Tag: FDA

  • Distributors Accused of Racketeering

    Distributors Accused of Racketeering

    Credit: Vitalii Vodolazskyi

    New York City has filed a lawsuit in federal court charging four vaping product distributors and six persons associated with the companies for illegally selling flavored vaping products other than tobacco in the city. It is possible more companies will be added to the suit.

    The civil lawsuit, filed Monday in the U.S. District Court for the Southern District of New York, claims the defendants violated “nearly every federal, New York State and New York City law applicable to the marketing, distribution, and sale of flavored e-cigarettes, the sales of which are prohibited under laws enacted by all three jurisdictions.”

    Named in the suit are Magellan Technology Inc., Ecto World LLC (Demand Vape), Mahant Krupa 56 LLC (Empire Vape Distributors) and Star Vape Corp. Also named were Matthew Glauser, Donald Hashagen, Russell Rogers, Nikunj Patel, Devang Koya and Nabil Hassen. The suit also mentions Puff Bar, Elf Bar and Hyde products, however, those manufacturers were not named in the suit.

    The lawsuit alleges the defendants committed mail and wire fraud, alongside violations of New York City’s Administrative Code, New York State Public Health Law, and the federal Tobacco Control Act. The city also accuses the companies of violating both the federal Racketeering Influenced Corrupt Organizations (RICO) Act and the Prevent All Cigarette Trafficking (PACT) Act.

    The suit centers on disposable flavored vapes. However, the suit alleges that is seeking relief for any type of flavored e-cigarette product on the market. This would suggest the suit could grow into anyone entity that has sold flavored vaping products in the city.

    “Although this action speaks principally about (flavored disposables), the favorite type of electronic nicotine delivery system among youth and the most intentionally directed to that market, the City seeks relief for defendants’ violation of laws applicable to e-cigarettes regardless of the type of device with which the violation is committed,” the suit states. “Any non-FDA approved [the FDA authorizes for marketing; it does not approve products] e-cigarette containing a flavored e-liquid is governed by the laws under which the City’s claims are brought and the City seeks relief with respect to all such devices.”

    The city says it “seeks to recover monetary damages and civil penalties from the defendants, potentially totaling millions,” according to a press release. The suit also alleges the sales of disposable flavored vapes created a youth use crisis. The suit alleges the largest increase in youth use ever. The claim is unsupported by any facts.

    “By distributing devices that provide larger than normal doses of nicotine in a mild aerosol formulated to reduce or eliminate the harshness of burning tobacco and tasting pleasantly of fruit, candy or desserts, [flavored vaping device] manufacturers and distributors have triggered the largest increases in youth nicotine use ever seen,” the suit claims.

    The lawsuit states the city will seek triple the damages awarded at trial under the RICO guidelines.

  • FDA Urged to Reconsider Menthol Ban

    FDA Urged to Reconsider Menthol Ban

    Image: Tobacco Reporter archive

    Twenty U.S. representatives are urging the Food and Drug Administration to reconsider the proposed ban on menthol cigarettes and flavored cigars, reports CSP. The ban would exacerbate existing illicit trade of tobacco products, according to a letter sent to FDA Commissioner Robert Califf.

    A final rule is set to be published in August but would not go into effect until at least next year.

    “When Congress enacted the Tobacco Control Act in 2009, the intent was for the FDA to use regulation to ensure proper oversight of the tobacco industry. When prohibition-based actions result in large illicit markets, it causes more risk for Americans, more crime, more burden on law enforcement and more opportunities for policy and community conflict,” the letter said. “We urge FDA to take illicit markets seriously. The FDA can do this by using regulation to safely meet adult consumer demand while also establishing controls on how those products are marketed to protect kids. We urge you to reconsider FDA’s proposed rules on menthol cigarettes and flavored cigars and refrain from any further prohibition-based actions that threaten to expand illicit markets.”

    The proposed ban would result in about one-third of all cigarettes sold in the U.S. becoming illegal, according to the letter, highlighting concern that the ban would lead to a similar illicit market to vapor products.

    “With this prohibition-based approach, we now see thriving illicit e-vapor markets all over the U.S.,” the letter stated, pointing to states that have enacted flavor bans. “These markets include illegal products with some of the highest incidence of underage use; products made in Chinese manufacturing facilities with no FDA oversight; products being illegally smuggled over U.S. borders and through U.S. ports; products being trafficked in violation of state and local criminal laws; and products being sold without age verification.”

    The letter was signed by U.S. Representatives John Rutherford, Don Bacon, David Valadao, Ben Cline, C. Scott Franklin, Troy Nehls, Richard Hudson, John Rose, Jerry Carl, Eric “Rick” Crawford, Daniel Meuser, Andrew Garbarino, Debbie Lesko, Byron Donalds, Mike Ezell, David Rouzer, Anthony D’Esposito, Kat Cammack, Diana Harshbarger and Jeff Duncan.

  • CTP Hires Health Equity Advisor

    CTP Hires Health Equity Advisor

    The U.S. Food and Drug Administration Center for Tobacco Products (CTP) has hired Charlene Le Fauve as its first senior advisor for health equity.

    “Dr. Le Fauve is a behavioral scientist and addiction researcher with 25 years of federal work experience related to health equity and health disparities research,” the CTP wrote on its website. “She has dedicated her career to advancing health equity and the health of underserved and underrepresented populations through research and research workforce development.”

    Most recently, Le Fauve served as the senior advisor to the chief officer for scientific workforce diversity at the National Institutes of Health (NIH). In this role, she educated national audiences about NIH’s role in scientific workforce diversity and health equity research.

    Prior to her NIH role, Le Fauve held various leadership roles, such as the deputy director of disparities research and global mental health at the National Institutes of Mental Health and the senior policy coordinator and lead for the Center for Medicare and Medicaid Services Team at the Department of Health and Human Services.

    “Diversity, Equity, Inclusion, and Accessibility are core values of CTP, and efforts are underway to ensure that the full scope of the Center’s work is reflective of these principles. In this new position, which is the first of its kind for any Center at FDA, Dr. Le Fauve will work with all of CTP’s Offices to ensure health equity is integrated into the Center’s programmatic plans and priorities,” the CTP said.

    “She also will serve as CTP’s primary representative in a variety of activities that promote and facilitate the reduction of tobacco-related health disparities, including during external meetings, conferences, and presentations.”

  • FDA to Seize Illegal Vapes

    FDA to Seize Illegal Vapes

    Photo: N Felix

    The U.S. Food and Drug Administration has issued “Import Alert 98-06” that states the regulatory agency will detain new tobacco products such as e-cigarettes without marketing authorization at the border.

    The companies impacted would include all importers, manufacturers and transporters of vaping product brands such as ELFBAR, EBDESIGN, Eonsmoke, Esco Bar and Stik that are on the agency’s “Red List.”

    The alert covers China, South Korea and the United States.

    “Divisions may detain, without physical examination, the tobacco products identified on the Red List of this Import Alert. If the division is not sure whether a tobacco product is the same product as one identified on the Red List, the division should consult with the Center for Tobacco Products (CTP)” the alert states. “CTP concurrence is required to add a product to the Red List.”

    In order to remove a firm’s product from the Red List, companies must provide information to the FDA that adequately demonstrates that the firm has resolved the conditions that gave rise to the appearance of the violation.

    “The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, ‘Detention without Physical Examination (DWPE),’” the alert states.

    The FDA states that the import alert is to prevent the sale of potentially illegal goods in America; Releasing agency resources to inspect other goods; provide uniform coverage across the country; shift the blame back to the importer to ensure that products imported into the United States comply with FDA laws and regulations, according to the agency.

    In June 2009, the Family Smoking Prevention and Tobacco Control Act gave the FDA the authority to regulate tobacco products, recognizing that it is the primary federal regulator for the manufacture, marketing, and distribution of cigarettes, cigarette tobacco, and smokeless tobacco.

    The designation rule, published in the Federal Register on May 10, 2016, and effective August 8, 2016, extends FDA’s authority to designated tobacco products, such as e-cigarettes, cigars, hookahs, and pipe tobacco, as well as their components and parts, but not their accessories.

  • Qnovia Adds Zeller to Advisory Board

    Qnovia Adds Zeller to Advisory Board

    Mitch Zeller

    Mitch Zeller, the former head of the U.S. Food and Drug Administration’s Center for Tobacco Product, has joined the advisory board of a company developing a first-of-its-kind smoking cessation inhalation product.

    Zeller said Qnovia’s nicotine inhalation product, RespiRX, has the potential to be a “game changer” in lowering the use of combustible cigarettes.

    The former director of the Center for Tobacco Products (CTP) from March 2013 until his retirement in April 2022, Zeller is now providing policy and regulatory strategy consulting to Qnovia, Inc.

    The company is currently preparing an application to the FDA’s Center for Drug Evaluation and Research (CDER) for a cessation therapy which, if approved, will be the first inhaled prescription therapy to help tobacco smokers quit.

    Zeller’s addition to the company’s advisory board comes as the FDA aims to finalize proposed bans on menthol cigarettes and flavored cigars by August. The FDA also plans to propose a rule limiting nicotine levels in cigarettes and some other tobacco products.

    Zeller said access to Qnovia’s product can be one essential tool along with an administration-wide effort to provide support to those with nicotine addictions once those product standards take effect.

    “Some people will be able to quit cold turkey, but a whole bunch won’t, and they will be seeking nicotine elsewhere,” Zeller said in an interview, told Bloomberg Law.

    “The last thing that we want smokers to do if any of those policies go into effect is to simply switch to another tobacco product,” he added.

    Qnovia’s goal is for RespiRx to be the first inhaled prescription smoking cessation therapy product, according to Qnovia CEO Brian Quigley. Instead of using heat to create vapor, the RespiRx device uses an orientation-agnostic vibrating mesh nebulizer. The aerosolizing engine is nothing like a traditional e-cigarette that heats a coil to atomize nicotine based in PG and/or VG. 

    RespiRx is activated when a user inhales on the device. To aerosolize the nicotine, it sends an electrical current that causes the perforated piezo mesh to vibrate more than 100,000 times a second. “It’s that vibrating action of the mesh that then forces the liquid to the holes, creating an aerosol that appears vapor-like, allowing it to be inhaled,” says Quigley. That, he says, is fundamentally different from a traditional e-cigarette product, where the heating process can create undesired thermal byproducts.

    RespiRx uses proprietary software to deliver a precise dose of nicotine. Every time it’s activated, the device fires for three seconds and delivers a targeted dose of the drug. The base is reusable and serves as the housing for the battery and software. The RespiRx nebulizer sits within the pod that houses the nicotine drug product. 

    “The nebulizing unit (cartridge) gets replaced by the patient every one to two days. That interface means that the patient doesn’t have to clean the nebulizer,” explains Quigley. “The biggest challenge with other vibrating mesh products is that they require cleaning if used over an extended period. We’re mitigating that through the design of the interface. There is no cleaning required. We do believe that this will result in RespiRx having a very long use life.”

    Late last year, Qnovia raised $17 million to continue the development of its RespiRx nicotine replacement product.

    In June of 2020, the company appointed Quigley, a 16-year veteran of Altria Group, as its Chief Operating Officer. At Altria, Quigley served as CEO of its smokeless tobacco business from 2012 to 2018, a $2.3 billion business with over 800 employees,

  • Reynolds Likely to Prevail in PMTA Lawsuit

    Reynolds Likely to Prevail in PMTA Lawsuit

    When the U.S. Court of Appeals for the 5th Circuit granted a stay to R.J. Reynolds Vapor Co. (RJRV) of the U.S. Food and Drug Administration’s denial of its 150,000-page premarket tobacco product application (PMTA) for its menthol Vuse products, the judges indicated that the court believes RJRV is likely to prevail on the merits when the full review is heard. 

    Tobacco harm reduction expert Clive Bates of Counterfactual said the substantive decision rests on three main arguments, as outlined by the judges granting the stay. The order states: “Specifically, RJRV demonstrates that the FDA failed to reasonably consider the company’s legitimate reliance interests concerning the need for longitudinal studies and marketing plans; failed to consider relevant evidence, inter alia, that youthful users do not like menthol-flavored e-cigarettes; and has created a de facto rule banning all nontobacco-flavored e-cigarettes without following APA notice and comment requirements.”

    The three main points argued by the court are outlined below:

    FDA changed the decision-making criteria after the application.

    1. Legitimate reliance interests

    “The FDA did not reasonably consider RJRV’s legitimate reliance interests before changing its position on the types of comparative studies and marketing plans critical to a compliant and complete PMTA.”

    Failure to consider Reynolds’ arguments adequately 

    2. Failure to consider relevant factors

    The FDA did not adequately address RJRV’s evidence that substantial health benefits would accrue to adult and youth cigarette smokers alike who switched to menthol Vuse while popularity among youth would remain low overall. For example, RJRV’s application contained studies that “switching from smoking to use of menthol Vuse Vibe substantially reduces toxicant exposure in a manner similar to smoking abstinence.” RJRV also submitted evidence of low popularity among youth relative to other flavored electronic nicotine-delivery systems (ENDS).

    Bates stated that at least one portion of the court’s argument looks troubling for Brian King, the newly appointed director of the FDA’s Center for Tobacco Products (CTP).

    “Then in July 2022, a new CTP director appeared on the scene and told OS that ‘the approach to menthol-flavored ENDS should be the same as for other flavored ENDS, i.e., the products could be found [appropriate for the protection of the public health] only if the evidence showed that the benefits of the menthol-flavored ENDS were greater than tobacco-flavored ENDS, which pose lower risk to youth.’ OS then changed its position.”

    FDA has been implementing a de facto tobacco product standard (a flavor ban) without using the rule-making process, public comment, etc. 

    3. “Tobacco product standard”

    RJRV has adduced evidence that the FDA has effectively banned all nontobacco-flavored e-cigarettes pursuant to its new and secret heightened evidentiary standard without affording affected persons any notice or the opportunity for public comment. There is no dispute that the TCA requires the FDA to abide by notice-and-comment rulemaking procedures before establishing a “tobacco product standard.” 8 21 U.S.C. § 387g(c)–(d). Similarly, it is clear that a ban on all but tobacco-flavored e-cigarettes would constitute a “tobacco product standard.” 

    Bates explains that the court justifies its assertion that the FDA is imposing a de facto standard with reference to the so-called “fatal flaw memo.” This was an expedited decision-making regime that stipulated that applications for nontobacco-flavored products must be supported with controlled trials or longitudinal studies showing a quitting or switching advantage over a tobacco flavor. Otherwise, they would be automatically denied. 

    “We conclude that the Fatal Flaw memo’s heightened evidentiary standard ‘bears all the hallmarks’ of a substantive rule. City of Arlington, 668 F.3d at 242. First, the memo is binding on its face by mandating that applications contain ‘the necessary type of studies.’ Second, it has been applied in a way that indicates it is binding; indeed, the subsequent, myriad Denial Orders refer to the same deficiencies identified as ‘fatal’ in the memo. Third, it took away the FDA reviewers’ former discretion to consider individual PMTAs solely on their merits and instead requires a cursory, box-checking review.

    “Finally, it affected the rights of literally hundreds of thousands of applicants whose PMTAs were denied. This is not a close call.”

    Bates stated that the third point the court makes is potentially “very” serious for the FDA and “not a close call,” as the court suggests. “A tobacco product standard under the TCA s.907 means that the burden is on the FDA to show that its de facto standard is appropriate for the protection of public health—e.g., considering the impact of closing down all vape shops, the likely impact on adults or youth who smoke, unintended consequences, illicit trade, etc.,” explains Bates. “It shifts the analysis from the individual applicant (PMTA) to the system-wide impact (Product Standard)—and FDA will find this difficult or impossible to meet, in my view.”

    Taking everything into account, the court weighs up its decision to grant the stay against four criteria, as Bates outlined: 

    “Our judgment is ‘guided by sound legal principles’ that ‘have been distilled into consideration of four factors: (1) whether the stay applicant has made a strong showing that he is likely to succeed on the merits; (2) whether the applicant will be irreparably injured absent a stay; (3) whether issuance of the stay will substantially injure the other parties interested in the proceeding; and (4) where the public interest lies.’”

    Bates stated that the first of these four criteria reflects the courts’ view on the merits discussed in the three above-stated substantive arguments. In the fourth: where the public interest lies, the court gives significant weight to the “highest public importance that federal agencies follow the law” and states: “In sum, ‘there is generally no public interest in the perpetuation of unlawful agency action,’ Texas v. Biden, 10 F.4th at 560. And there is no evidence that ‘Congress’s policy choice’ included an exemption from mandatory federal administrative procedures.”

    No date has been set for the court to complete its full review.

  • FDA Publishes Citizen Petition Webpage

    FDA Publishes Citizen Petition Webpage

    A new webpage was published by the U.S. Food and Drug Administration of all the tobacco products-related citizen petitions received by the agency’s Center for Tobacco Products (CTP).

    A citizen petition is a way for the FDA to give individuals, regulated industry representatives, or consumer groups to petition the agency to issue, amend, revoke a regulation, or take other administrative action. The requirements for a citizen petition are set out in the Code of Federal Regulations.

    As part of CTP’s stated commitment to increase transparency, the webpage was developed to provide the public with more easily accessible and user-friendly information about tobacco product-related citizen petitions submitted to FDA and the center’s responses.

    This webpage was one of the immediate actions toward transparency outlined by CTP Director Brian King in CTP’s Response to the Reagan-Udall Foundation’s report.

  • FDA Denies Marketing Applications for Vuse Menthol

    FDA Denies Marketing Applications for Vuse Menthol

    The U.S. Food and Drug Administration issued marketing denial orders (MDOs) for two menthol e-cigarette products currently marketed by R.J. Reynolds Vapor Company under the Vuse Solo brand.

    Reynolds is expected to challenge the order.

    The currently marketed products include the Vuse Replacement Cartridge Menthol 4.8% G1 and the Vuse Replacement Cartridge Menthol 4.8% G2, according to a statement. The company may resubmit applications or submit new applications to address the deficiencies for the products that are subject to these MDOs. 

    The FDA evaluates premarket tobacco product applications (PMTAs) based on a public health standard that considers the risks and benefits of the product on the population as a whole.

    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 the public health, which is the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.

    Specifically, the evidence submitted by the applicant did not demonstrate that its menthol-flavored e-cigarettes provide an added benefit for adult smokers relative to tobacco-flavored e-cigarettes.

    In October last year, the FDA issued MDOs for several menthol-flavored vaping products marketed by Logic Technology Development. It was the first time the FDA issued MDOs for menthol products after receiving a scientific review.

    A few days after the order was issued, Logic obtained a court order from the U.S. Circuit Court of Appeals for the 3rd Circuit that temporarily stayed the order.

    The case continues.

  • FDA Proposes New Rules for Manufacturing

    FDA Proposes New Rules for Manufacturing

    Photo: Tobacco Reporter archive

    The U.S. Food and Drug Administration is proposing new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of all tobacco products.

    The proposed requirements would help protect public health by, among other things, minimizing or preventing contamination and limiting additional risks by ensuring product consistency, according to an FDA statement.

    “While no tobacco product is safe, this proposed rule is intended to minimize or prevent additional risks associated with these products,”

    Brian King / Credit: FDA

    said Brian King, director of the FDA’s Center for Tobacco Products. “Once finalized, it would establish requirements for tobacco product manufacturers that will help protect public health.”

    The proposed new requirements would help manufacturers comply with the Federal Food, Drug, and Cosmetic Act by helping minimize or prevent the manufacture and distribution of tobacco products contaminated with foreign substances—such as metal, glass, and plastics—which have been found in tobacco products. T

    The proposed rule would also help address issues related to inconsistencies between e-liquid product labeling and the actual concentrations in e-liquids, “Such variability can be misleading to consumers, potentially intensifying addiction and exposure to toxins,” the agency states.

    The proposed rule would also establish several requirements related to the identification, tracing and corrective actions for tobacco products that don’t meet specifications or are contaminated, including for tobacco products that have already been distributed.

    In the event of an issue, these requirements would require manufacturers to take corrective actions, which may include conducting a recall.

    The proposed requirements apply to manufacturers of finished and bulk vaping and other tobacco products. As laid out in the proposed rule, a finished tobacco product is a tobacco product, including any component or part, sealed in final packaging; for example, an e-cigarette, a pack of cigarettes or a can of moist snuff.

    A bulk tobacco product is a tobacco product that isn’t sealed in final packaging, but is otherwise suitable for consumer use. 

    The proposed rule establishes a framework for manufacturers to adhere to, including: 

    • establishing tobacco product design and development controls;
    • ensuring that finished and bulk tobacco products are manufactured according to established specifications; 
    • minimizing the manufacture and distribution of tobacco products that don’t meet specifications;
    • requiring manufacturers to take appropriate measures to prevent contamination of tobacco products; 
    • requiring investigation and identification of products that don’t meet specifications to institute appropriate corrective actions, such as a recall; and
    • establishing the ability to trace all components or parts, ingredients, additives and materials, as well as each batch of finished or bulk tobacco product, to aid in investigations of those that don’t meet specifications. 

    The FDA will hold a public oral hearing on April 12 to gather additional comments from stakeholders, including industry, the scientific community, advocacy groups, and the public.

    The proposed rule also will be available for public comment for 180 days. The agency will review all comments as part of the rulemaking process for this foundational rule.

    “We remain committed to transparency and stakeholder engagement, including providing clarity to industry so that they are equipped to comply with the law,” said King. “We encourage all interested individuals and organizations to participate in the rulemaking process. When the public submits a comment based on sound grounds, that can make an important difference in the agency’s decision-making.”    

    The FDA will also hold a meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) on May 18 to seek recommendations from the agency’s outside panel of experts on the requirements laid out in the proposed rule. As part of the TPSAC meeting, the public will have an opportunity to make oral presentations. The FDA intends to make TPSAC meeting materials available on its website no later than 48 hours before the meeting. 

  • U.S. FDA May Publish Draft Guidance for CBD

    U.S. FDA May Publish Draft Guidance for CBD

    The U.S. Food and Drug Administration is planning to make recommendations on how to regulate the use of the popular cannabis compound cannabidiol (CBD) in food and supplements, the Wall Street Journal reported, citing agency officials.

    After weighing the evidence on the compound’s safety, the FDA will decide within months how to regulate legal cannabis and whether that will require new agency rules or new legislation from Congress, according to the report.

    In an interview, Janet Woodcock, the FDA’s deputy commissioner and leader of the agency’s cannabis regulation efforts, expressed concern about the safety of CBD and whether current regulatory pathways for food and dietary supplements are suitable for this substance.

    However, the agency is interested in determining whether it is safe to consume CBD on a daily basis for extended periods of time or during pregnancy.

    Woodcock mentioned concerns about potential effects on fertility in the future, but, at the same time, her comment signaled that the agency is working to establish regulatory frameworks for the legal sale of appropriate cannabis and cannabis-derived products.

    CBD is a chemical compound found in cannabis plants. It is one of the main ingredients in cannabis, but unlike THC, it does not cause a high or have psychoactive effects.

    The 2018 Farm Bill legalized hemp cultivation in the U.S., which led to significant growth in the market for CBD products. These products, sold as dietary supplements, are believed to have health benefits. As a result, many businesses in the cannabis industry are now selling CBD products across the country.

    Over the last few years, the FDA posted several warning letters to companies for illegally selling products containing CBD. The companies are accused of selling products containing CBD that the FDA states some people may confuse for traditional foods or beverages that do not contain CBD or were making medical claims about their CBD products.

    In 2021, The FDA told Charlotte’s Web Holdings, one of the world’s largest CBD companies, that its cannabidiol product cannot be sold as a dietary supplement, signaling that CBD reform may have to wait for congressional action.