Vivek Kumar Gupta d/b/a Prairie Creek Cove Grocery, DAB TB4303 (2019)

INITIAL DECISION AND DEFAULT JUDGMENT

The Center for Tobacco Products (CTP) began this matter by serving an administrative complaint on Respondent, Vivek Kumar Gupta d/b/a Prairie Creek Cove Grocery, at 14449 East Highway 12, Rogers, Arkansas 72756, and by filing a copy of the complaint with the Food and Drug Administration's (FDA) Division of Dockets Management. The complaint seeks an $11,410 civil money penalty from Respondent Prairie Creek Cove Grocery 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 Prairie Creek Cove Grocery. The prior action concluded after Respondent Prairie Creek Cove Grocery 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 two of the purchasers were 18 years of age or older. The complaint further alleges that Respondent Prairie Creek Cove Grocery subsequently committed two additional violations of the Act. Specifically, Respondent sold a regulated tobacco product 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

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money penalty against Respondent Prairie Creek Cove Grocery for a total of six violations within a 48-month period.

During the hearing process, Respondent failed to comply with multiple judicial orders and directions. 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, CTP served the complaint on Respondent Prairie Creek Cove Grocery by United Parcel Service on March 5, 2019. On April 3, 2019, Respondent timely filed its answer to the complaint. On April 5, 2019, I issued an Acknowledgment and Pre-hearing Order (APHO) 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 stated, in part, that a party had until May 13, 2019, to request that the other party provide copies of documents relevant to this case. APHO ¶ 12. 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. Id. In addition, the APHO stated that a party may file a motion for a protective order with the Civil Remedies Division within 10 days of receiving a request for the production of document. Id. See also 21 C.F.R. § 17.23(d). The parties were warned that failure to comply with any order including the APHO may result in sanctions. Id. ¶ 16.

On May 23, 2019, CTP filed a Motion to Compel Discovery stating that CTP's Request for Production of Documents (RFP) was sent to Respondent on April 9, 2019, and delivered to Respondent's establishment on April 10, 2019. CTP further stated that it did not receive a response from Respondent regarding its RFP, and requested that I issue an order compelling Respondent to respond to the RFP. In a May 24, 2019 letter issued by my direction, Respondent was given until June 7, 2019 to file a response to CTP's Motion to Compel Discovery. Respondent did not file a response to CTP's Motion to Compel Discovery or the May 24, 2019 letter. Moreover, Respondent failed to file a motion for protective order within 10 days of receiving the RFP. Therefore, on July 17, 2019, I granted CTP's Motion to Compel Discovery and ordered Respondent to comply with CTP's RFP by July 24, 2019. 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 alleged in the complaint and imposing a civil money penalty.

On July 29, 2019, CTP filed a Status Report and Motion to Impose Sanctions stating that Respondent had 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. On July 30, 2019, I issued an order allowing

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Respondent until August 13, 2019 to file a response to CTP's Motion to Impose Sanctions.1 I warned Respondent that if it failed to respond to the Motion to Impose Sanctions, I may grant the motion in its entirety and impose the requested civil money penalty. To date, Respondent has not responded to the Motion to Impose Sanctions or the July 30, 2019 order.

Therefore, pursuant to 21 C.F.R. § 17.35, I am granting CTP's Motion to Impose Sanctions, and striking Respondent's answer for failing to comply with multiple judicial orders and directions. Specifically, Respondent failed to comply with my April 5, 2019 APHO and July 17, 2019 order requiring it to respond to CTP's RFP. Additionally, Respondent failed to respond to CTP's Motion to Compel Discovery, CTP's Motion to Impose Sanctions, the May 24, 2019 letter issued by my direction, and the July 30, 2019 order. This repeated conduct is sufficiently egregious to warrant striking Respondent's answer and issuing an initial decision by default.

II. 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 March 7, 2018, CTP initiated a previous civil money penalty action, CRD Docket Number T-18-1542, FDA Docket Number FDA-2018-H-0990 (see also CRD Docket Number T-18-400; FDA Docket Number FDA-2017-H-6486), against Respondent for four2 violations of the Act within a 24-month period. CTP alleged those violations to have occurred at Respondent's business establishment, 14449 East Highway 12, Rogers, Arkansas 72756, on January 19, 2017, November 6, 2017, and February 26, 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 its right to contest such violations in subsequent actions;"

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• An FDA-commissioned inspector conducted a subsequent inspection on November 28, 2018, at approximately 12:27 PM at Respondent's business establishment located at 14449 East Highway 12, Rogers, Arkansas 72756. During this inspection, a person younger than 18 years of age was able to purchase a Black & Mild cigar. 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 Prairie Creek Cove Grocery'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(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(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 enter default judgment in the amount of $11,410 against Respondent Vivek Kumar Gupta d/b/a Prairie Creek Cove Grocery. 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.

• 1. My July 30, 2019 order also extended the parties' pre-hearing exchange deadlines.
• 2. The complaint alleges two violations were committed on January 19, 2017, one on November 6, 2017, and two on February 26, 2018. 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. See Orton Motor, Inc. d/b/a Orton's Bagley v. U.S. Dep't of Health & Human Serv., 884 F.3d 1205 (D.C. Cir. 2018).