Sajid S. Salimi, Inc. d/b/a Excel Mart / Conoco, DAB TB8736 (2024)

INITIAL DECISION

The Center for Tobacco Products (CTP) seeks to impose a $19,192 civil money penalty (CMP) against Respondent, Sajid S. Salimi, Inc. d/b/a Excel Mart / Conoco. CTP alleges that Respondent received in interstate commerce an electronic nicotine delivery system (ENDS) product that lacks the premarketing authorization required under the Federal Food, Drug, and Cosmetic Act (Act) and offered such product for sale, in violation of 21 U.S.C. § 331(c). Therefore, CTP seeks a $19,192 CMP against Respondent. For the reasons discussed below, I find that Respondent violated the Act as alleged by CTP and that a CMP of $19,192 is appropriate.

I. Background

CTP began this matter by serving an Administrative Complaint on Respondent at 5150 South 33rd West Avenue, Tulsa, Oklahoma 74107 by United Parcel Service (UPS), and by filing a copy of the Complaint with the Food and Drug Administration’s (FDA) Division of Dockets Management. Civil Remedies Division (CRD) Docket (Dkt.) Entry

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Nos. 1 (Complaint), 1b (Delivery Notification). Respondent timely filed its Answer where it denied that it received a warning letter from CTP or knowingly sold adulterated or misbranded products, raised defenses, and disputed the appropriateness of the CMP sought by CTP. CRD Dkt. Entry No. 3a (Answer).

On December 21, 2023, I issued an Acknowledgment and Pre-Hearing Order acknowledging receipt of Respondent’s Answer and establishing procedural deadlines for this case. CRD Dkt. Entry No. 4 (APHO). CTP timely submitted its pre-hearing exchange, consisting of its informal brief, list of proposed witnesses, and eight exhibits. See CRD Dkt. Entry Nos. 8-8i. CTP’s exchange included the written testimony of two witnesses: 1) James Bowling, Deputy Division Director for the Division of Enforcement and Manufacturing in the Office of Compliance and Enforcement, CTP Exhibit 1, and 2) Brett R. Martin, FDA-commissioned officer in the state of Oklahoma, CTP Exhibit 2.

Respondent submitted its informal brief along with a spreadsheet captioned “new items / dropped items / price changes from 9/8/22 – 9/15/22”; two photographs showing Hyde IQ and Elfbar products; and a screenshot of an internet search for an “elf bar bc5000 gumi.” CRD Dkt. Entry Nos. 6, 7, and 7a.

For identification purposes, I marked the spreadsheet as Respondent’s Exhibit 1, the two photographs as Respondent’s Exhibit 2; and the screenshot of the internet search for an as Respondent’s Exhibit 3. Respondent did not object to CTP’s proposed documentary evidence, however, CTP did object to Respondent’s submissions. See CRD Dkt. Entry No. 14 (Order Following PHC) at 1-2.

On March 21, 2024, following the deadline for seeking discovery, Respondent submitted a request for production of documents from CTP. CRD Dkt. Entry No. 9 (Request for Production). On April 2, 2024, CTP filed a Motion for a Protective Order arguing that Respondent’s requests should be quashed as untimely. CRD Dkt. Entry No. 10 (Motion for Protective Order). CTP received the Request for Production on March 21, 2024, nearly two months after the deadline of January 22, 2024, for requests for documents had expired. Id. On April 5, 2024, a letter was issued at my direction giving Respondent until April 17, 2024, to file a response to CTP’s Motion. CRD Dkt. Entry No. 11 (By Direction Letter). With no response from Respondent, I granted CTP’s Motion and issued a protective order on April 24, 2024, because Respondent’s request was untimely. CRD Dkt. Entry No. 12 (Protective Order).

On May 31, 2024, I conducted a pre-hearing conference (PHC). During the PHC, I explained the issues before me and the parties’ respective burdens of proof. CRD Dkt. Entry No. 14 (Order Following PHC) at 1-2. Respondent reiterated its denial of the allegations set forth in the Complaint and contested the proposed $19,192 CMP. Id. Respondent also expressed that it did not intend to cross-examine CTP’s proposed witnesses. Id. As Respondent did not wish to cross-examine CTP’s witnesses, and

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Respondent had not submitted any sworn witness testimony for CTP’s cross-examination, I determined that a hearing in this matter was not necessary and that this case would be decided on the written record. Id. at 3.

In an Order following the PHC, CTP was given until June 20, 2024, to file any written objections to Respondent’s documentary evidence and both parties were given until July 9, 2024, to file final briefs. Id. On June 20, 2024, CTP filed a Motion to Exclude Evidence. CRD Dkt. Entry No. 15 (Motion to Exclude). On June 22, 2024, Respondent filed a response to CTP’s Motion to Exclude. CRD Dkt. Entry No. 16 (R’s Response). On July 9, 2024, Respondent filed its final brief. CRD Dkt. Entry No. 17. (R’s Final Brief). On July 9, 2024, CTP filed a Notice of Intent to File Final Brief explaining that it intends to submit a final brief following a ruling on its Motion to Exclude. CRD Dkt. Entry No. 18 (Notice of Intent). On July 12, 2024, I issued an Order deferring the ruling on CTP’s Motion to Exclude, and CTP was given until August 12, 2024, to file a final brief. CRD Dkt. Entry No. 19 (Order Deferring Ruling).

On August 12, 2024, CTP filed its final brief and also included decisions in two prior cases. CRD Dkt. Entry Nos. 20-20b. The submitted decisions were 5th and Nine Vape Co. LLC d/b/a 5th and Nine Alternatives Co., CRD No. TB7906 (H.H.S. April 16, 2024) (Kessel, ALJ) and Go Vapor #2, LLC d/b/a Go Vapor, CRD No. TB8144 (H.H.S. June 11, 2024) (Kessel, ALJ).

I will consider the full administrative record in deciding this case. The administrative record contains the exhibits and other evidence admitted as well as all papers and requests filed in this proceeding. 21 C.F.R. § 17.41(b).

II. CTP’s Motion to Exclude Evidence is Denied

As a preliminary matter, I will address CTP’s Motion to Exclude Evidence. On June 20, 2024, CTP filed a Motion to Exclude Evidence. CRD Dkt. Entry No. 15 (Motion to Exclude). CTP moved to exclude evidence submitted by Respondent because it was not properly authenticated and not relevant or material to the issues presented in this case. Id. at 1.

According to the regulations, “[u]nless a party objects within 5 days prior to the hearing, documents exchanged in accordance with paragraph (a) of this section will be deemed to be authentic for the purpose of admissibility at the hearing.” 21 C.F.R. § 17.25(c). Also, “If a party objects to the proposed admission of evidence not exchanged in accordance with paragraph (a) of this section, the presiding officer will exclude such evidence if he or she determines that the failure to comply with paragraph (a) of this section should result in its exclusion.” 21 C.F.R. § 17.25(b)(1). Further, the presiding officer shall determine the admissibility of evidence and shall exclude evidence that is not relevant or material. 21 C.F.R. § 17.39(a) and (c). Though not bound by the Federal Rules of

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Evidence (FRE), an Administrative Law Judge (ALJ) may apply the FRE when appropriate, for example, to exclude unreliable evidence. Id. § 17.39(b). Pursuant to the FRE, to satisfy the requirement of authenticating or identifying an item of evidence, the proponent must “produce evidence sufficient to support a finding that the item is what its proponent claims it is.” Fed. R. Evid. 901(a). This requirement may be satisfied by, among other things, the testimony of a witness with knowledge or distinctive characteristics and the like. Fed. R. Evid. 901(b)(1) and (4).

Here, CTP argues that Respondent’s Exhibits have not been properly authenticated. CRD Dkt. Entry No. 15 at 1 (Motion to Exclude). Specifically, CTP argues that Respondent has not provided any sworn direct testimony of any witness, nor any explanation to explain these documents. Id. at 3. However, as mentioned earlier, I am not bound by the FRE. Therefore, witness testimony is not required to authenticate these documents. Respondent’s Exhibit 1 simply contains a spreadsheet of new/dropped ENDS products and their price changes from September 8, 2022, through September 15, 2022. Providing witness testimony to authenticate the list would be unnecessary as it does not contain any prejudicial information. Also, Respondent’s Exhibit 2, which contains two photographs of ENDS products and their availability for sale, does not require witness testimony to be authenticated for the same reason. Lastly, Respondent’s Exhibit 3, which is a screenshot of an internet search for an “elf bar bc5000 gumi,” is easily authenticated. Any person can perform a simple internet search and will be able to replicate the search results reflected in Respondent’s Exhibit 3. Therefore, I find that witness testimony is not necessary, and these documents are properly authenticated.

CTP also argues that Respondent’s Exhibits are not relevant or material to the issue present in this case. CTP explains that Respondent is presumably attempting to use these exhibits to mitigate its liability by shifting the blame to its wholesalers. CTP also cites to Farmers Cooperative Co. d/b/a Farmers Cooperative, where respondent in that case attempted to rebut evidence of noncompliance by arguing that it should not be held responsible for the actions of a third-party employee. Farmers Cooperative Co. d/b/a Farmers Cooperative CRD No. TB4918 (H.H.S. Mar. 3, 2020) (Hubbard, ALJ). The presiding ALJ found respondent’s arguments irrelevant to the issue of whether respondent was responsible for the improper conduct of an employee. Id. In response to CTP’s Motion, Respondent argues that the documents provided were submitted within the “request for production of documents.” CRD Dkt. Entry No. 16 (R’s Response). Respondent also argues that the exhibits show that the ENDS products are still available from tobacco wholesalers and retailers which are authorized to do business and monitored by the State of Oklahoma ABLE commission. Id.

21 C.F.R. § 17.39(c) requires me to exclude evidence that is irrelevant or immaterial. While these documents are of minimal probative value, they are relevant and material for the purpose of Respondent attempting to mitigate its liability for the proposed violation. CTP will not be prejudiced by these submissions as it had ample time to review these

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documents prior to briefing and formulating an argument against them. Moreover, I find the ends of justice will be served if Respondent is given a fair opportunity to defend itself against CTP’s allegations. Therefore, while these documents have limited probative value, they are admitted into the record.

CTP’s Motion to Exclude Evidence is hereby DENIED.

III. Issues

1. Whether Respondent received in interstate commerce an ENDS product that lacks the premarketing authorization required under the Act, specifically an Elfbar Gumi ENDS product, and offered such product for sale on August 15, 2023, in violation of 21 U.S.C. § 331©; and, if so,
2. Whether the $19,192 civil money penalty is appropriate, considering any mitigating or aggravating factors that I find in this case. 21 C.F.R. § 17.45.

IV. Findings of Fact and Conclusions of Law

1. CTP has demonstrated by a preponderance of the evidence that the Respondent received adulterated and misbranded ENDS products in interstate commerce and delivered or proffered those products for sale on August 15, 2023, in violation of the Act.

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).

The Act prohibits the receipt in interstate commerce of any tobacco product that is adulterated or misbranded and the delivery or proffered delivery of any tobacco product that is adulterated or misbranded for pay or otherwise. 21 U.S.C. § 331©; see also 21 U.S.C. § 321(b). Premarket authorization from the FDA is required for all “new tobacco products.” 21 U.S.C. § 387j(a)(2)(A).

A “new tobacco product” is defined as any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modification of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007. 21 U.S.C. § 387j(a)(1). A “new tobacco product” is required to have premarket review with a Marketing Granted Order unless it has a substantial equivalence or substantial equivalence exemption order (found-exempt order) in effect

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for such product. 21 U.S.C. §§ 387j(a)(2)(A), 387e(j)(3)(A). A new tobacco product is adulterated if it has not obtained the required premarket authorization. 21 U.S.C. § 387b(6)(A). A new tobacco product for which a “notice or other information respecting it was not provided as required” under the substantial equivalence or substantial equivalence pathway is misbranded. 21 U.S.C. §§ 387c(a)(6).

CTP’s case against Respondent relies on the written direct testimony of Deputy Director James Bowling, Office of Compliance and Enforcement, CTP, FDA, and Inspector Brett R. Martin, FDA-commissioned officer in the State of Oklahoma. CTP Exs. 1 and 2. Inspector Martin testified that during the inspection on August 15, 2023, at approximately 9:13 AM, he observed that the establishment sold FDA-regulated tobacco products and had a sales display containing tobacco products, including an Elfbar Gumi ENDS product, available for sale. CTP. Ex. at 2, ¶¶ 4, 6. See also CTP Exs. 3-6 (Inspector Martin’s narrative report, inspection details, photographs, and notice of inspection dated August 15, 2023).

Deputy Director Bowling testified that the ENDS product observed for sale during the August 15, 2023, inspection was manufactured in China, which is outside of the state in which Respondent operates. CTP Ex. 1 ¶ 9. Deputy Director Bowling further testified that he:

. . . can confirm that on August 15, 2023, the day on which FDA observed the Elfbar Gumi ENDS product being offered for sale at Excel Mart / Conoco, there was no record of this product having an FDA marketing granted order in effect under 21 U.S.C. § 387j©(1)(A)(i) . . . there was no record of this product having a substantial equivalence order in effect under 21 U.S.C. § 387j(a)(2)(A)(i), and the manufacturer of the Elfbar Gumi ENDS product had not submitted a report requesting a substantial equivalence order under 21 U.S.C. § 387e(j) . . . the Elfbar Gumi ENDS product did not have a found-exempt order in effect under 21 U.S.C. § 387e(j)(3)(A) (SE pathway under 21 U.S.C. § 387j(a)(2)(A)(ii)), and that the manufacturer of Elfbar Gumi ENDS products had not submitted an abbreviated report requesting a found-exempt order for such product(s) under 21 U.S.C. § 387e(j)(1).

CTP Ex. 1, ¶¶ 12-13.

In its Answer, Respondent denied the allegation that it knowingly sold adulterated/misbranded products. CRD Dkt. Entry No. 3a at 1 (Answer). Respondent also raised a number of defenses. Id. Specifically, Respondent asserted that the manager on duty resigned in July 2023 and did not pass on information of any warning letters. Id. at 2. In its final brief, Respondent supplements this defense by stating that, “I as a previous owner of the establishment did not receive any warning letters. If I had

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knowledge of the letter and its content I would have taken action to correct the problem and returned the products to the wholesale company.” CRD Dkt. Entry No. 17 at 1. (R’s Final Brief). Respondent also states that after receiving the letter from the FDA, all products were discarded. CRD Dkt. Entry No. 3a at 2 (Answer). Respondent claims that all the Elfbar and Escobar products were purchased legally from Oklahoma Licensed Tobacco wholesalers, who have not given any warning or even pulled their products. CRD Dkt. Entry No. 3a at 2 (Answer). Respondent also claims that Inspector Martin did not have full knowledge of what vape products are banned by the FDA. Id. Respondent asserts that during Inspector Martin’s compliance check inspection, when asked what products are banned, Inspector Martin replied that “he is not sure” and instructed Respondent to review the FDA’s website. CRD Dkt. Entry No. 17 at 2-3 (R’s Final Brief). Respondent avers that after the inspection, it went on the website and checked what was allowed for resale and removed all the ENDS products that were not approved by the FDA. Id. Finally, Respondent explains that the establishment has been in business for the last 20 years and has always complied with state and federal regulations. CRD Dkt. Entry No. 3a at 2 (Answer).

Respondent has not disputed any of the statements made by Inspector Martin or Deputy Director Bowling that the Elfbar observed during the August 15, 2023 inspection was a “new” tobacco product which did not have a premarket review or Marketing Granted Order (MGO). CTP Exhibit 1. Moreover, Respondent does not deny that the ENDS product observed by Inspector Martin was at its establishment and being proffered for sale. The basis of Respondent’s defense is that it did not “knowingly” sell adulterated/misbranded tobacco products and that a warning letter was not received, and if it were, Respondent would have remedied the violation. At the outset, lacking the knowledge of selling adulterated/misbranded tobacco products is not an adequate defense to absolve Respondent of this violation. Moreover, Respondent’s claim that it did not personally receive the June 2023 Warning Letter is unavailing. I note that a warning letter is not required by the regulations. In addition, while Respondent claims that a former manager failed to pass along the June 2023 Warning Letter, Respondent is responsible for the actions of its employees and cannot avoid liability on this basis. Station Management Consultants Inc. d/b/a Sunoco, DAB No. 2996, at 10 (2020); see also 1701 Express, Inc. d/b/a Citgo, DAB No. 2979, at 8 (2019) (“The onus is on Respondent to comply with the provisions of the Act and regulations. To that end, Respondent is responsible for ensuring that its employees follow steps as necessary for compliance with those authorities.”).

Respondent also claims that all the Elfbar and Escobar products were purchased legally from Oklahoma Licensed Tobacco wholesalers, who have not given any warning or even pulled their products. CRD Dkt. Entry No. 3a at 2 (Answer). In support, Respondent’s submitted a number of documents, which I have considered. See Respondent’s Exhibits 1, 2, 3. However, these ENDS products being offered for sale at other retailers, by state-licensed wholesalers and distributors, or through the internet do not absolve

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Respondent from its responsibility to ensure that it complies with the federal regulations and does not offer for sale ENDS products that lack premarket authorization. Respondent also seems to raise equitable estoppel claims. First, that Inspector Martin did not have full knowledge of what vape products are banned by the FDA and second, that the United States government allowed these vape products to be imported from China. CRD Dkt. Entry No. 3a at 2 (Answer). However, Respondent has not provided any authority showing that the equitable remedy of estoppel is even available in this administrative case. Both the Board and courts have questioned whether equitable estoppel can ever lie against the government, and concluded that the remedy would require, “at a minimum, a showing that the traditional requirements for estoppel are present (i.e., a factual misrepresentation by the government, reasonable reliance on the misrepresentation by the party seeking estoppel, and harm or detriment to that party as a result of the reliance) and that the government’s employees or agents engaged in affirmative misconduct.” Ill. Dep’t of Children and Family Servs., DAB No. 2734, at 8 (2016) (internal quotation marks omitted) (quoting Oaks of Mid City Nursing & Rehab. Ctr., DAB No. 2375, at 31 (2011) (citing Office of Pers. Mgmt. v. Richmond, 496 U.S. 414, 421 (1990) and Pacific Islander Council of Leaders, DAB No. 2091, at 12 (2007) (“[E]quitable estoppel does not lie against the federal government, if indeed it is available at all, absent at least a showing of affirmative misconduct.”))). As Respondent has not made any of these showings, let alone a showing of affirmative misconduct, its claim fails.

Finally, Respondent has made some statements suggesting that its store has closed. In its Answer, Respondent stated that, “[t]he establishment had been in business for the last 20 years and has always complied with the State and Federal Regulations,” CRD Dkt. Entry No. 3a at 2 (Answer). Also, in its final brief, Respondent stated that, “I as a previous owner of the establishment did not receive any warning letters.” CRD Dkt. Entry No. 17 at 1 (R’s Final Brief). Even if true, this does not amount to a defense and Respondent has not denied that it owned and operated the retail store that sold tobacco products that lacked the premarketing authorization on the date alleged in the complaint. Respondent therefore remains liable for the conduct that took place while its business was in operation.

As such, based on the testimony of Inspector Martin and Deputy Director Bowling, as well as the supporting evidence submitted by CTP, the ENDS product offered for sale at Respondent’s establishment on August 15, 2023, previously traveled in interstate commerce before the Respondent’s receipt and delivery or proffered delivery of such tobacco products for pay or otherwise. See 21 U.S.C. § 331; see also United States v. Sullivan, 332 U.S. 689, 696 (1948), 92 L. Ed. 297, 303 (holding that the Act applies “to articles from the moment of their introduction into interstate commerce all the way to the moment of their delivery to the ultimate consumer”). The ENDS product was adulterated because it lacked the required FDA marketing authorization and was not exempt from this requirement. 21 U.S.C. §§ 387j(a)(2)(A), 387e(j)(3)(A). Under 21 U.S.C.

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§ 387c(a)(6), the products were also misbranded because there was no substantially equivalent determination as required by 21 U.S.C. § 387e(j). Therefore, Respondent’s actions constitute violations of law that merit a CMP.

2. Respondent has not demonstrated by a preponderance of the evidence that mitigating circumstances support a reduced CMP.

I have determined that Respondent violated the prohibition against receiving and offering for sale a new tobacco product that was adulterated and misbranded. 21 U.S.C. § 331©. Pursuant to 21 U.S.C. § 333(f)(9), Respondent Excel Mart / Conoco is liable for a civil money penalty not to exceed the amounts listed in FDA’s CMP regulations at 21 C.F.R. § 17.2; see also 45 C.F.R. § 102.3.

In its Complaint, CTP seeks to impose a CMP amount of $19,192 against Respondent. CRD Dkt. Entry No. 1, ¶ 1 (Complaint). In its Answer, Respondent contends that; the CMP sought by CTP is too high because the inspector himself should have had told Respondent what it is allowed to sell and asked Respondent to pull the products from the shelves; not enough information was given to Respondent from the State or through wholesalers as to what is regulated or not; wholesalers are still selling these products and are not saying that they have heard anything from the State or the FDA; the establishment has taken the step of discarding all vape products; and that it is a small mom and pop establishment and cannot afford to pay these fines. CRD Dkt. Entry No. 3a at 2 (Answer).

When determining the appropriate amount of a CMP, I am required to consider any “circumstances that mitigate or aggravate the violation” and “the factors identified in the statute under which the penalty is assessed . . . .” 21 C.F.R. §§ 17.34(a); 17.34(b). Specifically, I must 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).

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

CTP contends that Respondent’s violations are serious in nature as they contravene FDA’s efforts to protect the public health from the multitude of adverse health effects associated with tobacco use. CRD Dkt. Entry No. 8 at 9. (Informal Brief of Complainant). CTP specifically refers to a warning letter it issued to the Respondent on June 8, 2023, citing Respondent for offering for sale a new tobacco product that lacked the required marketing authorization order on May 17, 2023. Id.; CTP Ex. 7 at 1-2. CTP states that the warning letter notified Respondent that future violations may lead to enforcement action, including, but not limited to, civil money penalties, seizure, and/or injunction by FDA. Id. at 9; CTP Ex. 7 at 2. Finally, CTP states the warning letter

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referred Respondent to the FDA website, which included information to help tobacco retailers understand and comply with FDA tobacco laws and regulations. Id.; CTP Exhibit 7 at 3-4.

Respondent claims that after the August 15, 2023 inspection and after visiting the FDA’s website, it removed all ENDS products that were not approved by the FDA. CRD Dkt. Entry No. 17 at 1. (R’s Final Brief). Respondent also makes the claim that the inspector, wholesaler, and the State should have notified Respondent of the legality of the ENDS products it proffers for sale. CRD Dkt. Entry No. 3a at 2 (Answer). However, it is Respondent’s responsibility to be knowledgeable of the tobacco products it sells and whether they have the proper authorization. Moreover, Respondent has not offered any evidence or testimony to prove that it otherwise attempted to remedy its violation after receiving the warning letter or the August 15, 2023 inspection. Thus, this is not a mitigating factor in this instance.

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

Respondent has offered no evidence that it is unable to pay the penalty sought by CTP. Similarly, Respondent offers no evidence or argument that paying the sought after CMP would affect its ability to do business.

While Respondent does claim that it is a small mom and pop establishment and cannot afford to pay the fines, the burden is on Respondent to prove any mitigating factors by a preponderance of the evidence. See 21 C.F.R. § 17.33©. Here, Respondent has not proffered any evidence in the record that demonstrates that it is unable to pay the sought after CMP amount, or that paying the amount would threaten its solvency or in any way effect its ability to do business. I acknowledge the Respondent’s statements regarding its status as a small mom and pop establishment, but if Respondent wished for me to consider further its ability to pay or to continue to do business as factors to reduce the proposed penalty amount, then the burden was on it to argue and provide evidence of the same. Therefore, I do not find that these arguments weigh in favor of reducing the CMP amount sought by CTP.

iii. History of Prior Violations

There is no indication in the record of any prior violations of section 331© of the Act resulting in a CMP. CTP notes, however, that Respondent received a warning letter that it had previously violated the law and that it nevertheless continued to receive in interstate commerce and offer for sale new tobacco products that lacked the required premarket authorization, which shows an unwillingness or inability to comply with the law. CRD Dkt. Entry No. 10 at 11-12 (Informal Brief of Complainant). CTP therefore proffers Respondent’s repeated violations supports a penalty of $19,192.

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I agree with CTP that the warning letter demonstrates a prior violation. I have further considered Respondent’s assertion in its Answer that the establishment, “had been in business for the last 20 years and has always complied with the State and Federal regulations.” CRD Dkt. Entry No. 3a at 2 (Answer). However, the record does not demonstrate that following receipt of the June 2023 Warning Letter that Respondent took any actions to comply with the regulations and thus demonstrates Respondent’s unwillingness or inability to comply with tobacco laws and regulations.

iv. Degree of Culpability

Based on my finding that Respondent committed the violation alleged in the Complaint, I hold the Respondent fully culpable for offering for sale new tobacco products that were adulterated and misbranded, in violation of the Act. The Act places a heavy burden on retailers who choose to sell tobacco products because of their highly dangerous and addictive nature. See 21 U.S.C. § 387 note (Findings and Purpose). Therefore, Respondent’s sale of these unauthorized products results in a finding of unmitigated culpability.

v. Other Matters as Justice May Require

The Act gives me discretion to consider any other evidence or arguments to mitigate the amount of the CMP. 21 U.S.C. § 333(f)(5)(B). Based on the statements above, I find the proposed penalty amount of $19,192 is appropriate. Having found that Respondent violated the law, the CMP should ensure future compliance with the Act and tobacco regulations.

For these reasons, after considering the record evidence, applicable law, and aggravating and mitigating circumstances in this case, I find that a penalty amount of $19,192 is appropriate under 21 U.S.C. §§ 333(f)(5)(B), (f)(5)(C), and (f)(9).

V. Conclusion

For these reasons set forth above, I impose a civil money penalty against Respondent Sajid S. Salimi, Inc. d/b/a Excel Mart / Conoco in the amount of $19,192 for receiving in interstate commerce ENDS products that lack the premarketing authorization required under the Act, and offering such product for sale. Pursuant to 21 C.F.R. §§ 17.11(b), 17.45(d), this decision becomes final and binding upon both parties after 30 days of the date of its issuance.