Center Point Vapes LLC d/b/a Center Point Vapes, DAB TB9917 (2025)

INITIAL DECISION

The Center for Tobacco Products (CTP) seeks to impose a $20,678 civil money penalty (CMP) against Respondent, Center Point Vapes LLC d/b/a Center Point Vapes.  CTP seeks to impose the CMP against Respondent for impermissibly manufacturing and selling new tobacco products that lacked the required premarketing authorization, thereby violating the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. §§ 301 et seq.  For the reasons discussed below, I find Respondent violated the Act as alleged by CTP and that a CMP in the amount of $15,678 is appropriate.

I. Background

CTP began this matter by serving an Administrative Complaint on Respondent at 3128 Forest Lane, Suite 214, Dallas, Texas 75234,1 by United Parcel Service, and by filing a copy of the Complaint with the Food and Drug Administration’s (FDA) Division of

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Dockets Management.  Civil Remedies Division (CRD) Docket (Dkt.) Entry Numbers (Nos.) 1 (Complaint), 1b (Proof of Service).  In its cover letter, CTP advised Respondent of several ways to respond to the Complaint which included filing an answer within 30 days of service or “you will be in default.”  See CRD Dkt. Entry No. 1a at 1, 3-6.  On September 20, 2024, CRD issued Guidance Establishing Procedures also reminding Respondent that its answer was due by October 18, 2024, and provided Respondent with a blank answer form.  CRD Dkt. Entry No. 2 at 1, 4-7.

On October 19, 2024, Respondent untimely filed its Answer denying the allegations stating:

The fine and aligations [sic] from the FDA indicates that we did not have proper PMTs for our juice but we did submit with FDA on 9/26/2017 submission tracking number HD000565 correspondence FDA number PR0002374 and have had no contact since.

CRD Dkt. Entry No. 3a (Answer Page 1).  Respondent raised the defense that the manager:

“took over management in October 2022 and was unaware that any part of the business was not in compliance with FDA and continue to do everything in my power to change that . . .”

and disputed the appropriateness of the CMP amount stating that it believed “this number is based on sales of house juice profit and house juice sales are the lowest of all business sales.”  CRD Dkt. Entry No. 3b (Answer Page 2).

On October 22, 2024, I issued an order establishing a deadline of November 1, 2024, for CTP to file any objection to Respondent’s untimely filing.  CRD Dkt. Entry No. 4.  On October 23, 2024, CTP indicated that it did not object to Respondent’s untimely answer. CRD Dkt. Entry No. 5 (Email from CTP).

On October 25, 2024, I issued an Acknowledgement and Pre-Hearing Order (APHO) establishing the discovery and pre-hearing exchange deadlines for this case.  CRD Dkt. Entry No. 6 (APHO) ¶¶ 4-6.  On December 19, 2024, Respondent emailed the attorney-advisor2 assisting me with the case to request an extension of time.  CRD Dkt. Entry No. 8.  Respondent was instructed to file its request via DAB e-file.  Id.  On December 27, 2024, CTP filed a Motion to Compel Discovery stating that Respondent had not replied to CTP’s Request for Production of Documents (RFP) served on November 22, 2024.  CRD Dkt. Entry No. 9.  On that same date, CTP filed a Motion to Extend Deadlines.  CRD Dkt. Entry No. 10.  On December 31, 2024, I issued an Order setting a deadline of

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January 14, 2025, for Respondent to file a response to CTP’s motion and I extended the parties’ exchange deadlines by 30 days.  CRD Dkt. Entry No. 11.

On January 17, 2025, after no response had been received from Respondent, I issued an Order granting CTP’s Motion to Compel Discovery and ordered Respondent to comply with CTP’s RFP by January 29, 2025, and confirmed the pre-hearing exchange deadlines for this case.  CRD Dkt. Entry No. 12.  On January 29, 2025, Respondent filed seven documents appearing to comply with CTP’s RFP.  See CRD Dkt. Entry Nos. 13, 13a-13f.

On February 18, 2025, CTP timely filed its pre-hearing exchange which included an Informal Brief of Complainant, Complainant’s List of Proposed Witnesses and Exhibits, and nine proposed exhibits (CTP Exhibits (Exs.) 1-9).  CRD Dkt. Entry Nos. 14, 14a-14j.  CTP’s pre-hearing exchange included the signed declaration of James Bowling, Deputy Division Director, Office of Compliance and Enforcement, CTP, FDA (CTP Ex. 1), as well as the signed declaration of Garrett Carter, FDA-commissioned officer with the state of South Carolina (CTP Ex. 2).  CRD Dkt. Entry Nos. 14b, 14c.

On June 10, 2025, I issued an Order Scheduling the Pre-Hearing Conference (PHC) for July 10, 2025, at 2:00 PM Eastern Time.3  CRD Dkt. Entry No. 24.

During the PHC, absent objection from Respondent, I admitted CTP’s proposed exhibits into the administrative record as CTP Exs. 1-9.  CRD Dkt. Entry No. 25 at 2 (Summary of PHC).  I informed Respondent that its seven filed documents were not marked as instructed in the APHO, and that to be considered as exhibits, Respondent must properly mark the documents in accordance with APHO paragraph 8 and then refile the documents.  Id.  I advised that Respondent would have until August 1, 2025, to properly mark and refile its seven documents.  Id.  CTP did not raise any objection to the admission of the seven documents submitted by Respondent if refiled in accordance with the APHO.  Id.  Further, I confirmed with Respondent that, although it denied the allegations in its Answer, it now admits the allegations in the complaint and the only issue remaining is to determine the appropriate penalty.  Id. at 1.  I explained to the parties that the purpose of conducting a hearing was to allow for the cross-examination of witnesses that have provided sworn direct testimony, as submitted in the parties’ respective pre-hearing exchanges.  Id. at 2.  Respondent stated that it did not wish to cross-examine CTP’s witnesses.  Id.  As Respondent waived its rights to a hearing, I found a hearing to not be necessary and, accordingly, advised the parties that I would proceed to decide this case based on the evidence of record.   Id.; see also APHO ¶ 17.

In my Summary of PHC Order, I advised the parties that they had until August 25, 2025, to file simultaneous final briefs.  Id. at 2.

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On July 30, 2025, Respondent timely refiled its proposed exhibits.  CRD Dkt. Entry Nos. 27-34, 34a, and 35.  On July 31, 2025, I issued an Order giving CTP until August 8, 2025, to file its objections to Respondent’s refiled proposed exhibits.  CRD Dkt. Entry No. 36.  CTP did not file any objections. Therefore, I ADMIT Respondents refiled proposed exhibits marked as R. Exs. 1-6.  See CRD Dkt. Entry Nos. 27-34, 34a, and 35.

On August 25, 2025, CTP filed a Notice of Waiver of Final Brief.  CRD Dkt. Entry No. 37 (Notice of Waiver of Final Brief).  Respondent did not file a final brief or notice of waiver of a final brief.

The administrative record is now complete and closed, and this matter is ready for a decision.  21 C.F.R. § 17.41; 21 C.F.R. § 17.45.  I will now decide this case based on the evidence in the administrative record.  21 C.F.R. § 17.19(b)(11), (17).

II. Issue

Respondent acknowledged that it violated the Act on May 10, 2024, by manufacturing and holding for sale new tobacco products that were adulterated and misbranded because they lacked the required FDA marketing authorization, therefore the only issue remaining that I must decide is whether the $20,678 CMP that CTP seeks is appropriate, considering any mitigating or aggravating factors that I find in this case.  See 21 C.F.R. § 17.21(c)(1).

III. Findings of Fact and Conclusions of Law

The FDA has the authority to seek civil money penalties from any person who violates any Act requirement that relates to tobacco products.  21 U.S.C. § 333(f)(9)(A).  The term “person” is defined to include individuals, partnerships, corporations, and associations.  21 U.S.C. § 321(e).  Any person who violates a requirement of the Act that relates to tobacco products may incur a CMP up to the maximum amounts provided for by law, which, at the time of the violation, was $20,678 for each such violation, and not to exceed $1,279,448 for all violations adjudicated in a single proceeding.  21 U.S.C. § 333(f)(9)(A); 21 C.F.R. § 17.2; 45 C.F.R. § 102.3 (2022); 87 Fed. Reg. 15,100, 15,104 (March 17, 2022).

CTP seeks to impose a CMP against Respondent pursuant to the authority conferred by the Act and implementing regulations at Part 21 of the Code of Federal Regulations.  CTP has the burden to prove the Respondent’s liability and the appropriateness of the penalty by a preponderance of the evidence.  21 C.F.R. § 17.33(b).  Respondent has the burden to prove any affirmative defenses and mitigating circumstances, also by a preponderance of the evidence.  Id. § 17.33(c).  Based upon Respondent’s admission that it violated the Act as alleged by CTP, I find that Respondent failed to obtain the required premarket authorization for its new tobacco

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products, causing them to become adulterated and misbranded while they were held for sale after interstate shipment of one or more of their components, thereby violating 21 U.S.C. § 331(k).  Answer at 1; see also Order Following PHC at 2.  Having found that Respondent violated the prohibition against holding for sale tobacco products that are adulterated or misbranded after shipment of one or more of its components in interstate commerce, I further find that Respondent is liable for a CMP not to exceed the amounts listed in FDA’s CMP regulations.

When determining the appropriate amount of a CMP, I must consider any aggravating or mitigating circumstances and the factors listed in the Act.  21 C.F.R. § 17.34(a)-(b).  Specifically, I am required to consider “the nature, circumstances, extent and gravity of the violations and, with respect to the violator, ability to pay, effect on ability to continue to do business, any history of prior such violations, the degree of culpability, and such other matters as justice may require.”  21 U.S.C. § 333(f)(5)(B); 21 C.F.R. § 17.45(b)(1)-(3).

In its Answer, Respondent denied the allegations stating that it was under the belief that it submitted premarket documents but had no contact from the FDA thereafter.  Answer ¶ 1.  Respondent further states, among other things, that the CMP is too high because it believes the CMP amount sought is based on the sale of “house juice.”  Id. ¶ 3.  Respondent also asks me to consider that the current manager took over in October 2022 and that it was unaware that the establishment was not in compliance with FDA regulations.  Id. ¶ 2.

For the reasons explained below, I conclude that a $15,678 CMP is appropriate based upon the record evidence, applicable law, and aggravating and mitigating circumstances in this case.

A. Nature, Circumstances, Extent and Gravity of the Violations

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) was enacted for the purpose of authorizing regulation of tobacco products for the “protection of the public health.”  21 U.S.C. § 387f(d).  There is no dispute that Respondent was in the business of manufacturing and selling highly regulated and dangerous products.  See 21 U.S.C. § 387 note (Findings and Purpose).

CTP contends that Respondent’s violations are particularly serious because they occurred despite earlier warnings that future violations could result in enforcement action.  CRD Dkt. Entry No. 14 at 8-9 (CTP’s Informal Brief).  CTP specifically refers to the warning letter it issued to Respondent on January 18, 2024, citing Respondent for manufacturing, selling and/or distributing to customers without the statutorily required premarket authority.  Id. at 9; CTP Ex. 7.  CTP states that the warning letter notified Respondent that future violations may lead to enforcement action, including, but not limited to, civil

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money penalties, seizure, and/or injunction by FDA and advised Respondent that “[t]he violation indicated in the January 2024 Warning Letter did not constitute an exhaustive list, and that Respondent should take prompt action to address any violations similar to the one listed in the January 2024 Warning Letter.”  Id.  Finally, CTP states the warning letter referred Respondent to an FDA website, which included information to help tobacco manufacturers and retailers understand and comply with FDA tobacco laws and regulations.  Id.

As discussed above, Respondent argues that it was unaware that it was not in compliance with FDA regulations since it submitted documents in September 2017 to the FDA.    Respondent offers as evidence letters from the FDA dated September 10, 2018, and December 27, 2019, which both state “[t]his acknowledgement does not constitute review or approval of your submission . . . we encourage you to visit our website . . . which include up-to-date information about the . . . regulations that have been promulgated . . . .  R. Ex. 5, page 1; R. Ex. 5 page 2 (emphasis added).  Respondent is solely responsible for ensuring all the tobacco products in its possession comply with tobacco regulations. Respondent’s awareness of its compliance is completely under its control.  The Act was designed to protect consumers from dangerous products that lack the premarketing authorization required under the Federal Food, Drug, and Cosmetic Act.

Therefore, I agree with CTP and find that Respondent’s violation after receipt of the warning letter demonstrates its inability, or perhaps unwillingness, to comply with federal tobacco law and demands a proportional CMP amount.

B. Respondent’s Ability to Pay and Effect on Ability to Do Business

When considering the impacts of the civil money penalty on Respondent’s ability to continue to do business, Respondent offered no argument.  Therefore, I find there is no apparent reason why Respondent could not continue to do business.

C. History of Prior Violations

There is no indication in the record of any prior violations of section 331(k) of the Act resulting in a CMP.  However, Respondent did receive a warning letter advising that it was in violation of federal law for manufacturing and selling a new tobacco product without marketing authorization.  CTP Ex. 7.  Respondent may not have initially known the status of its pending PMTA applications, however, in January 2024, it was put on notice that at least one of its products was being sold without a marketing authorization order and was also warned that the violations discussed were not exhaustive.

As the manufacturer and retailer of tobacco products, it was well-within Respondent’s ability and its responsibility to determine the status of its other products.  Instead of taking any action to determine whether it obtained the proper authorizations, Respondent

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simply continued to manufacture and sell its new tobacco products.  Therefore, I find at best, Respondent had an inability or, at worst, possessed an unwillingness to comply with federal tobacco laws and regulations and should be reflected in the CMP amount.

D. Degree of Culpability

The Act places a heavy burden on manufacturers who choose to manufacture or sell tobacco products because of their highly dangerous and addictive nature.  See 21 U.S.C. § 387 note (Findings and Purpose).  I find Respondent fully culpable for manufacturing and then holding for sale new tobacco products that were adulterated and misbranded, in violation of the Act.

E. Other Matters as Justice May Require

Respondent must prove any mitigating factors by a preponderance of the evidence.  21 C.F.R. § 17.33(c).  Respondent has participated in this matter from its onset.  Further, Respondent has provided what it deemed to be sufficient evidence to support its position. These civil money penalties are in place to ensure retailers uphold the regulations that aid in keeping the American people safe.

I have no reason to doubt Respondent’s sincerity regarding its attempts to register its new tobacco products, but the relevant inquiry is whether Respondent obtained the authorizations.  Respondent acknowledged that, although it submitted marketing authorization documents, it did not receive a market authorization for its products and neither did it make any attempts to ascertain the status of its applications.  I acknowledge Respondent’s sincere efforts; however, I am bound to decide this case solely on consideration of the statutory and regulatory required factors and the evidence presented.  Accordingly, I find that a CMP of $15,678 is appropriate.

IV. Conclusion

For the reasons set forth above, I enter a judgment of $15,678 against Respondent Center Point Vapes LLC d/b/a Center Point Vapes, for manufacturing and selling new tobacco products that lacked the premarketing authorization required by the Act, 21 U.S.C. §§ 301 et seq.  Pursuant to 21 C.F.R. § 17.45(d), this decision becomes final and binding upon both parties after 30 days of the date of its issuance.