Tag: regulation

Civil Money Penalties for 21 Vape Shops

The U.S. Food and Drug Administration has 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.
The complaints announced today represent the first set of CMPs FDA has filed for the sale of unauthorized Esco Bars e-cigarettes. “These retailers were duly warned of what could happen if they continued selling these unauthorized e-cigarettes,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “They should have acted responsibly to correct the violations, but they chose not to do so and now must face the consequences of that decision. FDA won’t sit back and tolerate inaction to comply with the law.”
Currently, $20,678 is the maximum civil money penalty amount FDA can seek for a single violation from each retailer, consistent with similar CMPs sought against retailers for the sale of unauthorized Elf Bar products in Sept., Nov., and Dec. of 2023.
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 a complaint risk a default order imposing the full penalty amount, according to the release.
“Today’s CMP actions are just the latest in the continued, comprehensive push by FDA to take action across the supply chain to remove unauthorized e-cigarettes, particularly those that are popular among youth, from the marketplace,” the release states. “As of Jan. 30, 2024, FDA has issued more than 440 warning letters and 88 CMPs to retailers, including brick and mortar and online retailers, for selling unauthorized tobacco products.
“In addition to actions involving retailers, FDA has issued more than 660 warning letters to firms for illegally manufacturing and/or distributing unauthorized new tobacco products, including e-cigarettes.
“The agency has also filed civil money penalty complaints against 48 e-cigarette firms for manufacturing unauthorized products and sought injunctions in coordination with the U.S. Department of Justice against seven manufacturers of unauthorized e-cigarette products.”
January 30, 2024
Bidi Vapor Appeals MDO of Tobacco Bidi Stick

Bidi Vapor will appeal the U.S. Food and Drug Administration’s January 2024 decision to deny the company’s premarket tobacco product application (PMTA) for Bidi Vapor’s “Classic” tobacco-flavored Bidi Stick electronic nicotine-delivery system.
Bidi Vapor has asked the U.S. Court of Appeals for the 11th Circuit to review the marketing denial order (MDO), which Bidi Vapor believes violates 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 Bidi Vapor founder and CEO Niraj Patel in a statement. “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.”
With its recent legal challenge, Bidi Vapor hopes to build on its record of successfully contesting adverse FDA decisions. In August 2022, the 11th Circuit set aside the original MDOs issued for its 10 nontobacco-flavored products. That ruling put the 10 PMTAs back into scientific review and allowed those flavors to remain available for sale pursuant to the FDA’s compliance policy for deemed tobacco products. During this evaluation period, the 10 nontobacco-flavored products are still under FDA enforcement discretion.
January 29, 2024
VTA: MDOs Continue ‘De-Facto’ Flavor Ban
Tony Abboud, director of the Vapor Technology Association.
When the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) issued marketing denial orders (MDOs) for Suorin and Blu PLUS+ e-cigarette products, Tony Abboud, executive director of the Vapor Technology Association (VTA), said the decision was just the latest installment of the FDA and CTP’s efforts to implement its de-facto ban on e-cigarettes in the U.S.
“The constant refrain from CTP is that e-cigarette manufacturers are not providing ‘sufficient scientific evidence’ in their PMTAs, yet CTP refused to answer the Reagan-Udall Foundation’s most fundamental criticism of CTP’s entire regulatory process: that CTP has not clearly articulated what is required to prove what is appropriate for the protection of the public health (APPH) or how it is interpreting what is APPH,” Abboud stated in a release.
He stated that the FDA has failed to objectively define the APPH standard while simultaneously using it to deny marketing authorization to critical smoking cessation and harm-reduction products, which is a “gross overreach” for any governmental institution whose mandate is to follow the science.
“Courts have found that the process has become ‘arbitrary and capricious’ in practice, with CTP leadership choosing on a case-by-case basis how the standard ought to be defined,” he stated. “Meanwhile, companies are simply trying to do the right thing by complying with and adhering to the PMTA process set forth by the FDA.”
Abboud stated that the actions of the FDA and CTP do nothing to protect public health or help Americans who smoke. “VTA once again calls on CTP to reverse course on its misguided actions and restore scientific integrity to its regulatory and decision-making process. Enough is enough,” he wrote.
January 21, 2024
FDA Denies Marketing of Suorin, Blu Plus+
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 Issues MDOs for SMOK
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 MDOs 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
Spain Bans Flavors for Heated Tobacco

Credit: Jorge Argazkiak
The government in Spain has approved a decree that equates the regulation of heated tobacco products with that of traditional cigarettes, prohibiting products with flavorings. The rules do not apply to all vaping products, such as e-cigarettes.
In addition, it will now be mandatory for labels to contain warnings for heated tobacco products that they products are harmful to health, according to Catalan News.
The country’s Ministry of Health is considering further regulations.
“The ban will cover tobacco products with an aroma or flavor in their components (such as filters, papers, packaging, or capsules) or any other technique that allows modifying the smell or taste of the products or intensify the smoke. Filters, papers and capsules cannot contain tobacco or nicotine,” the report states.
Heated tobacco products must include the following informative message on their outer packaging: “Tobacco smoke contains more than 70 carcinogenic substances,” with relevant accompanying photographs.
This decree will enter into force three months after its publication in the official state gazette (Boletín Oficial del Estado).
January 16, 2024
Colorado May Allow County Flavor Bans
Credit: Nathan
A Senate bill in Colorado would grant counties the power to regulate or ban the sale and distribution of flavored vaping, cigarettes and other nicotine products.
Senate Bill 24-022 defines flavored nicotine and tobacco products as anything with a scent or flavor other than tobacco, including products that induce a cooling or numbing sensation.
Citing the U.S. Centers for Disease Control and Prevention, Rep. Kyle Brown, a sponsor of the legislation, said nearly 9 out of 10 adults who smoke every day first tried smoking “before they turned age 18.”
He said tobacco products are linked to negative health effects, including cancer, and that e-cigarettes and other vape products are “highly addictive and can harm adolescent brain development.”
A similar bill was introduced during the 2022 legislative session but died in the Senate. At the time, Gov. Jared Polis said he opposed the bill because he thought the matter should be handled at a local level.
January 15, 2024
Virginia Proposes Approved Product List

Virginia has long been the epicenter of the tobacco industry; now, two bills that would ban flavored vaping products have been filed with the state’s General Assembly.
Sponsors say Virginia should step in where Washington has been ineffective in blocking unregulated flavored e-cigarettes, such as Elf Bar disposables, off of store shelves.
The bills, House Bill 1069 and Senate Bill 550, call for a fine of $1,000 a day for each product sold that the U.S. Food and Drug Administration has not authorized to be marketed in the U.S.
The Attorney General would maintain a directory of legal products, much like Alabama and Louisiana. Products not listed in that directory could not be legally sold in Virginia.
The bill states any retailer and wholesaler that sells or distributes any liquid nicotine or nicotine vapor product in the state is subject to scheduled or unscheduled compliance checks carried out by the Attorney General’s Office for enforcement purposes.
Manufacturers must certify, in a filing with the Attorney General, that an FDA marketing authorization order covers their product or is exempt from that because it was sold in the U.S. before 2016 or subject to a premarket tobacco product application dating from before 2020.
“It’s a public health issue,” said Del. Rodney Willett, who sponsored the House of Delegates bill.
“They’re targeting kids with the flavors,” he said, according to media reports. “When I walk into a convenience store, I’m just stunned by the number of these products that are for sale.”
January 13, 2024
Taxes had ‘No Impact’ on Singapore’s Vape Ban

The Singapore government said that the potential loss in revenue from tobacco tax was not a factor in its decision to ban the use of e-cigarettes in 2018.
In his reply to a question by a Workers’ Party and Sengkang member of Parliament, Deputy Prime Minister Lawrence Wong, who is also the Minister for Finance, said, “The Government’s decision to ban the use of e-cigarettes in 2018 was based on public health considerations, to protect our population from the harms of these products. The potential loss in tobacco tax revenue from the reduced consumption of tobacco products was not a factor in this decision.”
… our priority is to protect the health of our population and prevent e-cigarettes from causing harm to our people, especially to younger Singaporeans.”

Lawrence Wong
Wong added that if the government were to legalize and tax e-cigarettes “the challenges would be similar to those we encounter for cigarettes and other tobacco products today,” according to a Yahoo news report.
“In any case, the government has no plans to change our current approach, as our priority is to protect the health of our population and prevent e-cigarettes from causing harm to our people, especially to younger Singaporeans,” he said.
January 12, 2024
Durbin Blasts FDA Failures in Vape Rules

U.S. Senate Majority Whip Dick Durbin has again decried the Food and Drug Administration on its unacceptable failure to “protect children from the dangers of vaping” as the agency continues to miss and delay critical deadlines.
In a press release, Durbin stated that he has repeatedly criticized the FDA for its long-overdue review of premarket tobacco product applications (PMTAs) from e-cigarette manufacturers, which originally had a federal court deadline of September 9, 2021.
FDA has missed that court-ordered deadline by 28 months as unauthorized e-cigarettes flood the market.
During his speech, Durbin also called on the Biden Administration to swiftly implement a proposed public health rule to prohibit the production and retail sale of menthol cigarettes and flavored cigars.
“I know this President cares deeply about the toll of cancer. It has touched his family personally, as it has mine,” the Senator said. “If we want to make a difference in the health of Americans—and set a legacy for future generations—then the Administration must finalize this public health measure to end Big Tobacco’s predatory promotion of menthol cigarettes. Lives hang in the balance.”
The FDA stated in prior status reports for 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.
January 12, 2024