Category: U.S. FDA

SMOK Files Appeal of FDA’s Marketing Denial Orders
SMOK’s factory
One of the oldest MOD makers in the vaping industry has filed an appeal of the U.S. Food and Drug Administration’s marketing denial orders for six of the company’s open-system vaping devices.
China-based Shenzhen IVPS, the parent to SMOK brand vaping devices, filed the appeal after with the New Orleans, Louisiana-based U.S. Court of Appeals for the Fifth Circuit, and was joined in the suit by a Dallas, Texas-based distributor of the SMOK products that were denied marketing.
The FDA claimed that it had issued the MDOs for the premarket tobacco product applications (PMTAs) for the SMOK products because the applications “failed to provide sufficient data to characterize constituent delivery, product stability, and product abuse liability.” The agency also stated that SMOK failed to provide a specific e-liquid and consumers could use any e-liquid in the devices.
Shenzhen IVPS strongly challenges those assertions, as the company “invested more than $30 million in its applications, which totaled well over 600,000 pages in all, and collaborated with the world’s leading laboratories to conduct robust harmful and potentially harmful constituent aerosol testing, in vitro toxicology testing and toxicological analysis, accelerated and 24-month storage and stability testing, and rigorous clinical pharmacokinetic studies to test the products’ potential abuse liability profiles,” according to a press release.
Welfer Ouyang, Shenzhen IVPS CEO, said he was “very concerned” that the agency issued marketing denial orders on open-system devices that are sold without any nicotine-containing e-liquid.
“FDA is using isolated data from testing of the devices with e-liquid formulations that the products’ instruction manuals specifically warn are not compatible with these devices, and ignoring the overwhelmingly positive toxicological and safety profile of these products,” said Ouyang.
On Jan. 3, the U.S. Court of Appeals for the Fifth Circuit ruled that the FDA acted “arbitrarily and capriciously” in rejecting PMTAs of Wages and White Lion Investments, doing business as Triton Distribution, and Vapetasia for approval to sell their products in the United States.
The 9-5 decision by the New Orleans-based 5th U.S. Circuit reversed a July 2022 decision by a three-judge panel of that court.
The agency “sent manufacturers of flavored e-cigarette products on a wild goose chase,” telling them what would be needed to approve their products, and then denying all applications, the court said in an opinion by Judge Andrew S. Oldham. The FDA “never gave petitioners fair notice that they needed to conduct long-term studies on their specific flavored products,” Oldham wrote.
January 20, 2024
FDA Denies Marketing of Suorin, Blu Plus+ Products
The U.S. Food and Drug Administration has issued marketing denial orders (MDOs) to Shenzhen Youme Information Technology Co. Ltd. for two Suorin brand e-cigarette products. It also issued Fontem US, LLC MDOs for its Blu PLUS+ brand e-cigarette products.
“Thorough scientific review of tobacco products applications is a key pillar of FDA’s comprehensive regulatory approach,” said Brian King, director of FDA’s Center for Tobacco Products (CTP). “It is the applicant’s responsibility to ensure that sufficient scientific evidence is included in an application to meet the necessary public health standard required by law. In these cases, such evidence was lacking.”
The companies must not market or distribute these products in the United States or they risk FDA enforcement action. The companies may submit new applications for the products that are subject to these MDOs, according to an agency press release.
The FDA denied Suorin Air refillable vaporizers in various colors and an empty refillable cartridge. The FDA stated that Suorin Air’s empty cartridges would allow consumers to fill the cartridge with an e-liquid purchased separately.
“The applications submitted by Shenzhen Youme Information Technology Co. Ltd. lacked sufficient evidence regarding abuse liability, which is the ability of a tobacco product to promote continued use and the development of addiction and dependence,” the release states.
SMOK recently had 22 products denied, including devices, pods, atomizers, and cartridges. It was the first time the agency has denied strictly hardware products from one company en mass. The products were denied because they were submitted without a specific e-liquid to be used with the devices, according to the FDA.
The denied Blu PLUS+ products include a battery and several prefilled e-liquid pods:

blu PLUS+ Battery
blu PLUS+ Carolina Bold 2.0%
blu PLUS+ Classic Tobacco 1.2%
blu PLUS+ Classic Tobacco 2.4%
blu PLUS+ Gold Leaf 1.2%
blu PLUS+ Gold Leaf 2.4%
blu PLUS+ Menthol 1.2%
blu PLUS+ Menthol 2.4%
“Among other deficiencies in their applications, Fontem US, LLC failed to include sufficient ingredient information, harmful and potentially harmful constituent (HPHC) yield quantities, and abuse liability information.,” the FDA stated. “In addition, the applicant did not provide sufficient evidence demonstrating that the flavored new products have a potential to benefit adult smokers, in terms of complete switching or significant cigarette use reduction, that would outweigh the risk to youth.
The FDA also issued MDOs for additional blu PLUS+ products not listed above. The regulatory only publicly names products that the FDA or the manufacturer has confirmed to be currently marketed to avoid the release of confidential commercial information.
January 19, 2024
U.S. FDA Denies 22 SMOK Vape Hardware PMTAs
SMOK Osub One 50W AOI
The U.S. Food and Drug Administration issued marketing denial orders (MDOs) to Shenzhen IVPS Technology Co., Ltd for 22 SMOK vaping hardware products.
The denied products include devices, pods, atomizers, and cartridges. It’s the first time the agency has denied strictly hardware products from one company en mass.
The products were denied because they were submitted without a specific e-liquid to be used with the devices, according to the FDA. “The denied SMOK e-cigarette products are not sold with an e-liquid. A consumer instead adds their separately purchased e-liquid into the device,” the agency wrote. “Therefore, these SMOK products have the potential to be used with any e-liquid on the market and available to the consumer, which could include tobacco-flavored and non-tobacco-flavored e-liquids.”
The products receiving MODOs include:

SMOK OSUB ONE Device
SMOK OSUB ONE RPM Cartridge
SMOK RPM DC 0.8 Ω MTL Atomizer
SMOK OSUB ONE RPM Cartridge 3 Pack
SMOK RPM DC 0.8 Ω MTL Atomizer 5 Pack
SMOK Nfix Device
Nfix DC 0.8 Ω MTL Pod
SMOK POZZ Device
SMOK POZZ DC 0.8 Ω Pod
SMOK RPM 40 Device
SMOK RPM Empty Standard Cartridge
SMOK RPM Empty Nord Cartridge
SMOK RPM Mesh 0.4 Ω Atomizer
SMOK Nord DC 0.8 Ω MTL Atomizer
SMOK SCAR-P3 Device
SMOK SCAR-P3 Empty RPM 2 Cartridge
SMOK SCAR-P3 Empty RPM Cartridge
SMOK PRM 2 Mesh 0.16 Ω Atomizer
SMOK RPM Mesh 0.4 Ω Atomizer
SMOK Nord 2 Device
SMOK Nord 2 RPM Cartridge
SMOK Nord 2 Nord Cartridge
After reviewing the company’s PMTAs, the FDA determined that the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act. More specifically, the applicant failed to provide sufficient data to characterize constituent delivery, product stability, and product abuse liability.
“Science is a cornerstone of FDA’s tobacco product review process, and CTP remains committed to evaluating applications based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole,” said Brian King, director of FDA’s Center for Tobacco Products. “It is the applicant’s responsibility to provide sufficient scientific evidence to demonstrate that marketing a new tobacco product is appropriate for the protection of the public health. In this case, the applicant failed to provide this evidence.”
January 16, 2024
Court Rules FDA Sent Vapor Makers on ‘Wild Goose Chase’

Image: BCFC
Two e-liquid companies will be able to resubmit their marketing applications to the U.S. Food and Drug Administration following a court ruling, reports Bloomberg Law.
On Jan. 3, the U.S. Court of Appeals for the Fifth Circuit ruled that the FDA acted “arbitrarily and capriciously” in rejecting the premarket tobacco product applications (PMTA) of Wages and White Lion Investments, doing business as Triton Distribution, and Vapetasia for approval to sell their products in the United States.
The 9-5 decision by the New Orleans-based 5th U.S. Circuit reversed a July 2022 decision by a three-judge panel of that court.
The agency “sent manufacturers of flavored e-cigarette products on a wild goose chase,” telling them what would be needed to approve their products, and then denying all applications, the court said in an opinion by Judge Andrew S. Oldham. The FDA “never gave petitioners fair notice that they needed to conduct long-term studies on their specific flavored products,” Oldham wrote.
In a dissenting opinion, Judge Catharina Haynes stated that the agency “properly fulfilled its statutory mandate by considering the relevant portions of Petitioners’ PMTAs and coming to a reasonable conclusion that marketing Petitioners’ products is not appropriate for public health.”
Oldham stated that the manufacturers dutifully spent untold millions “conforming their behavior and their applications to FDA’s say-so.”
“Then, months after receiving hundreds of thousands of applications predicated on its instructions, FDA turned around, pretended it never gave anyone any instructions about anything, imposed new testing requirements without any notice, and denied all one million flavored e-cigarette applications for failing to predict the agency’s volte face. Worse, after telling manufacturers that their marketing plans were ‘critical’ to their applications, FDA candidly admitted that it did not read a single word of the one million plans.”
In an X post, Michael Siegel, a professor at Boston University School of Public Health, stated that the ruling “exposed” the FDA’s wrongful rejection of applications for flavored vapes, ultimately resulting in a “win for public health.”
Eric Heyer, a lawyer for e-liquid makers Triton Distribution and Vapetasia LLC, said he was pleased with the ruling and hoped it would lead the FDA to make “a significant course correction by communicating with specificity” what companies must do to get approval.
“No principle is more important when considering how the unelected administrators of the Fourth Branch of Government treat the American people,” Oldham wrote, apparently likening executive branch agencies such as the FDA to a separate branch of government. “And FDA’s regulatory switcheroos in this case bear no resemblance to square corners.”
It is expected that the FDA will seek a review of the decision by the Supreme Court of the United States, however, the justice department hasn’t made an official announcement.
January 3, 2024
Warning Letters for Vapes Resembling Alcohol Products

Image: FDA
On Dec. 20, 2023, the U.S. Food and Drug Administration issued warning letters to three online retailers for selling and/or distributing unauthorized e-cigarettes that imitate packaging for bottles of alcohol. These retailers sold Luckee Vape Daniels brands, which are flavored disposable e-cigarette products that come in a variety of common alcoholic drink flavors that may be appealing to young people, including icy pina colada, frozen strawberry daiquiri, frozen mangorita and watermelon martini.
Data from the 2023 National Youth Tobacco Survey indicate that disposable products are the most commonly used type of e-cigarettes among U.S. middle and high school students. Among current youth e-cigarette users, approximately nine in 10 reported using flavors, with fruit flavors being the most popular (63.4 percent) and about one in 14 (7.2 percent) reporting use of products with alcoholic drink flavors.
“FDA is committed to taking action across the supply chain, including among retailers, to remove unauthorized tobacco products from the marketplace,” said Brian King, director of the FDA’s Center for Tobacco Products, in a statement. “This includes continued monitoring of the online marketplace to identify and combat against emerging products of concern.”
December 21, 2023
Juul Labs Submits PMTA for JUUL2 Menthol Pods

Credit: Piter2121
Juul Labs announced on Tuesday that it is seeking FDA approval for its new menthol-flavored pods. The JUUL2 pods require age verification and are designed to be used with Juul’s e-cigarette device, which is currently under regulatory review.
The new menthol-flavored pods have a nicotine concentration of 18 mg/mL and are Juul’s latest premarket tobacco product application (PMTA) submission to the FDA, according to media reports.
This follows a submission Juul Labs made in July for a vaporizer with a unique Pod ID chip to prevent the use of counterfeit cartridges and restrict underage access. The July application included a proposal for tobacco-flavored pods.
The vaporizer is already on sale in the UK after its launch in 2021 as the JUUL2 System.
The menthol pod contains a secure microchip that communicates a requirement for age verification to the device before use. The device can be locked by users at any time to prevent unauthorized usage.
To mitigate the risk of social sourcing, Juul said it would limit not only the number of devices that can be purchased but also the number of new devices each unique age-verified user can activate and use with menthol-flavored pods.
So far, the FDA has authorized only 23 e-cigarette products for sale in the United States, all of them tobacco-flavored. The agency has denied menthol e-cigarette applications from several high-profile manufacturers, including British American Tobacco, which is appealing those decisions.
Juul Labs said in a statement it has submitted evidence showing its new menthol pods can help more cigarette smokers transition from smoking than tobacco-flavored e-cigarettes.
December 20, 2023
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 Says Next PMTA Update to Come in January

Credit: F Armstrong Photo
The U.S. Food and Drug Administration stated in prior status reports for its premarket tobacco product applications (PMTAs) that the agency would complete a review of 100 percent of the applications by the end of 2023.
The agency is now estimating that completion of the reviews may be delayed as the FDA considers the D.C. Circuit’s opinion in Fontem US v. FDA, affirming in part and vacating and remanding in part marketing denial orders for certain vaping products.
The regulatory agency is under court order to file regular status reports on the agency’s review of pending PMTAs for new tobacco products that were on the market as of Aug. 8, 2016.
For such new tobacco products to be lawfully marketed in the United States, the Family Smoking Prevention and Tobacco Control Act requires the FDA to complete a substantive review of the PMTA for each new tobacco product and issue a marketing granted order authorizing the sale of the product.
The court order stems from litigation filed by health groups against the FDA seeking a court-imposed deadline for finalizing the review of the PMTAs that were filed with the agency by Sept. 9, 2020.
The court-imposed deadline to complete the agency’s review was originally Sept. 9, 2021, which the FDA was unable to meet due to the extremely large number of PMTAs filed by manufacturers.
The most recent and FDA’s seventh status report was filed on Oct. 23, 2023, according to media reports. Specifically, in these reports, the FDA provides an update on the progress to finalize the agency’s review of pending PMTA “covered applications.”
A “covered application” is for new electronic cigarette/vapor products that were on the market as of Aug. 8, 2016, which had a PMTA filed with the FDA by Sept. 9, 2020, are sold under the brand names of Juul, Vuse, Njoy, Logic, Blu, Smok, Suorin, or Puff Bar, and reach 2 percent or more of the total retail sales volume in NielsenIQ’s various retail e-cigarette sales reports.
According to the FDA’s Oct. 23 status report, the agency has completed its review of 69 percent of the 186 pending covered applications.
The FDA states that it will file the next status report with the court by Jan. 22.
December 11, 2023
FDA Files Civil Money Action Against 25 Retailers

Credit: FDA
The U.S. Food and Drug Administration announced it has filed civil money penalty (CMP) complaints against 25 brick-and-mortar and online retailers for selling unauthorized Elf Bar, EB Design and other e-cigarette products.
In a press note, the FDA stated that it had previously warned each retailer in the form of a warning letter to stop selling unauthorized tobacco products. During follow-up inspections, the agency observed the retailers had not corrected the violations, resulting in civil money penalty actions. 
The complaints seek the maximum civil money penalty of $19,192 for a single violation from each retailer. The retailers can pay the penalty, enter into a settlement agreement based on mitigation factors, request an extension of time to file an answer to the complaint, or file an answer and request a hearing.
Retailers that do not take action within 30 days after receiving the complaint risk a default order imposing the full penalty amount. 
Today’s actions bring the total number of CMPs filed against retailers for the sale of unauthorized e-cigarettes up to 67.
Previously, in September, and then again in November, FDA sought CMPs for similar amounts against 42 brick-and-mortar retailers across 18 states for the sale of unauthorized Elf Bar products. Today’s actions include retailers from 14 states and, for the first time, include cases against online retailers.
December 5, 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