Kealani Distribution v. FDA - Tobacco Control Act Rule Challenge

United Sta tes Court of Appeals f or the Fifth Circuit ________ ____ No. 25 - 4013 5 ________ ____ Kealani Distri bution, L.L.C.; United States Vaping Associat ion, Inc orporat ed; D iamon d Vapo r, L.L.C.; Johnn y Copper, L.L.C.; SWT Global Su pply, Incorporated; C arolina Vapor Mill, L.L.C.; Carolina Vapo r Mi ll Wo od ruff Roa d; CVM3, L. L. C., Plaint iffs — App ellant s, versus Food & D rug Adm inistrat ion; Mar ty Mak ary, in his offic ial capacity as Comm issione r of Food & Drug Admi nis tration; Robert F. Kennedy, Jr., Se cret ary, U.S. Dep artm ent of He alth and Hum an Se rvices, Defendant s —Appellees. ________ ____ ___ _____ _______ ___ Appea l fr om the United State s Distri ct Court for the Eastern District of Te xas USDC N o. 4: 22 - CV - 856 ________ ____ ___ _____ _______ ___ Before Jones and Eng elhar dt, Cir cuit Judge s, and Summerh ays ∗, District Judge. Robert R. Summerhay s, Dist rict Judge: ________ ____ ___ _____ _ ∗ Distric t Jud ge of the W estern Distric t of Lou isian a, sittin g by de signa tion. United S tates Court of A ppeals Fifth Circuit FILED February 26, 2026 Lyle W. Cayce Clerk Case: 25-40135 Document: 63-1 Page: 1 Date Filed: 02/26/2026

No. 25 - 40135 2 The Fami ly Smoki ng Prevent ion and T obac co Control Act of 20 09 (“Tob acco Contro l Act” or “ TCA ”) restricts the sale of to bacco produ cts that we re no t comme rcially marke ted in the U nited States be fore Fe bruary 15, 2007. 1 Abse nt certain limited excep tions, a man ufacture r may not introduce such product s into interstate comm erce unles s the U.S. F ood and Drug Ad ministr ation (“ FDA ”) de termine s that the prod uct is “ appr opriate for the prote ction o f the public he alth.” 2 In this cas e, we cons ider wh ether the FDA satisfied the Re gulatory Flexibility Act (“ RFA ”), 5 U.S.C. § 60 1, et seq., when p romulgating a final ru le se tting for th req uire ments for prem arket tob acco pro duct applic ation s (“ Final PMTA Rule ” or “ Final Rule ”). Appe llants — seven sm all - business man ufacture rs of e - liquids and a trade asso ciatio n that re pres ents small - business vapor product manuf acturers and re tailers — file d suit fo r declarato ry an d inju nctive r elief, contend ing that the Fin al Rule w as promu lgated in violatio n of the Regulato ry Flexibility Act. They argu e that th e FDA ’s certification that the rule w ould no t have a sig nificant e cono mic impact on a substan tial nu mbe r of small en tities is arbitr ary and cap ricious. The d istric t c ourt g ranted summary judgm ent for the FD A, upho lding the Final Rule. Beca use we fi nd the FDA complie d with th e Regulatory F lexibility Act whe n promulgatin g the F inal PMTA Rule, the decisio n of th e district co urt is AFFIRM ED. I. Background The 2009 Tobacco Con trol Act e stablishe s a comp rehensive scheme for the regu lation of tobacc o prod ucts, w hich Co ngres s defin ed to in clude “any produc t made or deriv ed from toba cco, or c ontai ning nic otine from any ________ ____ ___ _____ _ 1 21 U.S.C. § § 387j(a)(1)(A), (a)(2). 2 Id. § 387j (c)(2)(A). Case: 25-40135 Document: 63-1 Page: 2 Date Filed: 02/26/2026

No. 25 - 40135 3 source, t hat is intended for human co nsump tion.” 3 T he Tobacc o Cont rol Act r equires FDA authorization before an y “ne w tobac co produc t” ma y be introd uced in to inte rstate co mme rce. 4 A “n ew tobacco pr oduct” is on e that was no t marketed in the Unite d States be fore Feb ruary 15, 2007, and the TCA subjects such prod ucts to a prem arket autho rization p rocess. 5 Ther e are se veral path ways to FDA approval. Rele vant here, a manufactu rer may submit a p remarke t tobacco pro duct app lication (“ PMTA ”) to the FDA to market its p rodu ct. Congre ss has m andated th at FDA “shal l deny ” a PMTA i f, aft er review of th e info rmation su bmitted in the applic ation “and any ot her informat ion bef ore th e [FDA ] w ith re spect to su ch tobacco prod uct, ” the FDA f inds “the re is a lack o f a show ing that p ermitting su ch tobacco prod uct to be m arkete d would be ap prop riate for the protectio n of th e public h ealth. ” 6 To de termine whether a pro duct is “appr opriate for the prote ction o f the public he alth,” th e FDA must consid er “t he ris ks and be nefits to th e popu lation as a w hole ” and “ tak[e] in to ac count — (A) the i ncrea sed or decre ased like lihoo d that exist ing use rs of to bacco pr oducts w ill sto p using such pr oducts; an d (B) the in creased or de creased like lihoo d tha t those who do not us e tobacco products will s tart using s uch p roducts. ” 7 Fur th er, the FDA ’s de cision must, “whe n approp riate, be d etermined on the basis of well - controlled in vestigation s,” includin g “clinica l inves tigatio ns. ” 8 ________ ____ ___ _____ _ 3 Id. § 321(rr)(1). 4 Id. § 387j(a)(1) – (2). 5 Id. § 387j (a)(1)(A), (a)(2). 6 Id. § 387j (c)(2). 7 Id. § 387j(c)(4). 8 Id. § 387j (c)(5)(A). Case: 25-40135 Document: 63-1 Page: 3 Date Filed: 02/26/2026

No. 25 - 40135 4 Howev er, FD A may base its de termin ation on “valid s cientific evid en ce” other than w ell - controlled inve stigatio ns if s uch evid ence “is suff icient to evaluate the tob acco p rodu ct.” 9 Congr ess ma de thes e requi re ments imme diately ap plicable to cer tain cate gorie s of tob acco p roducts (i.e., cigarette s, cigare tte tob acco, roll - you r - own tobacco, and s moke less tob acco) and ves ted th e Secr etary of H ealth an d Human Service s with the au thority to impose thes e requi rements on “any ot her tobac co produc ts that t he Secre tary by r egulatio n deems to be sub ject to this subchap ter.” 10 The Regu latory F lexibility Act impo ses certain procedural requir em ents on feder a l ag enci es t o ensur e th ey conside r the imp act of the ir regulatio ns on small entities. 11 The RFA is not a “subst antive a gen cy mandate.” 12 Rather, it is a “ proce dural statute se tting ou t precise, spe cific steps an agency must take. ” 13 One r equi rem ent of the RFA is that when agenc ies i ssu e rules un der the Administrative P roced ure Act (t he “ A PA ”), they are to publish a “ final r egula tory fle xibility analysis. ” 14 Th at analysis must inc lude “a d escri ption of the steps th e ag ency has taken to min imize th e signific ant eco nom ic impac t ” on small businesses, “ in cludin g a stat ement o f ________ ____ ___ _____ _ 9 Id. § 387j (c)(5)(B). 10 Id. § 387a(b). 11 5 U.S.C. § 601, et seq. 12 Alenco Co mmunications, Inc. v. F.C.C., 201 F.3d 608, 625 (5th Cir. 2000). 13 Aeronau tic al Repai r Sta tion Ass ’n, In c. v. F. A.A., 494 F.3d 161, 178 (D.C. C ir. 2007); s ee also Nat ’l Tel. Coop. Ass’n v. F.C.C., 563 F.3d 536, 540 (D.C. Cir. 2009) (Kavan augh, J.) (“Though it d irects agenc ies to s tate, summ arize, a nd d escribe, th e Act in and o f itself im pos es no s ubs tantive c onstra int on a genc y decis ionmakin g. In eff ect, therefor e, the A ct req uires agenc ies to p ublis h analys es tha t address certa in legally delinea ted topic s.”). 14 5 U.S.C. § 604. Gener ally, the RFA also re quir es an agency to prep are an in itial regula tory flexib ility a naly sis b efore is suin g a notic e of pr oposed rulema king. Id. § 603. Case: 25-40135 Document: 63-1 Page: 4 Date Filed: 02/26/2026

No. 25 - 40135 5 the factu al, po licy, and le gal re asons f or sele cting th e alte rnative ad op ted in the fin al rule an d wh y each o ne o f the o ther sign ificant a lternati ves to the rule consid ered by the agen cy which af fect the impact o n small e ntitie s was rejec ted.” 15 H owev er, a n agency need not co nduct a regulato ry fle xibility analysis if it “ certifie s t hat the rule w ill n ot, if pro mulgate d, have a sign ifican t econom ic impact o n a substantial n umbe r of small en tities,” publis hes the certifica tion in the F ederal Re gister, and inclu des “ a stateme nt pro viding th e factual bas is fo r such ce rtificatio n.” 16 In May 2016, t he FDA issue d a final ru le (“Deem ing Rule”) deeming all produ cts th at mee t the d efinitio n of “ tobacco p rodu ct” — including electro nic nico tine de livery sy stems (“ ENDS ”) and their co mponent parts (which includ e the vapor pr oducts m anufactu red by Appellan ts)— to be subje ct to the Tobacc o Co ntrol A ct. 17 As a result, t hese prod ucts became subje ct to the Tobac co Co ntrol A ct’s premark et rev iew prov is ions. In accordan ce with the RFA, the FD A published a final re gulato ry imp act analysis, w hich found t hat the Deemi ng Ru le would “have a significan t econom ic impact o n a su bstanti al nu mber o f small e ntities. ” 18 The FDA ________ ____ ___ _____ _ 15 Id. § 604(a)(6). A f inal reg ulatory flexib ility a naly sis must a dd itionally state the purp ose of the r ule; it must s ummariz e the c omments file d in resp onse to th e agency’s initial regu latory flexib ility a nalys is, the agen cy’s asses sment of those comm ents, and includ e a stat ement of any c hanges m ade t o the propo sed rul e as a resul t of such co mments; it mus t state the estim ated nu mber o f small bus iness that the ru le will af fect, if suc h an estima te is a vaila ble; an d it m us t provid e a de scr iption of p rojec ted re porting, recordkeeping and other c ompliance requirements of the rule and the typ e of pro fessiona l skill s neces sary fo r pre par atio n of such r eport s and r eco rds. Id. § 604. 16 Id. § 605(b). 17 Deeming Tobacco P roducts To Be Subjec t to the F ederal Food, D rug, and Cosmetic Act, 81 Fed. Reg. 28, 973, 28,975 (May 10, 2016). 18 That analy sis was challenged by multip le ma nufactu rers an d industry assoc iations in Nicopure Labs, LLC v. FDA, 266 F. S upp. 3d 360 (D.D.C. 2017). The court Case: 25-40135 Document: 63-1 Page: 5 Date Filed: 02/26/2026

No. 25 - 40135 6 recog nized that the PMTA r equireme nts “cou ld lead to significan t produ ct exit and reduced e ntry,” but maintain ed that such req uirements w ould “ help [] ensure that new tobacc o produc ts are appro priate fo r the protectio n of the public h ealth. ” While t he FD A noted that “[e]stim ating ex pecte d costs of submittin g PMTA s is made complicated. . . by the flexib ility firms have to decide on how bes t to provide the info rmation expecte d in the PMTA,” it nevert heles s estimated that the costs of s ubmittin g a PMTA for e- liqui ds wo uld be betw een $ 181, 686 a nd $ 2,01 4,120. On Octob er 5, 2021, the FDA issued t he F inal PMTA Rule— th e rul e challen ged in this pro cee ding. 19 While ackn owle dging that the F inal Rul e would “gene rate incr emental co sts relate d to the p repar ation of PMTA s for ENDS products,” the FDA nev erth eless certified th at the F inal R ule w ould “ not h ave a signific ant e conomic im pact on a substantia l num ber o f small entitie s.” 20 T he FDA based this certif ication on its f indin g that it exp ected the F inal PMTA Rule to “ gene rate ne t benefits o r ne gligible net co sts fo r most affe cted s mall entities,” in par t becaus e th e Final PMTA Rul e was intende d to improv e the effic iency of s ubmi ssion a nd review of P MTA s, there by redu cing the numbe r of prem arket app lication s that are re jected. 21 The FDA additionall y n oted that it had “alread y inclu ded th e costs to submit an d revie w PMTA s fo r deemed tobacco pro ducts” in th e final regulato ry imp act analy sis for th e May 2016 Deemin g Rule. 22 ________ ____ ___ _____ _ rejected th e challenge, finding th e FDA “ comp lied with th e proc edu ral req uiremen ts of the Regula tory F lexibili ty Ac t. ” Id. at 408. 19 Premarket Tobacc o Product Applications and Recordkeeping Requirements, 86 Fed. Reg. 55, 300 (Oct. 5, 2021). 20 Id. at 55,405. 21 Id. 22 Id. Case: 25-40135 Document: 63-1 Page: 6 Date Filed: 02/26/2026

No. 25 - 40135 7 Alon g with the Final Rule, the FDA pu blished a final re gulatory impact analy sis addressing the eff ect of the “new r equ irem ents ” of the Final Rule that were not include d in the Deeming Rule’s regulatory impact analysis. In th at reg ulator y impact an alys is, the FDA noted th at in 2 016, it had concluded that the Deeming Rule would “cause many ex isting firm s to exit the marke t, crea ting sig nifican t mar ket co nsolid ation ” due to “the complian ce cos ts assoc iated w ith the Deem ing Rule,” and that it exp ected the De emi ng Rule “to have a sign ificant impact on a substan tial num ber o f small en tities.” With regard to the Final PM TA Rule, the FDA found the forgoin g impacts “ are attribut able to the D eeming Rule and not th is fin al rule. ” It furth er fo und “that mo st appli cants th at submit ENDS P MTA bundle s will benefit from the fin al rule, ” due to its cl arifi cation of PMTA requir em ents a nd st rea mli ned pr oced ures. The FD A concluded that “m ost small en tities will e ith er be nefit from the f inal rule or w ill in cur sm all annualiz ed cos ts of appr oximate ly $2, 000.” Appellan ts then filed suit for d eclar atory an d inj unctive relief, assertin g that the Final PMTA Rule was prom ulgated in violatio n of th e Regulato ry Fle xibility A ct, becaus e the FD A ’s certificat ion th at the rul e would not h ave a sign ificant impact o n a subst antial n umbe r of sm all en tities is unsupp orted by the re cord and therefo re arbitrary and capric ious. The parti es fil ed cross mot ions for s ummar y judg ment. T he d istrict c ourt g rante d the FDA ’s m otion, findi ng Appellants ’ challen ge failed for tw o reasons: (1) the FDA satisfied the RFA by considerin g whether the Final PMTA Rul e would have a signific ant impact o n a subs tantial n umber o f small entiti es and certify ing, toge ther with a fa ctual b asis, that it w ould n ot, an d (2) Appellants failed to identif y any proce dural de fect in the FDA ’s certific ation, inste ad raising on ly sub stantiv e disag reeme nts with the FDA ’s factual basis, wh ich are ou tside th e scope of RFA rev ie w. Appellants now appeal that decisio n. Case: 25-40135 Document: 63-1 Page: 7 Date Filed: 02/26/2026

No. 25 - 40135 8 II. Standard of Review We rev iew the district cou rt’s grant of s umma ry jud gment d e nov o. 23 We review agency complian ce with the Regulato ry F lexibility A ct “on ly to determi ne wh ether an a gency ha s ma de a ‘rea sonable, good - faith effort’ to carry ou t the man date of the RFA.” 24 The Administrati ve Pro cedure Act’ s arbitrary - and - capric ious s tandard “ req uires that agenc y action b e reas onable and re asonably e xplaine d.” 25 Among ot her things, c ourts must assess whethe r an agen cy’s decision was base d on “conside ration of the relevan t factors. ” 26 “T he Re gulatory F lexibility A ct makes the in terests of small busine sses a ‘relevan t factor’ for c ertain r ules. Therefo re, the APA to gether with th e Regu latory Fle xibility Act req uire that a rule ’s impac t on small busine sses be reason able and re asonab ly explaine d. A regulatory flexibility analysis is, for APA purp oses, part of an age ncy ’ s e xplanatio n for its r ule. ” 27 Judicial r eview for com pliance with th e Regulator y Fle xibility Act is defe rential, and the court “ simply ensu res th at the age ncy h as acted w ithin a zone of reaso nablene ss and, in par ticular, has reas onably consid ered the relevan t issue s and re asonably explain ed the decision. ” 28 ________ ____ ___ _____ _ 23 Bruckner Truck Sales, Inc. v. Guz man, 148 F.4th 341, 3 44 (5th Cir. 20 25). 24 A lenco, 201 F.3d at 625 (quoting Associa ted Fisheries, Inc. v. D aley, 127 F.3 d 104, 114 (1st C ir. 199 7)). 25 Federal Co mmunications Co mmission v. Prometheu s Radio Project, 592 U.S. 414, 423 (2021). 26 Motor Vehicl e Mfrs. Ass’n, Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 4 3 (1983) (in terna l quota tion m arks omitted). 27 Nation al Tel. Coop. Ass’ n, 563 F. 3d at 540. 28 Prometheus Radio Project, 59 2 U. S. at 423. Case: 25-40135 Document: 63-1 Page: 8 Date Filed: 02/26/2026

No. 25 - 40135 9 III. Discussi on Appellan ts contend t he FDA ’s § 605(b) certification of the Final PMTA Rul e is arbitrary and cap ricious f or t wo reasons. First, Appellan ts contend that th e FDA ’s finding that the Fin al PMTA Rule “will not have a signific ant eco nomic imp act on a substan tial n umber o f small entitie s” lacks adeq uate factual s uppo rt, beca use it relies up on costs assessed in the 20 1 6 Deeming Rule. They argue th at these costs are not inclu sive of the costs requ ired to co mply with the F inal PMTA Rule. Second, Appellan ts contend that eve n assuming that th e FDA ’s reliance on th e cos ts assesse d in the Deemi ng R ule wa s pr oper, the FDA violated th e RFA by failing to cons ider less bur densome regulatory alte rnatives to the substantive PMTA content requir em ents i n eit her t he 2016 D ee ming Rul e or the 20 21 Fi nal PMTA Rule. Appellants c onfine their argume nts on both issues to the statutory requ irement th at a PMTA must include “fu ll repo rts of all infor mation, publis hed or k nown t o, or whi ch shoul d rea sonabl y be kno wn to, the applicant, co ncer ning inve stigation s which have been made to show the health risks of su ch tobacco pr oduct an d whether s uch tob acco produ ct presen ts less ris k than oth er to bacco produ cts.” 29 According ly, we foc us on that aspe ct of the Final PMTA Rule. A. Whether t he FDA lacks a fact ual b asis for it s 20 21 cert ificat ion. Appellan ts assert the Tobacco Contro l Act pr ovides a “ wide berth” for the FDA to regula te what a PMT A must inclu de w ith resp ect to h ealth risk inves tigation s. Appellan ts appear to argue th at because the TCA permits the FDA to r ely on “valid scien tific evide nce ” othe r than “we ll - controlle d investigat ions ” when revie wing a PMTA, 21 U.S.C. § 387j(c)(5), th e FDA should hav e consid ered l ess - costly alternativ es to the statu te’s re quirem ent ________ ____ ___ _____ _ 29 21 U.S.C. § 3 87j(b)(1)(A). Case: 25-40135 Document: 63-1 Page: 9 Date Filed: 02/26/2026

No. 25 - 40135 10 that an app licat ion to market a n ew to bacco pr oduct m ust inclu de fu ll re ports of all he alth r isk inf ormatio n known to the applicant, id. § 387j(b)(1)(A). Appellan ts furth er conten d that w hen the FDA is sued t he Deemi ng R ule, “it did n ot purp ort to flesh out th e PMTA r equir eme nts” bec ause i t anticipa ted do ing so in th e Final Rule. Accor ding to Ap pellants, the De eming Rule “ expr essl y pr emi sed the cost estimate s on th e ‘form at and c ontent requir em ents of a P MTA as describ ed in the TCA.’” B ecause the Final Rule expan ded the “catego ries of top ics cover ed and detail” r equ ired in a PMTA, the co st estimate s set forth in the Deem ing Rule con stitute “ an insufficien t factual pre dicate” f or the certificatio n of the Final PMTA R ule, a nd there fore th e certif ication lacks th e req uisite f actual basis to satisfy the RFA. In respons e, App ellees explain that the re quireme nt that a PMTA contain full rep orts of all health risk in vestigat ion s is mand ated by the Tobacco C ontro l Act, and t h e 201 6 Dee ming Rul e is what m akes that requ irement app licable to Appellan ts’ pro ducts. The 20 21 Fi nal PMTA Rule’s stated pu rpose is “to impr ove th e eff iciency of the su bmission an d revi ew of PMTA s” by giving re gulated entities add itional de tail abo ut the inform ation need ed to satisfy th e statuto ry standard and by es tablishing proced ures to s trea mli ne revi ew. 30 While acknow ledging that t he Final Rule would “gene rate incr emental co sts relate d to the p repar ation of PMTA s for ENDS products,” ulti mate ly the FDA expect ed t he F inal Rule to “ g enerat e net be nefits or negligib le n et costs for mo st affe cted s mall entitie s.” 31 In its regulato ry fle xibility an alysis ac comp anyin g the Fin al PMTA Rul e, th e FDA ________ ____ ___ _____ _ 30 86 Fed. Reg. 55, 300, 55, 301. 31 Id. at 55, 405 (ac knowledging the F in al R ule will g ener ate inc reme ntal c osts related to the pr eparation of PMTA s— e.g., pos tmarket repo rting req uirem ents, c osts incurred “ to re ad and under stand t he rul e,” and co sts incurr ed to mai ntain r ecords; add itionally find ing the ru le would crea te cos t savings for a pplica nts “by reducing th e number of PM TA s submitted ”). Case: 25-40135 Document: 63-1 Page: 10 Date Filed: 02/26/2026

No. 25 - 40135 11 explain ed that th e costs asso ciated w ith the preparatio n of a PMTA that satisfie s the T obacco Co ntro l Act are attr ibutable and acco unte d for in the Deemin g Rule, r ather th an the Final PMTA Rule. It furth er found t ha t its assessm ent of co sts associated w ith health studie s in the Deem ing Rule’s regulato ry fle xibility analy sis, afte r adj ustmen t for in flatio n and w age rate s, contin ued to refle ct the be st available esti mates f or the cost of studies necessary f or a PMTA and th at the Final Ru le would not impact th ose costs. On the basis of those findings, the FDA certifie d “the final rule will no t have a signifi cant eco nom ic impact on a substan tial n umber o f small e ntities. ” 32 The Tob acco Con trol Act requir es the FD A to deny an application to market a d eem ed to bacco pro duct i f “the re is a lack of a show ing that perm itting such tobacco p roduct to be marketed w ould be appr opriate for the prote ction o f the public h ealth. ” 33 In evaluating whe ther a deeme d tobacco produ ct is appro priate f or th e pro tection of the public h ealth, the FDA must consider “ whether such to bacco pro duct p res ents le ss risk than other tobacco p roducts,” 34 “ th e risks an d bene fits to the p opulation as a whole, ” 35 “the in creased or decreased like lihoo d that e xisting use rs of tobacco p roducts will stop using such p roducts,” 36 and “th e increase d or d ecre ased like lihood that tho se wh o do no t use tobacc o prod ucts will s tart us ing such produ cts.” 37 Ultimate ly, the burden is on the applicant to show its pro duct is ap propr iate ________ ____ ___ _____ _ 32 Id. 33 21 U.S.C. § 3 87j(c)(2)(A). 34 I d. § 387j(b)(1)(A). 35 I d. § 387j(c)(4). 36 I d. § 387j (c)(4)(A). 37 I d. § 387j (c)(4)(B). Case: 25-40135 Document: 63-1 Page: 11 Date Filed: 02/26/2026

No. 25 - 40135 12 for the prote ction o f the public he alth. 38 I n order to ma ke this showin g, t he TCA mandates that an applica tion to market a n ew to bacco pr oduct “ shall contain. . . full report s of all i nformat ion, publ ished or k nown to, or which shou ld reason ably be known to, the app licant, con cerning in vestigatio ns which have been made to show th e health risks of s uch tob acco pro duct and whethe r such to bacco pro duct presen ts less ris k than o ther tobacco products.” 39 Appellan ts do not explain how the F inal PMTA Rule sign ificantly expands the “categories o f topics co vere d and de tail” req uired in a PMTA from th at which w as requir ed in the Deeming Rule. 40 Nor do Appellants cite to any s pecific p ortion of the F inal PMTA Rule in suppor t of this argument. 41 Regardless, th e requ iremen t that an applican t inclu de all known inform ation co ncernin g health ris k investig atio ns for its produ ct in a PMTA is mand ated by statute. It was Congress, not the FDA, that imp osed this ________ ____ ___ _____ _ 38 See, e.g., Bidi Vapor L LC v. U.S. Food an d Dru g Admin istra tion, 134 F.4th 1282, 1292 (11th C ir. 2025). 39 21 U.S.C. § 3 87j(b)(1)(A). 40 T he C ourt note s App ellants “ do not d ispu te the FDA ’ s fac tual de termina tions ” and they make “no argument here t hat FDA arrived at a mistaken estimate of the cos t of a partic ular type of tes ting.” 41 Ru le 28 (a) of the Federal Rules of Appellate Procedure req uires citations to the “par ts of the rec ord on which the app ellant relie s,” Fe d. R. A pp. P. 28(a)(8)(A), a nd our loc al rules require that “[e] very ass ertion in b riefs rega rding matter in th e record mu st be supported by a reference to the pa ge number of the o riginal record .. . where the matter is found. ” 5th Cir. R. 28.2.2. It is no t th e duty of t he C ourt to com pare th e 15 6 - pa ge Deemin g Rule a gainst the 139 - page F inal PMTA Rule in a n eff ort to find evidenc e to suppo rt Appe llants ’ argu ment. See, e.g., Forsyth v. Barr, 19 F.3 d 1527, 1537 (5 th Cir. 1 994) (cour ts have n o duty to “sift throu gh the r ecord in sea rch of evid ence” to supp ort a par ties’ argument). Th us, th is argumen t is forf eited d ue to ina deq uate briefin g. S ee, e.g., Schnell v. State Farm Lloyds, 98 F.4 th 150, 16 1 (5th Cir. 2024) (“A pa rty forfeits an argument throu gh inade quate b riefing . . . by failing to o ffer re cord c itation s” (quota tion ma rks omitted)). Nevertheless, we address the merits. Case: 25-40135 Document: 63-1 Page: 12 Date Filed: 02/26/2026

No. 25 - 40135 13 requ irement on ne w tobacco p roducts. The FDA cannot b y regulatio n disp ense wit h a Congre ssiona l manda te. 42 Finally, t o the ext en t Appe llants take issue w ith the FDA ’s attributio n of PMTA - related costs to th e Deeming Ru le, that is a substantive factual con clusion unde rlying th e FDA ’s certification. A s such, it is ou tside of the scope of ju dicial revie w of alleged RFA viola tions. 43 H ere, t he FDA made a “ reasonab le, goo d - faith e ffort” to comply with the RFA ’s purely proce dural re quireme nts, and therefo re Appellants have f ailed to sh ow the FDA’s ce rtificat ion of the F inal PMTA Rule is arbitr ary an d capricio us. B. Whether the FDA F ailed to Consider Less Burdensome Regul atory Alter natives to the PMTA Content Require ment s. Appellan ts further con tend that the FDA ’s certificat ion of the Final PMTA Rule is arbitr ary an d capric ious b ecaus e the FDA “never co nsi dered any altern ative me ans of satisfy ing the TCA ’s substantive PMTA requir em ents” in the Deeming Rule or Final PMTA Rule, as required by the Regulato ry Fle xibility A ct. Acco rding to Appellants, b y allow ing the FDA “to re ly on its own stud ies, o r othe r publicly available inform ation” when dete rmining w hether a product is ap propr iate fo r the prote ction o f public health, the T obacco Con trol Act “ offers u p a clear alte rnative to th e most expensi ve porti on of PM TA s,” i.e., the require ment th at applicants subm it all inform ation re gardin g health risk inves tigation s. Becaus e the FD A failed ________ ____ ___ _____ _ 42 Djie v. Garland, 39 F.4th 280, 284 (5th C ir. 20 22) (“ To th e exten t a re gulatio n attemp ts to c arve o ut an exc eption fr om a c lear s tatutory requ iremen t, the r egulation is invalid. ”). 43 See, e.g., Council for U rolog ical Inte rests v. Burwe ll, 790 F.3d 212, 227 (D.C. C ir. 2015) (“ So l ong a s the p roced ura l requ irements of the c ertifica tion ar e met, however, this court ’ s review is highly defere ntial a s to the s ubs tanc e of the ana lys is, pa rticularly where an a gency is predictin g the l ikely ec onomic effec ts of a rule.” (quota tion ma rks omitte d)). Case: 25-40135 Document: 63-1 Page: 13 Date Filed: 02/26/2026

No. 25 - 40135 14 to con sider th ese or s imilar alte rnative s, App ellants cont end that the FDA failed to comply with th e Reg ulatory Fle xibility Act. The FDA respond s that because it certifie d that the F inal PMTA Rule w ould not h ave a sign ifican t econ omic imp act on a su bstantia l nu mber of small e ntities, it was no t require d to co nsider re gulator y altern atives to the content of a PMTA under RF A § 604(a)(6). N evert heles s, it did pro vide a “regu latory im pact an alysis con sisten t with § 604 (a) i n respon ding to commen ts sugge sting that the signific ant co sts of p reparin g marketing applicatio ns sh ould n ot be attributed to th e de eming ru le. ” As to Appellants ’ argume nt that the FDA should allow applican ts to re ly on the age ncy’s “ow n studies, or othe r publicly ava ilable inform ation” to satisfy th e statutory standard for PMTA s, the FDA notes that “t he PMTA rule in fact prese rves ap plicants’ f lexibility in th is respe ct.” To the ex ten t Appellants contend t he FDA should dispen se with the statutory req uirement th at a PMTA must include all he alth risk investigat ions know n to the applican t, ag ain, the FDA cannot by r egulation “carve o ut an e xception f rom a cle ar statutor y req uirement. ” 44 With re gard to Appellan ts ’ argume nt that th e FDA faile d to con sider regulato ry alternative s to the health risk inves tigation require ment in eithe r the Deemin g Rule o r the F inal PMTA R ule, their arg ument is unsupported by the rec ord. In the Dee ming Rul e, the FDA specifically addre ssed co mments pertain ing to “the ne ed for co stly c linical stu dies to develo p PMTA s that sati sfy the requi rement s” of t he TCA. 45 The FDA r espon ded: ________ ____ ___ _____ _ 44 Djie, 39 F.4th a t 284. To the extent A ppella nts a rgu e th e FDA is required by statu te to deve lop its own stu dies or pub licly a vaila ble in forma tion rega rdin g EN DS, th ey have fai led t o sup port su ch an argu ment. 45 81 Fed. Reg. 28, 973, 28, 997. Case: 25-40135 Document: 63-1 Page: 14 Date Filed: 02/26/2026

No. 25 - 40135 15 [I] n some case s, it may be po ssible fo r an app licant to ob tain a PMTA marketing au thorizatio n ord er witho ut conduc ting any new n onclinical or clini cal stu dies w here th ere is an e stablish ed body of evid ence re garding the public h ealth impact of the produc t. H owev er, i n ca ses wher e ther e ha ve been fe w or no scientific studie s of a product ’s poten tial impact on the p ublic health, new nonclin ical and clinical studie s may be req uired for market au thorizatio n. 46 The FDA also resp onded to com ments su ggesting that the TCA “p rov ides FDA with au thority to deve lop a fle xible fr amewo rk for PMTA s th at wou ld not req uir e well - controlle d investigation s,” along with propos ed “altern atives to th e re quirem ent of well - controlle d inve stigations. ” 47 T he FDA re jected e ach alte rnative, p rimari ly beca use the pr oposals e ither wo uld not sh ow th at marketin g the p roduc t is appr opriate for th e pro tection of th e public he alth, or the proposals d id not comply w ith t he require ments set fort h in the TCA. The FD A explicitly acknow ledged that the TCA allows it to consid er othe r “valid scie ntific evid ence ” in lie u of “we ll - contro lled investigat ions,” if such evide nce is su fficie nt to e valuate the p roduct. 48 A ccordin gly, “if an applicatio n includ es, for e xample, inform ation (e.g., publish ed liter ature, marke ting info rmation) with appro priate b ridgin g studies, FDA will review that inf ormation to de term ine whethe r it is valid scientific eviden ce suf ficient to dem onstrate th at the p roduct is app ropriate for the protectio n of the public h ealth. ” 49 ________ ____ ___ _____ _ 46 Id. 47 Id. 48 Id. at 28, 998. 49 Id.; see also id. at 28, 999 – 29, 001 (fu rther add ressing c omments sug gesting alterna tives to the PMTA requirements). Case: 25-40135 Document: 63-1 Page: 15 Date Filed: 02/26/2026

No. 25 - 40135 16 Lik ewise, t he Fin al PMTA Rul e n otes that the impleme nting regulatio ns do “ not set requ irements fo r spe cific studie s that m ust be contain ed in e very sin gle PMTA.” 50 Rather: As de scribed throughou t this docu ment, a PMT A mu st contain at least som e amo unt of sub stantive in formatio n regardin g each of the topic are as in [the regul ations] to be filed for sub stantive re view. Additio nally, a PMTA must con tain full rep orts of all in vest igation s that are pu blish ed or known to, or wh ich sho uld re asonably be know n to an app licant. . . . FDA gene rally ex pects that app licants wil l be able to mee t the substantive info rmation requirem ent. . . by submittin g investigat ions that are publis hed or known to, or which sh ould reason ably be known to, an ap plican t. . .; h owever, in t he event an applicatio n is lac king r equ ired substan tive inform ation, an applicant m ay ne ed to condu ct its own in vestigation to mee t the filin g req uireme nts. 51 In respo nse to co mment s sugg esting that the FDA was “providi ng too muc h flexibili ty for applican ts and s hould instead re quire app licants c ondu ct specific ty pes o f studie s,” the FDA respond ed: We declin e to r equire that an applic ant con duct a l ist of ne w studies as part o f eve ry applic ation unde r this rule b ecause there may be oth er ways in w hich an applicant can pr ovide scientific info rmation to inf orm FDA ’ s revi ew (e.g., bridging, publish ed liter ature). Add itionally, while a PMTA must contain substantive infor mation regardin g certain cate gories of informat ion. . ., an app licant has som e flexib ility in determi ning how to u se exis ting i nformat ion to support a PMTA for their product an d what ty pes of add itional investigat ions it may nee d to con duct to provide FDA with ________ ____ ___ _____ _ 50 86 Fed. Reg. 55, 300, 55, 357. 51 Id. Case: 25-40135 Document: 63-1 Page: 16 Date Filed: 02/26/2026

No. 25 - 40135 17 inform ation th at dem onstrates th at pe rmitting th e marke ting o f its new tobacco pro duct wo uld be [appro priate f or the prote ction o f the public h ealth]. 52 Consideri ng th ese resp onses, we conc lude t hat the FDA provided ad equate discussio n and r easoned r ejectio n of “s ignifica nt altern atives to the rule.” 53 * * * In sum, t he 2016 D eeming Rule’s a ssessment of the c ost for complian ce pro vides an adequ ate factual b asis f or the FDA ’s certif ication that th e 202 1 Fin al PMTA Rule would not have a signif icant econ omic impact on a sub stantial n umber o f small en titie s. Fu rther, both r ules in clude substantial d iscus sion an d reason ed rejection of significan t alter native s to the requ irements o f those r ules. Accord ingly, we conclude that t he FDA m ade a reasonab le, go od - faith effort to comply with the RFA ’s purely procedural requir em ents, and theref ore t he j udgme nt of the district c ourt is AFFIRMED. ________ ____ ___ _____ _ 52 Id. at 55, 357 - 55,3 58. 53 5 U.S.C. § 6 04(a)(5). Case: 25-40135 Document: 63-1 Page: 17 Date Filed: 02/26/2026