Tag: warning letters

The Smoker’s Alternative Receives FDA Warning No. 104
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.
May 11, 2021
FDA Issues 103rd PMTA Warning to Custom Vapes
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.
Credit: Marcus Krauss
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.
May 7, 2021
FDA: 102 Warnings for Illegal E-liquid Sales so Far in 2021
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.
Credit: Yuri Hoyda
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.
May 3, 2021
FDA Issues 2 More Warning Letters for Lack of PMTAs
The U.S. Food and Drug Administration (FDA) issued warning letters to two more e-liquid manufacturers for violating the agency’s marketing rules. Nice Guys Distributing and Lucky’s Vape Lounge received the letters and posted them to the FDA website on Thursday and Friday, respectively. The regulatory agency has issued 92 warning letters for illegal e-liquids in 2021, so far.
Credit: Bitcoin ATM Map

Nice Guys was warned for its “Mr. Nice Guy’s E-Juice Etc. 2 Pussy Cat e-liquid,” according to the FDA and has more than 600 products listed with the FDA. Lucky’s Vape :Lounge was cited for selling “Lucky’s VapeWaterpop 6 e-liquid product” and has more than 16,000 products with the FDA. It is impossible to know if more than the mentioned products that received the warning letters violate the FDA’s premarket tobacco product application (PMTA) rules.
The FDA states that the companies failed to submit PMTAs by the required Sept. 9, 2020 deadline. The FDA also 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.
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.
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.
April 16, 2021
FDA Issues 6 More Warnings for Vapor Marketing Violations
The U.S. Food and Drug Administration (FDA) has issued 6 more warning letters to vapor companies for failing to submit a premarket tobacco product application. Oregon Vapor, Northwest Vapors, Legend Vapor, Flavor Concepts, Hi Lyfe Vapors and LJ’s E-Smokes all received letters and April 9 and the FDA posted the letters on its website on April 13.
Today’s postings bring the total number of warning letters issued by the FDA to vapor companies for violating marketing rules to 90 this year. Oregon Vapor has 100 products listed with the FDA, Northwest Vapor has 4,400 and Legend Vapor has 2,500, according to the FDA. Flavor Concepts has 300 products listed, Hi Lyfe Vapors has 100 and LJ’s E-Smokes has 280 products registered with the regulatory agency.
The FDA states that the companies failed to submit PMTAs by the required Sept. 9, 2020 deadline. The FDA also 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.
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.
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.
Vapor Voice and TMA have created a PMTA tracking tool to help find legal vaping products.
April 13, 2021
Str8Vape and Xtreme Vapour Receive FDA Warning Letters
The U.S. Food and Drug Administration (FDA) handed down two more warning letters for vapor companies violating marketing rules for tobacco products on Thursday. Str8Vape and Extreme Vapour received letters for selling products without submitting a premarket tobacco product applications (PMTA) to the regulatory agency by the Sept. 9, 2020 deadline.
The total number of warning letters for the illegal sale of vapor products now stands at 84 in 2021. The letters were posted on the FDA’s website on April 8, the same day the businesses received the warnings.
The FDA states that is had determined that Extreme Vapour did “manufacture, sell, and/or distribute to customers in the United States the following Xtreme Vapour Babylon Vape Juice Pineapple 30ml e-liquid product without a marketing authorization order.” The company manufacturers over 80 products registered with FDA.
The FDA states that is has determined Str8Vape did “manufacture, sell, and/or distribute to customers in the United States the following STR8VAPE AMERICAN BLEND 3mg 70VG/30PG 30ML e-liquid product without a marketing authorization order.” The company is a registered manufacturer with over 27,400 products listed with FDA.
The FDA states that the companies failed to submit PMTAs by the required Sept. 9, 2020 deadline. The FDA also 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.
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.
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.
April 9, 2021
Vapor Products Total 46% of All 2021 FDA Warning Letters
In the first quarter of 2021, from Jan. 1 to March 31, the U.S. Food and Drug Administration (FDA) issued and posted a total of 166 warning letters. Compared to the same time period in 2020, only 97 total warning letters were issued. In 2020, the 139 letters issued by the Center for Tobacco Products comprised 22 percent of all warning letters issued by the FDA.
Credit: FDA
In the first quarter of this year, 80 of the 166 letters [that number is now 82], or 46 percent of warning letters, were related to tobacco products. The vast majority of products at issue were e-cigarette or e-liquid products that violated the FDA’s requirements for premarket approval before sale in the U.S.
In virtually every warning letter for a tobacco product issued during the period under consideration, the FDA cited the manufacturer because their e-liquid products were considered new tobacco products, and had not submitted a premarket tobacco product application (PMTA), and were not subject to an exemption from the rule, according to Katie Insogna, an analyst with law360.com.
As a result, the products were considered adulterated under Section 902(6)(A) of the Food, Drug and Cosmetics Act (FDCA). The agency also flagged many of these products for being misbranded under Section 903(a)(6) of the FDCA, because a notice or other information respecting these products were not provided as required by Section 905(j) of the FDCA.
Manufacturers are responsible for ensuring their tobacco products and all related labeling and/or advertising — including on websites, social media and search engines — comply with each applicable provision of the FDCA and the FDA’s implementing regulations. In many of the recent warning letters, the agency acknowledges that the recipient is a registered manufacturer with thousands of products already listed with the FDA.
As is customary in the case of most FDA warning letters, the agency has typically provided 15 working days for companies respond. Failure to address any violations may lead to regulatory action — including, but not limited to, civil money penalties, seizure and/or injunction. Because many of these companies already maintain authorizations for other tobacco products, they run the risk of additional regulatory scrutiny and negative action when they are flagged for selling unauthorized products, writes Insogna.
Many of the FDA’s warning letters centered on Covid-19-related products making false claims. Like Covid-19-related products, tobacco products — especially vaping products — are receiving exceptional regulatory scrutiny. Companies marketing products in both of these categories should be particularly cautious of applicable federal regulations, to avoid negative action.
April 9, 2021
FDA Issues 3 More Warning Letters for Illegal E-liquids
The total is now 73 in 2021. The U.S. Food and Drug Administration (FDA) issued four more warning letters for marketing illegal vapor products. Morin Enterprises Inc. d/b/a Ecig Crib, Nicoticket LLC, Bouji Moj Oyeeb, Inc. d/b/a MasterMix E-Liquid all received letters on on March 26 and those letters were posted to the FDA’s website today, March 30.
Credit: Sandy Millar
The FDA states that a review of the ecigcrib.com website revealed that the company “manufacture and offer for sale or distribution to customers in the United States e-liquid products without a marketing authorization order “including: E Cig Crib – Planet of the Grapes E Liquid and E Cig Crib – Cotton Candy E Liquid.” Nicoticket’s letter states the website “nicoticket.com revealed that you manufacture and offer for sale or distribution to customers in the United States e-liquid products without a marketing authorization order including: Nicoticket Wakonda and Nicoticket The Virus.” Bouji’s letter states that a review of “mastermixeliquid.com revealed that you manufacture and offer for sale or distribution to customers in the United States e-liquid products without a marketing authorization order including: MasterMix E-Liquid – Mango and MasterMix E-Liquid – Maraschino Cherry.”
The FDA also 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. “Your firm is a registered manufacturer with 1,433 products listed with FDA. 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,” the letter states.
Bouji has over 31,500 products listed with FDA. Nicoticket is a registered manufacturer with over 6,800 products listed with FDA and E-cig Crib is a registered manufacturer with over 4,700 products listed with FDA.
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.
March 30, 2021
No. 70: The FDA Issues Vintage Vapors PMTA Warning Letter
The U.S. Food and Drug Administration (FDA) issued its 70th warning letter this year to a company the regulatory agency says is violating marketing rules. Vintage Vapors received the letter on March 22 and the FDA posted the information on its website on March 25.
The FDA states that it determined the company did “manufacture, sell, and/or distribute to customers in the United States Vintage Vapors Unflavored Tobacco 03MG 30/70 e-liquid product without a marketing authorization order.” Premarket tobacco product applications (PMTA) were due to be submitted to the FDA by Sept. 9, 2020.
The FDA also 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. “Your firm is a registered manufacturer with 1,433 products listed with FDA. 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,” the letter states.
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.
March 28, 2021
U.S. FDA Sends 10 Warning Letters for Targeting Youth
Today, the U.S. Food and Drug Administration (FDA) issued 10 warning letters to retailers and manufacturers who sell, manufacture and/or import unauthorized electronic nicotine delivery system (ENDS) products targeted to youth or likely to promote use by youth.
The warning letters were sent to establishments marketing unauthorized products, such as a backpack and sweatshirt designed with stealth pockets to hold and conceal an e-cigarette, ENDS products that resemble smartwatches, or devices appearing as children’s toys such as a portable video game system or fidget spinner.
Warning letters were also issued to companies marketing e-liquids that imitate packaging for food products that often are marketed and appeal to youth, such as candy, or feature cartoon characters like SpongeBob SquarePants.
“The FDA is focused on manufacturers and retailers that make and sell ENDS products that are targeted to youth and increase their appeal. The public should really be outraged by these products. The FDA is especially disturbed by some of these new products being marketed to children and teens by promoting the ease with which they can be used to conceal product use, which appeals to kids because it allows them to conceal tobacco product use from parents, teachers, law enforcement or other adults,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “Even in the midst of the COVID-19 pandemic, we have not lost our focus on protecting youth against the dangers of e-cigarettes and will do everything we can to take action. These warning letters should send a clear message to all tobacco product manufacturers and retailers that the FDA is keeping a close watch on the marketplace. If you’re marketing or selling these products to youth, the FDA will not tolerate it.”
The following retailers and/or manufacturers or importers received a warning letter:
Vaprwear Gear, LLC (manufacturer, online retailer)
Vapewear, LLC (manufacturer, online retailer)
Wizman Limited (manufacturer, online retailer)
EightCig, LLC (online retailer)
Ejuicepack, LLC (online retailer)
Vape Royalty, LLC (online retailer)
VapeCentric, Inc. (online retailer)
Dukhan Store (online retailer)
VapeSourcing (online retailer)
Shenzhen Uwell Technology Co., Ltd. d/b/a DTD Distribution Inc. (importer, retailer)
The FDA has also issued warning letters to 73 brick-and-mortar retailers for selling unauthorized flavored, cartridge-based ENDS products. This follows 22 warning letters that FDA issued last month for similar violations to online and brick-and-mortar retailers and manufacturers across the country. These warning letters are part of a series of ongoing actions consistent with the FDA’s recently issued policy of enforcement priorities for e-cigarettes and other deemed products on the market.
April 27, 2020