Category: U.S. FDA

JWEI Submits PMTA to U.S. FDA for New Vape Device
China-based JWEI has announced today that they have successfully submitted a premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration for a device created with “new innovative technology” that focuses on safety, harm reduction and is designed to curb underage use.
“JWEI has been a leader in this industry from the start and this milestone again reiterates our commitment to the industry and public health: ensuring our adult customers continued access to less harmful alternatives to traditional tobacco products, while setting a new standard preventing underage youth access.” said VP of JWEI Group Jason Yao.
JWEI is the parent to the brands Joytech, Eleaf, Wismec and Joyevita. The company did not offer additional information on the specific device submitted for the PMTA.
JWEI developed a set of principles to guide through every step of its new product development, led by safety and effectiveness studies in early 2019. “The design philosophy is the foundation and guide rails for designing, manufacturing, verifying, validating, and continuously improving innovative, responsible, reliable, and high-quality products,” the release states.
The limited product debut in the UK has received overwhelming recognition from users and commercial partners after a few months’ actual use, according to JWEI
“As one of the world-leading device manufacturers and innovators of e-cigarette and vaping products, JWEI has over 3,600 granted patents and multiple internationally recognized manufacturing and quality certifications (GMP, HACCP, ISO9001, ISO13485, EHS, and ERP),” according to a press release.
July 21, 2022
FDA to Review Oversight Rules After Juul Debacle

Robert Califf / Credit: Modern Healthcare
The head of the U.S. Food and Drug Administration Tuesday said he has commissioned an independent review of the agency’s food and tobacco programs following months of criticism over its handling of the baby formula shortage and e-cigarette reviews, according to AP.
The announcement comes as FDA Commissioner Robert Califf attempts to push past several controversies that have dominated his second stint running the agency, including his issuing of a marketing denial order (MDO) to e-cigarette maker Juul Labs and later having to rescind that order.
“Fundamental questions about the structure, function, funding and leadership need to be addressed” in the agency’s programs, Califf said in a statement. The agency’s Center for Tobacco Products (CTP) is facing challenges navigating policy and enforcement issues from “an increasing number of novel products that could potentially have significant consequences for public health.”
Califf said the non-profit Reagan-Udall Foundation — a non-governmental research group created by Congress to support FDA’s work — would convene experts to deliver evaluations within 60 business days of both the food and tobacco operations.
July 19, 2022
U.S. FDA Updates Safety Reporting Portal for Tobacco
The U.S. Food and Drug Administration has made several updates to the desktop Safety Reporting Portal (SRP) tobacco questionnaire to improve the clarity, internal consistency and utility of the information being collected, according to the regulatory agency. The move will enhance the agency’s Center for Tobacco Products’ (CTP) public health surveillance for new and existing safety signals.
Some of the updates include:
Questions have been edited for inclusiveness and clarity that FDA is interested in health and product problems arising both from direct use of (by users) or exposure to (in nonusers) tobacco products
Questions about a tobacco product’s manufacturer are now designed with a search/select response list that provides submitters who know the manufacturer’s name with the full contact information for many of the manufacturers
The optional health questions now include questions about use of alcohol and other substances of abuse, and ask more details about diagnostic testing, treatment settings, and final health outcomes
Additionally, when manufacturers register an account in the SRP, they are asked to specify the type of manufacturer.
“FDA encourages anyone who has had a reaction to, or was hurt by, a tobacco product – or knows someone who experienced such effects – to visit the SRP and provide as much information as possible,” according to an FDA statement. “Reports from consumers/concerned citizens and healthcare professionals may be submitted anonymously, but including contact information allows FDA the option to find out more about the adverse experience. FDA reviews all tobacco-related SRP reports to identify new or concerning trends.”
July 11, 2022
FDA Suspends Juul Market Ban Pending Court Appeal

Photo: steheap
The U.S. Food and Drug Administration has temporarily halted its ban on Juul Labs products while the e-cigarette maker appeals the agency’s decision, the FDA announced on Twitter.
On June 23, the FDA ordered Juul Labs to pull its e-cigarettes from U.S. store shelves, saying the e-cigarette manufacturer had submitted insufficient evidence that they were “appropriate for the protection of the public health.”
A federal appeals court then granted Juul Labs a emergency stay of the order to give the judges time to evaluate the merits of Juul’s appeal. The e-cigarette company separately asked the FDA to stay its own order pending the appeal.
In a series of Twitter messages, the FDA said it had determined that there are scientific issues unique to the Juul application that warrant additional review. The agency stressed that the stay suspends but does not rescind it the marketing denial order (MDO).
The FDA initially rejected Juul’s request for a stay, prompting Juul to seek a stay of the ban in court, according to The Wall Street Journal.
In its court filing challenging the FDA ruling, Juul said the agency had overlooked more than 6,000 pages of data that the company had submitted to the FDA on the aerosols that users inhale. Juul also suggested that the FDA’s decision was influenced by political pressure.
The FDA’s marketing denial order for Juul surprised many in the vaping business, especially in the wake of marketing authorizations for vapor products manufactured by competitors such as Reynolds American Inc. and NJOY Holdings. A pioneer in the vaping segment and backed by Altria Group—a company boasting decades of experience with regulatory compliance—Juul labs appeared in a better position than most to meet the agency’s exacting standards.
Public health advocates criticized the stay of the FDA ruling.
“It is deeply disappointing and harmful to our nation’s kids that the FDA has issued an administrative stay of its marketing denial order for Juul’s e-cigarette products,” wrote Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, in a statement.
“This decision will allow the continued sale, at least for now, of the brand most responsible for creating and fueling the youth e-cigarette epidemic. We are nearly 10 months past a court-ordered deadline for the FDA to complete its review of e-cigarette marketing applications and can’t afford more delays by the FDA in removing kid-friendly products from the market.”
July 6, 2022
Juul: FDA ‘Overlooked’ 6,000 Pages of Aerosol Data

The U.S. Food and Drug Administration overlooked a key part of Juul’s premarket tobacco product application (PMTA) when the agency ordered Juul Labs’ products off the U.S. market, according to court documents.
In court filings Tuesday, Juul said the agency overlooked more than 6,000 pages of data that the company had submitted to the FDA on the aerosols that users inhale, according to the Wall Street Journal.
Juul also said the agency failed to consider the totality of Juul’s evidence, which the company said established that the public-health benefits of Juul products significantly outweighed the potential risks.
“FDA’s order acknowledged that ‘exposure to carcinogens and other toxicants present in cigarette smoke were greatly reduced with exclusive use’ of Juul products compared with combustible cigarettes,” Juul Labs stated in court documents.
The company added that the decision was reached “against a backdrop of immense political pressure” from Congressional lawmakers who “tainted the entire agency process” by pushing for a Juul ban. Juul officials say its products are held to a different regulatory standard than those made by rivals.
“If the court does not intervene, [Juul Labs] products will disappear from store shelves and politics will have won over sound science and evidence,” the filing said.
A federal appeals court last week granted Juul Labs a temporary stay of the FDA’s marketing denial order that requires the vaping company to pull its e-cigarettes off the U.S. market.
“The purpose of this administrative stay is to give the court sufficient opportunity to consider petitioner’s forthcoming emergency motion for stay pending court review and should not be construed in any way as a ruling on the merits of that motion,” the court wrote.
The FDA has until July 7 to respond to Juul’s motion and Juul Labs has until July 12 to reply to the FDA response if submitted.
“Having received the emergency temporary stay, we are now seeking the ability to continuously offer our products to adult smokers throughout our appeal with the court and science- and evidence-based engagement with our regulator,” said Joe Murillo, Juul Labs’ chief regulatory officer.
Last week, the Wall Street Journal reported that the company is mulling a potential bankruptcy filing if the FDA ban is upheld.
June 28, 2022
U.S. Appeals Court Delays FDA’s Ban on Juul

Credit: Tanasin
A federal appeals court today granted Juul Labs Inc. a temporary stay of the U.S. Food and Drug Administration’s order for the vaping company to pull its e-cigarettes off the U.S. market.
“The purpose of this administrative stay is to give the court sufficient opportunity to consider petitioner’s forthcoming emergency motion for stay pending court review and should not be construed in any way as a ruling on the merits of that motion,” the court wrote.
The e-cigarette maker had earlier asked the court to pause what it calls an “extraordinary and unlawful action by the regulatory agency that would require it to immediately halt its business.
The company filed an emergency motion with the U.S. Court of Appeals in Washington as it prepares to appeal the FDA´s decision.
Juul said that the FDA cannot argue that there was a “critical and urgent public interest” in immediately removing its products from the market when the agency allowed them to be sold during its review.
The company noted that the FDA denied its application while authorizing those submitted by competitors with similar products.
The order sets a briefing schedule of June 27 for the petitioner’s emergency motion; July 7 for the respondent’s response, and July 12 for the reply.
The request for an emergency stay while waiting to file an appeal was expected.
“We respectfully disagree with the FDA’s findings … intend to seek a stay and are exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator,” said Joe Murillo, chief regulatory officer at Juul Labs, said in a statement. “We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide.”
The marketing denial order, which concerns the FDA’s analysis of Juul products has not been released to the public. “Any portion of the record that was placed under seal . . . before an agency remains under seal in this court unless otherwise ordered,” the emergency motion states.
June 24, 2022
It’s Official: FDA Denies Juul U.S. Market Access

Today, the U.S. Food and Drug Administration confirmed what many had already been anticipating: Juul Labs must remove all currently marketed Juul products from the U.S. market.
“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” said FDA Commissioner Robert M. Califf. “The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.”
These marketing denial orders (MDO) pertain only to the commercial distribution, importation and retail sales of these products, and do not restrict individual consumer possession or use—the FDA cannot and will not enforce against individual consumer possession or use of Juul products or any other tobacco products.
“We respectfully disagree with the FDA’s findings … intend to seek a stay and are exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator,” said Joe Murillo, chief regulatory officer at Juul Labs, said in a statement. “We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide.”
After reviewing the company’s premarket tobacco product applications, the FDA determined that the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.
In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data—including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods—that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications.
Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, called the FDA decision “the most significant action the FDA has taken to reverse the youth e-cigarette epidemic. Juul, more than any other product or company, has been responsible for creating and fueling the youth e-cigarette epidemic.”
The FDA says that, to date, it has not received clinical information to suggest an immediate hazard associated with the use of the Juul device or Juul pods. However, the MDOs issued today reflect FDA’s determination that there is insufficient evidence to assess the potential toxicological risks of using the Juul products.
“There is also no way to know the potential harms from using other authorized or unauthorized third-party e-liquid pods with the Juul device or using Juul pods with a non-Juul device,” the agency wrote in a statement.
“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products. “As with all manufacturers, Juul had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”
Gregory Conley, president of the American Vaping Association, asserted on Twitter that the Juul decisions were “manufactured” and “complete nonsense.”
Andrew Bagley is the owner of the Illuminati Smoke Shop in Columbia, South Carolina, and says even with the popularity of Juul, he doesn’t have concerns about the ban’s effect on sales, reports News19.
“I’m not concerned,” he said. “We have quite a few other vape products that are PMTA approved, which just means at this point we are legally allowed to sell them and Juuls were a very small percent of our sales, it’s not that big of a deal.”
June 23, 2022
Juul Expected to be Pulled From Market Soon

Let the shock settle in. The U.S. Food and Drug Administration is preparing to order Juul Labs to take its e-cigarettes off the market in the United States, the Wall Street Journal reported on Wednesday, citing people familiar with the matter.
Todd Cecil, deputy director for the FDA’s Center for Tobacco Products’ Office of Science, told Vapor Voice during the Next Generation Nicotine Delivery seminar in Miami that he could not make a comment on the Juul decision until the FDA formerly issues a marketing denial order (MDO).
The news sent Altria’s stock (MO) on a massive drop, falling more than 10 percent once the news broke.
Wells Fargo analyst Bonnie Herzog wrote in an email that while the news comes as a bit of a surprise, she doesn’t believe all is lost for Altria and the company has several options it can pursue, adding that the sell-off today is overdone with the stock having lost an estimated $7 billion of market capital.
“First, assuming the FDA does in fact issue an MDO for Juul, we believe the impact is far from certain given Juul’s likely options to appeal or challenge it (via a court decision similar to Kaival Brands’ approach for Bidi Vapor Sticks and IMB’s use of the appeals process for myblu), revise its [premarket tobacco product application] PMTA application, or sue the FDA altogether,” wrote Herzog. “Also, with no detail yet on the FDA’s rationale, it is tough to know how the agency is thinking about an MDO on Juul in the context of its broader efforts to encourage adult smokers to quit and/or move down the continuum of risk to less harmful alternatives (e.g., e-vapor, heat-not-burn, oral nicotine pouches, etc) especially given Juul’s critical leadership in e-cigs.
“While it is unclear how the FDA is thinking about the remaining PMTAs that are pending (especially the popular VUSE Alto line), we have a hard time imagining the FDA would categorically remove highly popular e-cig brands without ensuring a suitable off-ramp for users (that isn’t back to combustible cigs).”
It is expected that Juul will receive the MDO in a response to its PMTA because of its product’s potential to appeal to youth. The company has also seen a slump in sales recently, and has been taken over by RJ Reynolds Vapor Company’s Vuse brand e-cigarette in Nielsen rankings for the last two quarters.
“We expect the company to appeal, with the products remaining on the market,” Vivien Azer, managing director for cannabis, consumer beverages and tobacco at Cowen Inc., New York, said in a research note.
George Cassels-Smith, CEO of Tobacco Technologies, says Juul receiving an MDO is ridiculous. “For a company that has that has been a standard in this industry and has some of the highest quality products on the market, its shocking,” he said. “The company has tried hard to move past its early issues of appealing to youth. This isn’t appropriate for the protection of public health and it isn’t good for the industry. It hurts adult smokers because Juul is a product that is successful in helping smokers switch.”
The decision is likely celebrated by some anti-nicotine groups who say Juul is the cause of the rise in teen vaping. That rise has also declined dramatically over the last 2-3 years. Recently, Juul Labs also settled several lawsuits related to youth marketing. Juul Labs — until recently the market leader in e-cigarette product sales — admitted to no wrongdoing in any of its settlements.
Tony Abboud, executive director of the Vapor Technology Association (VTA) said that he was surprised by the news because Juul was always expected to get an approval order.
“The reported denial of Juul’s PMTA application is stunning. While the company has certainly been at the epicenter of conflict, the amount of rigorous, peer reviewed science supporting their products’ ability to help smokers quit, raises serious questions about the FDA’s subjective balancing test, and whether public pressure campaigns will steer science policy,” said Abboud.
Americans for Tax Reform (ATR) strongly condemned the decision. Tim Andrews, ATR’s director of consumer issues, said the Juul MDO will devastate public health across the country, and lead to easily preventable deaths.
“Juul’s reduced risk tobacco alternatives are critical tools of smoking cessation that have been proven to help cigarette smokers across the U.S. save their lives through transitioning away from deadly combustible tobacco,” he said. ““This is a decision grounded in ideology, not science. It is a decision that will cause countless deaths that could have otherwise been prevented. For the sake of public health, it is a decision we hope will be overturned in the courts on appeal.”
In 2018, Altria spent nearly $13 billion taking a 35 percent stake in Juul. The company has taken non-cash charges on the investment as regulatory scrutiny of Juul and its marketing practices have impacted sales. As of March 31, Altria said the estimated fair value of its investment in Juul was $1.6 billion.
In 2019, Juul Labs announced it was suspending its print, broadcast and online advertising in the United States. That same year it halted the sale of its fruit and dessert flavors — including mango, creme brulee and cucumber — that were seen as a significant lure for teen users. The FDA also recently instituted a proposed rule to place a ban on menthol combustible cigarettes and flavored cigars. The menthol ban will not yet cover next-generation tobacco products, such as e-cigarettes, but the FDA has the authority to include them if it sees fit.
Juul Labs submitted its PMTAs in July 2020. At the time, the company said its submission included comprehensive scientific evidence for the Juul device and Juul pods in Virginia Tobacco and Menthol flavors at nicotine concentrations of 5.0 percent and 3.0 percent, as well as information on its data-driven measures to address underage use of its products.
Juul will not join NJOY as the only FDA-approved closed system, pod-style vaping device. The FDA is expected to make decisions on additional vaping brands that submitted timely PMTAs soon.
Now that at the FDA has approved a quality vaping product in Njoy, many tobacco harm reduction groups are hoping the FDA publicly clarifies that vaping is a less risky alternative to smoking combustible. A recent Rutgers University study found that more than 60 percent of all doctors incorrectly believe all tobacco products are equally harmful, making them less likely to recommend e-cigarettes for people trying to quit smoking.
June 22, 2022
NJoy Daily Disposable Gets FDA Marketing Approval
Credit: NJOY
NJOY now has two devices that have received marketing approval from the U.S. Food and Drug Administration. The regulatory agency today issued marketing granted orders (MGOs) under the premarket tobacco product application (PMTA) process for NJOY Daily Rich Tobacco 4.5% and NJOY Daily Extra Rich Tobacco 6%.
“It should be noted that our determination that the marketing of these products is APPH [appropriate for the protection of public health] is based in part on the submitted microbial stability data,” the MGO states. “The issuance of these marketing granted orders confirms that you have met the requirements of section 910(c) of the FD&C Act and authorizes marketing of your new tobacco products.”
The designation does not mean the products are safe and they are not “FDA approved,” the agency said, but the MGOs allows the company to legally market them in the United States.
“Our finding that permitting the marketing of the new products is APPH does not mean FDA has ‘approved’ the new tobacco products specified in Appendix A,” the MGO states. “Therefore, you may not make any express or implied statement or representation in a label, labeling, or through the media or advertising, that the new tobacco products specified in Appendix A are approved by FDA.”
The FDA also issued marketing denial orders (MDOs) to NJOY for multiple other Daily e-cigarette products. These are presumed to be for flavored products other than tobacco. Any of those products that remain on the market must be removed or risk FDA enforcement, the agency said. Applications for two menthol-flavored Daily products remain under FDA review.
Additionally, this authorization imposes strict marketing restrictions on the company to greatly reduce the potential for youth exposure to tobacco advertising for these products. The FDA said it will closely monitor how these products are marketed and will act as necessary if the company fails to comply with any applicable statutory or regulatory requirements, or if there is a notable increase in the number of non-smokers—including youth—using these products.
June 10, 2022
US FDA Campaign to Focus on E-Cig Use by Native Youth

The U.S. Food and Drug Administration announced the launch of its “Next Legends” youth vaping prevention campaign. The regulatory agency stated that the program is part of the FDA’s ongoing efforts to protect youth from the dangers of tobacco use.
The campaign will educate American Indian/Alaska Native (AI/AN) youth, ages 12-17, about the harms of vaping through unique branding and tailored messaging created to inspire a new generation to live Native strong and vape-free, according to a statement.
There are approximately 400,000 Native teens in the U.S., and more than half of them are at-risk of using tobacco products, including e-cigarettes, according to FDA. Studies show that Native youth are more susceptible to e-cigarette use than their non-Native peers, and they demonstrate disproportionately high experimentation and current use of e-cigarettes.
“The Next Legends campaign is an important and creative way to educate Native youth about the harms of vaping,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products. “E-cigarettes are the most used tobacco product among youth, and they pose serious health risks if used during adolescence, when the brain is still developing. Next Legends builds on the success of previous youth e-cigarette prevention campaigns while also addressing health disparities among Native Americans and Alaska Natives associated with tobacco use. Communicating with Native youth through culturally-aligned messages will help these young people make informed decisions about healthy behavior, including being vape-free.”
June 9, 2022