A U.S. District Court in California has dismissed a lawsuit filed by NJOY, the vape subsidiary of Altria Group, against multiple manufacturers, distributors, and retailers of disposable vapes. However, the case against IMiracle, the manufacturer of Elf Bar, has not been dismissed.
NJOY filed the lawsuit last October. The company alleges that the companies named in the suit are selling products illegal in California and the United States. NJOY asked for a nationwide injunction that would prevent future importation and sale of the products, and compensatory and punitive damages paid to NJOY.
Among the companies charged were manufacturers and distributors of Breeze, Elf Bar, Esco Bar, Flum, Juice Box, Lava Plus, Loon, Lost Mary, Mr. Fog and Puff Bar. Together the brands make up the majority of the U.S. disposable vape market.
The dismissal order was entered on Jan. 18 by Judge Terry J. Hatter Jr. of the U.S. District Court for the Central District of California. The court found that the defendants did not participate in “the same transaction, occurrence, or series of transactions or occurrences,” and therefore were improperly joined in the lawsuit. Because of that, Judge Hatter dropped all parties from the suit except the first named defendant, IMiracle, according to media reports.
The judge entered the orders “without prejudice” allowing NJOY to refile against the dismissed defendants individually or in smaller groups with demonstrable relationships. The court also dismissed NJOY’s claim of unfair competition and its motion for a preliminary injunction barring sales and distribution by the defendants.
The court denied NJOY’s motion to serve IMiracle, the manufacturer of Elf Bar headquartered in Hong Kong, by email, citing an established international process, the Hague Convention, for serving legal notice to foreign defendants.
NJOY’s lawsuit against IMiracle cannot proceed until the Chinese manufacturer is served notice.
Warning letters have been issued to 30 retailers, including one distributor, for illegally selling unauthorized disposable vaping products. The FDA typically sends warning letters to manufacturers, however, now retailers are facing stiffer scrutiny.
The U.S. Food and Drug Administration stated today that the unauthorized products were various types of Puff and Hyde brand disposable e-cigarettes, which were two of the most commonly reported brands used by youth e-cigarette users in 2022, according to the FDA.
The “action underscores the agency’s unwavering commitment to addressing the role retailers and distributors of unauthorized tobacco products play in this concerning public health issue facing America’s youth.,” according to the release.
FDA Commissioner Robert Califf said cracking down on disposable products most used by youth is a priority for the regulatory agency. “We’re committed to holding all players in the supply chain – not just manufacturers but also retailers and distributors – accountable to the law,” he said.
The warning letters are a result of a nationwide blitz to crack down on the sale of unauthorized e-cigarettes that are popular with youth – specifically Puff and Hyde products. The blitz included investigations of hundreds of retailers and distributors across the country. All products cited in the warning letters are disposable e-cigarettes.
“Since becoming director of CTP, I’ve been crystal clear that FDA will not stand by while retailers and distributors seek to profit off illegally selling products that are well-known to appeal to youth,” said Brian King, director of the FDA’s Center for Tobacco Products. “Retailers and distributors play a key role in keeping unauthorized tobacco products off the shelves, and if they fail to do so, we’re committed to taking appropriate action.”
The FDA generally sends warning letters the first time an inspection or investigation reveals a violation of the law, and recipients are given 15 working days to respond with the steps they’ll take to correct the violation and to prevent future violations. A majority of recipients of warning letters voluntarily correct the stated violation.
Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure and/or civil money penalties. In addition to today’s actions among retailers, the FDA issued a warning letter to an importer of Puff Bar in October 2022; that investigation remains ongoing.
In February, FDA filed the agency’s first civil money penalty complaints against four e-cigarette manufacturers; to date, FDA has filed civil money penalty complaints against ten e-cigarette manufacturers.
And in October 2022, the first complaints for permanent injunctions were filed against six e-cigarette manufacturers. From January 2021 through May 2023, FDA issued more than 560 warning letters. All of these actions are part of FDA’s standing compliance and enforcement portfolio, and the latest counts of these actions will continue to be reported on a routine basis.
“FDA will continue to take action against anyone making, distributing, importing, or selling unauthorized e-cigarette products, especially those most used by youth,” the release states.
Puff Bar rose to prominence in early 2020 after the Food and Drug Administration banned candy and fruit-flavored e-cigarettes because of their youth appeal but continued to permit the sale of flavored single-use devices like Puff Bar because they were not yet very popular.
Today, Puff Bar is the most popular e-cigarette brand among high school and middle schoolers. Nielsen reports that store sales of Puff Bar in the United States topped $150 million last fiscal year, but much of that is believed to be counterfeit product.
Puff Bar has operated in the shadows for most of its existence. It listed its mailing address first to a shuttered storefront on skid row in Los Angeles and more recently to a P.O. box. The company appeared to relish its obscurity. Last year, its website read “Who Makes Puff Bar? Everyone wants to know.” Minas and Beltran say the brand was originally developed in China, where it continues to be manufactured.
In 2020, the FDA ordered Puff Bar off the market amid lawsuits and a widening public outcry about youth appeal. The company pulled its products but later reintroduced redesigned versions using synthetic nicotine, which some believe remains outside of the FDA’s remit.
Four states have banned the product. It also faces a probe in the House of Representatives and lawsuits in at least three states. Recently, North Carolina’s attorney general launched an investigation.
In early November U.S. Representative Raja Krishnamoorthi, chair of the subcommittee on economic and consumer policy, wrote a letter to Minas and Beltran requesting information about its sale of synthetic nicotine products.
Minas and Beltran, both 27, are childhood friends from Southern California who said they are now the sole owners and co-CEOs of Puff Bar. During the CBS interview, Beltran said they wanted to speak out to “build trust” with their consumers.
“We’re aware that there is a lot of mystery and there was a lot of shadowiness before. Us being here right now, talking with you guys [CBS News] is our first step in kind of really, like, building the trust with our consumers,” he said.
The FDA declined to speak to CBS News about Puff Bar. In a statement, the agency said it was aware that companies have publicly announced strategies to switch to synthetic nicotine in an attempt to evade FDA jurisdiction, adding that it is investigating the issue.
North Carolina Attorney General Josh Stein on Nov. 16 announced “major actions” against the e-cigarette industry due to ongoing concerns about kid-friendly flavors, youth marketing and poor age verification.
In addition to suing Juul Labs founders James Monsees and Adam Bowen, Stein commenced a statewide investigation into Puff Bar and other e-cigarette manufacturers, distributors, and retailers.
“We made major progress in protecting young people from e-cigarette addiction when we secured a court order dramatically changing the way Juul does business and recovering $40 million to help kids conquer their nicotine addiction. But many of the billions Juul made from addicting kids to nicotine are now in the personal accounts of its founders and early investors. The people behind this company must be held accountable and pay to clean up the mess they made,” Stein said in a statement.
“At the same time, the market Juul created still exists, and other companies are filling the vacuum. We are actively investigating Puff Bar and other companies at all stages of the distribution chain, from manufacturers to retailers and everything in between to ensure they are not profiting off kids. Where I find illegal behavior, I will not hesitate to take legal action.”
As Juul discontinued some its flavored products in the U.S., Puff Bar has emerged as the vape of choice among young people. In 2020, the Food and Drug Administration told Puff Bar to stop selling its flavored vaporizers as part of a broader crackdown on underage vaping. However, the company resumed sales in early 2021 with products using synthetic nicotine, which the company believes are outside the FDA remit. In response, the agency launched an investigation of the redesigned Puff Bar.
Puff Bar sales in retail stores tracked by Nielsen totaled $156 million for the year ended Sept. 25, according to Goldman Sachs, although it is unclear how many of those sales are counterfeit products. In a federal survey released in Sept., 26 percent of high-school vaporizers said they used Puff Bars. Among middle-school e-cigarette users, 30 percent reported that their generic brand was Puff Bars.
The Wall Street Journal recently profiled Patrick Beltran and Nick Minas, co-CEOs of Puff Bar, a top-selling disposable e-cigarette brand in the United States.
Puff Bar entered the U.S. market in 2019. At the time, it was owned by Cool Clouds Distribution of California. Cool Clouds sold the Puff Bar to the brand’s Chinese manufacturer, DS Technology Licensing, in early 2020.
In February 2020, to curb youth vaping, the Food and Drug Administration implemented new restrictions excluding sweet and fruit flavors in reusable e-cigarettes such as those offered by Juul Labs. The restrictions did not apply to disposable devices such as Puff Bars.
In the summer of 2020, however, the FDA ordered Puff Bar products off the market. Critics said the brand was replacing Juul as the vape of choice among young people as Juul discontinued certain flavored products. In February 2021 Puff Bar resumed sales with redesigned product containing synthetic nicotine, which remains outside the FDA’s purview.
Minas and Beltran became executives of Puff Bar as CEO and CFO respectively in the spring of 2020, when the brand was taken over by two men and DS Technology as per company filings. The entrepreneurs owned and operated an online e-cigarette retailer called Eliquidstop.
In the Wall Street Journal article, Beltran described the Puff Bar ingredient change as “a forced innovation,” saying that the FDA gave the company no choice.
Puff Bar sales in retail stores tracked by Nielsen totaled $156 million for the year ended Sept. 25, according to Goldman Sachs, although it is unclear how many of those sales are counterfeit products. In a federal survey released in Sept., 26 percent of high-school vaporizers said they used Puff Bars. Among middle-school e-cigarette users, 30 percent reported that their generic brand was Puff Bars.
In July 2020, Puff Bar announced that it would cease all online sales and distribution in the U.S. until further notice. However, the brand resumed sales on its website last month with a changed product. To get around the ban, Puff Bar is now using tobacco-free nicotine, according to The Wall Street Journal.
Credit: Puff Bar
The U.S. Food and Drug Administration (FDA) has started investigating Puff Bar’s redesigned fruit-flavored disposable vaporizers because of the changes, reports The Hill. The regulatory agency said it was aware of Puff Bar’s actions but would not say whether the agency’s ban was still applicable, citing the ongoing investigation.
In mid-2020, the FDA told Puff Bar to stop selling its fruity vaporizers as part of a broader crackdown on underage vaping. In a letter to Puff Bar, the FDA’s Center for Tobacco Products said Puff Bar products hadn’t been authorized for sale by the agency and that the company had made unauthorized claims on its website that its vaporizers were less harmful than traditional cigarettes.
In early 2020, the Trump administration banned fruity flavored e-cigarettes in reusable devices like Juul, the blockbuster brand that helped trigger the teen vaping craze in the U.S. Under that policy, only menthol and tobacco flavors were allowed for those devices. But the flavor ban did not apply to disposable vaping products like Puff Bar, which is offered in more than 20 flavors, including pina colada and pink lemonade.
Following the ban, Puff Bar quickly emerged as the vape of choice among young people. Puff Bar has fallen to No. 3 in the disposable category this year, after Bidi Stick and Blu, according to Nielsen data.
It’s unclear who owns Puff Bar. Previous owners include Cool Clouds Distribution in California and DS Technology Licensing in China.
DS Technology Licensing, the owner of registered trademarks associated with the Puff Bar vapor device and its distributor Puff Inc.filed a lawsuit in Los Angeles County Superior Court against over 20 Chinese and American companies accused of distributing counterfeit vaping devices.
The companies included as defendants include international manufacturer and distributor CACUQ, US distributors, e-commerce companies, and brick and mortar retail stores. A list of current Defendants is below. Plaintiffs are represented by the law firm of Gallinger Law PC.
The lawsuit addresses both counterfeit “Puff Bar” vapor devices as well as knockoff products identified as “Puff Smart,” “Puff Mini,” “Puff Stig,” and “Airis Puff” and seeks $50 million in restitutionary and $25 million in punitive damages.
“Defendants in the lawsuit have infringed on the famous “Puff” and “Puff Bar” marks by introducing competing devices which use the stylized “Puff” associated with Puff Bar Vapor Devices as well as by openly selling fake or counterfeit Puff Bar vapor devices. Defendants are believed to be only a small number of the violators, as the anti-counterfeit verification system at puffbar.com has identified thousands of retail stores at which consumers bought devices which failed the check” the company said in a statement.
“Awards will be given to those with information which leads to the seizure of counterfeit goods. Contact 866-PUFF-BAR or report@puffbar.com for more info.”
The U. S. Customs and Border Protection is cracking down on illegal vape products. Customs officers seized more than $200,000 worth of unapproved disposable products destined for western Pennsylvania on Aug 11.
Customs officers at the Port of Philadelphia since June, have racked up 48 combined seizures worth an estimated $444,000, according to news reports.
According to customs, eight shipments of counterfeit and unapproved e-cigarettes destined to Bucks, Chester and Delaware counties were seized at the Port of Philadelphia between June 4 and Aug. 11.
The shipments included 30,400 e-cigarette pods under brand names Eonsmoke, Pop, Puff, and St!k and Bidi.
All of the products were shipped directly from China or Hong Kong, according to reports.
The U.S. Food and Drug Administration issued warning letters notifying ten companies, including Cool Clouds Distribution Inc. (doing business as Puff Bar), to remove their flavored disposable e-cigarettes and youth-appealing e-liquid products from the market because they do not have the required premarket authorization.
These new actions are part of the FDA’s ongoing, aggressive effort to act against illegally marketed tobacco products amid the public health crisis of youth e-cigarette use
The e-cigarette industry continues to shift in the Covid-19 environment.
By Maria Verven
The market for nicotine in all its forms is undergoing seismic shifts. While sales of nicotine products have been up slightly in the first half of 2020, the greatest growth was in the sales of traditional cigarettes. And when traditional cigarettes win, e-cigarettes lose.
A TROUBLING TREND
Despite the fact that vaping is considered a much safer alter-native to smoking by reputable public health organizations, the data is showing a troubling trend: Some vapers are return-ing to traditional cigarettes.
“Over the last several months, we’ve observed an increase in the number of age 50 and older smokers in the ciga-rette category,” said Altria CEO Billy Gifford in an April investor call. “We believe these smokers had previously switched to e-vapor products but recently returned to cigarettes due to negative publicity and regulatory and legislative developments in the e-vapor category.”
These same factors were in evidence during Altria’s July investor call when they credited the U.S. Food and Drug Administration (FDA) flavor ban for “helping the overall cigarette category” and predicted that the FDA’s premarket tobacco product application (PMTA) process will pause the growth in the e-cigarette market for the reasonable future.
“This is really unfortunate and a sign of serious misinfor-mation and misperceptions about the large risk difference between smoking and harm reduction nicotine products,” said Konstantinos Farsalinos, a cardiologist, clinical researcher with the Onassis Cardiac Surgery Center in Athens and an e-cigarette expert.
“Drastic measures are needed so that smokers receive reasonable, unbiased and evidence-based messages to make informed decisions,” Farsalinos said.
“This dramatic change in the market coincides with the concerted attacks on vaping over the past year,” said David Sweanor, an adjunct law professor at the University of Ottawa and the author of several e-cigarette studies. “By undermining the low-risk alternatives to cigarettes, they protected the cigarette business.”
STEADY DECLINE SINCE LAST SUMMER
According to Nielsen data reported in July, traditional ciga-rettes represented 80 percent of all U.S. tobacco sales, with $60 billion in convenience store sales over the past 52 weeks. Meanwhile, U.S. sales of e-cigarettes represented only 5 percent of the market, with sales at $3.8 billion.
In 2019, the global e-cigarette market reached a value of $13 billion and was expected to reach $53 billion by 2024, according to VnyZ Research USA. The U.S. share of the e-cigarette market was predicted to reach $16.5 billion by 2024.
These rosy projections now fly in the face of the steady decline in the growth of e-cigarette sales volume since Nielsen’s August 2019 report when it was up 60 percent year over year. Sales of traditional cigarettes have always eclipsed e-cigarette sales. But overall, e-cigarette sales have been down around 20 percent this year, according to Bonnie Herzog, managing director at Goldman Sachs and research analyst who has followed the tobacco industry for more than 20 years.
Much of the decline in e-cigarette sales may be due to the dramatic decline in Juul’s market, which was down around 33 percent after concerted attacks and bans on popular offerings. However, several other factors have clearly contributed to the impact on the overall market, including the vaping scare last year, media reports of a youth “epidemic” and the FDA’s flavor restrictions on the refill market.
In January 2020, the FDA announced it would enforce its policies banning unauthorized flavored e-cigarette products that it claims might appeal to youth—without regard to the appeal to adults who will otherwise smoke cigarettes—including fruit and mint flavors—indeed, any flavors except for tobacco and menthol.
The agency gave companies 30 days to remove fruit-flavored and dessert-flavored products from their shelves and apply for marketing authorization by Sept. 9. The FDA’s restrictions on the refill market, which repre-sents nearly 90 percent of the total category, had an immedi-ate and dramatic effect on the e-cigarette market, according to Herzog.
FDA THREATS CONTRIBUTE TO MARKET CONTRACTION
For months after the FDA’s announcement, the sales of e-cigarettes continued to trend downward by at least 13 percent in June 2020, with the possible exception of R.J. Reynolds’ Vuse. Vuse swiftly rose in popularity, taking second place only to Juul with nearly 16 percent market share. But Vuse is not without problems of its own.
Altria Group, which owns a 35 percent nonvoting stake in Juul Labs, which the Federal Trade Commission is seeking to scupper, filed a lawsuit in May against R.J. Reynolds Vapor Co. seeking “treble damages” (triple the damage amount) in its claim that Vuse violated nine of Altria’s patents involving heating technology, mouthpieces, batteries and liquid-filled pods. R.J. Reynolds had already filed its own patent infringement lawsuits against both Altria and Philip Morris International over the technology behind Marlboro HeatSticks, a competi-tor of Reynolds’ Eclipse line, that heats rather than burns the tobacco in cigarettes.
While Juul continues to reign supreme in the convenience store market, representing roughly 60 percent of sales, its market share has declined about 10 percent over the past year. Juul has taken much of the heat around the teen vaping “epidemic,” causing the company to stop advertising its prod-ucts in the U.S. and cease production of most of its flavors. In two rounds of layoffs, Juul slashed about 40 percent of its workforce, a direct result of its declining sales.
However, according to market research firm IRI, Juul remains the market leader in convenience stores and simi-lar outlets. Valued at $38 billion at the time of the Altria investment, Juul’s first-quarter sales reportedly reached $394 million. If the trend continues, Juul sales could fall somewhere between the $1.3 billion in sales reported in 2018 but significantly shy of the $2 billion in sales reported last year.
Credit: Haiberliu / Pixabay
Juul’s biggest hurdle may be this fall when the FDA starts reviewing Juul’s PMTA, which the company submitted in late July along with scientific studies showing its products are healthier alternatives for smokers as well as plans to prevent minors from using its products.
DISPOSABLE MARKET GAINS TRACTION
When one nicotine category slows, another tends to gain traction. This rule definitely holds true in the e-cigarette market where the contraction in the refill market allowed the much smaller disposable market to thrive.
Disposable devices openly exploited the loophole in the FDA’s regulations that banned fruit and dessert flavors in refillable cartridge-based e-cigarettes. For example, Puff Bar, one of the market leaders in the disposable category, boasts more than 20 flavors, including pina colada, pink lemonade and watermelon cartridges that are compatible with Juul devices.
Puff Bar, Stig and other small but fast-growing players like Fogg were the biggest winners, said Herzog, due to the fact that the disposable e-cigarette segment fell outside of the FDA’s flavor restrictions.
Based on convenience store data and retailer data but exclusive of online and vape store sales, Puff Bar is reportedly selling over 300,000 sticks a week with weekly sales of over $3 million.
However, pressure is mounting among House lawmakers to ban the fast-growing e-cigarettes that quickly replaced Juul as the most popular vapes among young people. And in July, the FDA sent warning letters to Cool Clouds Distribution (doing business as Puff Bar), HQD Tech USA, Myle Vape, Eleaf USA, Vape Deal, Majestic Vapor, E Cigarette Empire, Ohm City Vapes, Breazy and Hina Singh Enterprises (doing business as Just Eliquids Distro demanding they remove flavored disposable e-cigarettes that appeal to youth from the market because they lack the required premarket authorization.
Credit: Sarah J- Pixabay
The FDA also cited Puff Bar and HQD Tech USA for stating that their products were modified-risk tobacco products without having received FDA permission to make such claims. The FDA also recently blocked imports from EonSmoke and Relx, two Chinese manufacturers of flavored dispos-able e-cigarettes. Over the past several months, the FDA has banned at least 74 entries of disposable electronic nicotine-delivery system (ENDS) products from being sold in the U.S. that were in violation of the Federal Food, Drug and Cosmetic Act.
“The FDA continues to prioritize enforcement against e-cigarette products, specifically those most appealing and accessible to youth,” said FDA Commissioner Stephen M. Hahn. “We want to make clear to all tobacco product manu-facturers and retailers that, even during the ongoing pan-demic, the FDA is keeping a close watch on the marketplace and will hold companies accountable.”
NEGOTIATING THE ROADBLOCKS
Clearly, the vapor market is being held hostage by the FDA as well as local regulatory bodies. Only those that can successfully navigate the regulatory roadblocks will be able to survive. A key deadline is approaching on Sept. 9, the date when manufacturers must submit a PMTA for FDA approval. After that date, the clock starts ticking; manufacturers will have up to a year from that date to secure FDA compliance or they must sell off their vapor products. The biggest hurdle for companies is the requirement that they must prove that their products demonstrate a net ben-efit to public health.
Only those with deep pockets can possibly jump through the FDA’s hoops to demonstrate that their products provide a healthier alternative to smokers who make the switch. Despite the costs, at least 30 applications for FDA approval of vapor products are pending—with no guarantee that these applications will be approved.
It’s a safe bet that the e-cigarette brands associated with the tobacco giants, including Altria with its minority stake in Juul, R.J. Reynolds Vapor Company with its Vuse, and Imperial Brands, which owns Blu, will be among the first in line to seek FDA approval. Sweanor sees the situation in stark terms.
“If we want to see low-risk alternatives destroy the exceedingly lucrative but devastatingly lethal cigarette business, policies that hand the market to Big Tobacco [are] like giving control of the alternative energy market to Exxon,” he said. V
The original “Vaping Vamp,” Maria Verven owns Verve Communications, a PR and marketing firm specializing in the vapor industry.
The U.S. Food and Drug Administration (FDA) has issued warning letters to 10 companies, including Puff Bar parent Cool Clouds Distribution, asking for the removal of flavored disposable e-cigarettes from the market. The FDA cites youth-appeal and a lack of a required premarket authorization.
“These new actions are part of the FDA’s ongoing, aggressive effort to act against illegally marketed tobacco products amid the public health crisis of youth e-cigarette use in America,” said FDA Commissioner Stephen Hahn. “The agency is particularly concerned about the appeal of flavored, disposable e-cigarettes to youth and continues to monitor all available data.”
Three firms are receiving warning letters for illegally marketing disposable e-cigarettes—Puff Bar, HQD Tech USA LLC and Myle Vape Inc. The FDA’s review of the companies’ websites revealed that each firm is selling or distributing unauthorized tobacco products that were first introduced or modified after Aug. 8, 2016—the effective date of the deeming rule that extended the FDA’s authority to all tobacco products.
“Despite suspending in-person inspection activities—such as retail compliance checks and vape shop inspections—due to the COVID-19 pandemic, our enforcement against unauthorized e-cigarette products has endured,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “These warning letters are the result of ongoing internet monitoring for violations of tobacco laws and regulations.”
Any new tobacco product not in compliance with the premarket requirements of the Federal Food, Drug and Cosmetic Act (FD&C Act) is adulterated and misbranded and may not be marketed without FDA authorization, according to the FDA. Puff Bar and HQD Tech USA LLC were also cited for an additional violation for marketing their products as modified risk tobacco products without an FDA order in effect that permits such marketing.
Additionally, the FDA issued seven other warning letters to the following firms: Eleaf USA, Vape Deal LLC, Majestic Vapor LLC, E Cigarette Empire LLC, Ohm City Vapes Inc., Breazy Inc. and Hina Singh Enterprises (doing business as Just Eliquids Distro Inc.), who “sell or distribute unauthorized electronic nicotine delivery system (ENDS) products targeted to youth or likely to promote use by youth. These firms were cited for marketing unauthorized e-liquids that imitate packaging for food products that often are marketed and appeal to youth, such as Cinnamon Toast Crunch cereal, Twinkies, Cherry Coke and popcorn, or feature cartoon characters.”
The FDA has requested responses from each firm within 15 working days detailing how each company intends to address the agency’s concerns, including the dates on which each firm discontinued the sale and/or distribution of these tobacco products, and its plans for maintaining compliance. Failure to correct violations may result in further action such as a civil money penalty complaint, seizure or injunction. In addition, misbranded or adulterated products imported into the U.S. are subject to detention and refusal of admission, according to the FDA.
The FDA’s actions during the COVID-19 pandemic also include a recent warning letter to e-liquid manufacturer StemStix Inc. for violations of the FD&C Act, including marketing new tobacco products without authorization, marketing tobacco products with false and misleading advertising and marketing unauthorized modified risk tobacco products.
Additionally, last month the agency issued letters to seven tobacco product manufacturers requesting information to help the FDA examine whether certain tobacco products were first marketed after the deeming rule’s effective date and therefore not subject to FDA’s policy on deferred enforcement of the premarket requirements for certain deemed products. Over the past four months, the agency has also refused admission into the U.S. of at least 74 entries of disposable ENDS products for violations of the FD&C Act.
