Category: Regulation

SWT Global Asks 8th Circuit to Stay PMTA Denials

A Missouri-based maker of menthol-flavored e-liquids urged a federal appeals court to revive its application with the U.S. Food and Drug Administration to continue selling its products, saying the agency had not given it fair notice of what approval would require.
The appeal by SWT Global Supply Inc. is one of a slew of similar cases by e-cigarette companies in the wake of the FDA’s rule deeming e-cigarette products to be subject to the same law as combustible cigarettes and the agency’s subsequent denial of millions of premarket tobacco product applications (PMTAs) by manufacturers to sell their products, according to media reports. The question of whether the FDA acted fairly has already created a split among federal appeals courts.
Jerad Najvar, a lawyer for SWT, told a three-judge panel of the 8th U.S. Circuit Court of Appeals that the FDA had denied SWT’s applications because the company had not presented a controlled trial or study showing that the menthol liquids can help adult smokers quit smoking as compared to tobacco-flavored liquids. He said the agency’s guidance gave no hint that it would require such a study for approval.
The question of whether the FDA acted fairly has already created a split among federal appeals courts. Most other appeals courts that have considered similar appeals by manufacturers over denied applications – including the D.C., 2nd, 3rd, 4th, 7th and 9th Circuits – have sided with the FDA. However, the 5th Circuit last month ordered the agency to reconsider the denial of two companies’ applications in a case also involving menthol-flavored products.
Jerad Najvar, a lawyer for SWT, told a three-judge panel of the 8th U.S. Circuit Court of Appeals that the FDA had denied SWT’s applications because the company had not presented a controlled trial or study showing that the menthol liquids can help adult smokers quit smoking as compared to tobacco-flavored liquids. He said the agency’s guidance gave no hint that it would require such a study for approval.
Navjar said the lack of fair notice was particularly hard on small companies like SWT with limited resources. “A client like mine doesn’t have a lot of arrows in its quiver when it’s trying to fight a decision by a federal agency,” he said.
Catherine Padhi, a lawyer for the FDA, said that comparing products’ effectiveness to tobacco-flavored products was “a natural part of the risk-benefit analysis,” given that tobacco-flavored products have a “much-reduced risk of enticing children.” She also said that SWT could submit additional information to support its application.
February 16, 2024
Nebraska Seeks Vape Product List, End Online Sales

Credit: Sean Pavone Photo
The General Affairs Committee in Nebraska heard testimony on a bill that its sponsors say seeks to reduce access to vaping devices by minors in Nebraska.
LB1296, introduced by Seward Sen. Jana Hughes, would prohibit the sale of electronic nicotine delivery systems (ENDS) products that the U.S. Food and Drug Administration has not approved.
Violations would be considered a deceptive trade practice under the Uniform Controlled Substances Act. The state aims to use the same list that is used by states that have passed similar laws, such as Alabama and Louisiana, according to a release.
Devices that are pending approval from the FDA would be authorized for sale under the bill, but online sales of ENDS, regardless of FDA approval, would be prohibited.
“We have a serious problem on our hands that threatens to undermine the progress made over the past 40 years in reducing the use of nicotine products by our kids,” Hughes said.
LB1296 also would create a directory of ENDS manufacturers who have received or sought FDA approval. Beginning April 1, 2025, each manufacturer must register with the state tax commissioner and pay a $500 initial certification fee per device and $500 annually.
Payments received would be directed to the state Department of Revenue to reimburse the cost of enforcing the bill’s provisions.
The committee took no immediate action on LB1296.
Louisiana’s passed a law that bans retailers from selling vape products not listed on a state-approved registry, known as the V.A.P.E. Directory. Alabama and Florida use the same list.
To receive authorization, products need a marketing order from the U.S. Food and Drug Administration or must meet one of several narrow exceptions, which favor products that have been on the market since at least 2016.
The state’s Office of Alcohol and Tobacco Control (ATC) released its list of nearly 400 approved vape products
February 9, 2024
Health Department Wants Stricter Vape Rules

Image: Oleksii
The Philippines Department of Health (DOH) is gathering data on vaping prevalence in the country, reports Malaya Business Insight.
DOH Undersecretary Eric Tayag said the information will be used to convince policymakers to strengthen laws against vaping.
According to the Global Youth Tobacco Survey (GYTS), e-cigarette users among the youth increased from 11.7 percent in 2015 to 24.5 percent in 2019.
The DOH statement comes after nine former health officials called on the Philippine delegation to the 10th Session of the Conference of the Parties (COP10) of the World Health Organization Framework Convention on Tobacco Control (FCTC) to take the lead in pushing for the fight against vapes and electronic cigarettes.
The former DOH secretaries and undersecretaries believe the Philippine delegation should speak about the serious threat to public health brought about by weak Philippine regulations on e-cigarettes and vapes.
February 7, 2024
U.S. House Lawmakers Push FDA Chief on Vaping

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A news media outlet is reporting that U.S Reps. Rob Wittman and Raja Krishnamoorthi wrote a letter to Robert Califf, head of the Food and Drug Administration, asking for answers to inquiries they had sent to the agency in November.
“While we appreciate the recent joint federal operation resulting in the seizure of more than 1.4 million units of illegal e-cigarettes in December 2023, much more needs to be done,” the letter exclusively provided to The Hill states. “Illegal vaping products from the PRC [People’s Republic of China] now make up more than half of all vaping products sold in the United States and contribute significantly to underage vaping rates.”
The lawmakers specifically cited the brand Elf Bar as being “illegally imported” from China. The product line features brightly colored e-cigarettes with various fruity flavors, which anti-vaping advocates say attract youth.
The lawmakers asked what the FDA planned to do to stem the flow of e-cigarettes from China and whether it planned to enforce legal proceedings against manufacturers. They also asked why the FDA has not issued a rule requiring foreign manufacturing registration, which the Tobacco Control Act allows for.
The agency has repeatedly delayed its reviewing of premarket tobacco product applications (PMTAs), which are required for new tobacco products to be legally marketed in the U.S. The FDA previously said it would finish reviewing applications by the end of December 2023.
The FDA now states that it will complete all covered marketing applications by June 30. In its latest court-ordered status report, the agency stated that continued review is necessary in light of recent judicial decisions, including the D.C. Circuit’s decision in Fontem US.
Krishnamoorthi and Wittman asked when the FDA would complete its reviews and pressed the agency over the delay.
February 7, 2024
FDA Denies Blu Marketing of 5 Flavored Products
Credit: Fontem US
The U.S. Food and Drug Administration continued its de-facto flavor ban and issued marketing denial orders (MDOs) to Fontem US LLC for four Blu disposables and one Myblu brand e-cigarette product.
The currently marketed products that received an MDO are:

Blu Disposable Menthol 2.4%
Blu Disposable Vanilla 2.4%
Blu Disposable Polar Mint 2.4%
Blu Disposable Cherry 2.4%
Myblu Menthol 1.2%
After reviewing the company’s premarket tobacco product applications (PMTAs), the regulatory agency determined that the applications lacked sufficient evidence to demonstrate that permitting marketing of the products would be appropriate for the protection of the public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act, according to a press note.
“The application lacked sufficient evidence regarding harmful and potentially harmful ingredients in the aerosol for one product and battery safety for several products,” the release states. “Additionally, the applicant did not present sufficient data demonstrating that the 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.”
While the FDA has approved 23 vaping products, none have been a flavored product. Last month, the agency also issued Fontem US, LLC MDOs for its Blu PLUS+ brand e-cigarette products. Fontem is expected to appeal the FDA decision.
February 5, 2024
U.S. FDA Warns 14 More Sellers of Flavored Vapes

Credit: Chris Titze Imaging
The U.S. Food and Drug Administration has again issued warning letters to several small business owners for selling flavored disposable vaping products.
The regulatory agency issued letters to 14 online businesses for selling unauthorized e-cigarette products. The warning letters cite the sale of disposable e-cigarette products marketed under brand names, including Elf Bar/EB Design, Lava Plus, Funky Republic/Funky Lands, Lost Mary, Cali Bars, Cali Plus, and Kangvape.
“These warning letters were informed by FDA’s ongoing monitoring of multiple surveillance systems to identify products that are popular among youth or have youth appeal, an agency press release states. “Findings from the 2023 National Youth Tobacco Survey found that more than 50 percent of youth who use e-cigarettes reported using the disposable e-cigarette brand Elf Bar; in 2023, the manufacturer of Elf Bar began marketing the product under the name EB Design.”
In addition, the brands Lava Plus, Funky Republic/Funky Lands, Kangvape, Cali, and Breeze 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.
Retailers receiving warning letters sold or distributed e-cigarette products in the United States that lack marketing authorization from the FDA violate the Federal Food, Drug, and Cosmetic Act.
Warning letter recipients are given 15 working days to respond with the steps they will 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.
As of Jan. 30, 2024, FDA issued more than 440 warning letters and 88 CMPs to retailers for the sale of illegal e-cigarettes, including through a series of nationwide inspection efforts of brick-and-mortar retailers, according to the release.
Earlier this week, the FDA issued complaints for civil money penalties (CMPs) against 21 brick-and-mortar retailers for selling unauthorized Esco Bars e-cigarettes.
In a press release, the agency stated that it had previously issued each retailer a warning letter for their sale of unauthorized tobacco products. However, follow-up inspections revealed that the retailers had failed to correct the violations.
The agency now seeks the maximum penalty of $20,678 from each retailer.
February 1, 2024
Kaival Brands Appeals MDO of Tobacco Bidi Stick

A recent marketing denial order issued for a tobacco-flavored Bidi Stick only applies to one Bidi device. The company, Bidi Vapor, currently has 10 other flavors still in the U.S. Food and Drug Administration’s premarket tobacco product application (PMTA) process.
Bidi Vapor’s “Classic” tobacco-flavored Bidi Stick ENDS device is the only product affected. Kaival Brands, parent to Bidi Vapor, holds the worldwide license to distribute products made by Bidi Vapor.
In response to the MDO, Bidi Vapor filed a petition requesting that the U.S. Court of Appeals for the 11th Circuit review the MDO, which Bidi Vapor believes was, among other things, “arbitrary and capricious, in violation of the Administrative Procedure Act.” Bidi Vapor will also be seeking a stay of the MDO pending the outcome of the litigation.
“Bidi Vapor disagrees with the FDA’s decision and is taking immediate action accordingly,” said Niraj Patel, the founder and CEO of Bidi Vapor and Chief Science Officer and founder of Kaival Brands. “In the meantime, it is important to note that the decision only affects the ‘Classic’ or tobacco-flavored Bidi Stick. The remaining ten Bidi Stick flavors are still under FDA scientific review and remain in distribution in the United States through Kaival Brands, subject to the FDA’s enforcement discretion.”
Bidi Vapor has a history of successful outcomes when contesting adverse FDA decisions, having received a favorable 11th Circuit ruling in August 2022 that set aside the original MDOs received for its 10 non-tobacco flavored products, according to a press release.
“While we are disappointed with the FDA’s decision, we are in close contact with Bidi Vapor and laser-focused on selling the Bidi Vapor products that we are permitted to,” said Barry Hopkins, executive chairman of Kaival Brands. “Like Bidi Vapor, we are fully committed to the legal and responsible use of our products. Moreover, we are committed to increasing Kaival Brands’ revenues by strengthening our existing business and also diversifying our product portfolio, as evidenced by the intellectual property we acquired in May 2023 from GoFire, Inc.”
January 29, 2024
Ohio Veto Override Bans Local Tobacco Rules
Credit: Lucitanija
Local governments in Ohio cannot enact tobacco and nicotine rules. Those regulations must come from the state level.
The Ohio Senate on Wednesday voted to override Gov. Mike DeWine’s veto on a provision prohibiting local governments from enacting regulations on the sale of tobacco — including by banning flavored vaping products.
The policy, which will go into effect in three months, means that newly enacted flavored tobacco bans in Columbus, Worthington and other central Ohio cities cannot be enforced.
Republican state lawmakers have tried multiple times to prohibit local governments from restricting the sale of tobacco, only to be thwarted by DeWine’s vetoes.
In 2022, he struck down such a proposal. Last July, he struck the provision from the rest of the state budget, saying that local bans were “essential” to curb nicotine use, especially among children, without a statewide ban in place.
January 25, 2024
Juul Labs Supports Tighter Rules on Youth Access

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Juul Labs wants tighter e-cigarette regulations to help stave off youth demand while also making the industry safer overall.
In a recent open letter addressed to the Florida House of Representatives and Senate, the maker of JUUL vaping products urged lawmakers to endorse SB 1006 and HB 1007, legislative proposals to regulate the marketplace for legal nicotine vaping products in Florida.
The Senate and House versions of the bill both require state regulators to develop a directory listing of certified nicotine products manufacturers and certified nicotine products. They also subject retail and wholesale nicotine products dealers to inspections or audits; prohibits sale, shipment, or distribution of certain nicotine products into this state; provides criminal penalties; requires entities that seek to sell nicotine products or dispensing devices to obtain wholesale nicotine products dealer permit; provides permit holders must consent to inspections and searches without warrant; provides for seizure and destruction of unlawful nicotine products, according to Florida’s Senate.
In the letter, Juul Labs said it “is on a mission to transition the world’s billion adult smokers away from combustible cigarettes, eliminate their use, and combat underage usage of our products,” according to media reports.
The letter highlighted what the company described as extensive efforts to ensure product quality and compliance with regulatory standards. The letter also emphasized significant investments in product development, regulatory science, and manufacturing quality controls.
Penned by Juul Labs’ regional director for State Government Affairs, Jennifer Cunningham, the letter states that the company wants a better-regulated market. Cunningham cited measures implemented by Juul Labs, including supporting “Tobacco 21” laws to raise the legal age for tobacco product sales to 21, restricting vaping flavors to tobacco and menthol, limiting product purchases per transaction, and promoting retail partner compliance through ID checking and technology advancements.
However, despite these efforts, the letter points out the challenges posed by a burgeoning illegal vape market in Florida, with the state being the primary destination for sales of illicit vapor products in the U.S. The vape maker also expressed readiness to assist Florida legislators in formulating policies that foster a well-regulated market for legal vapor products.
January 23, 2024
FDA Issues MDO for Tobacco-Flavored Bidi Stick
The U.S. Food and Drug Administration has issued a marketing denial order (MDO) to Bidi Vapor LLC for its Bidi Stick classic e-cigarette. The Bidi Stick is a closed-system, disposable, tobacco-flavored vaping device.
“FDA has a key role to protect the public from the dangers of tobacco use,” said Matthew Farrelly, director of the Office of Science within FDA’s Center for Tobacco Products (CTP). “Integral to that role, our tobacco application review process relies on scientific evidence that demonstrates a product provides a net benefit to public health that outweighs the known risks. The science in this application did not show that.”
The company must not market or distribute this product in the United States or they risk FDA enforcement action. The company may submit a new application to the agency for review that addresses these deficiencies.
After reviewing the company’s PMTA, the FDA determined that the application lacked sufficient evidence to demonstrate that permitting marketing of the product would be appropriate for the protection of the public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act, an FDA press release states. Specifically, evidence submitted by the applicant did not demonstrate an overall net benefit to people who use tobacco products and lacked sufficient evidence to address health risks.
“The Center has made considerable progress in reviewing the massive volume of tobacco product applications submitted to the agency, thanks to the tireless efforts of our dedicated legion of civil servant scientists,” said Brian King, director of the CTP. “The Center remains committed to processing submitted applications as expeditiously as possible while ensuring the utmost scientific integrity of the reviews.”
Kavial Brands, the manufacturer of Bidi Stick, is expected to appeal the decision.
China-based Shenzhen IVPS, the parent to SMOK brand vaping devices, filed an appeal with the New Orleans, Louisiana-based U.S. Court of Appeals for the Fifth Circuit after it received an MDO and was joined in the suit by a Dallas, Texas-based distributor of the SMOK products that were denied marketing.
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.
January 23, 2024