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  • RJR Complaint Could Wreck Vaping Industry

    RJR Complaint Could Wreck Vaping Industry

    The implications could be far-reaching. Reynolds American Inc. (RAI)  has filed a U.S. International Trade Commission (ITC) complaint charging multiple manufacturers, distributors and retailers of several popular disposable vaping devices with unfair importation. It is one of several recent actions Reynolds has made to remove its competitor’s vaping products from store shelves.

    Reynolds is asking the ITC to investigate and issue an exclusion order preventing further U.S. imports of disposable vaping products. Several legal scholars have told Tobacco Reporter that if the ITC agrees with Reynolds, all flavored disposable vaping devices without marketing authorization could be stopped at the border and prevented from entering the U.S. market.

    Reynolds wants the ITC to issue a permanent “cease and desist order” prohibiting any businesses from selling illegal vaping products. The move would push nearly the entire vaping industry underground, with the exception of products owned by major tobacco companies such as Reynolds that have received marketing orders from the FDA.

    Several businesses were named specifically as “peddlers of illegal disposable vapes” in the Reynolds complaint, including the “manufacturers, importers, distributors and retailers” of Breeze, Elf Bar, Esco Bar, Hyde, Puff Bar, and R&M disposable vapes.

    Also named are several well-known U.S. wholesale and retailers of disposable vapes, including Element Vape, Flawless Vape, Magellan Technology, Mi-One Brands, Price Point Distributors, and Vape Sourcing.

    The ITC complaint accuses what amounts to the manufacturers of all unauthorized vaping products of importing “illegal disposable vapes” in violation of Section 337 of the Tariff Act of 1930. Specifically, Reynolds claims the named businesses either falsely advertised that their products are authorized for sale by the U.S. government, failed to comply with federal laws imposing registration and reporting requirements and limitations on sales, or violated customs laws and regulations.

    “As a result of the relentless influx of illegal vapor products flowing through U.S. borders, Reynolds American Inc. subsidiaries R.J. Reynolds Tobacco Co. and R.J. Reynolds Vapor Co. have filed a complaint with the U.S. International Trade Commission against more than 30 companies involved in illegally importing unregulated, youth appealing flavored disposable vapor products,” RAI wrote in a statement. “Many of the manufacturers of these disposable vapor devices intentionally and systematically market to youth, selling products with dessert and candy flavors and featuring cartoon characters.

    “These illegal disposable vapor devices, which have unknown ingredients and bypass regulations, are jeopardizing public health by refusing to adhere to the laws that regulate the sale of tobacco products. The complaint requests that the ITC institute an investigation into unfair acts in the importation and sale of these Chinese-manufactured, youth appealing flavored disposable vapor devices into the United States.”

    Reynolds owns the Vuse vaping brand, including the Vuse Alto. Last week, the FDA issued a marketing denial order, ordering Alto menthol refill pods off the market. The Alto device and tobacco-flavored pods are still under review by the agency. Two older Vuse vapes, the Solo and Vibe models (and their tobacco-flavored refills) are among the 23 products currently authorized by the FDA. The marketing denial order was subsequently stayed by the Fifth Circuit Court of Appeals.

    In its ITC complaint, Reynolds states it has the capacity to fill any void in the market if the illegal products were removed. “Reynolds has the capacity to replace any increase in demand if the Accused Products were excluded from importation,” the complaint states. “Reynolds is willing to meet any increased demand and can do so in a commercially reasonable time, given that it already supplies the industry with significant quantities of ENDS products, as well as oral tobacco and nicotine products.”

    The ITC has not yet made a decision on the complaint that was filed on Oct. 13.

  • Retailers Face Civil Money Penalties

    Retailers Face Civil Money Penalties

    The retailers selling illegal flavored disposable vapes are under scrutiny. The U.S. Food and Drug Administration issued complaints for civil money penalties (CMPs) against 22 retailers for the illegal sale of Elf Bar/EB Design.

    The FDA previously warned each retailer in the form of a warning letter to stop selling unauthorized tobacco products, according to the agency. During follow-up inspections, the FDA observed the retailers had not corrected the violations, which resulted in the civil money penalty actions. 

    “The FDA has been abundantly clear that we are committed to using the full scope of our authorities, as appropriate, to hold those who break the law accountable,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “These retailers were duly warned of what could happen if they failed to correct their violations. They chose inaction and will now face the consequences.”

    The complaints seek the maximum civil money penalty of $19,192 for a single violation from each retailer. While the FDA has issued civil money penalty complaints to retailers for selling unauthorized tobacco products in the past, this is the first time the agency is seeking CMPs for the maximum amount against retailers for selling illegal flavored disposable vapes.

    The retailers can pay the penalty, enter into a settlement agreement, request an extension of time to file an answer to the complaint or file an answer and request a hearing. Those that do not take action within 30 days after receiving the complaint risk a default order imposing the full penalty amount.

    Courtesy: US FDA

    In addition to the CMP complaints, today the FDA announced an additional 168 warning letters to brick-and-mortar retailers for illegally selling Elf Bar/EB Design products. These warning letters were the result of a coordinated nationwide retailer inspection effort conducted throughout the month of August, according to the agency.

    Warning letter recipients have 15 working days to respond with the steps they have taken to correct the violation and ensure compliance with the law. Failure to promptly correct the violations can result in additional FDA actions such as injunction, seizure or civil money penalties.

    “We continue to monitor closely all those in the supply chain, including retailers, for compliance with federal law,” said Ann Simoneau, director of the Office of Compliance and Enforcement in the CTP. “This includes follow-up inspections and surveillance of those who have received a warning letter, and taking additional action, as appropriate, to enforce the law.” 

  • BAT Outlines Five-Step Vapor Rules Plan

    BAT Outlines Five-Step Vapor Rules Plan

    BAT has released a blueprint for how regulators and governments could better regulate vapor products and help smokers switch to less risky products.

    During DTNF 2023, held from Sept 18-20 in Seoul, BAT’s global head of business communications, Jonathan Atwood, told attendees how BAT’s five-step plan for regulation could support achieving the right balance between harm reduction and the unintended consequences of access, including underage use.

    Speaking on behalf of Kingsley Wheaton, BAT’s chief strategy & growth officer, Atwood said that reckless players in the market need to be penalized when they do not abide by the rules. He said the five suggestions are the areas that regulators should explore and establish “smart regulation” that is right for their market.

    “First, on-device technology and functionality: vapor products should be accessible only to adults. Both underage prevention and restriction is crucial. On-device technology, when applied and enforced across entire markets, could help in this regard.

    “Second, more recognition is needed that flavors are an important driver of adoption for smokers seeking alternatives. However, flavors in vapor products should not particularly appeal to anyone underage.

    “Third is at the manufacturing and import level: ensuring that non-compliant products cannot reach the market in the first place.

    “Fourth, where no restrictions exist already, regulators may want to look at who should be able to sell vapor products and where. Reasonable safeguards at the point-of-sale would help ensure these products are sold only to adult consumers. Solutions such as retail licensing and facial recognition technologies should be seriously considered.

    “Lastly, enforcement and penalties: governments must wield their power and ensure consumers are purchasing legitimate products. Such measures should be rigorously enforced and those who fail to comply should face meaningful sanctions.”

    Atwood said BAT was calling upon governments, regulators, and industry peers to rally towards a sustainable and progressive environment in which vaping products are sold and marketed responsibly.

  • TPMP Comment Period Extended

    TPMP Comment Period Extended

    Credit: May1985

    The U.S. Food and Drug Administration has extended the comment period on its proposed rule for tobacco manufacturing practices.  

    Stakeholders now have until Oct. 6, 2023, to share their thoughts.

    The proposed rule would place new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of their products. According to the FDA, these proposed requirements would help protect public health by, among other things, minimizing or preventing contamination and limiting additional risks by ensuring product consistency.

  • FDA Tobacco Chief Discusses Relative Risk

    FDA Tobacco Chief Discusses Relative Risk

    Brian King (Photo: FDA)

    In an article published in Addiction magazine, Brian King, director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), explores the chances and considerations for informing adults who smoke cigarettes about the relative dangers of tobacco products, including e-cigarettes. He collaborated with Benjamin Toll, director of the Medical University of South Carolina Tobacco Treatment Program and co-director of the Lung Cancer Screening Program.

    The commentary highlights the findings of a recent survey about misperceptions of tobacco product harms, including cigarettes and e-cigarettes. The survey found that only about 20 percent of adults who smoke cigarettes believed e-cigarettes contain fewer harmful chemicals than cigarettes. While there are no safe tobacco products, the available scientific evidence indicates that tobacco products exist on a continuum of risk, with cigarettes being the most harmful. 

    The commentary notes that opportunities exist to educate adults who smoke about the relative risks of tobacco products, including e-cigarettes. However, these efforts should be accompanied by efforts to prevent youth tobacco product use; encourage first-line use of FDA-approved cessation therapies; and for adults who both smoke and use e-cigarettes, reinforce the importance of completely transitioning to e-cigarettes.

    The commentary further emphasizes that any education efforts on the relative risks of tobacco products must be evidence-based. In particular, it is important to assess the benefits among the intended population (i.e., adults who smoke) and risks among unintended populations (e.g., youth). Currently, FDA is in the early stages of a research effort to assess messaging about the continuum of risk of tobacco products among adults who smoke.

    Last week, the FDA announced a virtual listening session opportunity to verbally provide open public comment on the development of the new strategic plan, including proposed strategic goals. After introductions, the center will begin the listening session with an overview of the process used to develop the CTP’s strategic plan, including proposed goal areas.

    Registration is open for the virtual listening session on the development of the CTP’s five-year strategic plan, which will take place on Aug. 22 beginning at 10 a.m. EDT.

     

  • McKinney Regulatory Science’s New Website

    McKinney Regulatory Science’s New Website

    McKinney Regulatory Science Advisors has launch its new website that promises “a new era of innovation and transparency for their clients,” according to a press release.

    The new platform describes an array of advisory services to nicotine and cannabis clients, with an emphasis on providing McKinney clients with the best available regulatory services.

    Willie McKinney, CEO of McKinney, said the new website represents a significant milestone in journey to provide exceptional advisory services to our nicotine and cannabis clients.

    “The revamped platform reflects our dedication to innovation, transparency, and client satisfaction, making it easier for clients to explore our services and access valuable regulatory resources,” he said

    The new website offers a modern design that makes it easy for users to find the information they need quickly. It also features an intuitive navigation system that allows users to identify relevant services and access helpful resources rapidly, according to McKinney. Additionally, the site is optimized for mobile devices so that users can access the site from any device at any time.

    “McKinney RSA focuses on providing comprehensive solutions that meet complex regulatory requirements while also delivering superior customer service,” the release states. “With decades of industry experience under their belt, they are committed to helping their clients succeed by providing top-notch guidance every step of the way.”

  • Jason Carignan Joins Chemular

    Jason Carignan Joins Chemular

    Jason Carignan has joined Chemular, an FDA regulatory consultancy group, as its chief commercial officer.

    Carignan will lead the company’s revenue generation initiatives, strategic partnerships, and intellectual property monetization strategies across its diverse portfolio of business units, according to a press release.

    “Carignan brings a wealth of experience and expertise to Chemular, having held various leadership positions in the tobacco and nicotine industry. He most recently served as president of Phillips & King and the Total Product Expo (TPE), both part of the Kretek International Inc. family of companies,” the release states. “Prior to that, he served as president of DRYFT Sciences, overseeing the successful development of the DRYFT line of nicotine pouches before selling the company to British American Tobacco in late-2020.”

    With an impressive track record of driving growth and creating strategic alliances, Carignan is well-positioned to play a pivotal role in expanding Chemular’s market presence and further establishing the company as a leader in FDA regulatory matters.

    Kevin Burd, CEO of Chemular. said he is thrilled to welcome Carignan to the Chemular team. “His deep industry knowledge and proven leadership in revenue generation and partnership strategies will be instrumental in driving our growth and expanding our client base,” said Burd. “We believe Jason’s appointment will advance our mission of providing comprehensive regulatory solutions to our clients and partners.”

    Carignan will work closely with Chemular’s executive team to develop and execute business development strategies, identify new revenue opportunities, and forge strategic partnerships that enhance the company’s market position, according to the release.

    Carignan said he was excited to join the Chemular team.

    “Chemular has established itself as a trusted and innovative partner for clients navigating the complex landscape of FDA regulations,” Carignan said. “I look forward to leveraging my experience and expertise to drive revenue growth, establish impactful partnerships, and contribute to Chemular’s continued success.”

  • 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.

  • Flavored Vaping Ban Begins Tomorrow

    Flavored Vaping Ban Begins Tomorrow

    A ban on advertising e-cigarettes in Ukraine, including heated-tobacco products, goes into effect on July 11. Flavored electronic nicotine-delivery systems (ENDS) products are also banned.

    The advertising rule applies to all types of media, including the Internet, social media, public transportation, and public events.

    “The advertising, sales promotion and sponsorship of electronic cigarettes, liquids used in them, and devices for consumption of tobacco products without burning them (including IQOS and glo devices) will be prohibited from 11 July 2023,” according to the WHO Framework Convention on Tobacco Control (FCTC).

    “Flavored cigarettes and flavored liquids for ENDS will also be banned at that date. Further, from 11 January 2024, the combined textual plus pictorial warnings will be required to cover 65 percent of both sides of the pack of smoking tobacco products (conventional cigarettes).”

    The fine in the case of a violation is UAH30,000 ($812), and for each subsequent violation – UAH50,000. In addition, similar to the general smoking ban, the law prohibits the use of heated tobacco products in all public places and businesses.

    In 2021, Ukrainian lawmakers passed the law prohibiting the use of ENDS in public places as well as advertising, sponsorship, and promotion of e-cigarettes. The law also bans the sale of flavored e-liquids other than tobacco flavors.

  • Ghana Outlaws Vape Sales and Promotion

    Ghana Outlaws Vape Sales and Promotion

    Ghana has banned all recreational use of vaping and e-cigarette products.

    In a press release, the country’s Food and Drugs Authority (FDA) states that the “sale, advertisement and recreational use of electronic nicotine delivery systems (ENDS) such as vapes and other non-nicotine tobacco products by the public” is illegal.

    However, ENDS can be registered as a prescription-only medicine for the purposes of cessation therapy.

    The FDA claims it has sent notice to manufacturers, importers, wholesalers, and retailers to remove all advertisements on social media, billboards and neon signs immediately and refrain from the importation of the products.

    The FDA states that there “will be repercussions including sanctions” for failure to adhere to the rules.