Viper Vapor Springfield LLC d/b/a Viper Vapor, DAB TB8513 (2024)

INITIAL DECISION AND DEFAULT JUDGMENT

The Center for Tobacco Products (CTP) filed an Administrative Complaint (Complaint) against Respondent, Viper Vapor Springfield LLC d/b/a Viper Vapor, alleging facts and legal authority sufficient to justify imposing a civil money penalty of $687.  CTP began this case by serving a Complaint on Respondent and filing a copy of the Complaint with the Food and Drug Administration’s (FDA) Division of Dockets Management.  The Complaint alleges that Respondent’s staff sold regulated tobacco products to underage purchasers and failed to verify that the purchasers were of 21 years of age or older, thereby 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.  CTP seeks a civil money penalty of $687 for three violations of the regulations within a 24-month period.

During the course of these administrative proceedings, Respondent failed to comply with orders and procedures governing this proceeding and failed to defend its actions, which interfered with the speedy, orderly, or fair conduct of this proceeding.  21 C.F.R.

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§ 17.35(a).  Accordingly, pursuant to 21 C.F.R. § 17.35(c)(3), I strike Respondent’s Answer and issue this decision of default judgment.

I. Procedural History

On March 11, 2024, 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 April 10, 2024, I issued an Acknowledgment and Pre-Hearing Order (APHO) that set deadlines for the parties’ filings and exchanges, including a schedule for discovery.  I directed that a party receiving a discovery request must provide the requested documents within 30 days of the request.  APHO ¶ 4; see 21 C.F.R. § 17.23(a). I warned that I may impose sanctions if a party failed to comply with any order, including the APHO.  APHO ¶ 21.

On May 10, 2024, Respondent filed its pre-hearing brief.  On June 18, 2024, CTP filed a Motion to Extend Deadlines and a Motion to Compel Discovery asserting that Respondent did not respond to its discovery request as required by my APHO and regulations.  By Order of June 28, 2024, I informed Respondent of its deadline to file a response to CTP’s Motion to Compel Discovery, and warned that if Respondent failed to respond, “I may grant CTP’s motion in its entirety.”  June 28, 2024, Order at 2 (emphasis in original); see also 21 C.F.R. § 17.32(c); APHO ¶ 20.  Respondent did not respond.

On July 19, 2024, I issued an Order Granting Motion to Compel in which I granted CTP’s motion and ordered Respondent to produce documents responsive to CTP’s discovery request by August 1, 2024.  I warned Respondent that:

Failure to do so 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.

July 19, 2024, Order Granting Motion to Compel at 1 (emphasis added).

On August 6, 2024, CTP filed a Motion to Stay Deadlines and a Status Report and Motion to Impose Sanctions.  CTP advised that Respondent did not produce responsive documents in compliance with my Order Granting Motion to Compel at 1.   By Order of August 8, 2024, I informed Respondent of its deadline to file a response to CTP’s motion and warned Respondent that if it failed to file a response, “I may grant CTP’s Motion to Impose Sanctions and impose the requested civil money penalty of $687, pursuant to 21 C.F.R. § 17.35.”  August 8, 2024, Order (emphasis in original) at 2.  To date, Respondent has not responded.

II. Striking Respondent’s Answer

I may sanction a party for:

1. (1) Failing to comply with an order, subpoena, rule, or procedure governing the proceeding;
2. (2) Failing to prosecute or defend an action; or
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).

Respondent failed to comply with the following orders and procedures governing this proceeding:

• Respondent failed to comply with 21 C.F.R. § 17.23(a) and paragraph 4 of my APHO, when Respondent failed to respond to CTP’s Request for Production of Documents within 30 days; and
• Respondent failed to comply with my July 19, 2024 Order Granting Motion to Compel when it failed to submit the documents responsive to CTP’s Request for Production of Documents by August 1, 2024.

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Respondent also failed to defend its action despite my June 28, 2024, and August 8, 2024, orders informing Respondent of such opportunities and warning of consequences. 21 C.F.R. § 17.35(a)(2).

I find that Respondent failed to comply with orders and procedures governing this proceeding, failed to defend its case, and, as a result, interfered with the speedy, orderly, or fair conduct of this proceeding.  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 relate to the nature and severity of the misconduct or failure to comply.  21 C.F.R. § 17.35(b).  Here, Respondent failed to comply with a regulation governing this proceeding.  Respondent failed to comply with two of my orders, despite my explicit warnings that its failure could result in sanctions.  I specified that those sanctions may include “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.”  July 19, 2024 Order Granting Motion to Compel at 1; APHO ¶ 21.  Respondent also failed to defend its actions, despite my orders expressly reminding Respondent of the opportunity.  Respondent’s repeated misconduct interfered with the speedy, orderly, or fair conduct of this proceeding.

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(b), (c)(3). 

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Accordingly, I strike Respondent’s Answer, and issue this Initial Decision and Default Judgment, assuming the facts alleged in CTP’s Complaint to be true.  21 C.F.R. §§ 17.35(c)(3), 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. 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 Viper Vapor, an establishment that sells tobacco products and is located at 1840 North Glenstone Avenue, Springfield, Missouri 65803. Complaint ¶¶ 11-12.
• An FDA-commissioned inspector conducted an inspection of Respondent’s establishment on August 28, 2023, at approximately 12:27 PM, during which “a person younger than 21 years of age was able to purchase a Hyppe Max Mango Pineapple Orange electronic nicotine delivery system (ENDS) product . . . .” Additionally, “the underage purchaser’s age was not verified before the sale . . . .” Complaint ¶ 15.
• On September 26, 2023, CTP issued a Warning Letter to Respondent regarding the August 28, 2023 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 December 6, 2023, at approximately 1:21 PM, during which “a person younger than 21 years of age was able to purchase a Smok Novo Bar AL6000 Strazz electronic nicotine delivery system (ENDS) product . . .” Additionally, “the underage purchaser’s age was not verified before the sale . . .” Complaint ¶ 13.

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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 sold or distributed 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 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 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 August 28, 2023, and December 6, 2023.  Act § 906(d)(5).  On those 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] Id.  Therefore, Respondent’s actions constitute violations of law that merit a civil money penalty.

CTP has requested a civil money penalty of $687, which is a permissible penalty under the regulations.  21 C.F.R. § 17.2.  Therefore, I find that a civil money penalty of $687 is warranted and so order one imposed.

Endnotes

[1]  The identification violations alleged by CTP on August 28, 2023, and December 6, 2023, are governed by section 906(d) of the Act, which went into effect as of December 20, 2019, although CTP cites 21 C.F.R. § 1140.14(b)(2)(i), which has not been updated to reflect the age change.  See Complaint ¶¶ 13.b, 15.b.