Huff and Puffers, LLC d/b/a Huff and Puffers, DAB No. 3214 (2025)

FINAL DECISION ON REVIEW OF
ADMINISTRATIVE LAW JUDGE DECISION

Huff and Puffers, LLC (Respondent) operates an online retail site that sells tobacco products, including electronic nicotine delivery system (ENDS) products, to customers in the United States.  In December 2023, about six months after the Center for Tobacco Products (CTP) of the Food and Drug Administration (FDA) warned Respondent to stop selling ENDS products that lack the required FDA marketing authorization, Respondent sold and shipped an unauthorized ENDS product from California to an undercover FDA inspector in Virginia.  CTP then filed an administrative complaint, seeking a civil money penalty of $20,678 against Respondent for introducing into interstate commerce an ENDS product that lacked the required marketing authorization in violation of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq.     

In response to the complaint, Respondent did not deny violating the FDCA but raised various constitutional and equitable arguments.  It also sought (unsuccessfully) to have the administrative proceedings enjoined by a federal court.  After nearly ten months of discovery, motions practice, and a stay, CTP moved for a summary decision.  The Administrative Law Judge (ALJ) granted CTP’s motion after Respondent failed to timely respond or raise any genuine issue of material fact.  Huff and Puffers, LLC d/b/a Huff and Puffers, DAB TB8770 (2025) (ALJ Decision).  The ALJ determined that Respondent violated the FDCA when it introduced into interstate commerce an ENDS product that lacked the required FDA marketing authorization and further determined that a civil money penalty of $20,678 was appropriate.

Respondent appeals.  Before the Board, Respondent concedes that it violated the FDCA but argues that it is the victim of “selective enforcement” and that the civil money penalty is excessive.  We affirm the ALJ Decision because:  (1) Respondent’s selective enforcement defense has no merit; and (2) Respondent presented no evidence that would warrant a reduction in the penalty amount under the relevant statutory factors.

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Legal Background

In 2009, Congress amended the FDCA through the enactment of the Family Smoking Prevention and Tobacco Control Act (TCA).  See Pub. L. No. 111-31, 123 Stat. 1776 (2009).  Congress amended the FDCA to provide the FDA with primary regulatory authority over the manufacture, marketing, and distribution of tobacco products; to ensure that the FDA has “authority to address issues of particular concern to public health officials, especially the use of tobacco by young people and dependence on tobacco;” and “to provide new and flexible enforcement authority to ensure that there is effective oversight of the tobacco industry’s efforts to develop, introduce, and promote less harmful tobacco products.”  Id. § 3(1), (2), (4).  The FDCA, as amended, empowers FDA to set standards for tobacco products (21 U.S.C. § 387g); restrict sales and distribution (id. § 387f(d)(1)); and regulate manufacturing (id. § 387f(e)).  

“Tobacco product” is broadly defined to mean “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.”  21 U.S.C. § 321(rr). In 2016, FDA issued a final rule concluding that the statutory definition of “tobacco product,” includes ENDS products such as e-cigarettes, vape pens, personal vaporizers, or electronic pipes.  See Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, 81 Fed. Reg. 28,973, 28,976 (May 10, 2016).  As relevant here, the FDCA 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.  21 U.S.C. § 387j(a)(1) (defining “new tobacco product”).

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A new tobacco product (including ENDS products) may not be introduced into interstate commerce without FDA authorization.  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, FDA may issue an order finding that the marketing of the new tobacco product would be “appropriate for the protection of the public health.”  Id. § 387j(c)(1)(A)(i), (2)(A).¹  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 required premarketing authorization order.  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 introduction or delivery for introduction into interstate commerce of any . . . tobacco product . . . that is adulterated or misbranded” violates the FDCA.  Id. § 331(a). 

The FDCA authorizes civil money penalties against “any person who violates a requirement of [the FDCA] which relates to tobacco products.”  21 U.S.C. § 333(f)(9)(A).  At the time of the violation here, retailers who violated the FDCA relating to tobacco products were subject to a civil money penalty of up to $20,678 for each such violation, not to exceed $1,378,541 for all violations adjudicated in a single proceeding.  Id. § 333(f)(9)(A); 21 C.F.R. § 17.2; 45 C.F.R. § 102.3 (eff. Oct. 6, 2023).

To impose a penalty against a tobacco retailer, CTP must serve an administrative complaint on the retailer and file a copy of the complaint with FDA’s Division of Dockets Management.  21 C.F.R. § 17.5.  The retailer may request a hearing by filing an answer.  Id. § 17.9(a).  Cases are assigned to an ALJ, who conducts the hearing and issues an “initial decision” with findings, conclusions, and any penalty based on the record developed before the ALJ.  Id. §§ 17.5(d), 17.19, 17.45(a).  In determining the appropriate penalty amount, the ALJ must consider factors such as the nature, gravity, and extent of violations, ability to pay, effect on business, prior violations, and culpability.  See 21 U.S.C. § 333(f)(5)(B); 21 C.F.R. § 17.34(a), (b).  ALJs have no authority to declare federal statutes or regulations invalid.  21 C.F.R. § 17.19(c).

A motion for summary decision may be filed by either party at any time after a complaint is filed.  Id. § 17.17(a).  The ALJ may grant a motion for summary decision when there are no genuine issues of material fact, and the moving party is entitled to summary decision as a matter of law.  Id. § 17.17(b).  Any opposition to a motion for summary decision must be filed within 30 days of service; however, the ALJ may extend that deadline by 10 days for good cause.  Id. § 17.17(a).  The ALJ “may refuse to consider any motion, request, response, brief, or other document that is not filed in a timely fashion or in compliance with the [regulations].”  Id. § 17.35(f).

Either party may appeal an ALJ’s initial decision to the Board.  Id. § 17.47(a).  The Board may decline review, affirm, or reverse the initial decision, and may increase, reduce, reverse, or remand any civil money penalty determined by the ALJ.  Id. § 17.47(j).

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Case Background

I. CTP served a complaint alleging that Respondent violated the FDCA by introducing into interstate commerce an ENDS product lacking the required marketing authorization order.

On June 6, 2024, CTP filed an administrative complaint against Respondent, seeking a civil money penalty in the amount of $20,678 for selling an ENDS product without FDA premarket authorization.  CRD Dkt. 1 (Compl.) at ¶ 1.  The complaint alleged that Respondent operates an online retail site selling tobacco products; that in May 2023 CTP issued a warning letter to Respondent, stating that certain new tobacco products that Respondent sells are adulterated and misbranded because they lack the required FDA authorization; that in December 2023 an FDA-commissioned inspector purchased from Respondent a non-authorized ENDS product (EB Create BC5000 Sakura Grape), which was shipped from California to Virginia; that the product was a “new tobacco product” not commercially marketed before February 2007; and that the product was adulterated and misbranded because it lacked the required FDA authorization.  Compl. at ¶¶ 13-20.

Respondent filed an answer conceding the key factual allegations in the complaint, but raising three defenses:  (1) that the Seventh Amendment prohibits the Departmental Appeals Board from adjudicating the case because Respondent has a right to a jury trial; (2) that the case is barred by the doctrines of unclean hands and selective enforcement because, upon information and belief, CTP has not sought civil penalties against “Big Tobacco” for similar conduct; and (3) that the requested penalty is excessive given there is no allegation of an underage sale, the product is “generally considered” less harmful than combustible cigarettes, and penalties in “more serious” cases involving cigarette sales to underage purchasers are “much lower.”  CRD Dkt. 4a (Answer).

Respondent sought discovery from CTP in the form of document requests, broadly  seeking settlement agreements, final decisions, and administrative complaints in other cases involving other actors who allegedly introduced ENDS products into interstate commerce without FDA authorization.  CRD Dkt. 7, 7a.  CTP moved for a protective order.  Id.  Respondent then filed a declaratory judgment action in federal court to enjoin the administrative process and asked that the ALJ stay the case pending the federal court litigation.  CRD Dkt. 16, 16a.²  The ALJ temporarily stayed the proceedings due to outstanding discovery motions—not due to the federal court litigation.  CRD Dkt. 15, 20.  The ALJ subsequently granted CTP’s motion for protective order, lifted the stay, and set new pre-hearing exchange deadlines.  CRD Dkt. 23, 24. 

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II. CTP moved for summary decision and Respondent failed to timely respond.

In February 2025, CTP filed its pre-hearing brief with seven exhibits (CTP Exs. 1‑7), including written direct testimony of the Deputy Division Director for the Division of Enforcement and Manufacturing (CTP Ex. 1) and written direct testimony of the FDA officer who conducted the controlled online purchase investigation of Respondent (CTP Ex. 2).  CRD Dkt. 25 - 25h. 

Respondent filed its pre-hearing brief, with one exhibit (R. Ex. 1) and no witness testimony.  CRD Dkt. 27 - 28.  Respondent did not dispute that the ENDS product it sold and shipped to FDA was adulterated and misbranded.  CRD Dkt. 27.  Respondent reiterated that the penalty sought is “excessive” for the reasons stated in its answer but provided no evidence supporting its assertions.  Id. at 2.  Regarding its “affirmative defenses” of unclean hands and selective enforcement, Respondent claimed that R.J. Reynolds had not been subject to any penalties yet marketed, without authorization, one of the “most popular e-cigarettes” among underage users – “Vuse Menthol.”  Id. at 3 (citing R. Ex. 1).  Respondent’s only exhibit is an article reporting survey findings indicating that “Vuse” is a popular e-cigarette brand among youth; however, the article does not differentiate between authorized Vuse products and unauthorized menthol-flavored products.  R. Ex. 1, at 2.³

On March 31, 2025, the ALJ convened a pre-hearing conference, during which CTP indicated that it intended to move for summary decision.  CRD Dkt. 36.  On April 4, 2025, CTP filed its motion for summary decision, noting that the evidence establishing Respondent’s FDCA violation is uncontested and there is no factual dispute “regarding the penalty amount that necessitates a hearing.”  CRD Dkt. 34, 34a.  The ALJ issued an order requiring that Respondent file its response to the motion and any evidence or cross-motion for summary decision by May 5, 2025 (within 30 days as required by regulation) and notify the ALJ by May 30, 2025, whether it intended to cross-examine CTP’s two witnesses.  CRD Dkt. 36.  The ALJ scheduled the hearing for June 10, 2025, for purposes of cross-examination (if necessary).  Id. 

Respondent did not timely file a response to CTP’s motion for summary decision or notify the ALJ of its intent to cross-examine CTP’s witnesses.  On June 3, 2025, nearly a month after the deadline for opposing CTP’s motion, Respondent filed a “Combined Opposition to Complainant’s Motion for Summary Decision and Cross-Motion to Take Official Notice of Facts.”  CRD Dkt. 40.  Respondent provided no explanation for its late submission and made no request for an extension of time.  The ALJ entered an order setting a deadline for CTP’s response and stayed the case pending resolution of the motions.  CRD Dkt. 41.  CTP filed a response, arguing that the ALJ should refuse to 

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consider Respondent’s untimely submission for “disregarding the specified deadline without excuse or explanation.”  CRD Dkt. 42 (citing 21 C.F.R. § 17.35(f)).      

III.      The ALJ concluded that Respondent violated the FDCA and imposed a civil money penalty based on the applicable statutory factors.

On July 18, 2025, the ALJ granted summary decision in favor of CTP, finding that the undisputed material facts establish that Respondent violated the FDCA by introducing into interstate commerce an adulterated and misbranded ENDS product (EB Create BC5000 Sakura Grape) without FDA premarket authorization.  ALJ Decision at 1, 7-9.  Based on the uncontroverted testimony of CTP’s witnesses and other documentary evidence, the ALJ found that EB Create BC5000 Sakura Grape is a new tobacco product manufactured in China; that Respondent sold and shipped the product from California to Virginia; and that the product is “adulterated and misbranded” because it did not have a marketing authorization order, a substantial equivalence report, or an abbreviated report as required by the FDCA.  Id. at 8.  The ALJ noted that Respondent “does not challenge these findings” and “appears to concede that it violated the [FDCA] as alleged.”  Id. at 9.  The ALJ thus concluded “as a matter of law and undisputed fact” that “Respondent committed a violation of 21 U.S.C. § 331(a) for which it is liable.”  Id.

The ALJ further found that Respondent’s opposition to summary decision was “filed several weeks late with no explanation or excuse.”  Id.  The ALJ therefore declined to consider Respondent’s untimely filing because “Respondent did not request an extension for good cause and Respondent’s Opposition was received 29 days after the deadline.”  Id. (imposing sanction under 21 C.F.R. § 17.35(a), (b), (f)).  Even if Respondent had requested an extension, the ALJ noted that the regulations permit only an extension of up to 10 days.  Id. at 4 n.1 (citing 21 C.F.R. § 17.17(a)).⁴    

Next, the ALJ rejected Respondent’s unclean hands and selective enforcement defenses, explaining that:  (1) Respondent provided no evidence or testimony that “Big Tobacco” companies are similarly situated or that the alleged selective enforcement infringed on a constitutional right; (2) Respondent’s claims regarding other companies’ potential violations are based on matters outside the record and not relevant or material to whether Respondent violated the FDCA; (3) the ALJ lacks authority to grant equitable relief; and (4) the Board has held that “‘the alleged failure to take equally harsh steps’” against other 

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noncompliant entities may not be a defense or bar to future enforcement.  Id. at 10-11 (citations omitted). 

Having concluded that Respondent violated the FDCA and is liable for a civil money penalty under 21 U.S.C. § 333(f)(9), the ALJ considered whether the penalty sought by CTP is appropriate.  ALJ Decision at 11 (“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 . . .’” (citing 21 C.F.R. § 17.34)).  The ALJ thus considered “‘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.’”  Id. (quoting 21 U.S.C. § 333(f)(5)(B)).  Upon consideration of the applicable factors, the ALJ determined that the maximum allowable penalty of $20,678 is appropriate.  Id. at 12-13.  The ALJ noted, among other things, that Respondent had a history of violations, failed to present evidence disputing the violation in this case, and provided no proof of mitigating factors such as inability to pay or lack of culpability.  Id.  

Finally, the ALJ rejected Respondent’s Seventh Amendment defense, noting that ALJs are bound by applicable laws and regulations and “‘do not have the authority to find Federal statutes or regulations invalid.’”  Id. at 14 (quoting 21 C.F.R. § 17.19(c)).  Respondent appealed the ALJ Decision to the Board.⁵

Standard of Review

The standard of review on a disputed issue of law is whether the initial decision is erroneous.  21 C.F.R. § 17.47(k).  An initial decision granting summary decision is reviewed for legal error because that determination presents only a question of law. Summary decision is appropriate “if the pleadings, affidavits, and other materials filed in the record, or matters officially noticed, show that there is no genuine issue as to any material fact and that the party is entitled to summary decision as a matter of law.”  Id. § 17.17(b).  When a motion for summary decision has been properly filed, the party opposing the motion “may not rest on mere allegations or denials or general descriptions of positions and contentions; affidavits or other responses must set forth specific facts showing that there is a genuine issue of material fact for a hearing.”  Id. § 17.17(c); see also CRD Dkt. 5, Acknowledgment and Pre-Hearing Order ¶ 15 (“A party opposing a motion for summary decision must come forward with evidence of specific facts showing that a dispute exists.” (emphasis added)).  Conclusory or unsupported assertions are insufficient to establish the existence of a genuine issue of material fact.  See Norris v. 

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Wash. Metro. Area Transit Auth., 342 F. Supp. 3d 97, 108 (D.D.C. 2018) (citing Greene v. Dalton, 164 F.3d 671, 675 (D.C. Cir. 1999)).⁶

Analysis

Before the Board, Respondent argues that the ALJ erred in granting summary decision for CTP and imposing the maximum penalty.  First, Respondent contends that the ALJ improperly rejected its selective enforcement defense.  Notice of Appeal and Brief (NA) at 3-4.  Second, Respondent argues that the ALJ erred as a matter of law in assessing the maximum penalty, asserting that a genuine issue of material fact concerning the “gravity of the violation” precludes a summary decision.  Id. at 4-5.  Respondent requests that the Board set aside the summary decision and remand for a hearing on the merits.  Id. at 5.

I. Respondent violated the FDCA by introducing into interstate commerce an adulterated and misbranded ENDS product.

Respondent does not challenge the ALJ’s determination that the ENDS product it sold to an FDA inspector in December 2023 – EB Create BC5000 Sakura Grape – was not commercially marketed in the United States as of February 15, 2007, traveled in interstate commerce, and lacked the required FDA marketing authorization order, a substantial equivalence order, or a found-exempt order.  See NA at 1 (“[Respondent] did not contest the allegation that it sold a non-FDA-authorized electronic cigarette to an adult undercover FDA inspector.”); see also CTP Ex. 1, at 3-4 (¶¶ 10-12); CTP Ex. 2, at 2-3 (¶¶ 6-11); CTP Exs. 3-5 (narrative report, order confirmation, and photographs).  Accordingly, we summarily affirm the ALJ’s conclusion that Respondent violated 21 U.S.C. § 331(a) by introducing into interstate commerce an adulterated and misbranded ENDS product which lacked the required FDA marketing authorization order, a substantial equivalence order, or a found-exempt order.  ALJ Decision at 7-9; see also Smoker’s Haven 3 LLC d/b/a Smoker’s Haven, DAB No. 3164, at 5 (2024) (summarily affirming ALJ’s findings of fact and conclusions of law where respondent did not challenge those findings or conclusions on appeal); Leung’s, Inc. d/b/a El Faro Supermarket, DAB No. 3025, at 9 (2020) (same).

II. Respondent’s selective enforcement defense is without merit.

Respondent contends that the ALJ erred by rejecting its selective enforcement defense.  NA at 3-4.  Respondent argues that CTP has never pursued penalties against the “Big Tobacco” companies (e.g., Altria, R.J. Reynolds) for allegedly selling unauthorized ENDS products despite those entities being “similarly situated” to Respondent.  Id. at 3.  Respondent asserts that the ALJ’s own reasoning – that all unauthorized ENDS products 

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are “dangerous” – establishes the requisite similarity between Respondent and “Big Tobacco.”  Id.  Respondent further argues that the ALJ prevented it from presenting evidence that Altria and R.J. Reynolds were “similarly situated” by granting a protective order barring discovery into whether FDA had penalized those companies.  Id.  Respondent also asserts that selective enforcement in an administrative proceeding need not be a constitutional violation; rather, differential treatment of similarly situated entities is, according to Respondent, “arbitrary and capricious” agency action under the Administrative Procedure Act, 5 U.S.C. § 501 et seq. (APA).  Id. at 4.   

As an initial matter, Respondent did not argue before the ALJ that CTP violated the APA by engaging in “selective enforcement.”  See 21 C.F.R. § 17.47(g).  In any event, Respondent’s attempt to reconfigure its selective enforcement defense as a type of APA claim is misplaced in these administrative proceedings.  See Blair Allen Nelson, M.D., DAB No. 3024, at 11 (2020) (rejecting appellant’s reliance on the APA’s “arbitrary and capricious” standard of review because it is inapplicable in administrative appeals).  The APA authorizes federal court review of certain final agency actions.  Id.; see also Brian O’Connor, DAB No. 3140, at 18 (2024).  Our review authority is governed by the regulatory process and standard of review under 21 C.F.R. Part 17 – not the APA.       

Still further, the Supreme Court has long held that a federal agency’s decision not to exercise its enforcement authority is “presumptively unreviewable” under the APA.  See Heckler v. Chaney, 470 U.S. 821, 832-33 (1985).  In Heckler, the Court considered the question of whether the FDA’s decision not to exercise its “discretion” to pursue certain enforcement actions is subject to judicial review under the APA.  Id. at 828.⁷  The Court noted that “an agency’s decision not to prosecute or enforce, whether through civil or criminal process, is a decision generally committed to an agency’s absolute discretion.”  Id. at 831.  The Court explained that an agency’s decision not to enforce “often involves a complicated balancing of a number of factors,” including not only whether a violation has occurred, but also “whether agency resources are best spent on this violation or another, whether the agency is likely to succeed if it acts, whether the particular enforcement action requested best fits the agency’s overall policies, and, indeed, whether the agency has enough resources to undertake the action at all.”  Id.  Given such concerns, the Court held that an agency’s decision not to exercise its enforcement authority is “presumptively unreviewable” under 5 U.S.C. § 701(a)(2).  Id. at 832-33.  As relevant here, the Court further found that the enforcement provisions under the FDCA “commit complete discretion to the Secretary to decide how and when they should be exercised.”  Id. at 835.  Thus, the Court concluded that the presumption against judicial review was “not overcome by the enforcement provisions of the FDCA.”  Id. at 837-38. 

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While its Answer is unclear, to the extent that Respondent’s “selective enforcement” defense was based on ordinary equal protection standards, Respondent was required to show both:  (1) discriminatory effect (i.e., that others similarly situated were not subject to enforcement); and (2) discriminatory purpose (i.e., that the agency’s decision to enforce was based on an impermissible motive, such as race, religion, or retaliation for exercising protected rights).  See Wayte v. United States, 470 U.S. 598, 608 (1985); United States v. Armstrong, 517 U.S. 456, 464-65 (1996); see also Frederick Douglass Found., Inc. v. District of Columbia, 82 F.4th 1122, 1147-48 (D.C. Cir. 2023); Lacey v. Maricopa County, 693 F.3d 896, 920-22 (9th Cir. 2012).  A selective enforcement claim is untenable absent evidence that the prosecuted party was “singled out from others similarly situated” and “that their prosecution was improperly motivated.”  See Juluke v. Hodel, 811 F.2d 1553, 1561 (D.C. Cir. 1987). 

Here, Respondent failed to show either a “discriminatory effect” or “discriminatory purpose.”  Respondent made no showing that it is “similarly situated” to any large manufacturer of ENDS products.  The record contains no evidence that large manufacturers, such as Altria or R.J. Reynolds, operate online retail sites that market and sell unauthorized fruit-flavored or grape-flavored ENDS products in the United States.  Respondent’s only evidence is an article indicating that “Vuse” is a popular e-cigarette brand among youth; however, the article does not differentiate between authorized Vuse products and unauthorized menthol-flavored products.  R. Ex. 1, at 2.  While Respondent argued in its pre-hearing brief that “Vuse Menthol” is unauthorized and one of the “most popular e-cigarettes among underage users,” CRD Dkt. 27, at 3, Respondent provided no evidence that “Vuse Menthol” is popular among youth or that R.J. Reynolds markets or sells that product in the United States.  Moreover, allegations or evidence that online retailers (independent of R.J. Reynolds) marketed or sold “Vuse Menthol” does not, without more, establish that R.J. Reynolds violated the FDCA.

Respondent also failed to show any “discriminatory purpose.”  Respondent provided no evidence that CTP’s decision to file an administrative complaint against Respondent was based on any impermissible motive, such as race, religion, or retaliation for exercising a protected right.⁸  Indeed, Respondent’s FDCA violation is uncontested.  Respondent 

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cannot establish “selective enforcement” in violation of equal protection principles without evidence of a discriminatory purpose.  See Frederick Douglass Found., 82 F.4th at 1147-48 (affirming dismissal of selective enforcement claim absent showing that prosecution was “motivated by invidious discrimination”). 

We further reject Respondent’s argument that the ALJ should have allowed discovery into whether FDA imposed civil penalties against Altria or R.J. Reynolds.  NA at 3.  To obtain discovery in support of a selective prosecution claim, the defendant must first make a credible showing of both discriminatory effect and discriminatory purpose.  See Armstrong, 517 U.S. at 468-70 (disallowing discovery where defendant presented no evidence that similarly situated defendants of other races could have been prosecuted but were not).  “The justifications for a rigorous standard for the elements of a selective-prosecution claim thus require a correspondingly rigorous standard for discovery in aid of such a claim.”  Id. at 468.  Respondent made no credible showing of discriminatory effect or discriminatory purpose; accordingly, the ALJ did not err by issuing a protective order to preclude discovery relating to other actors in other cases.  CRD Dkt. 23. 

Finally, FDA’s enforcement of the penalty provisions under the FDCA cannot be limited by enforcement choices made in other cases.  The Board has long held that allegations of disparate treatment cannot prohibit an agency from exercising its responsibility to enforce statutory or regulatory requirements against a noncompliant party.  See Jewish Home of Eastern Pa., DAB No. 2254, at 15 (2009) (collecting cases).  “[S]elective enforcement by the agency, including any alleged failure to take equally harsh steps against other similarly noncompliant service providers, may not itself be made to constitute a defense or a bar to future enforcement actions.”  Beverly Health & Rehab. – Spring Hill, DAB No. 1696, at 28 (1999).  To hold otherwise would deprive the federal government of its authority and responsibility to enforce statutory and regulatory requirements merely because government officials did not act (or neglected to act) in other potentially meritorious cases.  See id. at 28-29.  We find no error in the ALJ’s rejection of Respondent’s selective enforcement defense because FDA’s enforcement choices involving other entities provides no basis for the ALJ (or the Board) to ignore or disregard the FDCA violation in this case.

III.      There is no basis to disturb the civil money 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).  At the time of the FDCA violation here, ALJs were authorized to impose a civil money penalty of up to $20,678 for each violation relating to tobacco products.  21 U.S.C. § 333(f)(9)(A); 21 C.F.R. § 17.2; 45 C.F.R. § 102.3 (eff. Oct. 6, 2023).  After analyzing each of the relevant statutory factors, and 

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finding no genuine issue of material fact, the ALJ imposed the penalty sought by CTP in the amount of $20,678.  See ALJ Decision at 11-13.  

Respondent argues that the ALJ erred in assessing the penalty amount but challenges only the assessment of one factor – the “gravity of the violation.”  NA at 4-5.  Respondent asserts that the “gravity of the violation” does not warrant the maximum allowable penalty because:  (1) the Tobacco Control Act does not say that unauthorized e-cigarettes are “dangerous” as a matter of law; (2) the “adulterated” status of an unauthorized product does not necessarily mean it is dangerous; and (3) the ALJ did not consider the “relative level” of risk or harm presented by e-cigarettes compared to combustible cigarettes.  Id.  Respondent does not challenge the ALJ’s findings regarding any of the other factors, all of which weigh in favor of imposing a significant penalty to ensure future compliance with the FDCA.  We affirm the ALJ’s assessment of the penalty  amount because it is not legally erroneous and Respondent presented no evidence that would warrant a reduction under the relevant statutory factors.

1. A. Nature, Circumstances, Extent, and Gravity of the Violation

The ALJ found the nature, circumstances, extent, and gravity of Respondent’s violations are “serious and warrant a substantial civil money penalty.”  ALJ Decision at 12.    Respondent’s violations are serious in nature, as they contravene the FDA’s efforts to protect public health from the numerous adverse health effects associated with tobacco and nicotine use.  See TCA, Pub. L. No. 111-31, § 2 (congressional findings detailing the serious health consequences of tobacco use and nicotine addiction, especially among adolescents).  The violation identified during the December 2023 investigation is particularly egregious because it occurred approximately six months after the FDA had issued a warning letter advising Respondent to stop selling ENDS products that lack the required authorization and after Respondent acknowledged its prior violations.  CTP Exs. 6, 7. 

Specifically, on May 31, 2023, the FDA issued a warning letter to Respondent, citing it for offering ENDS products for sale (two different flavored e-cigarettes) that lacked the required marketing authorizations.  CTP Ex. 6.  The warning letter expressly advised Respondent that any future violations could result in enforcement actions, including, but not limited to, the imposition of civil money penalties, seizure, or injunction.  Id. at 2.  The warning letter also defined the term “new tobacco product” and explained that all such products marketed without the requisite premarket authorization are unlawfully marketed and subject to FDA enforcement at the agency’s discretion.  Id.  Additionally, the FDA directed Respondent to resources designed to assist retailers in achieving compliance with federal tobacco laws and regulations.  Id.

On June 21, 2023, Respondent, through counsel, replied to the warning letter.  CTP Ex. 7.  Respondent did not deny that it violated the FDCA but stated that it had “permanently 

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ceased all consumer sales of Puff Xtra Disposable Vape products” and that the “last sale” of those products occurred no later than June 4, 2023.  Id. at 1.  Respondent also reported that it “does not intend to sell any Puff Xtra Disposable Vape products in the future.”  Id. 

Despite these assurances, Respondent continued to offer other ENDS products for sale without the required premarket authorization, as shown by the FDA’s December 2023 investigation.  Given Respondent’s repeated noncompliance and failure to fully correct previously identified violations, a substantial monetary penalty is warranted to compel compliance with federal law and to deter future violations of the requirements governing the sale of tobacco products.

Respondent’s contentions about the gravity of its violations are both unsupported by the record and unpersuasive.  Respondent complains that the ALJ did not consider the relative risk, harm, or danger posed by e-cigarettes compared to combustible cigarettes but provided no evidence about the purported safety of the EB Create BC5000 Sakura Grape product that it marketed and sold without FDA authorization.  While Respondent insists that e-cigarettes are “generally considered” less harmful than combustible cigarettes, Respondent provided no evidence that the grape-flavored e-cigarette it marketed and sold has been evaluated and deemed “less harmful” than combustible cigarettes.  Indeed, the very information necessary to obtain a marketing authorization order for such a product is plainly absent in this case.  No record evidence shows that this product, which is banned in its country of origin, is somehow “less harmful” such that the ALJ should have imposed a reduced civil money penalty.⁹ 

Before the ALJ, Respondent further argued that the penalty is “excessive” because CTP did not allege that it sold the ENDS product to an underage purchaser, and CTP requests “much lower” penalties in cases involving the sale of cigarettes to underage purchasers.  Answer at 3.  While it is undisputed that Respondent did not sell the ENDS product to an underage purchaser at FDA,¹⁰ the mere fact that Respondent did not violate the FDCA in other respects does not mitigate the gravity of repeatedly selling adulterated and misbranded ENDS products through its online store in the United States.  And, while CTP may request lower penalties for violations of 21 U.S.C. § 387f(d)(5) for underage sales, that is because the penalties for those violations are limited by regulation.  See 21 C.F.R. § 17.2; 45 C.F.R. § 102.3 (eff. Oct. 6, 2023) (authorizing penalties from $345 to $13,785 depending on the number and frequency of violations).  Respondent’s violation of 21 U.S.C. § 331(a), by contrast, was subject to a substantially higher penalty amount, reflecting a policy choice consistent with the government’s enforcement priorities.  See 

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21 U.S.C. § 333(f)(9)(A); 21 C.F.R. § 17.2; 45 C.F.R. § 102.3 (authorizing penalty up to $20,678 for a single violation). 

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

The ALJ found that Respondent provided no evidence showing an inability to pay the proposed penalty and no evidence relating to its ability to continue doing business.  ALJ Decision at 12.  Respondent submitted no financial records and made no argument that the imposition of a $20,678 civil money penalty would adversely affect its ability to do business.  The ALJ, therefore, appropriately concluded that these factors do not mitigate the penalty amount.     

1. C. History of Prior Violations

The ALJ found that Respondent’s history of violations, as evidenced by the warning letter, weighed in favor of imposing a civil money penalty of $20,678.  ALJ Decision at 13.  The ALJ noted that Respondent had not asserted any argument nor submitted any evidence concerning its prior violations.  As discussed above, Respondent has a history of violating the FDCA’s requirements concerning new tobacco products.  CTP Ex. 6.  Despite the warning letter, Respondent continued to offer ENDS products for sale in interstate commerce without the required premarket authorization or exemption.  This conduct demonstrates an unwillingness or inability to comply with federal law and supports a civil money penalty of $20,678.  

1. D. Degree of Culpability

The ALJ found Respondent “fully culpable” for offering for sale or distributing new tobacco products that lacked the required marketing authorization.  ALJ Decision at 13.  FDA previously advised Respondent of its legal obligations, directed it to compliance resources, and warned that continued violations could result in civil money penalties, seizure, or injunction.  CTP Ex. 6.  Despite the warning letter, there is no dispute that Respondent continued to sell ENDS products without the required authorization as alleged in the Complaint.  Moreover, Respondent presented no evidence that it took any steps to prevent future violations involving unauthorized ENDS products after its initial response to the warning letter.  CTP Ex. 7. 

The regulations authorized the ALJ to review the penalty that CTP sought to impose (21 C.F.R. § 17.1) and, based on the consideration of mitigating and aggravating factors, determine the appropriate amount of the penalty (id. §§ 17.34, 17.45).  Here, the ALJ concluded that based on the record evidence, applicable law, and aggravating and mitigating circumstances, including the factors in 21 U.S.C. § 333(f)(5)(B), a penalty in the amount of $20,678 is appropriate.  ALJ Decision at 13.  For all of the foregoing 

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reasons, we find no error in the ALJ’s evaluation of the relevant factors and assessment of a penalty in the amount of $20,678.

Conclusion

We affirm the ALJ Decision.