Tag: warning letters

More Warning Letters for Unauthorized Products

Photo: Adobe
On Dec. 13, the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) issued warning letters to 11 online retailers selling unauthorized e-cigarette products marketed under the brand names Lost Mary, Funky Republic/Funky Lands, Elf Bar/EB Design, Kangvape, Cali and Breeze. Warning letter recipients are given 15 working days to respond with the steps they’ll take to correct the violations discussed in the warning letter and to prevent future violations. Failure to promptly correct the violations can result in FDA enforcement actions such as an injunction, seizure and/or civil money penalties.
“It is illegal to sell, import, distribute or offer for sale or distribution to U.S. consumers any e-cigarette that has not been authorized by FDA,” said CTP Director Brian King in a statement. “The products identified in these warning letters are being marketed without the required authorization. We can issue, and have issued, warning letters for products for which an application has been submitted and is pending review. For unauthorized tobacco products, the pendency of an application does not create any sort of a safe harbor to sell that product.”
As of December 2023, the FDA has issued more than 400 warning letters to retailers for the sale of unauthorized e-cigarettes and filed civil money penalty complaints against more than 65 retailers and manufacturers for the manufacture or sale of unauthorized products.
To date, the FDA has authorized 23 e-cigarette devices and tobacco-flavored e-cigarette products.
December 14, 2023
FDA Sends More Warning Letters for Illegal Vapes

On Sept. 14, 2023, the U.S. Food and Drug Administration issued warning letters to 15 online retailers and three manufacturers and/or distributors for selling or distributing unauthorized e-cigarette products. Additionally, in one case, the retailer illegally sold a product to an underage purchaser. The warning letters cite a range of popular and youth-appealing e-cigarette products, including disposable products, marketed under the brand names Elf Bar, EB Design, Lava, Cali, Bang and Kangertech.
According to the FDA, the youth-appealing e-cigarette products of focus were identified through rapid surveillance and a data-driven approach to investigations. Retail sales data, emerging internal data from surveys of youth, as well as other data sources helped the agency to identify the rising popularity of these youth-appealing products, which were subsequently prioritized for investigation across the supply chain, from manufacturers to distributors to retailers.
“Given the rapidly evolving nature of the e-cigarette landscape, it’s essential that we have nimble surveillance tools that can best keep pace to protect public health,” said Brian King, director of the FDA’s Center for Tobacco Products. “They’re a critical component of our comprehensive surveillance toolbox, so that we can proactively identify and swiftly stave off emerging threats, particularly those affecting our nation’s youth.”
September 15, 2023
FDA Posts New Warning Letter Webinar for Retailers
The U.S. Food and Drug Administration has posted a new webinar to help online retailers respond to warning letters from regulatory agency’s Center for Tobacco Products (CTP).
The webinar provides an overview of warning letters and outlines the process for responding to a warning letter, such as corrective action taken by the firm to address any violations and its plan for maintaining compliance, according to an FDA release.
In the webinar, you will learn about:

FDA’s internet and publication surveillance of tobacco products
Examples of violations cited in warning letters sent to online tobacco product retailers
Actions to take after receiving a warning letter
Regulators in the United States began cracking down on online retailers selling vaping products that are attractive to youth. The Food and Drug Administration last week issued warning letters to 16 (the agency reported 15, but lists 16) online retailers for selling and/or distributing unauthorized e-cigarette products packaged to look like cartoon characters, school supplies, toys, and drinks.
August 30, 2023
U.S. FDA Cracking Down on Kid Friendly Products
Credit: FDA
Regulators in the United States are cracking down on online retailers selling vaping products that are attractive to youth. The Food and Drug Administration today issued warning letters to 16 (the agency reported 15, but lists 16) online retailers for selling and/or distributing unauthorized e-cigarette products packaged to look like cartoon characters, school supplies, toys, and drinks.
“The design of these products is a shamelessly egregious attempt to target kids,” said Brian King, director of FDA’s Center for Tobacco Products (CTP). “It’s a tough sell that adults using e-cigarettes to transition away from cigarettes need them to look like SpongeBob in order to do so successfully.”
The unauthorized products described in the warning letters include e-cigarettes that feature youth-appealing characters from TV shows, movies, and video games, including “SpongeBob,” “Lots-o’-Huggin’ Bear,” and “Mario.” The also imitate drinks from companies such as Starbucks and Dunkin coffee cups, soda and water bottles, according to press release.
“The retailers receiving these warning letters sell and/or distribute e-cigarettes in the United States that lack authorization from FDA, which is a requirement under the Federal Food, Drug, and Cosmetic (FD&C) Act to legally market a new tobacco product,” the FDA states. “In addition to the specified products mentioned in the warning letters, the retailers were warned to address any violations that are the same as or similar to those stated in the warning letter, and promptly take any necessary actions to bring the tobacco products that they offer for sale in the United States into compliance with the FD&C Act.”
The retailers were given 15 working days to respond with the steps they’ll take to correct the violation and to prevent future violations. Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalties.
“CTP will continue to closely monitor all those in the supply chain, including retailers, for compliance with federal law,” said attorney Ann Simoneau, director of the Office of Compliance and Enforcement within the CTP. “As always, we will hold anyone accountable that sells unauthorized tobacco products labeled, advertised, and/or designed to encourage use by our nation’s youth.”
The companies receiving warning letters include:

VR Products I LLC d/b/a eJuiceDB
Titan Star Resources d/b/a Vape Vandal Ltd
Vapesstores.com
Disposable Vapes Wholesale
Vapestore.to
Venture Concept Groups d/b/a High Light Vape Co.
Best Vapes Store
Apex Vape
The Juice Machine
StrikesUSA
Finest Ounce Vape Stor d/b/a Finest Ounce Vape Malaysia
Spongbob Vape
Mini Cup Vape
Vape123
Viper Vapor d/b/a Viper Vapor Kelso
Mochivap
These new warning letters mark another step in the FDA’s continued efforts to remove illegal e-cigarettes from the market, particularly those that appeal to youth, the agency states. As of August 2023, the FDA has issued approximately 600 warning letters to firms for manufacturing and/or distributing illegal tobacco products, including e-cigarettes, filed civil money penalty complaints against 26 e-cigarette manufacturers, and worked with the Department of Justice to seek injunctions against 6 e-cigarette manufacturers.
August 23, 2023
U.S. FDA Warns Retailers for Elf Bar, Esco Bar Sales

Credit: Pastel Cartel
The U.S. Food and Drug Administration is continuing its crackdown on illegal disposable vape devices. The regulatory agency has issued warning letters to 189 retailers for selling unauthorized tobacco products, specifically Elf Bar and Esco Bars brands.
“The FDA is prepared to use all of its authorities to ensure these, and other illegal and youth-appealing products, stay out of the hands of kids,” said FDA Commissioner Robert M. Califf. “We are committed to a multipronged approach using regulation, compliance and enforcement action and education to protect our nation’s youth.”
The warning letters are the result of a nationwide retailer inspection blitz over the past several weeks cracking down on the sale of these unauthorized e-cigarettes.
The FDA continuously monitors the marketplace and took these actions as emerging marketplace data led to concerns over their appeal and risks to young people, according to an FDA release. More specifically, the agency’s ongoing surveillance efforts helped FDA identify Elf Bar and Esco Bars as being among the most popular brands in the United States and having high youth appeal.
“All players in the supply chain—including retailers—have a role in keeping illegal e-cigarettes off the shelves,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “This latest blitz should be a wake-up call for retailers of Elf Bar and Esco Bars products nationwide. If they’re waiting for a personal invitation to comply with the law, they might just get it in the form of a warning letter or other action from the FDA.”
Last month, the FDA issued import alerts for all products under both the Elf Bar and Esco Bars brands. An import alert places these tobacco products on the red list, which makes them subject to Detention Without Physical Examination and allows the FDA to detain a product without physically examining it at the time of entry.
Elf Bar and Esco Bars products do not have the required marketing authorization from the FDA.
June 23, 2023
U.S. FDA Webinar Outlines Warning Letter Response
Credit: Marcus Krauss
The U.S. Food and Drug Administration has posted a new webinar to help manufacturers and vape shop owners respond to warning letters from the agency’s Center for Tobacco Products (CTP).
The webinar outlines the appropriate items for a response to a warning letter, which should be received by FDA within 15 business days. The webinar also includes an explanation of proper documentation concerning corrective actions that entities have taken.
In the webinar, participants will learn about:

Preparation for a response to CTP

Important items to include in a response

Additional compliance resources
March 7, 2023
Connecticut AG Sues 5 Companies for Delta-8 Sales

Credit: Andy Dean
The Attorney General in Connecticut is suing five retailers for some of the most “egregious violations” related to the illegal sale of delta-8 products.
Attorney General William Tong filed the suits for alleged violations of the Connecticut Unfair Trade Practices Act over the sale of illegal delta-8 THC products mimicking popular youth-oriented snacks and candies.
Tong is additionally in the process of sending warning letters to all Connecticut-licensed retailers of electronic vaping products, according to a statement from Tong’s office.

The letters advise that sale of delta-8 THC by unlicensed retailers may be illegal in Connecticut. Products that exceed .3 percent THC on a dry weight are considered cannabis products and may only be sold in the regulated market.
Cannabis products sold outside of the regulated market continue to be illegal and may subject sellers to civil and criminal penalties.

“If you offer delta-8 THC products for sale in your establishment that exceed .3 percent THC on a dry weight basis and you do not hold such a license, you are in violation of Connecticut law,” Tong states. “For your information, we have included below photographs of products that were recently purchased from retailers in Connecticut that purport to contain delta-8 THC.
“The sale of such products may expose you to criminal and civil liability. Please remove any such products from your shelves and dispose of them immediately.”
Cannabis products in Connecticut cannot be sold by unlicensed retailers and must meet rigorous testing and packaging requirements.
Tong also recently submitted testimony concerning House Bill 6488 stating that he fully supports the state’s proposed ban on flavored vaping and other tobacco products.

February 10, 2023
FDA Warns 5 Vapor Businesses for Illegal Marketing

The U.S Food and Drug Administration issued warning letters to five firms on Wednesday for the illegal marketing of 15 different e-cigarette products.
The letters were issued to Wizman Limited doing business as Wizvapor, Shenzhen Fumot Technology Co., doing business as R and M Vapes, Shenzhen Quawins Technology Co., Ruthless Vapor and Moti Global.
According to the FDA, all 15 products are packaged to resemble toys, food or cartoon characters.
“The designs of these products are an utterly flagrant attempt to target kids,” said Brian King, director of the FDA’s Center for Tobacco Products. “It’s a hard sell to suggest that adults using e-cigarettes with the goal of quitting smoking need a cartoon character emblazoned across the front of the product in order to do so successfully.”
None of the manufactures have submitted a premarket tobacco product application (PMTA) for the unauthorized products. The items described in the warning letter include e-cigarettes that are designed to look glow sticks, walkie talkies and Nintendo Game Boy game systems.
“The FDA is committed to keeping tobacco products out of the hands of our nation’s youth,” said King. “The agency will continue to hold companies accountable for illegally selling e-cigarettes, particularly those that shamelessly target youth.”
Additionally, the products feature characters from cartoons and media that are aimed at a youth and/or teen demographic including The Simpsons, Family Guy, Squid Game, Rick and Morty, Minions and Baby Bus, as well as imitate youth appealing foods such as popsicles.
Last month, the U.S. Department of Justice (DOJ) filed complaints for permanent injunctions in federal district courts against six e-cigarette manufacturers on behalf of the FDA. The cases represent the first time the FDA has initiated injunction proceedings to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act’s premarket review requirements for new tobacco products.
The FDA states that each of the defendants failed to submit PMTAs for their e-cigarettes and have continued to illegally manufacture, sell, and distribute their products, despite previous warning from the FDA that they were in violation of the law.
November 17, 2022
First Warning Letters for Synthetic Nicotine Products

Photo: 103tnn
The U.S. Food and Drug Administration on July 13 sent its first warning letters to manufacturers for unlawfully marketing non-tobacco nicotine e-liquid products without the required authorization.
In March, President Joe Biden signed into law a spending bill [the Act] that gives the FDA authority over synthetic nicotine. The provision took effect in April and gave manufacturers until May 14, 2022, to submit premarket tobacco product applications (PMTAs) to the FDA.
Products that did not receive marketing authorization by July 13, 2022, are considered illegal and must be removed from the market.
Since no authorizations have been granted as of today, many industry experts question whether the FDA will use its enforcement discretion to continue reviewing PMTAs.
In a recent op-ed, Tony Abboud, president for Strategic Government Solutions, and executive director of the Vapor Technology Association (VTA), stated that the FDA should use its enforcement discretion for synthetic products that have submitted PMTAs.
“In a series of direct engagements with FDA since the passage, the VTA has provided a complete set of scientific and policy justifications for synthetic nicotine products, and specific recommendations on how FDA should use its enforcement discretion – just as it has in the past – to allow synthetic nicotine products to remain on the market during the PMTA review process,” explained Abboud.
The recipients of the FDA’s first warnings letters, AZ Swagg Sauce and Electric Smoke Vapor House, have listed a combined total of approximately 10,000 products with FDA. Neither company submitted a premarket application for its non-tobacco nicotine products by the deadline, according to the FDA.
In addition, the FDA issued 107 warning letters to retailers in the last two weeks for illegally selling non-tobacco nicotine products, including certain e-cigarette or e-liquid products, to underage purchasers.
“FDA has been fully committed to actively implementing this critical new law regulating non-tobacco nicotine products since its passage, and the warning letters announced today are just the beginning of our compliance and enforcement actions” said Brian King, director of the FDA’s Center for Tobacco Products, in a statement. “In the coming weeks, we will continue to investigate companies that may be marketing, selling, or distributing non-tobacco nicotine products illegally and will pursue action, as appropriate.”
The FDA says it is currently processing applications for approximately 1 million non-tobacco nicotine products submitted by more than 200 manufacturers by the May 14, 2022, deadline.
“FDA is working diligently to process the substantial number of applications submitted and, as always, will make marketing decisions based on the best available science and will pursue compliance and enforcement actions when warranted,” said King. “We remain fully committed to taking whatever steps are necessary to protect the public health and to provide timely updates on our ongoing progress regulating non-tobacco nicotine products.”
July 14, 2022
US FDA Warns Four for Illegally Selling CBD Products
Credit: Anankkml
The U.S. Food and Drug Administration (FDA) yesterday issued warning letters to four companies illegally selling unapproved animal drugs containing cannabidiol (CBD) that are intended for use in food-producing animals. The companies include Haniel Concepts dba Free State Oils, Hope Botanicals, Plantacea LLC dba Kahm CBD and Kingdom Harvest.
“While the FDA does not know the current extent of CBD use in food-producing animals, the agency is taking steps regarding these unapproved and potentially unsafe products now to help protect animals and the safety of the food supply,” a press release states. “After a food-producing animal is treated with a drug, residues of that drug may be present in the milk, eggs, or meat if the animal is milked, eggs are collected, or the animal is sent to slaughter before the drug is completely out of its system.”
The FDA has not approved any human or animal products containing CBD other than one prescription drug product to treat rare, severe forms of epilepsy in children. The regulatory agency states all other CBD products intended for use as a drug (i.e. making medical claims) are considered unapproved drugs and are illegal to sell.
Some of the claims made by the companies in the warning letters refer to helping “farm animals with stress, anxiety, pain, inflammation, injuries…” and providing “support to help manage normal stress, promote a calming effect, maintain a healthy gut, maintain a normal and balanced behavior, maintain healthy joints, maintain a normal inflammatory response….” These claims, among others, establish the intended use of the products as drugs, according to FDA.
The FDA has requested responses from the companies within 15 working days stating how they will address these violations and prevent their recurrence. Failure to promptly address the violations may result in legal action, including product seizure and/or injunction.
May 27, 2022