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.
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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.
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.
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“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:
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.
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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.
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.
The agency isn’t slowing down. In the U.S. Food and Drug Administration’s (FDA) quest to relieve the market of illegal vapor products, the regulatory agency has issued 104 warning letters since Jan. 1, 2021. The latest recipient is Texas-based The Smoker’s Alternative. The letters were sent today May, 11, and posted the FDA’s website the same day.
The FDA states that The Smoker’s Alternative did “manufacture, sell, and/or distribute to customers in the United States The Smoker’s Alternative Vanilla Custard 60 ml 3mg e-liquid product without a marketing authorization order.” In order to legally sell vaping products, a company must have submitted a premarket tobacco product authorization (PMTA) to the FDA’s Center for Tobacco Products by Sept. 9, 2020.
The FDA often only lists a product or two that a company is selling as illegal. 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.
:Your firm is a registered manufacturer with over 1,800 products listed with FDA,” the FDA letter to The Smoker’s Alternative states. “It is your responsibility to ensure that your tobacco products comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to adequately address this matter may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction.”
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.
Since Jan. 1, 2021, the U.S. Food and Drug Administration (FDA) has issued a total of 103 warning letters to firms selling or distributing over 904,000 unauthorized vaping products and who did not submit premarket tobacco product applications (PMTAs) by the Sept. 9 deadline.
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In April alone, the regulatory agency issued a total of 24 warning letters to companies that manufacture and sell unauthorized e-liquids, advising them that selling products which lack premarket authorization is illegal and therefore they cannot be sold or distributed in the U.S. While each of these 24 warning letters cites specific products as examples of tobacco products that lack the required premarket authorization, collectively these firms have listed a combined total of more than 154,000 products with the FDA, according to an FDA statement.
The 103rd warning letter was issued on March 6 and posted to the FDA’s website on the same day. The 103rd letter was received Mississippi-based Custom Vapes. The FDA states that the company did “manufacture, sell, and/or distribute to customers in the United States Custom Vapes Amaretto 3MG 3ML 70VG/30PG e-liquid product without a marketing authorization order.” The company is a registered manufacturer with over 2,300 products listed with the regulatory agency.
Unfortunately, the FDA often only lists a product or two that a company is selling as illegal. It then states that there may be more, but it is impossible to know if the warnings encompass all the company’s registered products.
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.
It is now at 102 in 2021. Posting on its website on April 30 that it has issued six more warning letters to companies for marketing illegal e-liquids, the U.S. Food and Drug Administration (FDA) continues its blitz to pull any vaping products from the U.S. market that haven’t submitted a premarket tobacco product application (PMTA) to the FDA’s Center for Tobacco Products.
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Unfortunately, the FDA often only lists a product or two that a company is selling as illegal. 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 companies receiving the letters on April 9, the products they were cited for and the number of products each has registered with the FDA include:
Smoking Fire Vapor: e-liquid products without a marketing authorization order including: Smokin’ Fire Vapor Captain Custard and Smokin’ Fire Vapor Wrecking Ball; registered manufacturer with over 180 products listed with FDA.
Simply E-Juice: e-liquid without a marketing authorization order including: Simply Bodacious Blueberry and Simply Glorious Grape; registered manufacturer with over 200 products listed with FDA.
Smokecignals: e-liquid products without a marketing authorization order including: Blue Puppet and Black Frost; registered manufacturer with over 100 products listed with FDA.
Rocky Top Vapor: e-liquid products without a marketing authorization order including: RTV LTD Berry Shake and RTV LTD Pink Lemonade; registered manufacturer with over 470 products listed with FDA.
VaporBombCOM: e-liquid products without a marketing authorization order including VaporBomb.com: Cafe Mocha and Cinnamon Danish Swirl; a registered manufacturer with over 2,200 listed with FDA.
B-X Vapor: e-liquid products without a marketing authorization order including: B-X Vapor Dad’s Milk and B-X Vapor Watermelon Crack; registered manufacturer with over 1,100 products listed with FDA.
The regulatory agency has now issued warning letters to 102 companies in 2021 for violating PMTA rules. 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.
In February, the director of the FDA’s Center for Tobacco Products, Mitch Zeller, said that there were over 400 million vaping-related products that required a PMTA in order to remain on the market. “These warning letters are the result of continued surveillance and internet monitoring for violations of tobacco laws and regulations. We want to make clear to all tobacco product manufacturers and retailers that the FDA is keeping a close watch on the marketplace and will hold companies accountable for breaking the law,” said Zeller.
Four more companies have received warning letters for violating marketing orders for the sale of e-liquids. The U.S. Food and Drug Administration (FDA) says the companies failed to submit a premarket tobacco product applications (PMTA) by the Sept. 9, 2020 deadline. The regulatory agency posted the letters to RP Vapor, DIY Vapor Supply, Electric Freedom (Crown7) and KV Liquids were received on April 23 and posted to the FDA website on April 27.
RP Vapor has over 4,600 products listed with the FDA. DIY Vapor Supply is the registered manufacturer for over 73,300 products listed with FDA. Electric Freedom has over 80 products listed with the FDA, while KV Liquids has more than 300. The FDA states that “the violations discussed in this letter do not necessarily constitute an exhaustive list” and companies should quickly address any products that violate the same rules as the product mentioned in the letter. This means that the company may or may not have submitted a PMTA for some of its registered products.
The regulatory agency has now issued warning letters to 96 companies in 2021 for violating PMTA rules. 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.
In February, the director of the FDA’s Center for Tobacco Products, Mitch Zeller, said that there were over 400 million vaping-related products that required a PMTA in order to remain on the market. “These warning letters are the result of continued surveillance and internet monitoring for violations of tobacco laws and regulations. We want to make clear to all tobacco product manufacturers and retailers that the FDA is keeping a close watch on the marketplace and will hold companies accountable for breaking the law,” said Zeller.
Beard Management announced that its premarket tobacco product application (PMTA) has advanced to the filing stage of the regulatory review process. Beard submitted 45 of its nicotine-based e-liquids to the U.S. Food and Drug Administration (FDA), including its The One and Beard Vape Co. brands. Blackbriar Regulatory Services (BRS), the company’s manufacturing partner and FDA agent of record, will be responsible for assisting Beard throughout the next steps of the FDA regulatory process.
“We are pleased to see our application moving through the PMTA process in order to scientifically demonstrate our products are appropriate for the protection of public health,” said Casey Bates, CFO at Beard, stated in a press release. “Partnering with BRS as our manufacturer gives us much broader access to a multitude of regulatory and scientific data that is critical to our ongoing PMTA work.”
BRS is providing Beard with cost-effective, turnkey solutions for manufacturing and regulatory needs, using a science-driven approach to testing for harmful and potentially harmful constituents, demonstrating good manufacturing practices, as well as providing additional analytical lab testing critical to the PMTA process, according to the release.
“We are very happy to be managing Beard’s PMTAs,” said Russ Rogers, CEO at BRS. “We have strong respect for the quality and brand marketing of their products, and we are confident that we can help Beard to achieve a marketing order from the FDA.”
The Artisan Vapor & CBD company announced that its premarket tobacco product application (PMTA) has been accepted by the U.S. Food and Drug Administration (FDA). The company submitted 39 e-liquid products, seven of which are nicotine salt blends, according to its website.
Credit: Artisan Vapor & CBD
The company announced in a press release that its research included in the submission offered “detailed scientific research demonstrating that their products are appropriate for adult use.” No specific date was given for when Artisan received its acceptance letter, only that the letter was received in April.
Founded in Texas in 2013, Artisan Vapor & CBD has grown to become one of the largest vapor retailers in the world, with more than 70 stores operating across three continents, according to its website. The company now waits for a filing letter from the FDA. Artisan’s application would then move on to the Substantive Review phase where the scientific data is analyzed.
The U.S. Food and Drug Administration (FDA) said it received thousands of premarket tobacco product application (PMTA) submissions covering millions of tobacco products, the majority of which came in very close to the Sept. 9, 2020 deadline. The submissions varied substantially in number of tobacco products contained in each submission, size, format and organization, including paper submissions and even hard drives and CDs, according to a press release.
