FDA 共拒绝了 295 家电子烟公司的 超108万份PMTA

FDA 宣布，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）。新的 MDO 代表了大约 100,000 种产品——几乎包含了除烟草或薄荷醇外的所有瓶装电子烟油的口味。

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能进行营销。

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“有足够的特定产品科学证据来证明既对成年吸烟者有足够的益处，又可以减少烟草和薄荷醇对青年构成的风险。”

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，我们报道了 Turning Point Brands 和 AVAIL Vapor 是本周收到 MDO 的公司之一，用于调味电子烟产品。

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 一次性小烟生产线的制造商。 一些知名和长期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
Vaping Oasis,9/2
Vapor Bank E-liquid,9/10
Vapor Outlet of Wyoming LLC dba Juicity Vapor,9/8
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