{"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\/da\/the-demand-for-disposable-vapes-falls-on-the-fdas-decision-making-process\/","title":{"rendered":"Eftersp\u00f8rgslen efter engangsdampere falder i FDA's beslutningsproces ..."},"content":{"rendered":"

Engangsdampere, den nye torn i \u00f8jet p\u00e5 FDA, ser ud til at s\u00e6tte sine spor hos tilsynsmyndighederne, da der ofte dukker nye forbud op, imens de k\u00e6mper for at l\u00f8se dette "problem".\u201c\u00a0<\/span><\/p>\n

Men hvem er skyld i dette marked p\u00e5 $2 milliarder dollars?\u00a0<\/span><\/p>\n

Med strenge regler for sm\u00e5 virksomheder, der prim\u00e6rt s\u00e6lger \u00e5bne systemer med frie baser af e-v\u00e6sker, n\u00e6gter FDA's beslutningsproces voksne deres foretrukne vapingprodukt. Dette resulterer i en ny eftersp\u00f8rgsel efter engangsprodukter, der har oversv\u00f8mmet det amerikanske marked.\u00a0<\/span><\/p>\n

Der er fremkommet beviser for, at FDA har fastsat\u00a0<\/span>kunstigt h\u00f8je standarder<\/span><\/a>\u00a0<\/span>efter\u00a0<\/span><\/i>millioner af PMTA'er blev indsendt i 2020. Interne agenturdokumenter afsl\u00f8rede ogs\u00e5, at CTP's ledelse\u00a0<\/span>tilsidesat<\/span><\/a>\u00a0dets videnskabelige anmeldere, der var parate til at give markedsf\u00f8ringstilladelse til visse smagssatte vaping-produkter.\u00a0<\/span><\/p>\n

Ans\u00f8gningen om pr\u00e6markedstobak (<\/span>PMTA<\/span><\/a>)-processen er agenturets reguleringstilgang udformet til at sikre, at et produkt appellerer til voksne rygere uden at tiltr\u00e6kke ikke-rygere, is\u00e6r b\u00f8rn.\u00a0<\/span><\/p>\n

Det virker som en rimelig standard, men PMTA-proceduren er et mareridt for ans\u00f8gere. Det kan tage \u00e5r og koste millioner af dollars at indsende en ans\u00f8gning til FDA's Center for Tobacco Products (CTP); det er n\u00e6sten umuligt at opn\u00e5 agenturets godkendelse. Til dato har producenter indsendt PMTA'er for n\u00e6sten syv millioner vapingprodukter, og FDA\u00a0<\/span>har autoriseret<\/span><\/a>\u00a0kun 23 e-cigaretv\u00e6sker og -enheder med tobakssmag.<\/span><\/p>\n

S\u00e5 kunne alt dette have v\u00e6ret undg\u00e5et med fair reguleringer og hensyntagen til, hvor mange voksne vapers der kan lide smagsvarianter??<\/span><\/p>\n

Med risiko for at gentage mig selv ... igen ... forbud virker ikke.\u00a0<\/span><\/p>\n

Kan vi l\u00e6re af historien? Intentionen bag alkoholforbuddet var at reducere kriminalitet, korruption og sociale problemer forbundet med alkoholforbrug.<\/span><\/p>\n

Det havde dog utilsigtede konsekvenser, der f\u00f8rte til forskellige negative udfald.<\/span><\/p>\n

    \n
  1. \n
      \n
    1. Fremkomsten af organiseret kriminalitet:<\/b> Forbudstiden skabte et lukrativt sort marked for alkohol, som blev udnyttet af organiserede kriminelle syndikater. Kriminelle organisationer som Chicago Outfit, anf\u00f8rt af personer som Al Capone, blev utroligt velhavende og magtfulde ved at smugle, producere og distribuere ulovlig alkohol.<\/span><\/li>\n
    2. Stigning i kriminalitet:<\/b> I stedet for at reducere kriminaliteten forv\u00e6rrede forbudstiden den ofte. Organiserede kriminelle grupper k\u00e6mpede om territorium, hvilket f\u00f8rte til vold og bandekrige. Smugleri og distributionsnetv\u00e6rk f\u00f8rte til en stigning i ulovlige aktiviteter, herunder piratkopiering og bestikkelse af politibetjente.<\/span><\/li>\n<\/ol>\n<\/li>\n<\/ol>\n
        \n
      • Folkesundhedsproblemer:<\/b> Med ureguleret produktion og distribution af alkohol var der en betydelig stigning i produktionen af d\u00e5rligt fremstillede eller endda giftige alkoholprodukter. Folk, der indtog disse stoffer, stod over for sundhedsrisici, herunder forgiftning og d\u00f8d.<\/span><\/li>\n<\/ul>\n
          \n
        1. \n
            \n
          1. Korruption:<\/b> Forbudstiden f\u00f8rte til udbredt korruption inden for retsh\u00e5ndh\u00e6vende myndigheder og embedsm\u00e6nd. Mange politibetjente blev bestukket for at lukke \u00f8jnene for ulovlige alkoholhandlere.<\/span><\/li>\n
          2. \u00d8konomisk indvirkning:<\/b> Den lovlige alkoholindustri blev h\u00e5rdt p\u00e5virket af forbuddet, hvilket resulterede i tab af arbejdspladser og indt\u00e6gter for legitime virksomheder og regeringen.<\/span><\/li>\n
          3. Sociale problemer:<\/b> Forbuddet mod alkoholforbrug f\u00f8rte til fremkomsten af "speakeasies", ulovlige steder hvor alkohol blev serveret i det skjulte. Dette opmuntrede til en kultur af hemmeligholdelse og tilsides\u00e6ttelse af loven.<\/span><\/li>\n<\/ol>\n<\/li>\n<\/ol>\n
              \n
            • Undergravning af respekt for loven:<\/b> Forbudslovens manglende evne til effektivt at begr\u00e6nse alkoholforbruget undergravede offentlighedens respekt for loven, da mange mennesker s\u00e5 den som en un\u00f8dvendig og uretf\u00e6rdig begr\u00e6nsning.<\/span><\/li>\n<\/ul>\n

              S\u00e5 hvorfor mener FDA, at et forbud mod vaping vil give andre resultater?\u00a0<\/span><\/p>\n

              "N\u00e5r et forbud mislykkes, s\u00e5 forbyd det h\u00e5rdere"-tilgangen stopper tydeligvis ikke vaping-revolutionen. Men det, der sker med disse legitime virksomheder, har v\u00e6ret smertefuldt og uretf\u00e6rdigt. Disse sm\u00e5 vape-butikker har \u00e9t m\u00e5l: at hj\u00e6lpe rygere med at skifte til et mindre skadeligt alternativ. De fleste butiksejere er knuste over FDA's handlinger, ikke kun for dem selv og de mennesker, de ans\u00e6tter, men ogs\u00e5 for forbrugerne, der ikke har haft andre steder at henvende sig end til det illegale marked.<\/span><\/p>\n

              Med alt, hvad vi ved om de d\u00f8delige konsekvenser af alkoholforbud, er det tid til, at FDA gent\u00e6nker deres valg af, hvad der virkelig er passende for folkesundheden.<\/span><\/p>\n

              Ansvarsfraskrivelse: Synspunkter og meninger udtrykt i g\u00e6steindl\u00e6g offentliggjort p\u00e5 World Vapers' Alliance's hjemmeside er de enkelte forfatteres og repr\u00e6senterer ikke n\u00f8dvendigvis World Vapers' Alliance's eller dets tilknyttede selskabers synspunkter eller holdninger. Offentligg\u00f8relse af tredjepartsindhold udg\u00f8r ikke en godkendelse fra WVA af de synspunkter, der udtrykkes deri.<\/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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