21 U.S.C. § 387j

Application for review of certain tobacco products

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(a) In general(1) New tobacco product definedFor purposes of this section the term “new tobacco product” means—(A) any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or(B) any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.(2) Premarket review required(A) New productsAn order under subsection (c)(1)(A)(i) for a new tobacco product is required unless—(i) the manufacturer has submitted a report under section 387e(j) of this title; and the Secretary has issued an order that the tobacco product—(I) is substantially equivalent to a tobacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007; and(II) is in compliance with the requirements of this chapter; or(ii) the tobacco product is exempt from the requirements of section 387e(j) of this title pursuant to a regulation issued under section 387e(j)(3) of this title.(B) Application to certain post-February 15, 2007, productsSubparagraph (A) shall not apply to a tobacco product—(i) that was first introduced or delivered for introduction into interstate commerce for commercial distribution in the United States after February 15, 2007, and prior to the date that is 21 months after June 22, 2009; and(ii) for which a report was submitted under section 387e(j) of this title within such 21-month period,except that subparagraph (A) shall apply to the tobacco product if the Secretary issues an order that the tobacco product is not substantially equivalent.(3) Substantially equivalent defined(A) In generalIn this section and section 387e(j) of this title, the term “substantially equivalent” or “substantial equivalence” means, with respect to the tobacco product being compared to the predicate tobacco product, that the Secretary by order has found that the tobacco product—(i) has the same characteristics as the predicate tobacco product; or(ii) has different characteristics and the information submitted contains information, including clinical data if deemed necessary by the Secretary, that demonstrates that it is not appropriate to regulate the product under this section because the product does not raise different questions of public health.(B) Characteristics

In subparagraph (A), the term “characteristics” means the materials, ingredients, design, composition, heating source, or other features of a tobacco product.

A tobacco product may not be found to be substantially equivalent to a predicate tobacco product that has been removed from the market at the initiative of the Secretary or that has been determined by a judicial order to be misbranded or adulterated.

(4) Health information(A) Summary

As part of a submission under section 387e(j) of this title respecting a tobacco product, the person required to file a premarket notification under such section shall provide an adequate summary of any health information related to the tobacco product or state that such information will be made available upon request by any person.

(B) Required information

Any summary under subparagraph (A) respecting a tobacco product shall contain detailed information regarding data concerning adverse health effects and shall be made available to the public by the Secretary within 30 days of the issuance of a determination that such tobacco product is substantially equivalent to another tobacco product.

(b) Application(1) ContentsAn application under this section shall contain—(A) full reports of all information, published or known to, or which should reasonably be known to, the applicant, concerning investigations which have been made to show the health risks of such tobacco product and whether such tobacco product presents less risk than other tobacco products;(B) a full statement of the components, ingredients, additives, and properties, and of the principle or principles of operation, of such tobacco product;(C) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such tobacco product;(D) an identifying reference to any tobacco product standard under section 387g of this title which would be applicable to any aspect of such tobacco product, and either adequate information to show that such aspect of such tobacco product fully meets such tobacco product standard or adequate information to justify any deviation from such standard;(E) such samples of such tobacco product and of components thereof as the Secretary may reasonably require;(F) specimens of the labeling proposed to be used for such tobacco product; and(G) such other information relevant to the subject matter of the application as the Secretary may require.(2) Referral to Tobacco Products Scientific Advisory CommitteeUpon receipt of an application meeting the requirements set forth in paragraph (1), the Secretary—(A) may, on the Secretary’s own initiative; or(B) may, upon the request of an applicant,refer such application to the Tobacco Products Scientific Advisory Committee for reference and for submission (within such period as the Secretary may establish) of a report and recommendation respecting the application, together with all underlying data and the reasons or basis for the recommendation.(c) Action on application(1) Deadline(A) In generalAs promptly as possible, but in no event later than 180 days after the receipt of an application under subsection (b), the Secretary, after considering the report and recommendation submitted under subsection (b)(2), shall—(i) issue an order that the new product may be introduced or delivered for introduction into interstate commerce if the Secretary finds that none of the grounds specified in paragraph (2) of this subsection applies; or(ii) issue an order that the new product may not be introduced or delivered for introduction into interstate commerce if the Secretary finds (and sets forth the basis for such finding as part of or accompanying such denial) that 1 or more grounds for denial specified in paragraph (2) of this subsection apply.(B) Restrictions on sale and distribution

An order under subparagraph (A)(i) may require that the sale and distribution of the tobacco product be restricted but only to the extent that the sale and distribution of a tobacco product may be restricted under a regulation under section 387f(d) of this title.

(2) Denial of applicationThe Secretary shall deny an application submitted under subsection (b) if, upon the basis of the information submitted to the Secretary as part of the application and any other information before the Secretary with respect to such tobacco product, the Secretary finds that—(A) there is a lack of a showing that permitting such tobacco product to be marketed would be appropriate for the protection of the public health;(B) the methods used in, or the facilities or controls used for, the manufacture, processing, or packing of such tobacco product do not conform to the requirements of section 387f(e) of this title;(C) based on a fair evaluation of all material facts, the proposed labeling is false or misleading in any particular; or(D) such tobacco product is not shown to conform in all respects to a tobacco product standard in effect under section 387g of this title, and there is a lack of adequate information to justify the deviation from such standard.(3) Denial information

Any denial of an application shall, insofar as the Secretary determines to be practicable, be accompanied by a statement informing the applicant of the measures required to remove such application from deniable form (which measures may include further research by the applicant in accordance with 1 or more protocols prescribed by the Secretary).

(4) Basis for findingFor purposes of this section, the finding as to whether the marketing of a tobacco product for which an application has been submitted is appropriate for the protection of the public health shall be determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account—(A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and(B) the increased or decreased likelihood that those who do not use tobacco products will start using such products.(5) Basis for action(A) Investigations

For purposes of paragraph (2)(A), whether permitting a tobacco product to be marketed would be appropriate for the protection of the public health shall, when appropriate, be determined on the basis of well-controlled investigations, which may include 1 or more clinical investigations by experts qualified by training and experience to evaluate the tobacco product.

(B) Other evidence

If the Secretary determines that there exists valid scientific evidence (other than evidence derived from investigations described in subparagraph (A)) which is sufficient to evaluate the tobacco product, the Secretary may authorize that the determination for purposes of paragraph (2)(A) be made on the basis of such evidence.

(d) Withdrawal and temporary suspension(1) In generalThe Secretary shall, upon obtaining, where appropriate, advice on scientific matters from the Tobacco Products Scientific Advisory Committee, and after due notice and opportunity for informal hearing for a tobacco product for which an order was issued under subsection (c)(1)(A)(i), issue an order withdrawing the order if the Secretary finds—(A) that the continued marketing of such tobacco product no longer is appropriate for the protection of the public health;(B) that the application contained or was accompanied by an untrue statement of a material fact;(C) that the applicant—(i) has failed to establish a system for maintaining records, or has repeatedly or deliberately failed to maintain records or to make reports, required by an applicable regulation under section 387i of this title;(ii) has refused to permit access to, or copying or verification of, such records as required by section 374 of this title; or(iii) has not complied with the requirements of section 387e of this title;(D) on the basis of new information before the Secretary with respect to such tobacco product, evaluated together with the evidence before the Secretary when the application was reviewed, that the methods used in, or the facilities and controls used for, the manufacture, processing, packing, or installation of such tobacco product do not conform with the requirements of section 387f(e) of this title and were not brought into conformity with such requirements within a reasonable time after receipt of written notice from the Secretary of nonconformity;(E) on the basis of new information before the Secretary, evaluated together with the evidence before the Secretary when the application was reviewed, that the labeling of such tobacco product, based on a fair evaluation of all material facts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the Secretary of such fact; or(F) on the basis of new information before the Secretary, evaluated together with the evidence before the Secretary when such order was issued, that such tobacco product is not shown to conform in all respects to a tobacco product standard which is in effect under section 387g of this title, compliance with which was a condition to the issuance of an order relating to the application, and that there is a lack of adequate information to justify the deviation from such standard.(2) Appeal

The holder of an application subject to an order issued under paragraph (1) withdrawing an order issued pursuant to subsection (c)(1)(A)(i) may, by petition filed on or before the 30th day after the date upon which such holder receives notice of such withdrawal, obtain review thereof in accordance with section 387l of this title.

(3) Temporary suspension

If, after providing an opportunity for an informal hearing, the Secretary determines there is reasonable probability that the continuation of distribution of a tobacco product under an order would cause serious, adverse health consequences or death, that is greater than ordinarily caused by tobacco products on the market, the Secretary shall by order temporarily suspend the authority of the manufacturer to market the product. If the Secretary issues such an order, the Secretary shall proceed expeditiously under paragraph (1) to withdraw such application.

(e) Service of orderAn order issued by the Secretary under this section shall be served—(1) in person by any officer or employee of the department designated by the Secretary; or(2) by mailing the order by registered mail or certified mail addressed to the applicant at the applicant’s last known address in the records of the Secretary.(f) Records(1) Additional information

In the case of any tobacco product for which an order issued pursuant to subsection (c)(1)(A)(i) for an application filed under subsection (b) is in effect, the applicant shall establish and maintain such records, and make such reports to the Secretary, as the Secretary may by regulation, or by order with respect to such application, prescribe on the basis of a finding that such records and reports are necessary in order to enable the Secretary to determine, or facilitate a determination of, whether there is or may be grounds for withdrawing or temporarily suspending such order.

(2) Access to records

Each person required under this section to maintain records, and each person in charge of custody thereof, shall, upon request of an officer or employee designated by the Secretary, permit such officer or employee at all reasonable times to have access to and copy and verify such records.

(g) Investigational tobacco product exemption for investigational use

The Secretary may exempt tobacco products intended for investigational use from the provisions of this subchapter under such conditions as the Secretary may by regulation prescribe.

(June 25, 1938, ch. 675, § 910, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1807.)Editorial NotesPrior Provisions

A prior section 910 of act June 25, 1938, was renumbered section 1010 and is classified to section 399a of this title.

Statutory Notes and Related SubsidiariesSubmission of Applications for Previously Marketed Products

Pub. L. 117–103, div. P, title I, § 111(d), Mar. 15, 2022, 136 Stat. 789, provided that:“(1)Transition period for all products.—With respect to a tobacco product that contains nicotine from any source other than tobacco and that was being marketed in the United States within 30 days after the date of enactment of this Act [Mar. 15, 2022], such product shall not be considered to be in violation of section 910 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387j) (relating to applications for review of certain tobacco products) during the 60-day period following the date of enactment of this Act.“(2)Submission of applications.—“(A)In general.—As a condition for continuing to market a product described in paragraph (1) after the 60-day period specified in such paragraph, during the 30-day period beginning on the effective date specified in subsection (c) [21 U.S.C. 321 note], the manufacturer shall submit a new tobacco product application under section 910(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387j(b)) with respect to such product.“(B)Transition period.—Except as provided in subparagraph (C), with respect to a tobacco product for which an application is submitted as described in subparagraph (A), the manufacturer of such product may continue to market such product during the 90-day period beginning on the effective date specified in subsection (c).“(C)Exception.—If the Secretary of Health and Human Services previously denied an application under section 910(c)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387j(c)(2)), refused to file an application under section 910(b) of such Act, or withdrew an order under section 910(d) of such Act for a previous version of a tobacco product that used nicotine made or derived from tobacco, such product is not eligible for continued marketing under subparagraph (B).“(3)End of transition period.—Beginning on the date that is 90 days after the effective date specified in subsection (c), a tobacco product described in paragraph (1) (including such a tobacco product that is the subject of a pending application under section 910 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387j)) is in violation of such section 910 if such tobacco product does not have an order in effect under subsection (c)(1)(A)(i) of such section.”

Notes of Decisions

Cited in 54 cases (44 in the last 5 years), 2014–2026 · leading case: Nicopure Labs, LLC v. Food & Drug Admin., 266 F. Supp. 3d 360 (D.D.C. 2017).

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Nicopure Labs, LLC v. Food & Drug Admin., 266 F. Supp. 3d 360 (D.D.C. 2017). · cites it 16× “21 U.S.C. § 387j. The existing or “predicate” product to be used for comparison purposes must have been “commercially marketed .”

Am. Acad. Pediatrics v. Food & Drug Admin., 379 F. Supp. 3d 461 (D. Maryland 2019). · cites it 12× “21 U.S.C. § 387j(a)(1)-(2), (b)(1) ; see also Defs.”

Prohibition Juice Co. v. FDA, 45 F.4th 8 (D.C. Cir. 2022). · cites it 8× “21 U.S.C. § 387j(a)(1)-(2). The FDA in turn “shall deny” an application to market a new tobacco product unless the agency finds “that permitting such tobacco product to be marketed would be appropriate for the protection of the public health.”

FDA v. Wages & White Lion Investments, LLC, 604 U.S. 542 (2025). · cites it 9× “21 U. S. C. §387j(a)(1)(A). And because those products had not re- ceived premarket authorization, the effect of the rule was to make their continued sale illegal.”

Liquid Labs LLC v. FDA, 52 F.4th 533 (3rd Cir. 2022). · cites it 10× “§ 387a(b); see also 21 U.S.C. § 387j(a)(1)(A) (defining “a new tobacco product,” as relevant here, to be “any tobacco product .”

Nicopure Labs, LLC v. FDA, 944 F.3d 267 (D.C. Cir. 2019). · cites it 6× “See 21 U.S.C. § 387j. Modified risk products must meet more stringent public-health standards.”

Wages & White Lion Invst v. FDA, 16 F.4th 1130 (5th Cir. 2021). · cites it 3× “21 U.S.C. § 387j(b)–(c). In the months and years following the Deeming Rule, the FDA moved its regulatory goalposts in at least two important ways.”

Wages & White Lion Invst v. FDA, 41 F.4th 427 (5th Cir. 2022). · cites it 7× “To do so, Petitioners needed to submit premarket tobacco product applications as required by 21 U.S.C. § 387j—which the Food and Drug Administration (“FDA”) deemed applicable to e-cigarette tobacco products in 2016.”

Fontem Us, LLC v. Fda, 82 F.4th 1207 (D.C. Cir. 2023). · cites it 10× “” 21 U.S.C. § 387j(c)(2)(A). Fontem petitions for review, arguing the denial was unlawful.”

Logic Tech. Dev. LLC v. FDA, 84 F.4th 537 (3rd Cir. 2023). · cites it 12× “See 21 U.S.C. § 387j(a)(1)–(2). Only if the FDA concludes that “permitting such tobacco product to be marketed would be appropriate for the protection of the public health” (health-appropriate) can the product be approved.”

Magellan Tech., Inc. v. United States Food & Drug Admin., 70 F.4th 622 (2d Cir. 2023). · cites it 5× “5 1 The TCA requires the FDA’s premarket review of “new tobacco products” 2 (defined in 21 U.S.C. § 387j(a)(1) as, inter alia, tobacco products not commercially 3 marketed in the United States as of February 15, 2007).”

FDA v. R. J. Reynolds Vapor Co., 606 U.S. 226 (2025). · cites it 5× “” 21 U. S. C. §387j. In 2016, the FDA decided that e-cigarettes and related products were new tobacco products subject to the TCA.”

Show all 54 citing cases →

— 21 U.S.C. § 387j(a) — 7 cases

Nicopure Labs, LLC v. Food & Drug Admin., 266 F. Supp. 3d 360 (D.D.C. 2017). “21 U.S.C. § 387j. The existing or “predicate” product to be used for comparison purposes must have been “commercially marketed .”

Avail Vapor, LLC v. FDA, 55 F.4th 409 (4th Cir. 2022).

Vapor Tech. Ass'n v. FDA, 977 F.3d 496 (6th Cir. 2020).

GoodCat, LLC v. Cook, 202 F. Supp. 3d 896 (S.D. Ind. 2016).

Swisher Int'l, Inc. v. United States Food & Drug Admin. (11th Cir. 2022).

— 21 U.S.C. § 387j(a)(1) — 11 cases

Am. Acad. Pediatrics v. Food & Drug Admin., 379 F. Supp. 3d 461 (D. Maryland 2019). “21 U.S.C. § 387j(a)(1)-(2), (b)(1) ; see also Defs.”

Magellan Tech., Inc. v. United States Food & Drug Admin., 70 F.4th 622 (2d Cir. 2023). “5 1 The TCA requires the FDA’s premarket review of “new tobacco products” 2 (defined in 21 U.S.C. § 387j(a)(1) as, inter alia, tobacco products not commercially 3 marketed in the United States as of February 15, 2007).”

Prohibition Juice Co. v. FDA, 45 F.4th 8 (D.C. Cir. 2022). “21 U.S.C. § 387j(a)(1)-(2). The FDA in turn “shall deny” an application to market a new tobacco product unless the agency finds “that permitting such tobacco product to be marketed would be appropriate for the protection of the public health.”

Cigar Ass'n of Am. v. FDA, 5 F.4th 68 (D.C. Cir. 2021).

Logic Tech. Dev. LLC v. FDA, 84 F.4th 537 (3rd Cir. 2023). “See 21 U.S.C. § 387j(a)(1)–(2). Only if the FDA concludes that “permitting such tobacco product to be marketed would be appropriate for the protection of the public health” (health-appropriate) can the product be approved.”

— 21 U.S.C. § 387j(a)(1)(A) — 4 cases

FDA v. Wages & White Lion Investments, LLC, 604 U.S. 542 (2025). “21 U. S. C. §387j(a)(1)(A). And because those products had not re- ceived premarket authorization, the effect of the rule was to make their continued sale illegal.”

Liquid Labs LLC v. FDA, 52 F.4th 533 (3rd Cir. 2022). “§ 387a(b); see also 21 U.S.C. § 387j(a)(1)(A) (defining “a new tobacco product,” as relevant here, to be “any tobacco product .”

Shenzhen Youme v. FDA (5th Cir. 2025).

Kealani Distrib. v. FDA (5th Cir. 2026).

— 21 U.S.C. § 387j(a)(1)(a) — 2 cases

Vapor Tech. v. Graham (5th Cir. 2026).

— 21 U.S.C. § 387j(a)(2) — 6 cases

Am. Acad. Pediatrics v. Food & Drug Admin., 379 F. Supp. 3d 461 (D. Maryland 2019). “21 U.S.C. § 387j(a)(1)-(2), (b)(1) ; see also Defs.”

Wages & White Lion Invst v. FDA, 41 F.4th 427 (5th Cir. 2022). “To do so, Petitioners needed to submit premarket tobacco product applications as required by 21 U.S.C. § 387j—which the Food and Drug Administration (“FDA”) deemed applicable to e-cigarette tobacco products in 2016.”

Liquid Labs LLC v. FDA, 52 F.4th 533 (3rd Cir. 2022). “§ 387a(b); see also 21 U.S.C. § 387j(a)(1)(A) (defining “a new tobacco product,” as relevant here, to be “any tobacco product .”

— 21 U.S.C. § 387j(a)(2)(A) — 5 cases

Wages & White Lion Invest v. FDA (5th Cir. 2024).

Kealani Distrib. LLC v. Food & Drug Admin. (E.D. Tex. 2025).

VDX Distro v. FDA (5th Cir. 2026).

— 21 U.S.C. § 387j(a)(2)(A)(i) — 3 cases

Vapor Tech. Ass'n v. FDA, 977 F.3d 496 (6th Cir. 2020).

Breeze Smoke LLC v. Yatin Enter. Inc. (W.D. Mich. 2023).

— 21 U.S.C. § 387j(a)(2)(A)(ii) — 2 cases

Nicopure Labs, LLC v. FDA, 944 F.3d 267 (D.C. Cir. 2019). “See 21 U.S.C. § 387j. Modified risk products must meet more stringent public-health standards.”

Swisher Int'l, Inc. v. United States Food & Drug Admin. (D.D.C. 2023).

— 21 U.S.C. § 387j(a)(2)(B)(ii) — 1 case

Swisher Int'l, Inc. v. United States Food & Drug Admin. (D.D.C. 2024).

— 21 U.S.C. § 387j(a)(3) — 1 case

Swisher Int'l, Inc. v. United States Food & Drug Admin. (D.D.C. 2024).

— 21 U.S.C. § 387j(a)(3)(A) — 1 case

— 21 U.S.C. § 387j(a)(3)(A)(i) — 1 case

— 21 U.S.C. § 387j(a)(3)(B) — 1 case

— 21 U.S.C. § 387j(a)(3)(i) — 1 case

Swisher Int'l, Inc. v. United States Food & Drug Admin. (D.D.C. 2024).

— 21 U.S.C. § 387j(a)(3)(ii) — 1 case

Swisher Int'l, Inc. v. United States Food & Drug Admin. (D.D.C. 2024).

— 21 U.S.C. § 387j(a)(4)(B) — 1 case

Am. Acad. Pediatrics v. Food & Drug Admin., 379 F. Supp. 3d 461 (D. Maryland 2019). “21 U.S.C. § 387j(a)(1)-(2), (b)(1) ; see also Defs.”

— 21 U.S.C. § 387j(b) — 6 cases

Wages & White Lion Invst v. FDA, 16 F.4th 1130 (5th Cir. 2021). “21 U.S.C. § 387j(b)–(c). In the months and years following the Deeming Rule, the FDA moved its regulatory goalposts in at least two important ways.”

Liquid Labs LLC v. FDA, 52 F.4th 533 (3rd Cir. 2022). “§ 387a(b); see also 21 U.S.C. § 387j(a)(1)(A) (defining “a new tobacco product,” as relevant here, to be “any tobacco product .”

Vapor Tech. Ass'n v. FDA, 977 F.3d 496 (6th Cir. 2020).

SWT Global Supply, Inc. v. U.S. Food & Drug Admin., 139 F.4th 957 (8th Cir. 2025).

— 21 U.S.C. § 387j(b)(1) — 2 cases

Nude Nicotine Inc. v. Fda (9th Cir. 2023).

Shenzhen Youme v. FDA (5th Cir. 2025).

— 21 U.S.C. § 387j(b)(1)(A) — 7 cases

Liquid Labs LLC v. FDA, 52 F.4th 533 (3rd Cir. 2022). “§ 387a(b); see also 21 U.S.C. § 387j(a)(1)(A) (defining “a new tobacco product,” as relevant here, to be “any tobacco product .”

Kealani Distrib. v. FDA (5th Cir. 2026).

— 21 U.S.C. § 387j(b)(2) — 1 case

Lorillard Inc v. United States Food & Drug Admin., 56 F. Supp. 3d 37 (D.D.C. 2014).

— 21 U.S.C. § 387j(c) — 4 cases

FDA v. R. J. Reynolds Vapor Co., 606 U.S. 226 (2025). “” 21 U. S. C. §387j. In 2016, the FDA decided that e-cigarettes and related products were new tobacco products subject to the TCA.”

Wages & White Lion Invest v. FDA (5th Cir. 2024).

Shenzhen IVPS Tech v. FDA (5th Cir. 2025).

— 21 U.S.C. § 387j(c)(1)(A) — 5 cases

Am. Acad. Pediatrics v. Food & Drug Admin., 379 F. Supp. 3d 461 (D. Maryland 2019). “21 U.S.C. § 387j(a)(1)-(2), (b)(1) ; see also Defs.”

Swisher Int'l, Inc. v. United States Food & Drug Admin. (D.D.C. 2023).

Vapor Train 2 LLC v. U.S. Food & Drug Admin. (E.D. Tex. 2023).

Swisher Int'l, Inc. v. United States Food & Drug Admin. (D.D.C. 2024).

— 21 U.S.C. § 387j(c)(2) — 10 cases

Liquid Labs LLC v. FDA, 52 F.4th 533 (3rd Cir. 2022). “§ 387a(b); see also 21 U.S.C. § 387j(a)(1)(A) (defining “a new tobacco product,” as relevant here, to be “any tobacco product .”

Am. Acad. Pediatrics v. Food & Drug Admin., 379 F. Supp. 3d 461 (D. Maryland 2019). “21 U.S.C. § 387j(a)(1)-(2), (b)(1) ; see also Defs.”

Breeze Smoke, LLC v. FDA, 18 F.4th 499 (6th Cir. 2021).

— 21 U.S.C. § 387j(c)(2)(A) — 16 cases

Nicopure Labs, LLC v. FDA, 944 F.3d 267 (D.C. Cir. 2019). “See 21 U.S.C. § 387j. Modified risk products must meet more stringent public-health standards.”

Fontem Us, LLC v. Fda, 82 F.4th 1207 (D.C. Cir. 2023). “” 21 U.S.C. § 387j(c)(2)(A). Fontem petitions for review, arguing the denial was unlawful.”

— 21 U.S.C. § 387j(c)(2)(B) — 2 cases

FDA v. R. J. Reynolds Vapor Co., 606 U.S. 226 (2025). “” 21 U. S. C. §387j. In 2016, the FDA decided that e-cigarettes and related products were new tobacco products subject to the TCA.”

Nude Nicotine Inc. v. Fda (9th Cir. 2023).

— 21 U.S.C. § 387j(c)(2)(C) — 1 case

Pharm. Mfg. Rsch. Servs., Inc. v. FDA, 957 F.3d 254 (D.C. Cir. 2020).

— 21 U.S.C. § 387j(c)(2)(D) — 1 case

VDX Distro v. FDA (5th Cir. 2026).

— 21 U.S.C. § 387j(c)(3) — 1 case

Fontem Us, LLC v. Fda, 82 F.4th 1207 (D.C. Cir. 2023). “” 21 U.S.C. § 387j(c)(2)(A). Fontem petitions for review, arguing the denial was unlawful.”

— 21 U.S.C. § 387j(c)(4) — 10 cases

Fontem Us, LLC v. Fda, 82 F.4th 1207 (D.C. Cir. 2023). “” 21 U.S.C. § 387j(c)(2)(A). Fontem petitions for review, arguing the denial was unlawful.”

Nicopure Labs, LLC v. FDA, 944 F.3d 267 (D.C. Cir. 2019). “See 21 U.S.C. § 387j. Modified risk products must meet more stringent public-health standards.”

Liquid Labs LLC v. FDA, 52 F.4th 533 (3rd Cir. 2022). “§ 387a(b); see also 21 U.S.C. § 387j(a)(1)(A) (defining “a new tobacco product,” as relevant here, to be “any tobacco product .”

— 21 U.S.C. § 387j(c)(4)(A) — 7 cases

Liquid Labs LLC v. FDA, 52 F.4th 533 (3rd Cir. 2022). “§ 387a(b); see also 21 U.S.C. § 387j(a)(1)(A) (defining “a new tobacco product,” as relevant here, to be “any tobacco product .”

Fontem Us, LLC v. Fda, 82 F.4th 1207 (D.C. Cir. 2023). “” 21 U.S.C. § 387j(c)(2)(A). Fontem petitions for review, arguing the denial was unlawful.”

Elec. Clouds v. FDA, 94 F.4th 950 (10th Cir. 2024).

— 21 U.S.C. § 387j(c)(5) — 1 case

Kealani Distrib. v. FDA (5th Cir. 2026).

— 21 U.S.C. § 387j(c)(5)(A) — 6 cases

Nicopure Labs, LLC v. FDA, 944 F.3d 267 (D.C. Cir. 2019). “See 21 U.S.C. § 387j. Modified risk products must meet more stringent public-health standards.”

— 21 U.S.C. § 387j(c)(5)(B) — 2 cases

SWT Global Supply, Inc. v. U.S. Food & Drug Admin., 139 F.4th 957 (8th Cir. 2025).

Elec. Clouds v. FDA, 94 F.4th 950 (10th Cir. 2024).

— 21 U.S.C. § 387j(c)(l)(A) — 1 case

— 21 U.S.C. § 387j(e) — 1 case

Fumizer, LLC v. United States Food & Drug Admin. (9th Cir. 2026).

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