of the Departmental Appeals Board (DAB).  The Complaint seeks an $11,410 civil money penalty from Respondent for 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, at least six times within a 48-month period.
The Complaint alleges CTP previously initiated a civil money penalty action against Respondent.  The prior action concluded after Respondent admitted to four violations of the Act.  Specifically, Respondent admitted that it sold regulated tobacco products to minors and failed to verify, by means of photo identification containing a date of birth, that a purchaser was 18 years of age or older.  The Complaint further alleges that Respondent subsequently committed two additional violations of the Act.  Specifically, Respondent sold regulated 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 Act.  Therefore, CTP seeks an $11,410 civil money penalty against Respondent for a total of six violations within a 48-month period.
Page 2
I.  Background and Procedural History
On January 9, 2020, CTP served the Complaint on Respondent, located at 1801 Georges Lane, Philadelphia, Pennsylvania 19131, by United Parcel Service, as required by 21 C.F.R. §§ 17.5 and 17.7.  Respondent registered for the DAB E-File system, and filed a timely Answer.  In its Answer, Respondent denied the allegations in the Complaint.
On January 31, 2020, I issued an Acknowledgment and Prehearing Order (APHO), acknowledging receipt of Respondent’s Answer and establishing procedural deadlines for this case.  The APHO ordered CTP to file its prehearing exchange by April 24, 2020 and Respondent to file its prehearing exchange by May 15, 2020.  APHO ¶ 4.  Further, the APHO warned the parties 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.”  APHO ¶ 16; *see also*21 C.F.R. § 17.35.
On April 24, 2020, CTP timely filed its prehearing exchange, consisting of a pre-hearing brief, a list of proposed witnesses and exhibits, and 15 exhibits (CTP Exs. 1-15), including the written direct testimony of two proposed witnesses, CTP’s Senior Regulatory Counsel Laurie Sternberg (CTP Ex. 5) and Inspector Jocelyn Carroll-Dixon (CTP Ex. 6).  Respondent did not file a prehearing exchange as directed by the APHO.
On May 20, 2020, I issued an order scheduling a prehearing conference.  I informed the parties of the date and time of the prehearing conference as well as the procedure to attend.  On May 28, 2020, the prehearing conference was rescheduled to June 18, 2020.  On June 18, 2020, I held the prehearing conference call.  Representatives for CTP appeared at the prehearing conference.  Respondent failed to appear as ordered.
On June 18, 2020, I issued an Order to Show Cause (OSC) giving Respondent until June 30, 2020****to show cause for its failure to appear at the prehearing conference.   Respondent was warned that failure to respond to the OSC 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.  To date, Respondent failed to respond to the OSC.
II.  Sanctions
The regulations authorize me to impose sanctions on any party for:
(1) Failing to comply with an order, subpoena, rule, or procedure governing the proceeding;
	(2) Failing to prosecute or defend an action; or
Page 3
(3) Engaging in other misconduct that interferes with the speedy, orderly, or fair conduct of the hearing.
21 C.F.R. § 17.35(a).  During the course of this administrative proceeding, Respondent failed to comply with two of my orders.  Specifically, Respondent failed to comply with my May 28, 2020 Order requiring it to appear at the prehearing conference, and Respondent failed to comply with my June 18, 2020 OSC requiring it to show cause for its failure to appear at the prehearing conference.  Respondent has also failed to defend this action.  After filing its Answer, Respondent has made no further submissions.  In its Answer, Respondent claimed to possess video surveillance evidence that it did not commit the violations as alleged in the Complaint.  However, Respondent failed to file a prehearing exchange or come forward with any evidence to support its position.  Respondent’s failure to file a prehearing exchange, failure to appear at the prehearing conference, and failure to respond to my OSC lead me to conclude that Respondent does not intend to defend this action.
Accordingly, I conclude that sanctions against Respondent are warranted.  Any sanction “shall reasonably relate to the severity and nature of the failure or misconduct.”  21 C.F.R. § 17.35(b).  I find that Respondent’s actions are sufficient to warrant striking its Answer and issuing a decision by default, without further proceedings.  21 C.F.R. § 17.35.
III.  Default Decision
Striking Respondent’s Answer leaves the Complaint unanswered.  Pursuant to 21 C.F.R. § 17.11, I assume that the facts alleged in the Complaint (but not its conclusory statements) are true.  Specifically:
On November 19, 2018, CTP initiated a previous civil money penalty action, CRD Docket Number T-19-565, FDA Docket Number FDA-2018-H-4384, against Respondent for four1
 violations of the Act.  CTP alleged those violations to have occurred at Respondent’s business establishment, 1801 Georges Lane, Philadelphia, Pennsylvania 19131, on June 29, 2017, April 7, 2018, and August 31, 2018;
	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 itsPage 4
right to contest such violations in subsequent actions;”
	An FDA-commissioned inspector conducted a subsequent inspection on October 27, 2019, at approximately 5:10 PM at Respondent’s business establishment located at 1801 Georges Lane, Philadelphia, Pennsylvania 19131.  During this inspection, a person younger than 18 years of age was able to purchase a package of two Garcia y Vega Game Pineapple cigars.  Additionally, Respondent’s 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’s liability under the Act.  The Act prohibits misbranding of a regulated tobacco product.  21 U.S.C. § 331(k).  A regulated 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 also*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).  Under 21 C.F.R. § 1140.14(a)(1) and 21 C.F.R. § 1140.14(b)(1), no retailer may sell regulated tobacco products to any person younger than 18 years of age.  Under 21 C.F.R. § 1140.14(a)(2)(i) and 21 C.F.R. § 1140.14(b)(2)(i), retailers must verify, by means of photographic identification containing a purchaser’s date of birth, that no regulated tobacco product purchasers are younger than 18 years of age.
Under 21 C.F.R. § 17.2, an $11,410 civil money penalty is permissible for six violations of the regulations found at 21 C.F.R. pt. 1140 within a 48-month period.
Order
For these reasons, I strike Respondent’s Answer and enter default judgment in the amount of $11,410 against Respondent.  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
      1. The complaint alleges one violation was committed on June 29, 2017, one on April 7, 2018, and two on August 31, 2018. back to note 1 Back to top
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