{"id":4564,"date":"2023-08-28T03:10:00","date_gmt":"2023-08-28T07:10:00","guid":{"rendered":"https:\/\/worldvapersalliance.com\/?p=4564"},"modified":"2025-09-11T07:26:34","modified_gmt":"2025-09-11T11:26:34","slug":"the-demand-for-disposable-vapes-falls-on-the-fdas-decision-making-process","status":"publish","type":"post","link":"https:\/\/worldvapersalliance.com\/cs\/the-demand-for-disposable-vapes-falls-on-the-fdas-decision-making-process\/","title":{"rendered":"Popt\u00e1vka po jednor\u00e1zov\u00fdch vapech kles\u00e1 v rozhodovac\u00edm procesu FDA\u2026"},"content":{"rendered":"

Jednor\u00e1zov\u00e9 vaporiz\u00e9ry, nov\u00fd trn v oku FDA, si z\u0159ejm\u011b vyb\u00edraj\u00ed svou da\u0148 na regula\u010dn\u00edch org\u00e1nech, kter\u00e9 se sna\u017e\u00ed tento \u201cprobl\u00e9m\u201d vy\u0159e\u0161it. \u010casto se objevuj\u00ed nov\u00e9 z\u00e1kazy.\u201d\u00a0<\/span><\/p>\n

Ale kdo m\u016f\u017ee za tento trh v hodnot\u011b $2 miliard dolar\u016f?\u00a0<\/span><\/p>\n

Kv\u016fli drtiv\u00fdm regulac\u00edm pro mal\u00e9 podniky, kter\u00e9 prim\u00e1rn\u011b prod\u00e1vaj\u00ed otev\u0159en\u00e9 syst\u00e9my s e-liquidy na b\u00e1zi voln\u00e9 b\u00e1ze, rozhodovac\u00ed proces FDA up\u00edr\u00e1 dosp\u011bl\u00fdm jejich preferovan\u00fd produkt pro vapov\u00e1n\u00ed. To m\u00e1 za n\u00e1sledek novou popt\u00e1vku po jednor\u00e1zov\u00fdch n\u00e1pln\u00edch, kter\u00e9 zaplavily americk\u00fd trh.\u00a0<\/span><\/p>\n

Objevily se d\u016fkazy, \u017ee FDA stanovila\u00a0<\/span>um\u011ble vysok\u00e9 standardy<\/span><\/a>\u00a0<\/span>po\u00a0<\/span><\/i>V roce 2020 byly p\u0159edlo\u017eeny miliony \u017e\u00e1dost\u00ed o pomoc p\u0159i posuzov\u00e1n\u00ed hospod\u00e1\u0159sk\u00e9 situace (PMTA). Intern\u00ed dokumenty agentury rovn\u011b\u017e odhalily, \u017ee veden\u00ed CTP\u00a0<\/span>zam\u00edtnuto<\/span><\/a>\u00a0jeho v\u011bde\u010dt\u00ed recenzenti, kte\u0159\u00ed byli p\u0159ipraveni ud\u011blit registraci n\u011bkter\u00fdm ochucen\u00fdm vapingov\u00fdm produkt\u016fm.\u00a0<\/span><\/p>\n

\u017d\u00e1dost o p\u0159edprodej tab\u00e1kov\u00fdch v\u00fdrobk\u016f (<\/span>PMTA<\/span><\/a>) je regula\u010dn\u00ed p\u0159\u00edstup agentury navr\u017een tak, aby zajistil, \u017ee produkt bude l\u00e1kat dosp\u011bl\u00e9 ku\u0159\u00e1ky, ani\u017e by l\u00e1kal neku\u0159\u00e1ky, zejm\u00e9na d\u011bti.\u00a0<\/span><\/p>\n

Zd\u00e1 se to jako rozumn\u00fd standard, ale cesta k PMTA je pro \u017eadatele no\u010dn\u00ed m\u016frou. Pod\u00e1n\u00ed \u017e\u00e1dosti Centru pro tab\u00e1kov\u00e9 v\u00fdrobky (CTP) FDA m\u016f\u017ee trvat roky a st\u00e1t miliony dolar\u016f; z\u00edskat autorizaci agentury je t\u00e9m\u011b\u0159 nemo\u017en\u00e9. V\u00fdrobci dosud podali PMTA pro t\u00e9m\u011b\u0159 sedm milion\u016f vapingov\u00fdch produkt\u016f a FDA\u00a0<\/span>povolil<\/span><\/a>\u00a0pouh\u00fdch 23 tekutin a za\u0159\u00edzen\u00ed pro elektronick\u00e9 cigarety s p\u0159\u00edchut\u00ed tab\u00e1ku.<\/span><\/p>\n

Dalo se tedy tomu v\u0161emu p\u0159edej\u00edt spravedliv\u00fdmi regulacemi a s ohledem na to, kolik dosp\u011bl\u00fdch vaper\u016f m\u00e1 r\u00e1do p\u0159\u00edchut\u011b??<\/span><\/p>\n

S rizikem opakov\u00e1n\u00ed\u2026 znovu\u2026 prohibice nefunguje.\u00a0<\/span><\/p>\n

M\u016f\u017eeme se pou\u010dit z historie? Z\u00e1m\u011brem prohibice alkoholu bylo sn\u00ed\u017eit kriminalitu, korupci a soci\u00e1ln\u00ed probl\u00e9my spojen\u00e9 s konzumac\u00ed alkoholu.<\/span><\/p>\n

M\u011blo to v\u0161ak nezam\u00fd\u0161len\u00e9 d\u016fsledky, kter\u00e9 vedly k r\u016fzn\u00fdm negativn\u00edm v\u00fdsledk\u016fm.<\/span><\/p>\n

    \n
  1. \n
      \n
    1. Vzestup organizovan\u00e9ho zlo\u010dinu:<\/b> Prohibice vytvo\u0159ila lukrativn\u00ed \u010dern\u00fd trh s alkoholem, kter\u00fd zneu\u017e\u00edvaly organizovan\u00e9 zlo\u010dineck\u00e9 syndik\u00e1ty. Zlo\u010dineck\u00e9 organizace jako Chicago Outfit, veden\u00e9 osobnostmi jako Al Capone, se staly neuv\u011b\u0159iteln\u011b bohat\u00fdmi a mocn\u00fdmi pa\u0161ov\u00e1n\u00edm, v\u00fdrobou a distribuc\u00ed neleg\u00e1ln\u00edho alkoholu.<\/span><\/li>\n
    2. N\u00e1r\u016fst kriminality:<\/b> Prohibice m\u00edsto sni\u017eov\u00e1n\u00ed kriminality ji \u010dasto zhor\u0161ovala. Organizovan\u00e9 zlo\u010dineck\u00e9 skupiny bojovaly o \u00fazem\u00ed, co\u017e vedlo k n\u00e1sil\u00ed a v\u00e1lk\u00e1m gang\u016f. Pa\u0161er\u00e1ck\u00e9 a distribu\u010dn\u00ed s\u00edt\u011b vedly k n\u00e1r\u016fstu neleg\u00e1ln\u00edch aktivit, v\u010detn\u011b pa\u0161ov\u00e1n\u00ed alkoholu a podpl\u00e1cen\u00ed policist\u016f.<\/span><\/li>\n<\/ol>\n<\/li>\n<\/ol>\n
        \n
      • Probl\u00e9my ve\u0159ejn\u00e9ho zdrav\u00ed:<\/b> Vzhledem k neregulovan\u00e9 v\u00fdrob\u011b a distribuci alkoholu do\u0161lo k v\u00fdrazn\u00e9mu n\u00e1r\u016fstu produkce nekvalitn\u011b vyroben\u00fdch nebo dokonce toxick\u00fdch alkoholick\u00fdch v\u00fdrobk\u016f. Lid\u00e9, kte\u0159\u00ed tyto l\u00e1tky konzumovali, \u010delili zdravotn\u00edm rizik\u016fm, v\u010detn\u011b otravy a smrti.<\/span><\/li>\n<\/ul>\n
          \n
        1. \n
            \n
          1. Korupce:<\/b> Prohibice vedla k rozs\u00e1hl\u00e9 korupci v r\u00e1mci donucovac\u00edch org\u00e1n\u016f a vl\u00e1dn\u00edch \u00fa\u0159edn\u00edk\u016f. Mnoho policist\u016f bylo podplaceno, aby p\u0159iv\u00edrali o\u010di p\u0159ed neleg\u00e1ln\u00edmi obchody s alkoholem.<\/span><\/li>\n
          2. Ekonomick\u00fd dopad:<\/b> Leg\u00e1ln\u00ed alkoholov\u00fd pr\u016fmysl byl siln\u011b ovlivn\u011bn prohibic\u00ed, co\u017e vedlo ke ztr\u00e1t\u011b pracovn\u00edch m\u00edst a p\u0159\u00edjm\u016f pro legitimn\u00ed podniky a vl\u00e1du.<\/span><\/li>\n
          3. Soci\u00e1ln\u00ed probl\u00e9my:<\/b> Z\u00e1kaz konzumace alkoholu vedl ke vzniku \u201cspeakeasies\u201d, neleg\u00e1ln\u00edch podnik\u016f, kde se alkohol tajn\u011b pod\u00e1val. To podporovalo kulturu utajov\u00e1n\u00ed a ignorov\u00e1n\u00ed z\u00e1kona.<\/span><\/li>\n<\/ol>\n<\/li>\n<\/ol>\n
              \n
            • Eroze \u00facty k z\u00e1konu:<\/b> Neschopnost prohibice \u00fa\u010dinn\u011b omezit konzumaci alkoholu naru\u0161ila ve\u0159ejnou \u00factu k z\u00e1konu, proto\u017ee mnoho lid\u00ed jej pova\u017eovalo za zbyte\u010dn\u00e9 a nespravedliv\u00e9 omezen\u00ed.<\/span><\/li>\n<\/ul>\n

              Pro\u010d si tedy FDA mysl\u00ed, \u017ee prohibice vapingu p\u0159inese jin\u00e9 v\u00fdsledky?\u00a0<\/span><\/p>\n

              P\u0159\u00edstup \u201ekdy\u017e z\u00e1kaz sel\u017ee, z\u00e1kaz bude p\u0159\u00edsn\u011bj\u0161\u00ed\u201c zjevn\u011b nezastav\u00ed vapingovou revoluci. Ale to, co se d\u011bje t\u011bmto legitimn\u00edm podnik\u016fm, je bolestiv\u00e9 a nespravedliv\u00e9. Tyto mal\u00e9 vape shopy maj\u00ed jeden c\u00edl, pomoci lidem, kte\u0159\u00ed kou\u0159\u00ed, p\u0159ej\u00edt na m\u00e9n\u011b \u0161kodlivou alternativu. V\u011bt\u0161ina majitel\u016f obchod\u016f je z krok\u016f FDA zdrcena, a to nejen kv\u016fli nim a lidem, kter\u00e9 zam\u011bstn\u00e1vaj\u00ed, ale i kv\u016fli spot\u0159ebitel\u016fm, kte\u0159\u00ed se nem\u011bli kam obr\u00e1tit ne\u017e na neleg\u00e1ln\u00ed trh.<\/span><\/p>\n

              Vzhledem k tomu, co v\u00edme o smrteln\u00fdch d\u016fsledc\u00edch prohibice alkoholu, je na\u010dase, aby FDA p\u0159ehodnotila sv\u00e1 rozhodnut\u00ed ohledn\u011b toho, co je skute\u010dn\u011b vhodn\u00e9 pro ve\u0159ejn\u00e9 zdrav\u00ed.<\/span><\/p>\n

              Prohl\u00e1\u0161en\u00ed: N\u00e1zory a stanoviska vyj\u00e1d\u0159en\u00e9 v hostuj\u00edc\u00edch p\u0159\u00edsp\u011bvc\u00edch publikovan\u00fdch na webov\u00fdch str\u00e1nk\u00e1ch Sv\u011btov\u00e9 aliance vaper\u016f (WVA) jsou n\u00e1zory jednotliv\u00fdch autor\u016f a nemus\u00ed nutn\u011b reprezentovat n\u00e1zory nebo postoje Sv\u011btov\u00e9 aliance vaper\u016f nebo jej\u00edch p\u0159idru\u017een\u00fdch spole\u010dnost\u00ed. Zve\u0159ejn\u011bn\u00ed obsahu t\u0159et\u00edch stran nep\u0159edstavuje schv\u00e1len\u00ed n\u00e1zor\u016f v nich vyj\u00e1d\u0159en\u00fdch ze strany WVA.<\/em><\/p>","protected":false},"excerpt":{"rendered":"

              Disposable vapes, the new thorn in the FDA\u2019s side, seem to be taking a toll on regulators with new bans emerging frequently as they scramble to fix this \u201cproblem.\u201d\u00a0 But who is to blame for this $2 billion dollar market?\u00a0 With crushing regulations on small businesses that primarily sell open systems with free base e-liquids, […]<\/p>\n","protected":false},"author":15,"featured_media":3512,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[17],"tags":[],"class_list":["post-4564","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"yoast_head":"\nThe Demand for Disposable Vapes Falls on the FDA\u2019s Decision Making Process<\/title>\n<meta name=\"description\" content=\"Disposable vapes seem to be taking a toll on regulators with new bans emerging frequently as they scramble to fix this \u201cproblem.\u201d\u00a0\" 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