Trees Vape Supply LLC, DAB No. 3187 (2025)

FINAL DECISION ON REVIEW OF ADMINISTRATIVE LAW JUDGE DECISION

Trees Vape Supply, LLC d/b/a Tea Time E-liquid Co. (Respondent) appeals the initial decision of an Administrative Law Judge (ALJ) imposing a civil money penalty (penalty) of $15,192 against Respondent for violating the Federal Food, Drug, and Cosmetic Act (FDCA).  Trees Vape Supply, LLC d/b/a Tea Time E-liquid Co., DAB TB9013 (2025) (Initial Decision).  Based on a complaint and uncontroverted evidence filed by the Center for Tobacco Products (CTP) of the Food and Drug Administration (FDA), the ALJ determined that Respondent violated the FDCA when it offered for sale and introduced into interstate commerce e-liquid products containing synthetic nicotine that lacked the required premarketing authorization.  For the reasons explained below, we affirm the Initial Decision because it is supported by substantial evidence and free of legal error.

Legal Background

To protect public health, the FDCA, 21 U.S.C. § 301 et seq., imposes restrictions on the sale, distribution, and use of tobacco products.  See 21 U.S.C. §§ 301, 331(b), 331(k), 387a(a)-(b), 387c(a)(7)(B), 387f(d).  The FDCA prohibits the “receipt in interstate commerce of any . . . tobacco product . . . that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.”  Id. § 331(c).  A “tobacco product” means “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption, including any component, part, or accessory of a tobacco product.”  Id. § 321(rr) (emphasis added).¹  The FDCA, as amended, extends to and imposes additional requirements for “new tobacco products”—that is, tobacco products that were not commercially marketed in the United States as of February 15, 2007.  Id. § 387j(a)(1) (defining “new tobacco product”).

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A new tobacco product may not be introduced into interstate commerce without authorization from FDA.  See 21 U.S.C. § 387j(a)(2)(A).  FDA may grant such authorization in three ways.  First, based on FDA’s review of a premarket tobacco product application (PMTA), FDA may issue an order finding that the marketing of the new tobacco product would be “appropriate for the protection of the public health.”  21 U.S.C. § 387j(c)(1)(A)(i), (2)(A).²  Second, based on FDA’s review of a substantial equivalence report (SE report), FDA may issue an order determining that the new tobacco product is “substantially equivalent” to a tobacco product commercially marketed in the United States as of February 15, 2007, or a tobacco product marketed after that date, but which FDA previously determined to be substantially equivalent.  Id. §§ 387j(a)(2)(A)(i), 387e(j).  Third, based on FDA’s review of an exemption request and “abbreviated report,” FDA may issue an order finding an exemption.  Id. §§ 387j(a)(2)(A)(ii), 387e(j)(1), (3)(A); 21 C.F.R. § 1107.1.

A new tobacco product is “adulterated” if it is required to have, but does not have, a premarketing authorization order under section 387j(c)(1)(A)(i).  21 U.S.C. § 387b(6)(A).  A new tobacco product is “misbranded” if a report required under section 387e(j) (i.e., an SE report or abbreviated report) for that product was not submitted to FDA.  Id. § 387c(a)(6).

The FDCA authorizes penalties against “any person who violates a requirement of [the FDCA] which relates to tobacco products.”  21 U.S.C. § 333(f)(9)(A).  The implementing regulations concerning civil money penalties, 21 C.F.R. Part 17 and 45 C.F.R. § 102.3, establish a schedule of maximum penalty amounts.  See 21 C.F.R. § 17.2 (citing 45 C.F.R. § 102.3 (table)).  In 2023, the maximum penalty amount for penalties authorized under 21 U.S.C. § 333(f)(9)(A) was $20,678.  See 45 C.F.R. § 102.3 (Oct. 6, 2023).

To impose a penalty against a tobacco retailer, CTP serves an administrative complaint (complaint) on the retailer, and files a copy of the complaint with FDA’s Division of Dockets Management.  See 21 C.F.R. §§ 17.5, 17.7.  The retailer may then request a hearing before an ALJ by filing an answer to the complaint.  Id. § 17.9(a).  The ALJ issues an “initial decision” based on the record developed before the ALJ.  Id. § 17.45(a).

A retailer dissatisfied with an ALJ’s initial decision may appeal it to the Board. 21 C.F.R. § 17.47(a).  The notice of appeal “must identify specific exceptions to the initial decision, must support each exception with citations to the record, and must explain the basis for each exception.”  Id. § 17.47(c).  The Board may decline review, affirm, or reverse the initial decision, and may increase, reduce, reverse, or remand any penalty determined by the ALJ.  Id. § 17.47(j).

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Case Background

A.        CTP served a complaint alleging that Respondent violated the FDCA by marketing and selling e-liquid products without the required premarketing authorization.

In March 2024, CTP filed and served a complaint seeking to impose a penalty of $19,192 against Respondent for introducing into interstate commerce e-liquid products that lack the premarketing authorization required by the FDCA.  Compl. ¶ 1.  Respondent operates an online store through which it sells e-liquids containing synthetic nicotine under the name Tea Time E-liquid Co.  Compl. ¶ 13; CRD Dkt. 12 (Respondent’s Resp. to Req. for Prod. of Docs.).³  The complaint recounted that on September 9, 2022, CTP issued a warning letter to Respondent, informing Respondent that new tobacco products being offered for sale through its website were adulterated or misbranded.  Compl. ¶ 14; CTP Ex. 7 (warning letter).  The warning letter explained that legislation amending the FDCA, enacted on March 15, 2022, extended the FDA’s jurisdiction “to products ‘containing nicotine from any source,’ not just nicotine derived from tobacco.”  CTP Ex. 7, at 1 (“Tobacco products, including e-liquid products containing nicotine from any source, must be in compliance with the [FDCA] and its implementing regulations.”).  CTP warned Respondent that the e-liquid products being offered for sale on its website, including Peach Mango Tea and Raspberry Limeaid Tea, were adulterated and misbranded because they lacked the required premarketing authorization.  Id. at 2.  The letter further warned Respondent that its failure to address these or any similar violations may lead to regulatory action, including a civil money penalty.  Id.

By letter dated September 30, 2022, and in response to the warning letter, Respondent acknowledged that the FDA had jurisdiction to regulate synthetic nicotine products and did not deny selling such products in interstate commerce without the premarketing authorization required by the FDCA.  CTP Ex. 8, at 1 (“I understand that back in March of 2022, the FDA was granted regulation over synthetic nicotine products.”).  Respondent further acknowledged the need to submit a PMTA for products containing synthetic nicotine but expressed concern about the timeframe for doing so.  Id. at 2 (“Please explain how it is possible to file the PMTA in 8 weeks (about 2 months) when it is a process that takes at least a year or more.”).  There is no record evidence indicating that Respondent (or the manufacturer of Respondent’s products) submitted a PMTA to FDA for any of the synthetic nicotine products that Respondent continued selling through its website.

On November 29, 2023, more than a year after CTP issued the warning letter to Respondent, an FDA-commissioned inspector conducted an inspection of Tea Time E-

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liquid Co.’s online store and purchased two of the e-liquid products identified in the warning letter:  Peach Mango Tea and Raspberry Limeaid Tea.  Compl. ¶ 15; see also CTP Exs. 1-6.  Respondent shipped the e-liquid products, which were not commercially marketed in the United States as of February 15, 2007, from Connecticut to Maryland.  Compl. ¶¶ 16-17; see also CTP Exs. 2-6.  CTP alleged that these “new tobacco products” were “adulterated” because they did not have the required marketing authorization order under 21 U.S.C. § 387b(6)(A) and “misbranded” because neither an SE report nor abbreviated report had been submitted for either product under 21 U.S.C. § 387c(a)(6).  Compl. ¶¶ 17-19; see also CTP Ex. 1.

Respondent filed a timely answer to the complaint raising two defenses:  First, Respondent claimed that its owner was told by an FDA investigator in May 2021 that what it was selling (i.e., e-liquid products containing synthetic nicotine) was “okay to sell.”  Answer at 1.  Second, Respondent asserted that, even if it did “something wrong,” it was “not in any position financially to pay a $20,000.00 fine.”  Id.

On June 20, 2024, Respondent filed a pre-hearing brief, acknowledging that it sells “e-liquids that contain synthetic nicotine” and reiterating that an FDA investigator told Respondent’s owner in May 2021 that synthetic nicotine products “currently do not fall under an FDA regulation.”  CRD Dkt. 8, at 3.  Respondent also argued that the CMP amount is “not appropriate” and would “bankrupt” the company, which had year to date sales of only $20,000.  Id. at 6.  Respondent filed three exhibits with its brief.  CRD Dkt. 9, 10, 11.  On July 20, 2024, Respondent filed three more exhibits, including a written response to CTP’s request for production of documents.  CRD Dkt. 12, 12a, 12b.

On August 12, 2024, CTP filed its pre-hearing brief with eight exhibits (CTP Exs. 1‑8), including written direct testimony of the Deputy Division Director for the Division of Enforcement and Manufacturing (CTP Ex. 1) and written direct testimony of FDA officers who participated in the controlled online purchase investigation of Respondent (CTP Exs. 2, 3).  CRD Dkt. 13-13k.  Respondent filed a reply contesting its ability to pay the CMP and a copy of its owner’s 2023 individual tax return.  CRD Dkt. 14, 14a.  The ALJ admitted the parties’ respective exhibits into evidence without objection.  Initial Decision at 2.  The parties waived an in-person hearing, and the ALJ proceeded to issue a decision based on the written record.  Id. at 2-3.

B.        The ALJ found Respondent violated the FDCA and imposed a reduced CMP.

The ALJ considered all of the record evidence and concluded that on November 29, 2023, Respondent introduced into interstate commerce adulterated and misbranded e-liquid products, specifically Tea Time E-liquid Co. Peach Mango Tea and Tea Time E-liquid Co. Raspberry Limeaid Tea, in violation of the FDCA.  Initial Decision at 4-6.  Rejecting Respondent’s argument that it did not violate the FDCA because an FDA investigator told Respondent’s owner in May 2021 that synthetic nicotine was not regulated, the ALJ noted

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that Respondent, by its own admission, knew the law changed after May 2021 and was aware by 2022 that e-liquid products containing synthetic nicotine were regulated and required FDA approval.  Id. at 6 (citing CTP Ex. 8).  The ALJ determined, based on the uncontroverted testimony of CTP’s three witnesses and documentary evidence, that the two e-liquid products Respondent sold and shipped to FDA investigators, Peach Mango Tea and Raspberry Limeaid Tea, were adulterated because they “lacked the required FDA marketing authorization and were not exempt,” and were misbranded because “there was no substantially equivalent determination.”  Id. at 7 (citing  21 U.S.C. §§ 387j(a)(2)(A), 387e(j)(3)(A), 387c(a)(6), 387e(j)).  The ALJ concluded that Respondent violated 21 U.S.C. § 331(a) and that such a violation merits a civil money penalty.  Id. at 7.

The ALJ determined the amount of the penalty, considering “‘the nature, circumstances, extent, and gravity of the violation or 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.’”  Initial Decision at 7-8 (citing 21 U.S.C. § 333(f)(5)(B); 21 C.F.R. § 17.34).  Upon consideration of the applicable factors, including Respondent’s evidence and arguments concerning its financial status, the ALJ determined that a reduced penalty of $15,192 is appropriate.  Id. at 8-11.  Respondent appealed the Initial Decision to the Board.

Standard of Review

The Board’s standard of review on a disputed issue of fact is whether the initial decision is supported by substantial evidence on the whole record.  21 C.F.R. § 17.47(k).  The standard of review on a disputed issue of law is whether the initial decision is erroneous.  Id.

Analysis

Respondent filed a notice of appeal raising the following three arguments:  (1) the “actual forms” provided by FDA investigators in connection with a May 2021 inspection confirmed that Respondent’s products “did not fall under FDA regulation at the time due to their synthetic nicotine content”; (2) FDA did not consider Respondent’s question (raised in response to the September 2022 warning letter) about the “impracticality of the eight-week deadline for PMTA submission” or the feasibility “for any company to prepare and submit a compliant PMTA within such a constrained timeframe”; and (3) the penalty imposed is unjust, “financially crippling,” and would require Respondent to “shut down” its business.  Notice of Appeal (NA) at 1-2.  Respondent requested that the penalty be “reconsidered and rescinded.”  Id. at 2.

CTP filed a response brief, arguing that the Initial Decision should be affirmed because it is supported by substantial evidence and free of legal error.  Dkt. 3.  That same day, Respondent filed a reply, repeating its argument that the penalty should be reconsidered.

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Dkt. 4.  Respondent also raised a new argument, asserting that the FDA’s “regulatory stance on nicotine products, particularly synthetic nicotine, is currently the subject of ongoing litigation” and that it is “both premature and unjust to penalize [Respondent] while the courts are actively reviewing these regulatory decisions.”  Id. at 1.  Respondent requested that “any enforcement actions against [it] be suspended until these legal challenges are resolved.”  Id. at 2.

The Board treated Respondent’s request to “suspend” these proceedings as a request for a stay and ordered further briefing under 21 C.F.R. § 17.47(h).  Dkt. 5.  CTP filed a response arguing that there is no known pending litigation that would warrant a stay.  Dkt. 6.  Respondent submitted a reply arguing that a stay is “reasonable and necessary” due to unspecified “ongoing federal litigation.”  Dkt. 7.  Respondent subsequently filed a further reply conceding that there is no pending litigation challenging FDA’s regulatory authority over synthetic nicotine but asserting that a stay is nevertheless appropriate because the law might face “further legal scrutiny or challenge” in the future.  Dkt. 9.

A.        Respondent’s request for a stay is denied.

Respondent concedes there is no pending litigation challenging FDA’s regulatory authority over synthetic nicotine.  Respondent’s contention that a stay is nevertheless appropriate because the law might possibly face “further legal scrutiny or challenge” in the future has no merit.  We have no authority to ignore or question currently applicable law and stay this appeal based on the possibility that the FDA’s regulatory authority over synthetic nicotine could be challenged by other parties in future litigation.  See J. Peaceful, L.C., DAB No. 2742, at 15 (2016) (“Neither the ALJs nor this Board are empowered to ignore . . . applicable statutes or regulations.”).  Moreover, to the extent Respondent seeks to raise a constitutional challenge to the FDA’s regulatory authority, the Board has no authority to declare federal statutes or regulations invalid or unconstitutional.  See Drive Thru Vapors, LLC, DAB No. 3168, at 11 (2025); see also 21 C.F.R § 17.19(c).  Accordingly, Respondent’s request to stay this appeal is denied.

B.        Respondent violated the FDCA by introducing into interstate commerce adulterated and misbranded e-liquid products containing synthetic nicotine.

Respondent does not challenge the ALJ’s determination that the e-liquid products it sold to FDA investigators in November 2023―Tea Time E-liquid Co. Peach Mango Tea and Tea Time E-liquid Co. Raspberry Limeaid Tea―were not commercially marketed in the United States as of February 15, 2007, contain synthetic nicotine, and traveled in interstate commerce.  Initial Decision at 4-7; see also CTP Exs. 1-6.  Nor does Respondent dispute the ALJ’s finding that Respondent never obtained an FDA marketing authorization order, a substantial equivalence order, or a found-exempt order for these

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products.  Initial Decision at 7; see also CTP Ex. 1, at 4-5 (¶¶ 10-12).⁴  Accordingly, we find no error in the ALJ’s conclusion that Respondent violated the FDCA by introducing into interstate commerce adulterated and misbranded tobacco products, specifically Tea Time E-liquid Co. Peach Mango Tea and Tea Time E-liquid Co. Raspberry Limeaid Tea, which lacked the required FDA marketing authorization order, a substantial equivalence order, or a found-exempt order.  Initial Decision at 7.

Respondent’s assertion that FDA investigators confirmed at a May 2021 inspection that synthetic nicotine products were not regulated by FDA at that time is beside the point.  NA at 1.⁵  Even if that were true, as Respondent knows, Congress subsequently amended the FDCA to expand the definition of “tobacco product” to include products containing synthetic nicotine.  Consolidated Appropriations Act, 2022, Public Law 117-103, Division P, Title I, Subtitle B, 136 Stat 49, 789 (Mar. 15, 2022); CTP Ex. 8, at 1 (“I understand that back in March of 2022, the FDA was granted regulation over synthetic nicotine products.”).  Thus, there is no question that the new tobacco products that Respondent marketed and sold in interstate commerce in September 2022 and November 2023 were subject to the premarketing authorization requirements of the FDCA.  See CTP Ex. 7; CTP Ex. 1, at 3-5 (¶¶ 7-12).

Respondent’s further assertion that the FDA “omitted from consideration” Respondent’s concern about the “impracticality of the eight-week deadline for PMTA submission” is also unavailing.  NA at 1-2 (“I reasonably assumed that the short submission window [for a PMTA] must have been an error.”).  Even if Respondent believed it would have a full year to submit a PMTA after receiving the warning letter, there is no evidence that Respondent ever submitted a PMTA for its e-liquid products and no evidence that Respondent followed-up with FDA after Respondent’s written response to the warning letter.  CTP Ex. 8.  Instead, the record reflects that Respondent continued selling e-liquid products containing synthetic nicotine, including Peach Mango Tea and Raspberry Limeaid Tea, without the required marketing authorization order or a valid exemption, more than 14 months after Respondent was warned that the marketing of those products was unlawful and subject to enforcement action.  CTP Ex. 7, at 2.  Nothing in CTP’s warning letter suggested Respondent had the option to continue selling adulterated and misbranded tobacco products while it awaited further instructions.  Id.  To the contrary, the letter advised Respondent that “[i]t is your responsibility to ensure that your tobacco products . . . comply with each applicable provision of the [FDCA] and FDA’s implementing regulations.”  Id.

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As the ALJ noted, “Respondent’s claims regarding its uncertainty with the law, misunderstanding of the Warning Letter, and waiting for FDA [or] CTP to contact it, are not valid affirmative defenses that can relieve Respondent of its liability.”  Initial Decision at 9.  We find no error in the ALJ’s conclusion that Respondent is obligated to understand and comply with the laws governing the highly addictive products it sells and distributes.  Id.; see also 21 C.F.R. § 1140.10 (“Each manufacturer, distributor, importer, and retailer is responsible for ensuring that the cigarettes, smokeless tobacco, or covered tobacco products it manufactures, labels, advertises, packages, distributes, imports, sells, or otherwise holds for sale comply with all applicable requirements under this part.”); D & A Business Invest. LLC, DAB No. 3166, at 10 (2024) (rejecting retailer’s argument that it “reasonably believed” its products were authorized for sale where warning letter informed retailer of violations related to its vaping products).

C.        There is no basis to disturb the reduced penalty imposed by the ALJ.

In determining the appropriate penalty amount, ALJs must consider “the nature, circumstances, extent, and gravity of the violation or 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. § 17.34(b).  After analyzing each of the factors for determining the appropriate penalty amount, including Respondent’s ability to pay the penalty and its effect on Respondent’s ability to continue to do business, the ALJ reduced the penalty sought by CTP to $15,192.  See Initial Decision at 8-11.  We affirm the penalty amount imposed by the ALJ because it is supported by substantial evidence and not legally erroneous.

Before the Board, Respondent asserts that the penalty imposed by the ALJ is “financially crippling” given the company’s financial struggles.  NA at 2 (“The imposition of this fine would leave me no choice but to shut down Trees Vape Supply, LLC entirely.”); see also Dkt. 4, at 1 (“My monthly sales range between $2,000 and $3,000, with approximately $500 in operational expenses.”).  Respondent raised this argument before the ALJ; the ALJ carefully considered it, and, accordingly, reduced the penalty amount.  Initial Decision at 9-10.  Before the ALJ, Respondent submitted a screenshot showing year to date revenue in the amount of $20,196 from January 1 through June 20, 2024 (CRD Dkt. 10); a screenshot showing year to date revenue in the amount of $23,475 from January 1 through July 20, 2024 (CRD Dkt. 12a); a 1099-K showing payment card transactions totaling $61,424 for 2023 (CRD Dkt. 12b); and Respondent’s owner’s individual 2023 tax return showing an adjusted gross income of $11,958 (CRD Dkt. 14a).  Respondent submitted no other financial records for its business, such as profit and loss statements.  Respondent did not show what part of its profits in 2022 or 2023 came from tobacco products that were not adulterated or misbranded or explain why it should be permitted to profit from the unlawful sale of adulterated and misbranded products.

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Nevertheless, based on the evidence presented, the ALJ found Respondent demonstrated that the penalty sought by CTP would have a “significant negative effect on Respondent’s ability to do business” and found this to be a mitigating factor warranting a reduction in the penalty amount.  Initial Decision at 9-10.  The ALJ stated:

I find that a $19,192 deduction from Respondent’s stated business income is significant even as an online retailer with limited overhead.  I consider as a mitigating factor that the penalty CTP is seeking represents close to 100% of Respondent’s 2024 revenue for the first half of . . . the calendar year from e-liquid products sales.

Id. at 10.  Accordingly, the ALJ considered this mitigating factor along with all other relevant factors in determining the appropriate penalty amount.  Id. at 11.

Respondent identifies no legal or factual error in the ALJ’s analysis, nor does Respondent challenge the ALJ’s findings regarding any of the other factors, which weigh in favor of imposing a significant penalty to ensure future compliance with the FDCA.  Regarding the nature, circumstances, extent and gravity of the violations, the ALJ rejected Respondent’s assertion concerning its purported uncertainty about the law, pointing to its response to the warning letter, which stated that it provides “hundreds of customers” with e-liquid products and was aware of the change in the law in 2022 concerning FDA’s regulation of synthetic nicotine products and the need to submit a PMTA.  Id. at 8-9 (citing CTP Ex. 8).  In terms of Respondent’s history of violations, the ALJ acknowledged there is no record of a prior penalty but pointed out that despite the warning letter regarding the unlawful marketing of Peach Mango Tea and Raspberry Limeaid Tea e-liquid products, Respondent continued selling the same products more than a year later without the required premarketing authorization.  Id. at 10-11.  The ALJ further found Respondent “fully culpable” for introducing into interstate commerce adulterated and misbranded e-liquid products, noting its owner’s admission that he understood the FDA was granted regulatory authority over synthetic nicotine products in March 2022 and that such products required FDA approval.  Id. at 11.  Despite this awareness, the ALJ noted, Respondent took no active steps between March 2022 and November 29, 2023, to prevent future violations.  Id.  The ALJ thus concluded that based on the record evidence, applicable law, and aggravating and mitigating circumstances, a penalty in the amount of $15,192 is appropriate.  Id. at 11.  We find no legal or factual error in the ALJ’s evaluation of the relevant factors or the imposition of the penalty.

Finally, we decline to remand this matter to the ALJ for consideration of additional evidence submitted for the first time before the Board.  Along with its Notice of Appeal, Respondent submitted (1) a screenshot of a business checking account balance without identifying the account owner (Dkt. 1b); and (2) a screenshot purporting to show the January 2025 revenue of Tea Time E-liquid Co. (Dkt. 1c).  The regulations governing this appeal authorize the Board to remand a matter to the ALJ for consideration of additional

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evidence, if “any party demonstrates to the satisfaction” of the Board that “additional evidence not presented at the hearing is relevant and material and that there were reasonable grounds for the failure to adduce such evidence at the hearing.”  21 C.F.R. § 17.47(i).  Respondent did not address why checking account information was not provided to the ALJ and, in any event, the screenshot submitted provides no relevant information about the account owner or account transactions.  Respondent also has not demonstrated to our satisfaction that the January 2025 revenue information is relevant and material.  Respondent already had provided the ALJ with revenue information from January 1, 2024, through July 20, 2024, and does not explain why a single, isolated, revenue statement, generated six months later and after the record closed (CRD Dkt. 17, at 2-3), is relevant and material to this case.  Respondent had ample opportunity to submit financial information to the ALJ, and we do not find the additional evidence submitted here warrants a remand for further consideration.

In short, the regulations authorized the ALJ to review the penalty that CTP sought to impose (21 C.F.R. § 17.1) and, based on the ALJ’s consideration of mitigating and aggravating factors, determine the appropriate amount of the penalty (21 C.F.R. §§ 17.34, 17.45).  That is what the ALJ did here.  We find no legal or factual error in the ALJ’s evaluation of the relevant factors and assessment of a penalty in the amount of $15,192.

Conclusion

We affirm the Initial Decision.

Endnotes

¹  Effective April 14, 2022, Congress amended the FDCA to expand the definition of “tobacco product” to include products that contain nicotine from any source (i.e., synthetic nicotine).  See Consolidated Appropriations Act, 2022, Public Law 117-103, Division P, Title I, Subtitle B, 136 Stat 49, 789 (Mar. 15, 2022).

²  In making this determination, FDA must consider “the risks and benefits to the population as a whole,” “taking into account” both the “likelihood that existing users of tobacco products will stop using such products” and the “likelihood that those who do not use tobacco products will start using such products.”  21 U.S.C. § 387j(c)(4).

³  Many of the materials filed by Respondent in the Civil Remedies Division (Docket No. T-24-2163) were not properly labeled or not marked as exhibits.  We cite to the specific docket entries in that case as “CRD Dkt. _.”

⁴  There is also no evidence that the California manufacturer of these products submitted a report to FDA requesting a substantial equivalence order or an abbreviated report requesting a found-exempt order.  CTP Ex. 1, at 3 (¶¶ 7-8), 4-5 (¶ 12).

⁵  The “actual forms” in which Respondent claims FDA investigators confirmed that Respondent’s synthetic nicotine products are not subject to FDA regulation were signed on May 25, 2021, and, in any event, contain no such statement by any FDA investigator or employee.  CRD Dkt. 9 (“Exhibit A”).