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最新下架名单:FDA已拒绝295家电子烟公司PMTA

9月18日消息,据外电报道,美国FDA宣布,目前又有另外127家电子烟制造商已收到针对在上市前烟草申请(PMTA)中提交的产品的营销拒绝令(MDO)。

最新下架名单:FDA已拒绝295家电子烟公司PMTA

新的 MDO 代表了大约 100000 种产品——几乎包括所有除了烟草和薄荷醇外的瓶装电子液体的口味。


自 8 月 26 日以来,已有 295 家制造商收到了超过 1,089,000 种产品的 MDO。自 9 月 9 日将未经授权的产品从市场上移除的最后期限以来,FDA 烟草产品中心尚未授权任何一种电子烟产品进行营销。


被拒绝 PMTA 的产品应该从市场上撤下或接受 FDA 的进一步执法。


FDA 表示,其最高执法优先事项包括已收到 MDO 或从未提交审查的产品。然而,所有目前可用的产品在技术上仍受 FDA 执法自由裁量权的支配,包括 JUUL Labs 和 Reynolds American 的 Vuse 品牌等大众市场电子烟制造商的产品。


随着第一轮 MDO,FDA宣布了一项先前未公布的标准,要求对烟草和薄荷醇以外的调味产品使用 PMTA,以证明足够的特定产品科学证据证明对成年吸烟者有足够的好处,可以克服对烟草和薄荷醇构成的风险。


自 FDA 宣布该要求以来,它首次拒绝向有资源将此类证据包含在其 PMTA 中的开放系统制造商。今天早些时候,美国电子烟油制造商Turning Point Brands 和 AVAIL Vapor 是本周收到 MDO 的公司之一,主要是调味电子烟产品类申请。


据信已在其 PMTA 中提交了大量科学证据的其他人也收到了 MDO,包括 Bidi Stick 一次性电子烟的制造商。一些知名且历史悠久的电子烟油制造商收到了 MDO,包括 Beard Vape Company、Cosmic Fog、Ruthless 和 Mister E-Liquid。


截至 2021 年 9 月 17 日的营销拒绝令 (MDO) 清单


尽管 FDA 表示已经发布了 295 个 MDO,但该列表仅包含 240 个名称。该机构表示,制造商对目前未上市的产品发出的否认没有点名。


该列表按字母顺序排列,每个名称的右侧都注明了 MDO 的发布日期。


10 Days Inc. dba Pod Juice,9/14

611 Vapes dba Erie Shore Vapors,9/16

7 Daze LLC,9/8

A Perfect Vape,9/16

AAA Strate Vape,9/10

Abomination LLP,9/13

Absolute Vapor Lounge LLC,9/10

ACH Group LLC dba Bomb Bombz E-liquid,9/15

Alaska Elixirs Vape LLC,9/8

American Vapor Group,9/1

American Vapor Inc.,9/8

APOLLO Future Technology Inc.,9/10

Arc LLC,9/7

Ashlynn Marketing Group,9/15

Avail Vapor LLC,9/15

Awesome Sauce Vapor,9/15

Axioco Corporation,9/16

Baker White Inc.,9/10

Balboa,9/7

Bang Bang Vapors LLC,9/9

Beard Vape Company,9/16

Bidi Vapor,9/7

Big Time Vapes,8/30

BJC,9/15

BMF Labs dba Bad Modder Fogger LLC ,9/10

Bogart Enterprises LLC,9/16

Bombies Inc.,9/8

Boomtown Vapors,9/8

Buckshot Vapors Inc.,9/1

California Grown E-Liquid ,9/15

Cassadaga Liquids, LLC,9/15

Central Vapors,9/10

Cig Free Vape Shop,9/15

CITTG dba Orgnx E Liquids,9/1

Cosmic Fog Vapors Operating Company LLC,9/15

Creative Focus dba Red Devil Vapors,9/7

CRFT Labs Tennessee LLC,9/15

Custom Vapor Blends LLC,9/7

Custom Vapors,8/31

Decent Juice,9/3

Desert Vapors LLC,9/13

DFW Vapor Holdings Inc.,9/8

DiAMOnd Vapor,9/1

Dominant Vapor,9/1

Doomsday Gourmet,9/7

DR Distributors LLC,9/17

Drippers Vape Shop LLC ,9/14

Drippers Vape Shop LLC,9/10

E-Vapor Hut LLC,9/9

Ecig Charleston LLC,9/15

ECS Global,9/10

Einstein Vapes,9/10

Ejuice Blvd LLP,9/15

Electric SMOKe Vapor House,9/8

Element E-Liquid LLC,9/15

Elite Brothers,9/15

Everything Vapor,9/16

Feel Life Health Inc.,9/17

Flair Products, LLC,9/10

Flavor Labs dba Mob Liquid Labs,9/7

Fuma International LLC,9/16

Fuma International LLC,9/17

FUMA Vapor, Inc.,9/10

Fumee LLC,9/14

Fumizer LLC,9/9

Gentlemen’s Draw LLC,9/7

Gothic Vapor,8/31

Great American Vapes,8/26

Gripum LLC,9/8

Grove Inc.,9/15

Gundo Distro,9/9

Heartlandvapes LLC,9/17

Holy Cow ejuice,9/13

HotSpot Caf� LLC dba VV-Juice,9/8

Howard Enterprises,9/16

Humble Juice Co., LLC,9/15

Imperial Vapors,9/1

InfAMOus E Juice,9/15

Innevape,9/15

J-Vapor LLC dba North Shore Vapor,8/31

Jaded Vapors LLC,9/8

Jai Mundi, Inc. Kai’s Virgin Vapor E-Liquid,9/15

JD Nova Group LLC,8/26

JDvapour LLC,9/8

JMJL Global,9/8

Johnny COPper,9/7

JT Wood Investments LLC dba Vape It,9/10

Juice Guys Distribution LLC,9/9

Juice Roll Upz Inc.,9/8

Jungle Nation,9/15

Jvapes LLC,9/9

K&C Aitken, LLC Dba Elysian Labs,9/16

Kinghorn Holding,9/9

KJJ Enterprises,9/9

Kloc Vapor LLC dba The Vapor Edge,9/8

Lady Boss Vapor,9/8

LAS Ventures Limited,9/15

Lazarus Vintage Corporation,9/8

LDP Designs LLC,9/14

Lead by Sales LLC dba White Cloud Cigarettes,9/14

LeCig Enterprises Inc.,9/15

Liquid Art Inc.,9/10

Liquid Nics LLC,9/3

Lotus Vaping Technologies,9/17

Loveli Design LLC dba Alice in Vapeland,9/1

LXJ LLC,9/13

Magellan Technology Inc.,9/8

Malicious Liquids Inc,9/8

Marina technology LLC,9/7

Marlin Steam Company, LLC,9/14

MATrix Minds,9/8

MH Global LLC dba Steamline Vape Co. LLC,9/16

Midas Vape LLC,9/8

Midwest Vape Supply,9/1

Mighty Vapors,9/15

Millennial One Inc. dba The Finest E-Liquid ,9/2

Mister-E-Liquid LLC,9/16

Mix Masters Inc.,9/10

MJ Asset Holdings,9/3

Mom and Pop Vapor Shop,9/8

Mothers Milk WTA,9/15

Mountain Oak Vapors, LLC,9/8

Mountain Vaporz,9/1

Mr. Salt-E LLC,9/15

MV Enterprises,9/1

My Vape Order Inc.,9/8

Nasty Worldwide SDN BHD,9/7

New Orleans Cloud Alchemy,9/15

Nicquid,9/1

Northeast Vapor Supplies LLC,9/9

Northland Vapor Company,9/17

Nude Nicotine,9/7

One Up Vapors LLC,9/15

Oueis Gas Inc. dba Oasis Vape,9/10

Ovapes Ejuice LLC,9/9

Paradigm Distribution ,9/15

Paradigm Distribution,9/10

Performance Plus Marketing Inc.,9/7

Pettee & D’Sylva Enterprises, LLC,9/13

Planet of the Vapes,9/1

Pop Vapor Co LLC,9/15

Pop Vapor Co LLC,9/16

Prohibition Juice Co.,9/13

Propaganda E-Liquid LLC,9/8

Prophet Premium Blends, LLC,9/15

PUFF Labs LLC,9/14

puff Labs,9/9

Quad City Vapers Club,9/7

Red Rock Vapor,9/7

Redwood Ejuice LLC,9/13

Riot Labs,9/9

Ripe Vapes,9/15

Rock Ridge Vapor LLC,9/13

Royalty Premium E Juice,9/1

RP Vapors,9/9

Ruthless Vapor Corporation,9/16

SadBoy,9/3

Seattle ,9/7

Securience LLC,9/8

Shop Vapes,9/9

Simple Vapor Company,9/10

Simply Vapour,9/10

Sir Vapes -A-Lot,9/1

Smax International LLC,9/14

Smokeless Smoking Inc.,9/9

South Coast Vapor Co.,9/9

Southwest Smokeless ,9/15

SS Vape Brands Inc. Dba Monster Vape Labs,8/31

SSY E-juice,9/10

Stark Vapor LLC,9/9

Steep Slope Vape Supply,9/8

SV Packaging LLC,9/10

SWT Global Supply,8/31

SWT Global Supply,9/7

Tampa Vapor Inc.,9/10

Tasty Cloud Vape Co. LLC,9/9

Tasty Haze,9/7

Tasty Puff LLC,9/14

Teardrip Holdings,9/14

Texas Select Ventures LLC dba Texas Select Vapor,9/14

Texas Tobacco Barn dba TXVape Barn,9/8

The Ecig Caf� LLC,9/9

The Michigan Juice Company LLC,9/8

The Vape Lounge,9/15

The Vaping Tiger,8/31

The Vapor Vendor LLC,9/9

The Zen Vaper E-Liquids LLC,9/15

TPB International LLC,9/14

Treehouse Vapor Company dba Flagship Vapor,9/7

TrendSetters E-liquid LLC,8/31

True Lab Creations,9/10

TruVibe Inc. dba Vapor Station FDL,9/8

Turncoat Industries,9/15

Twisted Tongue Inc.,9/13

UIS Manufacturing, LLC,9/14

Underdog E-liquids LLC,9/8

Union Street Brand,9/15

Valley Vapors LLC,9/8

Vape Craft,9/9

Vape Crusaders Premium E-liquids,9/8

Vape Hut Inc.,9/13

Vape n Juice,9/16

Vape of a Kind,9/8

Vape On,9/7

Vaper Generation,9/9

VaperMate LLC,9/15

Vapetasia LLC,9/16

Vaping Oasis,9/2

Vapor Bank E-liquid,9/10

Vapor Outlet of Wyoming LLC dba Juicity Vapor,9/8

Vapor Plus OK,9/7

Vapor Rage LLC,9/8

Vapor Salon,8/26

Vapor Solutions & Labs,9/8

Vapor Source Inc.,9/3

Vapor Stockroom,9/9

Vapor Stop,9/15

Vapor Trail LLC dba Mig Vapor,9/8

Vapor Ventures Inc dba Innovated Vapors,9/15

Vaporized Inc.,9/8

Vapors of Ohio Inc. dba NOStalgic Vapes,9/1

VDX Distribution,9/15

Verdict Vapors,9/15

Vertigo Vapor,9/8

Victory Liquid LLC,9/10

VIM Blends,9/8

Vintage & Vapor Marketplace Inc.,9/17

Viper Vapor,9/3

Viper Vapor,9/3

VPR Collection,9/8

VR Labs,9/9

Wadina Distribution LLC DBA GOST Vapor,9/9

Wages & White Lion Investments dba Triton Distribution,9/14

Walker Enterprises,9/9

Warlock Vapes dba Zuluvapes,9/8

Wyoming Vapor Company,9/3

Xtreme Vapors,9/8

Yogi’s Vape,9/9

Yoshicon LLC dba Vapergate,9/13

Zen RVA LLC,9/7