Tag: PMTA

  • FDA Seeks Fines for 18 Sellers of Illegal Vapes

    FDA Seeks Fines for 18 Sellers of Illegal Vapes

    Credit: Adobe Stock

    The U.S. Food and Drug Administration announced it is seeking fines against two brick-and-mortar retailers and 16 online retailers who have continued to sell unauthorized vaping products.

    The regulatory agency previously issued warning letters to these retailers for their sale of unauthorized tobacco products; however, follow-up inspections revealed that the retailers had failed to correct the violations, according to an agency press release.

    “Many recipients of warning letters correct the violative conduct, the release states. “However, failure to promptly correct the violations can result in additional enforcement actions such as civil money penalties, as is the case for these companies.”

    The FDA has filed civil money penalty complaints against 79 manufacturers and 175 retailers for distribution and/or sale of unauthorized tobacco products. Additionally, the FDA works closely with federal enforcement partners, including through a newly announced federal interagency task force.

    For example, FDA and U.S. Customs and Border Protection recently announced the seizure of $76 million in illegal e-cigarettes.

    A bipartisan group of influential House lawmakers recently stated their doubts about the Food and Drug Administration’s proposal to begin collecting fees from e-cigarette companies, akin to how the agency charges fees to tobacco firms.

    FDA officials say that the fees would give regulators resources to tackle the thousands of illegal vapes lining store shelves.

  • FDA Clears RespiRx IND Inhaler Application

    FDA Clears RespiRx IND Inhaler Application

    Image: Qnovia

    The U.S. Food and Drug Administration has cleared an Investigational New Drug (IND) application for Qnovia’s RespiRx nicotine inhaler (QN-01).

    According to Qnovia, the RespiRx is the first truly inhalable nicotine replacement therapy (NRT) to assist smokers attempting to quit smoking.

    The company will initiate a Phase 1, randomized, crossover, open-label trial to determine the pharmacokinetics, safety and tolerability following self-administration of nicotine-containing products in up to 24 healthy adult subjects who currently smoke combustible cigarettes.

    “The FDA clearance of our IND application for QN-01 marks a significant achievement for Qnovia as we transition to a clinical-stage therapeutics company,” said Qnovia CEO Brian Quigley in a statement.

    “Our U.S. clinical development plan is derisked by the positive first-in-human data we generated last year in support of advancing QN-01 in the United Kingdom where we demonstrated pulmonary delivery and a superior pharmacokinetic profile for the RespiRx when compared to existing nicotine replacement therapies,”

    “The next step for our U.S. program is to initiate a randomized Phase 1 trial that evaluates QN-01 compared to the Nicotrol Inhaler and combustible cigarettes in a head-to-head comparison. We remain on track to dose our first patient in the fourth quarter of 2024 and in parallel will be advancing to a pivotal clinical trial in the U.K. to support an MAA submission [Marketing Authorization Application] to the MHRA [ Medicines and Healthcare products Regulatory Agency] in 2026.”

    Qnovia’s proprietary drug/device combination already demonstrated dose-dependent pharmacokinetics, pulmonary delivery and was well tolerated in a first-in-human study conducted to support advancing QN-01 in the U.K., according to the company.

    “There have been no treatment options for smoking cessation approved in the U.S. in over 20 years. As a result, attempting to quit ‘cold turkey’ remains the most popular method of quitting smoking,” said Mitch Zeller, Qnovia’s policy and regulatory strategy advisor.

    “There is an extraordinary public health need for truly innovative products to help health-concerned smokers stop using cigarettes. Any effort to reduce the death and disease caused by tobacco use must include new and better tools in the treatment toolkit,” Zeller added.

  • Penalties for U.S. Retailers Selling Illegal Vapes

    Penalties for U.S. Retailers Selling Illegal Vapes

    The U.S. Food and Drug Administration is seeking fines against two brick-and-mortar retailers and nine online retailers. The FDA previously issued warning letters to these retailers for their sale of unauthorized tobacco products, however, follow-up inspections revealed that the retailers had failed to correct the violations. Accordingly, the agency is now seeking a civil money penalty of $20,678 from each retailer.

    To date, the FDA has filed civil money penalty complaints against 70 manufacturers and 160 retailers for distribution and/or sale of unauthorized tobacco products. These actions reflect the FDA’s continued dedication to bringing enforcement actions against entities along the supply chain who violate the law relating to tobacco products.

    The FDA has currently authorized 34 e-cigarette products and devices. The agency maintains a printable one-page flyer of all authorized e-cigarette products that retailers can easily consult to determine which products may be lawfully marketed and sold in the United States. Entities manufacturing, importing, selling or distributing e-cigarettes that lack the required premarket authorization risk enforcement actions.

     

  • Registry Rules in Kentucky Decimating Vape Shops

    Registry Rules in Kentucky Decimating Vape Shops

    Credit: Zoran Milic

    A leading figure in the retail vaping industry in Kentucky has stated that businesses statewide are experiencing a decline. A new law that affects most vaping product outlets will come into effect this January.

    Tony Florence owns six vape stores in Kentucky and a manufacturing facility. He said his father died from lung cancer and his interest in the business has been to provide an avenue to help people quit smoking cigarettes. Florence said open-system vaping devices can work to that end.

    “If it got to the point where 20 years from now, I went out of business because there were no more people smoking and no more people vaping, mission accomplished. I’m good with that,” said Florence, according to media reports.

    But Florence predicts a vast majority of vape shops in Kentucky will be closing in the months ahead. He said HB 11, passed earlier this year, limits legal sales to relatively few products. Florence said disposable vape devices often do have higher nicotine levels, which can foster continued use.

    Florence said he’s seen a trend since April when lawmakers passed the legislation.

    “More and more stores just going out of business. They are not renewing leases. I mean, from a manufacturing-distribution standpoint, I’m down 80 percent since April. Because stores are just … they’re either not buying new product because they’re selling off the old or they’re going out of business,” said Florence.

  • FDA Almost Finished Reviewing PMTA Products

    FDA Almost Finished Reviewing PMTA Products

    Photo: thodonal

    The U.S. Food and Drug Administration is almost done reviewing premarket tobacco product applications (PMTAs) for mass-market vaping products.

    In a July 22 progress report the agency said it had taken action on 185 of 186 marketing applications for e-cigarette products covered by a 2022 court order, which applied to products with significant market share that filed applications by Sep. 9, 2020.

    The manufacturers of those orders have received either a marketing denial order (MDO) or FDA authorization.

    Observers say the one application still under review is Juul. The FDA issued an MDO to Juul in 2022, but quickly stayed its order and agreed to further review the application. In June, the FDA rescinded the denial order, returning Juul’s products to full scientific review.

    In its report, the FDA says it has also issued more than 18 million refuse-to-accept decisions, over 67,000 refuse-to-file decisions, and approximately 46,000 MDOs—most of them for bottled e-liquid made by small- to medium-sized manufacturers.

    The new progress report is the most recent in a series of reports mandated by the U.S. District Court for Maryland as part of its decision that forced the FDA to move the PMTA submission deadline forward.

  • More Warnings for Sellers of Elf Bar, Lost Mary Vapes

    More Warnings for Sellers of Elf Bar, Lost Mary Vapes

    Credit: Chris Titze Imaging

    The U.S. Food and Drug Administration announced on July 25 that it had issued warning letters to 80 brick-and-mortar retailers in 15 states for selling unauthorized e-cigarette products, including Elf Bar and Lost Mary. 

    The regulatory agency also filed complaints for civil money penalties (CMPs) against eight other retailers who failed to take action after being previously warned about selling unauthorized e-cigarettes.

    “These warning letters and CMPs are a result of FDA’s ongoing monitoring of multiple surveillance systems to identify products that are popular among youth or have youth appeal. The 2023 National Youth Tobacco Survey, according to an FDA release, found that more than 50 percent of youth who use e-cigarettes reported using the brand Elf Bar.

    Additionally, the brand Lost Mary—manufactured by the same firm as Elf Bar—was identified as popular or youth-appealing following an agency review of retail sales data and emerging internal data from a youth-use survey. 

    The FDA generally sends warning letters the first time an investigation or inspection reveals a violation. Warning letter recipients have 15 working days to respond with the steps they will take to correct current violations and prevent future violations. However, failure to promptly correct the violations may result in additional FDA action, including CMPs.

    For the retailers receiving the eight CMPs, the FDA previously issued warning letters for to them for selling unauthorized tobacco products. Follow-up inspections revealed that the retailers had failed to correct the violations, and the agency is now seeking $20,678 from each retailer.

    These actions are the latest in the FDA’s ongoing efforts to address the marketing and sale of unauthorized e-cigarettes that appeal to youth. Throughout the last year, the agency has conducted inspections of retailers to identify those selling unauthorized e-cigarettes, including in May, March, and February. As a result of these actions, the FDA has issued more than 690 warning letters and more than 140 civil money penalty actions to retailers for the sale of unauthorized e-cigarettes.

    To date, the FDA has authorized 34 e-cigarette products and devices. These are the only e-cigarette products that currently may be lawfully marketed and sold in the United States. Further information on tobacco products that may be legally marketed in the United States is available in the FDA’s Searchable Tobacco Products Database.

  • Court Bans Soul Vapor From Selling Illegal Vapes

    Court Bans Soul Vapor From Selling Illegal Vapes

    Credit: Yelp

    The United States District Court for the Southern District of West Virginia enjoined Soul Vapor LLC, a West Virginia-based company, and the company’s owner, Aurelius Jeffrey, from “directly or indirectly manufacturing, distributing, selling, and/or offering for sale any new tobacco product” that has not received marketing authorization from FDA.

    The court also ordered Soul Vapor and Jeffrey to destroy e-cigarette products that were manufactured by Soul Vapor and are in their custody, control, or possession.

    “FDA vigorously enforces the law and will continue to work with the U.S. Department of Justice to take enforcement actions, such as pursuing permanent injunctions, against those who defy the law,” said John Verbeten, director of CTP’s Office of Compliance and Enforcement. “This injunction is another reminder that FDA will use the full scope of its enforcement tools to protect public health.”

    According to the complaint filed by the U.S. Department of Justice (DOJ) on FDA’s behalf, the defendants were previously warned they were in violation of the Federal Food, Drug, and Cosmetic Act’s (FD&C Act) premarket review requirements for manufacturing, selling, and distributing new tobacco products by failing to first obtain marketing authorization from FDA. The complaint also alleged that the defendants submitted materially false information to FDA.

    “The court’s order is yet another example of how FDA – in coordination with federal partners – is successfully ramping up enforcement to combat unauthorized e-cigarettes,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “We will continue to work with our federal partners to identify and bring enforcement actions against bad actors, while continuing to educate stakeholders about the need for additional resources to best support these efforts.”

    CTP’s ability to pursue enforcement actions, including injunctions, is solely dependent on user fees. CTP is 100 percent funded by user fees, which the FD&C Act authorizes FDA to collect from manufacturers and importers of cigarettes, snuff, chewing tobacco, roll-your-own tobacco, cigars, and pipe tobacco. However, this authority has not been updated to reflect the realities of the tobacco product marketplace, including the emergence of e-cigarettes over a decade ago, according to a release.

    As a result of this inequity, e-cigarette manufacturers are currently paying no fees while continuing to profit off unauthorized products. In order to enhance the CTP’s enforcement actions, including pursuit of injunctions, the agency has requested updated authority from Congress to modernize the tobacco user fee framework to apply to all tobacco products regulated by the agency.

    The injunction against Soul Vapor highlights the successful cooperation between FDA and the DOJ to enjoin bad actors from manufacturing, selling, and distributing unauthorized e-cigarette products. FDA has taken numerous judicial enforcement actions as a part of its comprehensive approach to enforcing the law, including eight injunctions in coordination with DOJ since 2022, according to the FDA.

    Additionally, on June 10, 2024, FDA and DOJ announced the creation of an interagency task force focused on using an all-government approach to combat the illegal distribution and sale of unauthorized e-cigarettes in the U.S.

  • FDA Issues Warning Letters for Delta-8 THC Foods

    FDA Issues Warning Letters for Delta-8 THC Foods

    Credit: FDA

    The U.S. Food and Drug Administration and the Federal Trade Commission (FTC) issued warning letters to five companies for illegally selling copycat food products containing delta-8 THC and introducing them into the marketplace in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

    The warning letters were issued to: Hippy Mood, Earthly Hemps, Shamrockshrooms.com, Mary Janes Bakery Co. LLC and Life Leaf Medical CBD Center. The FDA also issued a warning letter independently to the company GrowGod LLC for the same FD&C Act violations. 

    These warnings are part of the FDA and FTC’s ongoing joint effort to take action against companies selling illegal copycat food products containing delta-8 THC. In June 2023, the two agencies worked together to warn six other companies about selling edible food products containing delta-8 THC in packaging that could easily be confused for foods sold by popular national brands.

    All six of those companies no longer have such products in stock.

    “Inadequate or confusing labeling can result in children or unsuspecting adults consuming products with strong resemblance to popular snacks and candies that contain delta-8 THC without realizing it,” said FDA Principal Deputy Commissioner Namandjé Bumpus. “As accidental ingestion and/or overconsumption of delta-8 THC containing products could pose considerable health risks, the companies who sell these illegal products are demonstrating complete neglect for consumer safety.

    “The FDA will continue to work to safeguard the health and safety of U.S. consumers by monitoring the marketplace and taking action when companies sell products that present a threat to public health.”

    In June 2022, the FDA warned consumers about children accidentally ingesting food products containing delta-8 THC. From Jan. 1, 2021, to Dec. 31, 2023, the FDA received over 300 adverse event reports involving children and adults who consumed delta-8 THC products.

    Nearly half of these reports involved hospitalization or emergency department visits, and approximately two-thirds of these adverse events followed ingestion of delta-8 THC-containing food products such as candy or brownies. Adverse events included, but were not limited to, hallucinations, vomiting, tremors, anxiety, dizziness, confusion, and loss of consciousness.

  • FDA Officially Issues Notice of Better Web Portal

    FDA Officially Issues Notice of Better Web Portal

    Credit: Postmodern Studio

    According to a release, today, FDA’s Center for Tobacco Products (CTP) issued two notices in the Federal Register regarding its intention to launch CTP Portal Next Generation—an improved web portal for the submission of applications for certain new tobacco products—next year.

    The improvements are intended to:

    • Streamline electronic submission into one system for substantial equivalence (SE) reports and premarket tobacco product applications (PMTAs), amendments to previous submissions, and submission of general correspondence;
    • Introduce a more efficient submission process by eliminating the need for multiple tools, including combining PDF-editing software, FDA’s eSubmitter Desktop Tool, and FDA’s CTP Portal Web application in one place;
    • Provide tools to expedite data entry, guide applicants to relevant sections, and verify that the applicant has provided all required data.

    No action is needed from current users of any CTP systems regarding these planned improvements. Existing CTP Portal accounts, along with any pending or in-process applications, will be automatically migrated to the new CTP Portal Next Generation.

    CTP is committed to ensuring a smooth transition to CTP Portal Next Generation and will provide additional communication and support, including resources on how to use the new system, leading up to the change. 

  • Reynolds Files PMTA for Age-Gated Vuse Pro System

    Reynolds Files PMTA for Age-Gated Vuse Pro System

    R.J. Reynolds Vapor Co. has filed the final pre-market tobacco product application submissions with the U.S. Food and Drug Administration for its Vuse Pro age-gated device. The electronic nicotine delivery system device platform connects to a mobile application that verifies the consumer’s age through a third-party provider.

    Once verified, the device will unlock. It uses a unique design to only allow compatible Vuse Pro pods to be used. The technology and mobile application also enable features such as auto-lock and proximity lock to further secure device access.

    “Our PMTA submissions to the FDA underscore our commitment to both offering adult tobacco and vapor consumers choices as well as underage access prevention,” said Reynolds Executive Vice President of Scientific Research and Development Tim Nestor in a statement. “We don’t want our products in the hands of youth, period. The Vuse Pro ENDS platform provides a solution that limits access to adult consumers while also offering flavors that appeal to current adult smokers and a unique vapor experience.”