{"id":7116,"date":"2026-08-31T08:15:03","date_gmt":"2026-08-31T12:15:03","guid":{"rendered":"https:\/\/worldvapersalliance.com\/?p=7116"},"modified":"2026-08-31T08:15:03","modified_gmt":"2026-08-31T12:15:03","slug":"the-us-is-moving-fast-on-pouches-the-eu-should-follow-its-lead","status":"publish","type":"post","link":"https:\/\/worldvapersalliance.com\/cs\/the-us-is-moving-fast-on-pouches-the-eu-should-follow-its-lead\/","title":{"rendered":"USA postupuj\u00ed rychle v ot\u00e1zce s\u00e1\u010dk\u016f, EU by se m\u011bla \u0159\u00eddit jejich p\u0159\u00edkladem."},"content":{"rendered":"

Teprve minul\u00fd t\u00fdden americk\u00fd \u00da\u0159ad pro kontrolu potravin a l\u00e9\u010div (FDA) <\/span>autorizovan\u00fd<\/span><\/a> Na americk\u00fd trh vstoup\u00ed 11 nov\u00fdch nikotinov\u00fdch s\u00e1\u010dk\u016f, kter\u00e9 projdou procesem agentury pro pod\u00e1v\u00e1n\u00ed \u017e\u00e1dost\u00ed o p\u0159edprodejn\u00ed povolen\u00ed k prodeji tab\u00e1kov\u00fdch v\u00fdrobk\u016f (PMTA).\u00a0<\/span><\/p>\n

T\u00edm se celkov\u00fd po\u010det nikotinov\u00fdch s\u00e1\u010dk\u016f schv\u00e1len\u00fdch FDA zv\u00fd\u0161il na <\/span>43<\/span><\/a>, z nich\u017e 15 bylo schv\u00e1leno a\u017e v srpnu a 21 v lo\u0148sk\u00e9m roce. 23 ze 43, v\u010detn\u011b t\u00e9to posledn\u00ed \u0161ar\u017ee, pro\u0161lo pilotn\u00edm programem, kter\u00fd FDA vytvo\u0159ila speci\u00e1ln\u011b pro urychlen\u00ed posuzov\u00e1n\u00ed \u017e\u00e1dost\u00ed o uveden\u00ed s\u00e1\u010dk\u016f na trh.<\/span><\/p>\n

Zat\u00edmco Washington D.C. buduje rychlej\u0161\u00ed trasy, aby dosp\u011bl\u00fdm ku\u0159\u00e1k\u016fm dod\u00e1val nikotinov\u00e9 v\u00fdrobky s ni\u017e\u0161\u00edm rizikem, Brusel neust\u00e1le tvrd\u00ed, \u017ee jsou stejn\u011b \u0161kodliv\u00e9 jako kou\u0159en\u00ed a m\u011bly by b\u00fdt omezeny, ne-li p\u0159\u00edmo zak\u00e1z\u00e1ny.<\/span><\/p>\n

Program, kter\u00fd p\u0159in\u00e1\u0161\u00ed<\/b><\/h4>\n

FDA <\/span>pilotn\u00ed program nikotinov\u00fdch s\u00e1\u010dk\u016f<\/span><\/a> d\u011bl\u00e1 to, co jeho n\u00e1zev napov\u00edd\u00e1. Podle agentury vedlo k rychlej\u0161\u00edmu \u0159e\u0161en\u00ed v\u011bdeck\u00fdch ot\u00e1zek, krat\u0161\u00ed dob\u011b odezvy \u017eadatel\u016f na dopisy a celkov\u011b k efektivn\u011bj\u0161\u00edmu posouzen\u00ed.\u00a0<\/span><\/p>\n

FDA nyn\u00ed tento postup zav\u00e1d\u00ed do sv\u00e9ho \u0161ir\u0161\u00edho procesu PMTA. Nejde v\u0161ak o raz\u00edtko na doklady, FDA st\u00e1le vy\u017eaduje d\u016fkazy o tom, \u017ee produkt p\u0159in\u00e1\u0161\u00ed v\u011bt\u0161\u00ed p\u0159\u00ednos pro zdrav\u00ed populace ne\u017e riziko, a u t\u00e9to \u0161ar\u017ee s\u00e1\u010dk\u016f zjistila ni\u017e\u0161\u00ed hladiny \u0161kodliv\u00fdch a potenci\u00e1ln\u011b \u0161kodliv\u00fdch slo\u017eek ne\u017e v jin\u00fdch bezd\u00fdmn\u00fdch tab\u00e1kov\u00fdch v\u00fdrobc\u00edch, o n\u011bkolik m\u00e1lo m\u00e9n\u011b, ne\u017e aby se daly kvantifikovat!<\/span><\/p>\n

Jde o to, \u017ee se uk\u00e1zalo, \u017ee d\u016fslednost a efektivita se vz\u00e1jemn\u011b nevylu\u010duj\u00ed, jak uvedl \u00fa\u0159aduj\u00edc\u00ed \u0159editel Centra pro tab\u00e1kov\u00e9 v\u00fdrobky \u00da\u0159adu pro kontrolu potravin a l\u00e9\u010div (FDA) Bret Koplow. <\/span>stanoven\u00fd<\/span><\/a> pot\u00e9, co loni schv\u00e1lila 6 dal\u0161\u00edch nikotinov\u00fdch s\u00e1\u010dk\u016f. Agentura vymyslela, jak udr\u017eet la\u0165ku vysokou a z\u00e1rove\u0148 zkr\u00e1tit dobu pot\u0159ebnou k jej\u00edmu vy\u010di\u0161t\u011bn\u00ed, a ka\u017ed\u00fd u\u0161et\u0159en\u00fd den je o den d\u0159\u00edve, ne\u017e m\u016f\u017ee dosp\u011bl\u00fd ku\u0159\u00e1k p\u0159ej\u00edt na n\u011bco m\u00e9n\u011b \u0161kodliv\u00e9ho.<\/span><\/p>\n

Evropa se nem\u016f\u017ee dohodnout na s\u00e1\u010dc\u00edch<\/b><\/h4>\n

EU ji\u017e m\u00e1 nejlep\u0161\u00ed d\u016fkazy na sv\u011bt\u011b o tom, \u017ee nikotinov\u00e9 s\u00e1\u010dky funguj\u00ed, a nach\u00e1z\u00ed se uvnit\u0159 sv\u00fdch vlastn\u00edch hranic. \u0160v\u00e9dsko p\u0159ekro\u010dilo<\/span> pod 5% denn\u00ed kou\u0159en\u00ed<\/span><\/a>, \u010d\u00edm\u017e se stala prvn\u00ed zem\u00ed, kter\u00e1 dos\u00e1hla prahov\u00e9 hodnoty WHO pro neku\u0159\u00e1ckou oblast, a to o 15 let d\u0159\u00edve, ne\u017e dos\u00e1hla vlastn\u00edho c\u00edle EU pro rok 2040.\u00a0<\/span><\/p>\n

Tento posun n\u00e1sleduje po n\u00e1r\u016fstu u\u017e\u00edv\u00e1n\u00ed nikotinov\u00fdch s\u00e1\u010dk\u016f a v\u00fdsledek je jasn\u00fd: \u0161v\u00e9d\u0161t\u00ed mu\u017ei maj\u00ed \u00famrtnost na rakovinu plic o 61% ni\u017e\u0161\u00ed ne\u017e pr\u016fm\u011br EU a celkov\u00fd po\u010det \u00famrt\u00ed na rakovinu je zde o 34% ni\u017e\u0161\u00ed. Pr\u00e1v\u011b tento mechanismus FDA citovala p\u0159i schvalov\u00e1n\u00ed s\u00e1\u010dk\u016f: produkt s ni\u017e\u0161\u00edm rizikem, kter\u00fd odrazuje ku\u0159\u00e1ky od cigaret. Evropsk\u00e1 komise v\u0161ak sama... <\/span>hodnocen\u00ed<\/span><\/a> Ve sv\u00fdch z\u00e1konech o tab\u00e1ku se \u0160v\u00e9dsko zmi\u0148uje hlavn\u011b jako varov\u00e1n\u00ed p\u0159ed pou\u017e\u00edv\u00e1n\u00edm nikotinov\u00fdch s\u00e1\u010dk\u016f, nikoli jako p\u0159\u00edpadov\u00e1 studie, kterou je.<\/span><\/p>\n

Neochota pou\u010dit se od jedin\u00e9 zem\u011b EU, kter\u00e1 probl\u00e9m vy\u0159e\u0161ila, se projevuje i ve zbytku mozaiky bloku. Francie od 1. dubna zak\u00e1zala prodej, dovoz, dr\u017een\u00ed a u\u017e\u00edv\u00e1n\u00ed peror\u00e1ln\u00edch nikotinov\u00fdch v\u00fdrobk\u016f, co\u017e je jeden z nejp\u0159\u00edsn\u011bj\u0161\u00edch re\u017eim\u016f v Evrop\u011b. Belgie od roku 2022 zcela zak\u00e1zala v\u00fdrobu a prodej. N\u011bmecko pova\u017euje s\u00e1\u010dky za nov\u00e9 potraviny, co\u017e vytv\u00e1\u0159\u00ed sm\u011bsici region\u00e1ln\u00edch z\u00e1kaz\u016f sp\u00ed\u0161e ne\u017e jedno n\u00e1rodn\u00ed pravidlo. Mnoho dal\u0161\u00edch \u010dlensk\u00fdch st\u00e1t\u016f EU dosud nem\u00e1 \u017e\u00e1dnou legislativu t\u00fdkaj\u00edc\u00ed se nikotinov\u00fdch s\u00e1\u010dk\u016f. O\u010dek\u00e1v\u00e1 se, \u017ee Evropsk\u00e1 komise do konce roku navrhne revidovanou sm\u011brnici o tab\u00e1kov\u00fdch v\u00fdrobc\u00edch, kter\u00e1 by mohla kone\u010dn\u011b harmonizovat pravidla.<\/span><\/p>\n

V\u011bd\u00ed to byrokrat\u00e9 EU l\u00e9pe ne\u017e FDA?<\/b><\/h4>\n

Ta nechu\u0165 m\u00e1 jm\u00e9no: komisa\u0159 pro zdravotnictv\u00ed Oliv\u00e9r V\u00e1rhelyi. V z\u00e1\u0159\u00ed 2025 V\u00e1rhelyi <\/span>tweetoval<\/span><\/a> \u017ee \u201cnikotin\u2026zp\u016fsobuje rakovinu\u201d.<\/span> p\u00edsemn\u00e1 odpov\u011b\u010f poslanci Evropsk\u00e9ho parlamentu Kristofferu Stormovi<\/span><\/a>, V\u00e1rhelyi prohl\u00e1sil, \u017ee bezd\u00fdmn\u00e9 nikotinov\u00e9 v\u00fdrobky \u201cnesni\u017euj\u00ed zdravotn\u00ed riziko\u201d ve srovn\u00e1n\u00ed s cigaretami. Kdy\u017e Komise pot\u0159ebovala d\u016fkazy na podporu sv\u00e9ho postoje, \u017ee nov\u00e9 nikotinov\u00e9 v\u00fdrobky nesou rizika \u201csrovnateln\u00e1 s kou\u0159en\u00edm\u201d, jej\u00ed<\/span> zpr\u00e1va odporovala vlastn\u00edm citovan\u00fdm zdroj\u016fm<\/span><\/a>, kter\u00e1 zjistila, \u017ee nikotinov\u00e9 v\u00fdrobky bez spalov\u00e1n\u00ed nesou ve srovn\u00e1n\u00ed s kou\u0159en\u00edm cigaret n\u00edzk\u00e9 riziko.<\/span><\/p>\n

A <\/span>Pr\u016fzkum mezi poslanci Evropsk\u00e9ho parlamentu z roku 2025<\/span><\/a> zjistila, \u017ee pod\u00edl t\u011bch, kte\u0159\u00ed pova\u017euj\u00ed nov\u00e9 nikotinov\u00e9 v\u00fdrobky za p\u0159inejmen\u0161\u00edm stejn\u011b \u0161kodliv\u00e9 jako kou\u0159en\u00ed, vzrostl za rok ze 19% na 33%. To je d\u016fle\u017eit\u00e9, proto\u017ee ti sam\u00ed poslanci Evropsk\u00e9ho parlamentu budou hlasovat o dal\u0161\u00edm r\u00e1mci EU pro kontrolu tab\u00e1ku, kter\u00fd vypracovalo V\u00e1rhelyiho vlastn\u00ed odd\u011blen\u00ed, G\u0158 SANTE, je\u0161t\u011b ne\u017e se dostane do Parlamentu a Rady.<\/span><\/p>\n

O budoucnosti produktu, kter\u00fd je mnohem bezpe\u010dn\u011bj\u0161\u00ed ne\u017e cigarety, by m\u011bla rozhodovat v\u011bda, nikoli ideologie. Pokud FDA dok\u00e1\u017ee b\u00fdt d\u016fsledn\u00e1 a rychl\u00e1, mohou b\u00fdt evrop\u0161t\u00ed tv\u016frci politik nuceni dodr\u017eovat stejn\u00fd standard.<\/span><\/p>","protected":false},"excerpt":{"rendered":"

Just last week, the US Food and Drug Administration (FDA) authorised 11 new nicotine pouches to enter the American market, clearing them through the agency\u2019s premarket tobacco product application (PMTA) process.\u00a0 That brings the total number of FDA-authorised nicotine pouches to 43, of which 15 have been approved only in August, and 21 in the […]<\/p>\n","protected":false},"author":14,"featured_media":7119,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[17],"tags":[],"class_list":["post-7116","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"yoast_head":"\nThe US is moving fast on pouches, the EU should follow its lead - World Vapers' Alliance<\/title>\n<meta name=\"description\" content=\"The FDA is speeding nicotine pouch approvals while the EU considers bans, despite Sweden\u2019s success in reducing smoking through safer alternatives.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/worldvapersalliance.com\/cs\/the-us-is-moving-fast-on-pouches-the-eu-should-follow-its-lead\/\" \/>\n<meta property=\"og:locale\" content=\"cs_CZ\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The US is moving fast on pouches, the EU should follow its lead - 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