Category: Regulation

  • FDA Continues Warning Letter Blitz for PMTA Offenses

    FDA Continues Warning Letter Blitz for PMTA Offenses

    The U.S. Food and Drug Administration (FDA) continues to be adamant about removing illegal e-liquids from the market. On Tuesday, the regulatory agency issued two more warning letters for companies selling e-liquids without having filed a premarket tobacco product application (PMTA). The total now stands at 115 companies that have received notice since Jan.1 of this year.

    Credit: Hurricane Hank

    Adirondack Juice d/b/a Adirondack Vapor & Co. and Blue Eyed Vapor (BEV) received the letters from the FDA on May 14, however the agency didn’t post the letters to its website until May 25. Adirondack and BEV both were accused of selling or marketing multiple e-liquid flavors. The companies have 5,800 and 20 products registered with the FDA, respectively.

    Last week, the FDA released its list of products that are legal for sale in the U.S. A total of 360 companies filed more than 6 million PMTAs. The FDA stressed it has not independently verified the information provided by applicants about the marketing status of their products. In addition, the list excludes entries of products from companies that did not provide information on current marketing status of their products to the FDA so that the agency could determine whether the existence of the application could be disclosed.

    The FDA often only lists a few products that a company is selling as illegal in the letter. It then states that there may be more, but it is impossible to know if the warnings encompass all the company’s registered products. The agency states that it is the responsibility of the company to only sell products with a submitted PMTA. Companies have until Sept. 9, 2021 to sell product unless the agency makes a decision on the PMTA approval or grants an extension.

    Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.

  • Revised Philippines Vaping Rules Heads to Senate

    Revised Philippines Vaping Rules Heads to Senate

    The House of Representatives in Philippines today approved on final reading a proposal that would regulate the manufacture, use, sale, distribution, and promotion of electronic nicotine- and non-nicotine-delivery systems (ENDS/ENNDS), as well as heated tobacco products (HTPs), according to a government release.

    Credit: Craitza

    With 192 affirmative votes, 34 negative votes, and four abstentions, the chamber passed on third reading House Bill 9007, otherwise known as the “Non-Combustible Nicotine Delivery Systems Regulation Act.” Rep. Sharon Garin, principal sponsor of the measure, said the bill seeks to address the unintended or potential adverse consequences on the use of HTPs and vaping products among Filipino consumers.

    “We have included in this bill mechanisms on controlling safety risks and preventing youth uptake of all tobacco and nicotine products,” she said during the virtual session.

    • The bill provides protection to minors from accessing ENDS/ENNDS or HTPs by setting the minimum allowable age for the purchase, sale, and use of such products to 18 years old.
    • Retailers shall ensure that no individual purchasing these products are below 18 years old by verifying the age through presentation of any valid government-issued identification card exhibiting the buyer’s photograph and age or date of birth.
    • The sale and distribution of the products shall be prohibited within 100 meters from any point of the perimeter of a school, playground or other facility frequented by minors shall be prohibited.
    • Online trade through Internet websites or via e-commerce and other similar media shall be allowed provided that sellers ensure that access is restricted to persons 18 years old or older and that the internet website bears the signage required by the bill.
    • Advertisements of the products shall be allowed in retailer establishments, through direct marketing, and on the internet.

    “These shall not be aimed at or particularly appeal to persons under 18 years of age. These should not undermine quit-smoking messages and should not encourage non-tobacco and non-nicotine users to use ENDS/ENNDS and HTPs. These should not contain any information that is untrue in particular with regard to product characteristics, health effects, risks, or emissions,” the bill states.

    The use of ENDS/ENNDS or HTPs shall be prohibited in all enclosed public places, as well as in schools, hospitals, government offices, and facilities intended particularly for minors. However, there shall be designated vaping areas that should comply with standards specified in the proposed law.

    The Department of Trade and Industry, in consultation with the Food and Drug Administration, the National Tobacco Administration, and other concerned agencies shall promulgate rules, regulations, and standards on packaging, ingredients, graphic health warnings, detailed information on the allowable nicotine-containing e-liquid, the strength of e-liquids, compliance with applicable electrical standards as well as with applicable industry standards for batteries, according to the release.

    Existing industries and businesses affected by the implementation of the Act shall be given an 18-month transitory period from the effectivity of the implementing rules and regulations to comply with the requirements.

  • CAPHRA: Philippine’s 21 Age to Vape Rule ‘Nonsensical’

    CAPHRA: Philippine’s 21 Age to Vape Rule ‘Nonsensical’

    A new bill to regulate vaping products in the Philippines is supported by the region’s vapor advocacy groups. House Bill 9007, the proposed “Non-Combustible Nicotine Delivery Systems Regulation Act” is a “massive legislative achievement for tobacco harm reduction advocates” in the Philippines, says Nancy Loucas, executive coordinator of the Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA).

    Clarisse Virgino and Peter Paul Dator of CAPHRA

    “Nearly 90,000 Filipinos die from smoking-related diseases every year. This legislation will not only save thousands of lives, but the Philippines is now leading the way in the Asia-Pacific region with reasonable, risk proportionate regulation which will be very effective in curbing smoking rates,” said Loucas.

    Consumer advocates in the Philippines promoted the regulation of e-cigarettes as a consumer product. They argued that the “age of majority” in the Philippines is 18 – they age to purchase combustible tobacco products, alcohol and get married – so the current age to purchase vaping products set at 21 was “nonsensical.” Supporting the minimum age for the purchase, sale and use of such products to 18 would bring vapor products in line with other “adult” activities and privileges.

    At the same time, the advocates argued adult smokers keen to quit tobacco need reasonable access to safer alternatives and restricted advertising should be permitted. Product safety standards were also critically important to the consumer advocates.

    Clarisse Virgino, the Philippine representative of CAPHRA, said she is “delighted that the country’s legislators have listened,” adding that the prospect of more Filipinos successfully quitting smoking is of historic significance given the country’s “stubbornly high” smoking rates for decades.

    “The proposed Act will legitimize the market of vaporized nicotine products which means that consumers will have better protection. We hope that the Senate will also support this bill to provide millions of Filipino smokers with less harmful alternatives to combustible cigarettes,” said Virgino.

    Consumer groups in the Asia-Pacific region have launched a petition that urges the World Health Organization (WHO) to respect consumer rights ahead of its next biennial meeting of the WHO Framework Convention of Tobacco Control (WHO FCTC) in November. They are asking for supporters to sign and share the petition at change.org/v4v-petition.

  • Lawmaker Brings Back Bill for Vapor Usage Reporting

    Lawmaker Brings Back Bill for Vapor Usage Reporting

    Utah Rep. Chris Stewart has joined two other members of U.S. Congress to reintroduce a bipartisan bill aimed at providing more accurate information regarding electronic cigarette use. Presently, electronic health records (EHRs) allow doctors to record whether a patient uses traditional cigarettes or cigars, however, there are no options for e-cigarette or other harm reduction products, according to a press release from Stewart’s office.

    Credit: Lazy Llama

    The bill, called the Accurate Reporting of Smoking Variants Act, would require the National Coordinator for Health Information Technology to ensure that the electronic health records include options for vapor products and other reduced harm variants, such as heat tobacco products.

    According to the press release, the change would allow for health care providers and researchers to better understand the prevalence of e-cigarette usage, understand the long-term health impacts of these products, and develop strategies to curb vaping among young people.

    “Young people in Utah and across the country are using e-cigs at alarming rates,” said Stewart. “I’m proud to reintroduce this bipartisan bill in an effort to take concrete steps to reverse this trend. There’s no denying it: This is a public health crisis that demands action. Let’s give health providers and researches the tools they need to ensure a healthier America for future generations.”

    Co-sponsoring the bill along with Stewart are Reps. David Trone of Maryland and Raja Krishnamoorthi of Illinois.

  • FDA Issues Warning 112, 113 in 2021 for Illegal E-Liquid

    FDA Issues Warning 112, 113 in 2021 for Illegal E-Liquid

    On the same day it released its much anticipated list of legal electronic nicotine-delivery system (ENDS) products, the U.S. Food and Drug Administration (FDA) issued its 112 warning letter to a company for selling products without a marketing order. Companies must have submitted a Premarket tobacco product application to the FDA by Sept. 9, 2020 in order to legally sell vaping products. The following day the agency issued No. 113.

    Credit: Postmodern Studio

    Louisiana-based Big Chief Vapor received the letter for selling its Zulu Pride 6mg nicotine e-liquid product without a marketing authorization order, according to the FDA. The letter was posted to the regulatory agency’s website on May 20. Big Chief Vapor has over 4,400 products registered with the FDA.

    On May 21, the FDA posted on its website that it had issued also a letter to Mississippi-based Vape Lizard Co. for selling Vape Lizard Strawmelon 3mg without a marketing order. The company has over 400 products registered with the FDA.

    The FDA often only lists a few products that a company is selling as illegal in the letter. It then states that there may be more, but it is impossible to know if the warnings encompass all the company’s registered products. The agency states that it is the responsibility of the company to only sell products with a submitted PMTA. Companies have until Sept. 9, 2021 to sell product unless the agency makes a decision on the PMTA approval or grants an extension.

    Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.

  • FDA Publishes List of Legal ENDS Products for US Sales

    FDA Publishes List of Legal ENDS Products for US Sales

    The list has arrived. The U.S. Food and Drug Administration (FDA) published its list of electronic nicotine-delivery system (ENDS) products that can be legally marketed in the U.S. Due to the sheer volume of the list, Vapor Voice has not yet been able to break down the full contents of the list. However, if each of the 15 files the agency published contains 430,000 cells that’s over 6 million individual products. 

    The publication of the list likely signals the start of enforcement crack-downs. The FDA has already issued 111 warning letters to vapor companies in 2021.

    One item that stands out immediately is that one company, JD Nova Group, parent to Vapolocity and De-Ja Juice among others, has filed the majority (an estimated 4 million) of the PMTA submissions.

    The FDA stressed it has not independently verified the information provided by applicants about the marketing status of their products. In addition, the list excludes entries of products from companies that did not provide information on current marketing status of their products to the FDA so that the agency could determine whether the existence of the application could be disclosed.

    Credit: Hase Hoch

    “Please note that FDA has not independently verified the information provided by applicants about the marketing status of their products. In addition, the list does not include entries of products from companies that did not provide information on current marketing status of their products to FDA so that the Agency could determine whether the existence of the application could be disclosed,” the FDA states. “It is important to note that the lists are not comprehensive lists intended to cover all currently marketed deemed tobacco products that a company generally might manufacture, distribute, or sell without risking FDA enforcement.”

    The FDA had stated in September of 2020 that it would publish a list of vapor companies that had submitted PMTA’s by the Sept. 9, 2020 deadline. The news came just one week after several retail groups submitted a letter to the agency asking for a published list of applicants. Nearly eight months later the list has been published on the FDA’s website.

    Companies that submitted their application by the Sept. 9, 2020, deadline can keep their products on the market for one year pending FDA review.

    If a negative action is taken by the FDA on the application prior to Sept. 9, 2021, the product must be removed from the market or risk FDA enforcement. If a positive order is issued by the FDA on a product in the lists, the product will be listed on the positive marketing orders page and may continue to be marketed according to the terms specified in the order letter.

    The list consists of 361 companies that filed PMTAs. The company’s on the list are as follows:

    • 10 Days Inc dba Pod Juice
    • 611 Vapes, LLC, dba Erie Shore Vapors
    • 7 Daze LLC
    • AAA Strate Vape
    • Abomination LLP
    • Absolute Vapor Inc.
    • Absolute Vapor Lounge LLC
    • ACH Group LLC dba Bomb Bombz E-Liquid
    • Al Khalifa Group LLC
    • Alaska Elixirs Vape LLC
    • Alien Vape LLC
    • American Vapor Group LLC
    • American Vapor Inc.
    • Anna Mae’s
    • Apollo Future Technology Inc.
    • ARC LLC
    • Ashlynn Marketing Group Inc.
    • Aspire North America LLC
    • Atlantic Vape Supply
    • Avail Vapor LLC
    • Awesome Sauce Vapor, Inc
    • Axcentria Pharmaceuticals LLC
    • Axiocore Corporation
    • Bad Drip Labs Inc.
    • Baker White Inc.
    • Balboa Vapes LLC
    • Beard Vape Company
    • Bidi Vapor LLC
    • Big Time Vapes
    • BJC
    • Black Note Inc.
    • Blackbriar Regulatory Services LLC
    • BLB7 LLC dbaThe Vape Mall
    • BMF Labs dba Bad Modder Fogger LLC
    • Bogart Enterprises LLC
    • Boomtown Vapor LLC
    • Boss Vapes LLC
    • Boulder International Inc.
    • Breeze Smoke LLC
    • Buckshot Vapors Inc
    • Cali Steam LLC
    • California Grown E-liquids LLC
    • Camelot Distribution
    • Carolina Wholesale Distributing LLC
    • Cassadaga Liquids LLC
    • Central Vapors
    • Charlie’s Chalk Dust LLC
    • Cig Free Vape Shop
    • CITTG dba Orgnx E Liquids
    • Cloud House LLC
    • Coastal Clouds Co.
    • Cool Breeze Vapor LLC
    • Corso Bleu Vapor Company
    • Cosco International Inc.
    • Cosmic Fog Vapors Operating Company LLC
    • Craving Vapor Industries
    • Creative Focus LLC dba Red Devil Vapors
    • CRFT Labs Tennessee LLC
    • Custom Technologies Inc.
    • Custom Vapor Blends LLC
    • Custom Vapors LLC
    • Decent Juice Co. LLC
    • Delaware Vapor LLC
    • Desert Vapors LLC
    • DFW Vapor Holdings Inc.
    • Diamond Vapor LLC
    • DNA Enterprise LLC dba Mech Sauce
    • Dominant Vapor LLC
    • Doomsday Gourmet LLC
    • Dotmod Inc.
    • Dovpo USA INC.
    • DR Distributors LLC
    • Dream Smoke
    • Drip More LLC
    • Drippers Vape Shop LLC
    • DS Technology Licensing LLC
    • Duke And Drews LLC
    • E Vapor Hut LLC
    • E-Alternative Solutions LLC
    • E-liquid Brands LLC
    • E-Six LLC
    • East Coast Liquids
    • ECBlend LLC
    • Ecig Charleston
    • eCig Source
    • ECS Global LLC
    • Einstein Vapes LLC
    • EjuiceBLVD LLP
    • Electric Smoke Vapor House LLC
    • Element E-Liquid LLC
    • Elite Brothers, LLC
    • Elysian Labs
    • Essex E Liquid
    • Evolv LLC
    • Feel Life Co Limited
    • Feel Life Health Inc.
    • Flair Products LLC
    • Flavor Vapors LLC/ Mob Liquid Labs
    • Fliq Vapor LLC
    • Fontem US LLC
    • Fridays Vapor-ettes LLC
    • Fuma International LLC
    • Fumizer LLC
    • FuZion Vapor LLC
    • Gentleman’s Draw LLC
    • GloBrands LLC
    • Gothic Vapor LLC
    • Great American Vapes LLC
    • Great Lakes Vapor
    • GRIPUM LLC
    • Ground Zero Vaping
    • Grove Inc.
    • Gundo Distro
    • Heartlandvapes LLC
    • HMD Investment Group LLC
    • Holland Resolute Solutions Inc.
    • Holy Cow eJuice
    • Hong Kong Man Tin International
    • Hoosier Vapes Inc.
    • HotSpot Cafe LLC dba VV-Juice
    • Howard Enterprises Inc.
    • Humble Juice Co.
    • Imperial Vapors LLC
    • Infamous E Juice
    • Innevape LLC
    • Innotel Inc.
    • INTELLISMOKE, LLC
    • Ivg Acme
    • J-Vapor LLC dba North Shore Vapor
    • Jaded Vapors LLC
    • Jai Mundi Inc. dba Kai’s Virgin Vapor
    • JD Nova Group LLC
    • JDvapour LLC
    • JMJL Global Inc.
    • Johnny Copper LLC
    • JT Wood Investments LLC dba Vape It
    • Juice Guys Distribution LLC
    • Juice Roll Upz Inc.
    • Juicemafia Inc.
    • JUUL Labs Inc.
    • Jvapes LLC
    • Kinghorn Holding LLC
    • KJJ Enterprises LLC
    • Kloc Vapor LLC (dba “The Vapor Edge”)
    • Lady Boss Vapor Inc.
    • LAS Ventures Limited
    • Lazarus Vintage Corporation
    • LDP Designs LLC
    • LDSD Vapor LLC
    • Lead by Sales LLC dba White Cloud Cigarettes
    • LeCig Enterprises Inc.
    • Licensed E-Liquid Manufacturing
    • Liquid Art Inc.
    • Liquid Nics LLC
    • Liquid Reign Inc.
    • Logic Technology Development LLC
    • LoneStar Vapor Shop LLC
    • Lotus Vaping Technologies LLC
    • Loveli Design LLC DBA Alice in Vapeland
    • Ludovico, Inc.
    • LXJ, LLC
    • Magellan Technology Inc.
    • Malicious Liquids Inc.
    • Maniac Vapor LLC
    • Marina Technology LLC
    • Marlin Steam Co., LLC
    • Matrix Minds LLC
    • MH Global LLC dba Streamline Vape Co. LLC
    • Mid Cities Vapor LLC
    • Midas Vape LLC
    • Midwest Vape Supply, Inc.
    • Mighty Vapors, LLC
    • Millennial One Inc. dba The Finest E-Liquid
    • Mister-E-Liquid LLC
    • Mix Masters Inc.
    • MJ Asset Holdings LLC
    • MMWTA, Mothers Milk WTA
    • Mom and Pop Vapor Shop
    • Mountain Oak Vapors LLC
    • Mountain Vaporz, LLC
    • MV Enterprises LLC
    • My US Eliquids, LLC
    • My Vape Bar LLC
    • My Vape Order Inc.
    • Myle Vape Inc.
    • Nasty Worldwide SDN BHD
    • New Orleans Cloud Alchemy LLC
    • Newhere Inc. dba Madhatter Juice
    • Nicopure Labs LLC
    • NicQuid LLC
    • NJOY LLC
    • Northeast Vapor Supplies LLC
    • Northland Vapor Company
    • Northwest’s Finest ELiquid LLC
    • Nu-Tech Holdings LLC
    • Nude Nicotine Inc.
    • Ohm Slaw Juice LLC / Ohm Slaw Vapors dba Justin Parrott
    • One Up Vapor LLC
    • Opt2mist Vapor Shop LLC
    • Osment Enterprises LLC dba The Vapor Apothecary
    • Oueis Gas Inc. dba Oasis Vape
    • OVapes Ejuice LLC
    • Paradigm Distribution
    • Parallel Direct LLC dba The Magic Mist
    • Perfect Vape LLC
    • Performance Plus Marketing Inc.
    • Pettee & D’Sylva Enterprises
    • Phantasm Vapors LLC
    • Phatty’s E-Liquid
    • Pixotine Products Inc.
    • Planet of the Vapes, LLC (MD21122)
    • Pop Vapor Co. LLC
    • Prohibition Juice Co.
    • Propaganda E-Liquid LLC
    • Prophet Premium Blends LLC
    • Public Bru Inc.
    • Puff Labs LLC
    • Pure Cigs LLC
    • Quad City Vapers Club LLC
    • J. Reynolds Vapor Company
    • Red Shield Reserve Inc.
    • Redwood Ejuice LLC
    • Riot Labs Ltd
    • Ripe Vapes Inc.
    • Rock Ridge Vapor LLC
    • Rogue Liquids
    • Rogue Vapers LLC
    • Romo LLC dba CrossBar
    • Royalty Premium E Juice LLC
    • RP Vapors, Inc.
    • Ruthless Vapor Corporation
    • S. Vape Brands Inc. dba Monster Vape Labs
    • Sadboy LLC
    • Saffire Vapor
    • Saucy Los Angeles
    • Savage Enterprises
    • Save A Smoker
    • Science Holdings LLC
    • Seattle Vapor Co LLC
    • Securience LLC
    • Shenzhen First Union Technology Co. LTD.
    • Shenzhen Greensound High-Tech Co Ltd
    • Shenzhen Innokin Technology Co., Ltd
    • Shenzhen IVPS Technology Co.Ltd.
    • Shenzhen Smoore Technology Limited
    • Shenzhen Vaporesso Technology Limited
    • Shenzhen Yibo Technology Co. Ltd.
    • Shenzhen Youme Information Technology Co. Ltd
    • Shop Vapes Inc
    • Simple Vapor Company
    • Simply Vapour
    • Sir Vapes-A-Lot LLC.
    • Smax International LLC
    • Smokeless Smoking Inc.
    • SN Holdings Inc
    • Soft Vape Inc
    • South Beach Holdings LLC
    • South Coast Vapor Company
    • Southwest Smokeless
    • Spring Vapor, LLC
    • SSY Ejuice Inc.
    • Stark Vapor LLC
    • Steep Slope Vape Supply
    • Super Dope Laboratories
    • SV Packaging LLC
    • SV3 LLC
    • SWT Global Supply Inc.
    • Synergy Mixing Labs LLC
    • Taffy Splash
    • Tampa Vapor Inc
    • Tasty Cloud Vape Co. LLC
    • Tasty Haze LLC
    • Tasty Puff LLC
    • Teardrip Holdings Inc.
    • Texas Select Ventures LLC dba Texas Select Vapor
    • Texas Smoke Accessories
    • Texas Tobacco Barn LLC dba Ciggy Shack
    • Texas Tobacco Barn LLC dba TXVapeBarn
    • That 1 Vape
    • The AVE E-Cigarette and Vapor
    • The Company MFG
    • The Ecig Cafe LLC
    • The Jones Lab Inc.
    • The Michigan Juice Company LLC
    • The Plume Room LLC
    • The Schwartz E Liquid dba USA Vape Lab
    • The Vape Lounge Inc.
    • The Vape Stop
    • The Vaping Oasis LLC
    • The Vaping Tiger LLC
    • The Vapor Outlet of Wyoming LLC dba Juicity Vapor
    • The Vapor Vendor LLC
    • The Zen Vaper E-Liquids LLC
    • Tinted Brew, Inc
    • Toe Toe Inc. dba Juana Vape
    • Town Vapor Co.
    • TPB International LLC
    • Treehouse Vapor Co. DBA Flagship Vapor
    • Trendsetters E-Liquid LLC
    • True Lab Creations
    • TruVibe Inc. dba Vapor Station FDL
    • Turncoat Industries Inc.
    • Twelfth State Brands LLC
    • Twisted Tongue Inc.
    • UIS Manufacturing, LLC
    • Underdog E Liquids LLC
    • Union Street Brands
    • Unique eCigs Inc.
    • Valley Vapors LLC
    • Vape Craft Inc
    • Vape Crusaders Premium E-Liquid LLC
    • Vape Element LLC dba BLVK Unicorn
    • Vape Hut Inc.
    • Vape of A Kind Inc.
    • Vape On LLC dba Imperial Vapor Co.
    • VapeDaugz LLC
    • Vapejoose, Inc.
    • Vaper Generation LLC
    • VaperMate LLC
    • Vapetasia LLC
    • Vapewear Inc.
    • Vapology Inc.
    • Vapor Bank E-Liquid LLC
    • Vapor Depot LLC
    • Vapor Plus Ok
    • Vapor Rage LLC
    • Vapor Salon
    • Vapor Select Inc.
    • Vapor Solutions & Labs
    • Vapor Source Inc.
    • Vapor Stockroom LLC
    • Vapor Stop
    • Vapor Studios LLC dba The Vapor Studio
    • Vapor Trail LLC dba Mig Vapor
    • Vapor Unlimited LLC
    • Vapor Ventures Inc dba Innovated Vapors
    • Vaporized Inc.
    • Vapornine LLC dba New Leaf Vapor Company
    • Vapors of Ohio Inc. dba Nostalgic Vapes
    • Verdict Vapors LLC
    • Vertigo Vapor Inc.
    • Victory Liquid LLC
    • Victory Vapor Inc.
    • Victory Vapor Wholesale Inc
    • VIM Blends Inc.
    • Vintage & Vapor Marketplace Inc.
    • Viper Vapor LLC
    • Vital Vapers LLC
    • VPR Collection
    • VR Labs LLC
    • Wadina Distribution LLC DBA GOST Vapor
    • Wages & White Lion Investments LLC dba Triton Distribution
    • Walker Enterprises LLC dba MaddCatt Vapors
    • Wall 2 Wall Vape
    • Warlock Vapes LLC dba Zuluvape
    • What A Smoke LLC
    • Wyoming Vapor Company
    • Xtreme Vapes LLC
    • Yogi’s Vape
    • Yoshicon LLC dba Vapergate
    • Zen RVA LLC

    This story will be updated as information becomes available.

  • Netherlands Pressed to Restrict ENDS Ahead of COP9

    Netherlands Pressed to Restrict ENDS Ahead of COP9

    Photo: vichie81

    Anti-smoking groups and pharmaceuticals company Pfizer are urging the next Dutch government to extend smoking bans and restrict tobacco alternatives such as e-cigarettes, reports Dutch News.

    The outgoing government has increased cigarette prices and limited sales outlets as steps towards a smoke free generation by 2040, and the number of smokers has gone down from 25 percent to 20 percent in the last five years.

    However, even though there are fewer smokers, the total amount of tobacco being consumed has remained stable. “The remaining smokers are smoking more,” campaigner Wanda de Kanter told Financieele Dagblad.

    De Kanter is skeptical about Philip Morris International’s attempts to market its IQOS tobacco-heating device as a less-risky alternative to smoking. The multinational is trying to persuade the Dutch government to relax rules around such products. Health institute RIVM has stated that heated tobacco still contains cancer causing substances and can damage lung cells.

    I am concerned about these reports, especially in light of the global World Health Organization’s COP9 summit which takes place in the Netherlands in November 2021.

    The U.K. Vaping Industry Association (UKVIA) warned that cracking down on smoking alternatives would be counterproductive.

    “To further reduce smoking rates in the Netherlands, legislators should be embracing alternative tobacco products, such as vaping—not introducing stricter regulations which will only serve to facilitate tobacco consumption,” the group wrote in a press note. “Adopting an evidence-based approach, like that which has been successful in the United Kingdom, will help cement the concept of tobacco harm reduction.”

    “I am concerned about these reports, especially in light of the global World Health Organization’s COP9 summit which takes place in the Netherlands in November 2021,” said UKVIA Director-General John Dunne.

    “Smoking-related illness still kills many thousands of people each year in both the U.K. and the Netherlands. It is imperative on both governments to do all that they can to reduce this number of smoking related deaths. They should trust the science and the overwhelming evidence and embrace vaping products and e-cigarettes. They are the most popular and effective nicotine replacement products on the market.”

  • FDA Drops 7 More Warning Letters, Total Now 111

    FDA Drops 7 More Warning Letters, Total Now 111

    The U.S. Food and Drug Administration (FDA) issued seven more warning letters to vapor companies for selling illegal products. The total now stands at 111 for the number of warning letters the regulatory agency has issued to vapor companies in 2021. The FDA accuses the companies of selling vapor products without having submitted a premarket tobacco product application (PMTA) by Sept. 9, 2020.

    Credit: Trend Objects

    The companies all received their letters on May 7, however the FDA didn’t post the letters on its website until May 18. The companies receiving letters include:

    • Nicotine Nirvana, which has over 50 products registered with the FDA;
    • FF Vapors, which has over 257,000 registered products with the FDA;
    • JP & SN Enterprises Inc. d/b/a eCigs International, which has over 4,500 products listed with the FDA;
    • The Iron Crow, which has 400 products listed with the FDA;
    • Sema International, which has over 500 products listed with the FDA;
    • Central Iowa Electronic Cigarettes, which has over 3,400 products listed with the FDA;
    • High Voltage Vaporz, which has over 600 products registered with the FDA.

    The FDA often only lists a few products that a company is selling as illegal in the letter. It then states that there may be more, but it is impossible to know if the warnings encompass all the company’s registered products. The agency states that it is the responsibility of the company to only sell products with a submitted PMTA. Companies have until Sept. 9, 2021 to sell product unless the agency makes a decision on the PMTA approval or grants an extension.

    Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.

  • FDA Invites Comments on IQOS 3 Modified-Risk Application

    FDA Invites Comments on IQOS 3 Modified-Risk Application

    Photo: Кузнецова Евгения

    The U.S. Food and Drug Administration (FDA) today opened a public comment period on Philip Morris International’s application seeking authorization to market the IQOS 3 electrically heated tobacco system as a modified risk tobacco product (MRTP).

    PMI’s application requests the same reduced exposure modification orders granted on July 7, 2020, for the IQOS 2.4 system—the first, and only, electronic nicotine product to be granted marketing orders through the FDA’s MRTP process. To authorize MRTP consumer communications, the FDA’s Center for Tobacco Products is required by law to conclude that a product is appropriate to promote the public health.

    The IQOS 3 device contains a number of technological advancements, compared to the IQOS 2.4 device, including longer battery life and quicker recharge between uses. It was authorized for sale in the U.S. via the FDA’s pre-market review process on Dec. 7, 2020, having met the standard that permitting its sale is appropriate to protect public health.

    This application underscores PMI’s ongoing commitment to make new innovations available to American adult smokers through the FDA process.

    “PMI is fully committed to a smoke-free future, one where we completely replace cigarettes with scientifically substantiated smoke-free alternatives that are a better choice for adults who would otherwise continue smoking,” said PMI CEO Jacek Olczak.

    “Our commitment to a science-based future is unmatched, having invested more than $8 billion since 2008 on smoke-free products. This application underscores PMI’s ongoing commitment to make new innovations available to American adult smokers through the FDA process; the confidence we have in our science; and our belief that public scrutiny and open engagement with governments is vital to achieving a smoke-free future.”

  • FDA to Discuss Scientific Review of PMTA Submissions

    FDA to Discuss Scientific Review of PMTA Submissions

    Photo: Grandbrothers

    The U.S. Food and Drug Administration Center for Tobacco Products (CTP) will host a virtual meeting June 11 from 13:00 to 15:30 Eastern Daylight Time. The meeting will discuss the scientific review of tobacco marketing applications received by Sept. 9, 2020. It will focus on the application intake process, review progress and allocation of review resources. There will be time allotted for audience questions as well.

    Matt Holman

    The meeting will feature a presentation from CTP Office of Science Director Matt Holman and include a question-and-answer session. Other Office of Science staff participating in the meeting include Todd L. Cecil, deputy director for regulatory management; Crystal Allard, director for the division of regulatory science and informatics; Joanna C. Randazzo, D.C., acting chief for the science policy branch; and Cristi Stark, director of the division of regulatory project management.

    The CTP Office of Science is responsible for identifying, developing and enhancing the science related to tobacco products, their use, and the resulting morbidity and mortality so that regulatory decisions will have the greatest impact on improving public health.

    The Office of Science provides the scientific support for regulations and guidance, reviews tobacco product applications, evaluates the knowledge basis for regulatory decisions and carries out research to fill the gaps in scientific knowledge related to tobacco product regulation.

    For more information, click here.