Tag: FDA

DOJ Injunction Filed Against Vape Junkie for Illicit Vapes

Credit: Egokhan
The U.S. Department of Justice (DOJ) today filed a complaint for a permanent injunction against Jessica M. Fitzgerald and Michelle L. Allen doing business as Vape Junkie Ejuice (Vape Junkie Ejuice) for “manufacturing, selling, and distributing unauthorized e-cigarette” products.
The injunction was filed on behalf of the U.S. Food and Drug Administration.
The move represents the seventh time FDA has initiated injunction proceedings to enforce the Federal Food, Drug, and Cosmetic Act’s (FD&C Act) premarket tobacco product review requirements for new tobacco products.
The FDA previously warned Vape Junkie Ejuice that they were in violation of the FD&C Act’s premarket review requirements for new tobacco products by manufacturing, selling, and distributing new tobacco products without first obtaining marketing authorization from FDA, according to the FDA.
The agency’s warning noted that continued violations could lead to further action, including an injunction. However, Vape Junkie Ejuice continued to manufacture, sell, and distribute unauthorized e-cigarette products to consumers, according to the FDA.
“FDA has been abundantly clear that we will not stand by as bad actors choose to blatantly disregard the law, especially after being duly warned. This manufacturer continued to break the law, and that behavior has consequences.”
Brian King, director of the FDA’s Center for Tobacco Products (CTP)
DOJ institutes judicial enforcement actions under the FD&C Act in court. DOJ filed the injunction complaint on behalf of the FDA against Vape Junkie Ejuice in the Middle District of Florida, the manufacturer’s respective U.S. District Court.
If the injunction is handed down, it would require Vape Junkie Ejuice to stop manufacturing, selling, and distributing their e-liquids. The injunction would also require the manufacturer to obtain marketing authorization from the FDA before marketing such products.
“Today’s injunction action should be a clear reminder to all manufacturers: If you continue to sell illegal products, we are equipped to use the full force of the law. FDA is committed to working with federal partners, including the Department of Justice, to enforce the law.”
Ann Simoneau, director of CTP’s Office of Compliance and Enforcement.
Today’s action is part of the FDA’s comprehensive approach to enforcing the law, according to the agency. Within the past year, the FDA has acted against manufacturers, distributors, importers, and retailers of illegal e-cigarette products.
As of Nov. 2023, the FDA has issued approximately 640 warning letters to firms for manufacturing and/or distributing illegal e-cigarette products and devices, issued more than 400 warning letters to retailers for the sale of unauthorized e-cigarettes, filed civil money penalty complaints against 36 e-cigarette manufacturers and 42 retailers for manufacture and/or sale of unauthorized products.
December 4, 2023
Bidi Vapor Calls for Removal of Non-Compliant Vapes

Credit: Iama Sing
During a recent webcast, Bidi Vapor leadership called on the U.S. Food and Drug Administration to do more to stop the flood of non-compliant vaping products from entering the market.
In a recently produced webcast, “Vape Update: Getting Noncompliant Devices Off the Market,” Bidi Vapor executives detailed current enforcement activities the agency has been ramping up throughout the industry and touched on potential solutions, such as tracking scan data to identify unlawful companies.
“It’s a major public health concern when these illicit, noncompliant and non-regulated products are overtaking the legal products,” said Niraj Patel, CEO of Bidi Vapor. “These illegal products used to be in just mom-and-pop stores, but now, these products are breaking into the franchise market, and showing up in the Nielsen numbers. But this list also puts pressure on the FDA and all other law enforcement agencies to do their jobs.”
Data from Nielsen, a New York-based data-collection firm, has the ability to provide the information needed to make a larger impact on the illicit market, according to Russell Quick, president of Bidi Vapor’s marketing firm, Kaival Marketing Services, reports CStoreDecisions.
Photo: Kaival Brands Innovations Group
“Law enforcement can now track the supply chain,” Quick said in the webcast. “We can identify the distributors and retailers that are selling these non-compliant, illegal, illicit products. So both federal and state level authorities can issue warnings, fines, civil penalties or even harsher monetary penalties to these companies that are participating in and distributing these illegal products.”
Bidi Vapor also produced two related infographics on illicit vape products and the illicit market to accompany the webcast. To download the graphics: “How to Spot Illicit Vape” and “Rise of Illicit Vape.”
The full webcast can be found here.
November 30, 2023
Report Finds Herbal Heated Sticks Market ‘On Fire’

Photo: cirquedesprit
Herbal heated sticks are rapidly spreading worldwide not only as a replacement for conventional smoking, but also as an alternative to heated tobacco products, according to new research from TobaccoIntelligence.
These products provide an experience similar to using heated tobacco, but unlike heated tobacco products they do not contain any tobacco. Instead, they use a different substance—often tea—to hold flavorings and, sometimes, nicotine.
Now, the new TobaccoIntelligence Herbal Heated Sticks Tracker casts light on this fast-growing but poorly understood market.
It reveals that fruit flavors are the most popular in most countries covered, but nicotine strengths vary greatly. In some countries, such as Japan, only zero-nicotine products are sold.
“Heated herbal sticks are typically cheaper than comparable tobacco products, and are also compatible with some heated tobacco devices. So from the consumer’s point of view, they offer a low-cost alternative—while for manufacturers, they can provide a legal way of providing flavors in countries where heated tobacco flavors are banned,” explains Eva Antal, director of market analysis at TobaccoIntelligence’s publisher Tamarind Intelligence.
“We expect more product launches in more countries–but at the same time, we don’t expect regulators to ignore them forever,” says Antal.
Currently, Japan and Poland have the most products available, although there are far more different brands in Japan.
And Japan is also among the countries where these products are cheapest. By contrast, Germany is the most expensive.
The Herbal Heated Sticks Tracker covers nine major markets: the Czech Republic, Germany, Hungary, Japan, Malaysia, the Philippines, Poland, Russia and the U.K.
November 29, 2023
ElfBar, Lost Mary Sales Boost Supreme’s Profits

Credit: JIRSAK
ElfBar and LostMary could be the ones to thank for Supreme’s favorable six months as the firm rings in the half-year mark with record revenues and profit growth.
The ElfBar distribution alone contributed to £26.4 million ($33.3 million) of its £64.6 million revenue in the period, Supreme said today, alongside “strong organic growth” of £8.7 million in areas such as lighting, vaping, nutrition and wellness.
Gross profits for the firm are up 63 percent, from £18.2 million to £28.5 million, according to media reports.
The numbers come after the firm was chosen this summer as the master distributor for two leading UK vaping brands, ElfBar and Lost Mary, which it has begun to supply to major UK retailers such as Tesco, Morrisons and WHSmith Travel.
The London-listed company said at the time it expected the partnership to generate revenues of £25 million to £30 million over the next fiscal year ending March 2024.
In just four months since the partnership was announced, it’s reached over double the goal.
November 28, 2023
FDA Continues Crackdown on Youth Appealing Vapes
Credit: iCheer
Today, the U.S. Food and Drug Administration issued warning letters to seven online retailers for selling and/or distributing unauthorized e-cigarettes.
The unauthorized e-cigarettes are packaged to look like youth-appealing toys and drink containers, including milk cartons, soft drink bottles, and slushies. The products’ design may also help youth conceal the e-cigarettes from adults or be confused with an everyday object and the contents accidentally ingested by young children, according to the agency.
“As we continue into the school year, it’s critical that parents, teachers, and other adults are aware of illegal e-cigarettes deceptively packaged to look like everyday items,” said Brian King, director of FDA’s Center for Tobacco Products (CTP). “These types of products can be easily concealed and contain nicotine, which is highly addictive and can harm the developing adolescent brain.”
The unauthorized products described in the warning letters issued today include e-cigarettes that:

Imitate drink containers for youth-appealing drinks such as milk, soft drinks, and slushies.
Are designed to look like youth-appealing toys such as dice, phones, and action figures.
“FDA uses a variety of surveillance tools to monitor the rapidly evolving e-cigarette landscape and to identify emerging threats to public health,” said Ann Simoneau, director of the Office of Compliance and Enforcement within the CTP. “We use data from these tools to help prioritize investigations of youth-appealing products across the supply chain to ensure illegal products stay off the shelves.”
The retailers receiving these warning letters sell and/or distribute e-cigarettes in the United States that lack authorization from the FDA, which is a requirement under the Federal Food, Drug, and Cosmetic (FD&C) Act to legally market a new tobacco product.
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 seven retailers issued warning letters were given 15 working days to respond with the steps they will take to correct any violations 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.
Today’s warning letters are the latest in a series of FDA’s efforts across the supply chain to address illegal e-cigarettes that appeal to youth.
As of November 2023, FDA has issued approximately 630 warning letters to firms for manufacturing and/or distributing illegal e-cigarette products and devices, issued more than 400 warning letters to retailers for the sale of unauthorized e-cigarettes, filed civil money penalty complaints against 35 e-cigarette manufacturers and 42 retailers for manufacture or sale of unauthorized products, and worked with the Department of Justice to seek injunctions against 6 manufacturers of unauthorized e-cigarettes.
November 16, 2023
Kaival Brands: Scan Data Key to Beating Back Black Market

At a conference of administrators, attorneys, and businesspeople on tobacco regulation, Russell Quick, president of Kaival Marketing Services, said regulatory agencies can use the same data in a recently published ranking of disposable vape devices as a “roadmap” to identifying companies marketing illegal vaping products.
Quick, whose company markets the Bidi Stick brand of electronic nicotine delivery system (ENDS), spoke at the Tobacco and Nicotine Products Regulation and Policy Conference sponsored by the Food and Drug Law Institute (FDLI) in Washington, D.C.
He said a ranking from New York-based Nielsen shows 10 of the 11 named disposable ENDS were not compliant with the U.S. Food and Drug Administration’s regulatory processes, according to a press release.
Thirty-four companies were named in a lawsuit filed in October by Altria subsidiary NJOY over non-compliant products.
“Scan data now is at our fingertips … and you can literally pull this data to see which retailers are selling which non-compliant product and which wholesalers are distributing [these products] — that’s one good way to revolutionize vape enforcement,” Quick told the roughly 200 attendees during a panel discussion. “What’s really hurting the industry are illegal, non-compliant bad actors in the U.S. vaping market undermining the potential of e-cigarettes to help adult smokers quit.”
Quick said that if law enforcement agencies started using scan data to call out illegal activity, the vaping industry could ultimately regulate itself. “Most major stakeholders already follow the rules,” Quick said, “but non-compliant companies take a major share of the market.”
For its part, Bidi Vapor submitted premarket tobacco product applications (PMTAs) to the FDA for all 11 of its flavored devices, which are currently under scientific review.
During the PMTA evaluation period, Bidi Vapor can market its Bidi Stick products, subject to FDA enforcement discretion.
November 14, 2023
Attorney General of Virginia Pens Letter to U.S. FDA

Credit: RawF8
Virginia Attorney General Jason Miyares sent a letter to the U.S. Food and Drug Administration commissioner asking for increased regulation of illegal electronic nicotine delivery systems (ENDS) products.
Miyares emphasizes that despite efforts to curtail underage access to vaping and e-cigarette products, there is no centralized enforcement mechanism or license to hold shops accountable.
Additionally, many illegal knock-off ENDS products are being brought into the country from China and pose the risk of being laced with fentanyl, Miyares claims. He says the FDA must focus on bolstering enforcement and regulation to mitigate the possible risks associated with youth-targeted products.
The letter states that “the Associated Press recently advanced the opinion that the influx of illegal disposable ENDS products are due to ‘the Food and Drug Administration’s inability to control the tumultuous vaping market more than three years after declaring a crackdown on kid-friendly flavors.’”
November 12, 2023
U.S. FDA Warns Online Retailers for Illegal Vape Sales

The U.S. Food and Drug Administration issued warning letters to seven online retailers for selling unauthorized vaping and e-cigarette products.
According to a press release, the warning letters cite the sale of “popular and youth-appealing” disposable products marketed under the brand names Elf Bar, EB Design, Bang, Cali Bars, and Lava.
The warning letters were aided by FDA’s ongoing monitoring of multiple surveillance systems to identify products that are popular among youth or have youth appeal, the agency states.
Findings released last week from the 2023 National Youth Tobacco Survey found that more than half of current youth e-cigarette users reported using the disposable e-cigarette brand Elf Bar; earlier this year, the manufacturer of Elf Bar began marketing the product under the name “EB Design.”
In addition, the brands Bang, Cali Bars, and Lava were identified as popular or youth appealing by the agency following a review of retail sales data and emerging internal data from a survey among youth, according to the agency.
“FDA’s robust surveillance of the e-cigarette landscape helps us to identify youth-appealing products and to act quickly to protect public health,” said Brian King, director of FDA’s Center for Tobacco Products (CTP). “The goal is to identify, prevent, and reduce these risks to our nation’s youth before they escalate further.”
The retailers receiving warning letters sold or distributed e-cigarette products in the United States that lack authorization from FDA, in violation of the Federal Food, Drug, and Cosmetic Act, according to the agency.
Warning letter recipients are 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.
In the past year, the FDA has issued more than 400 warning letters to retailers for the sale of illegal e-cigarettes, including through a series of nationwide inspection efforts of brick-and-mortar retailers that resulted in civil money penalties issued to more than 40 retailers nationwide for the highest amount levied to date.
“CTP will continue to closely monitor all those in the supply chain, including retailers, for compliance with federal law,” said Ann Simoneau, director of the Office of Compliance and Enforcement within CTP. “As always, we will hold anyone accountable who sells unauthorized e-cigarettes labeled, advertised, and/or designed to encourage youth use.”
The FDA has authorized 23 tobacco-flavored e-cigarette products and devices.
November 9, 2023
FDA Warns Nic Nac Naturals for Illegal Flavored ‘Nicotine Mints’

The U.S. Food and Drug Administration issued a warning letter to Nic Nac Naturals for the marketing of their unauthorized dissolvable nicotine products, which the company describes as “nicotine mints” and which resemble a pack of mints. These products are of particular concern because of their resemblance to popular candies and the potential to cause severe nicotine toxicity or even death if accidentally ingested by young children, according to the FDA.
“FDA remains steadfast in our commitment to actively monitor the marketplace and to crack down on companies selling unlawful products, particularly those that can appeal to youth,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “Our goal is to identify and prevent these emerging threats to our nation’s youth before they become mainstream.”
The manufacturer markets these tobacco products in a variety of mint and fruit flavors, all of which come in two nicotine strengths (3 mg or 6 mg). The packaging states the products contain nontobacco nicotine. The FDA regulates tobacco products containing nicotine from any source, including nontobacco nicotine. Nic Nac Naturals does not have a marketing authorization order from the agency to sell or distribute these products in the U.S.
One container of 15 of these mints can have as much as 90 mg of nicotine total. According to research, the FDA stated, ingesting 1 mg to 4 mg of nicotine could be toxic or severely toxic to a child under 6 years old, depending on body weight. This means ingesting one mint could be severely toxic to a child under 6 years old. Nicotine toxicity among youth of any age can lead to nausea, vomiting, abdominal pain, increased blood pressure and heart rate, seizures, respiratory failure, coma and even death. The FDA also stated that nicotine is highly addictive and exposure during adolescence can harm the developing brain.
“Today’s action is another example of our ongoing efforts against illegal nontobacco nicotine products,” said Ann Simoneau, director of the CTP’s Office of Compliance and Enforcement. “We remain unwavering in our use of compliance and enforcement resources to curb unlawful marketing of tobacco products, particularly those that youth could easily confuse with something that they consume regularly—like candy.”
The company has 15 working days to respond to the FDA with steps they will take to correct and prevent future violations. Failure to respond and correct violations may result in addition FDA action, such as an injunction, seizure and/or civil money penalties.
November 7, 2023
Vaping Down Among U.S. High School Students

Photo: Daisy Daisy
One in 10 U.S. middle and high school students reported using of any type of tobacco, according to data from the 2023 National Youth Tobacco Survey (NYST) that were collected between March and June 2023 and released today.
Among U.S. high school students, current overall tobacco product use declined during 2022-2023 from 16.5 percent to 12.6 percent, a development attributed primarily to reduced e-cigarette use, which dropped from 14.1 percent to 10 percent. Among high school students, declines in current use were also observed during 2022-2023 for cigars and overall combustible tobacco smoking, representing all-time lows.
“It’s encouraging to see this substantial decline in e-cigarette use among high schoolers within the past year, which is a win for public health,” said Brian King, director of the U.S. Food and Drug Administration’s Center for Tobacco Products, in a statement. “But we can’t rest on our laurels. There’s more work to be done to build on this progress.”
Among middle school students there was an increase in current overall tobacco product use (4.5 percent to 6.6 percent) and multiple tobacco product use (1.5 percent to 2.5 percent). However, among middle school students overall, no significant change was observed during 2022-2023 for current use of any individual tobacco product type, including e-cigarettes.

It’s encouraging to see this substantial decline in e-cigarette use among high schoolers within the past year, which is a win for public health. But we can’t rest on our laurels.
Brian King, Director, CTP
E-cigarettes remained the most commonly used tobacco product among both high school and middle school students for the 10th year in a row. Among youth who reported current e-cigarette use, approximately one-quarter reported using e-cigarettes every day. Disposable e-cigarette products were the most common product type used by youth who reported e-cigarette use. However, the most popular brands included both disposable and cartridge-based products. Among current youth e-cigarette users, the most commonly reported brands were Elf Bar (56.7 percent), Esco Bars (21.6 percent), Vuse (20.7 percent), Juul (16.5 percent) and Mr. Fog (13.6 percent).
Among youth who reported current e-cigarette use, nearly all used flavored products (89.4 percent), with fruit, candy, mint and menthol being the most commonly used flavors. For the first time in NYTS, the 2023 questionnaire asked about use of flavors that included the word “ice” or “iced” in their name, along with other concept flavor names—that is, names that imply flavor but do not explicitly indicate any particular flavor, such as “island bash.”
R.J. Reynolds Tobacco Co. said it welcomed the decline in overall youth tobacco use. “This is good news, and we agree with Dr. King that more needs to be done,” the company wrote in an e-mailed statement. “Future progress requires regulators—especially FDA—to seriously address the influx of irresponsibly marketed, illegal flavored disposable vapor products.”
In October, Reynolds filed a complaint with the International Trade Commission charging multiple manufacturers, distributors and retailers of disposable vaping devices with unfair importation.
November 2, 2023