Category: Regulation

  • FDA: New 5-Year Strategic Plan Announced for CTP

    FDA: New 5-Year Strategic Plan Announced for CTP

    Image: Tada Images

    On Dec. 18, Brian King, director of the U.S. Food and Drug Administration Center for Tobacco Products, published a statement about the release of the center’s comprehensive strategic plan. The new strategic plan outlines CTP’s programmatic and workforce initiatives for the next five years.

    The CTP’s strategic plan defines five goals, 10 outcomes and several corresponding objectives. As outlined in the goals and outcomes in the plan, the center is collectively committed to issuing impactful regulations, using robust science to inform application reviews, pursuing timely and impactful compliance and enforcement strategies, and educating the public about the risks of tobacco products.

    King said the CTP will also continue to invest in its staff by advancing operational enhancements and supporting the further development of its workforce.

    In conjunction with the strategic plan, the CTP also published the center’s policy agenda of rules and guidance documents that are in development or planned for development. According to the agency, this policy agenda will create a more efficient approach to meeting the CTP’s strategic plan. The agenda will be updated annually.

  • U.S. Senators Demand FDA Reform its PMTA Process

    U.S. Senators Demand FDA Reform its PMTA Process

    Credit: Blue

    U.S. Senators Joe Manchin, Rand Paul and Ted Budd (R-NC) penned a letter urging the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) to reform its premarket tobacco product application (PMTA) process.

    The Senators also requested information regarding CTP’s policies and actions that would ensure they are acting in an efficient way that is based on science and evidence.

    “Cigarette smoking is the leading cause of preventable disease and death in the United States, where nearly 31 million Americans smoke cigarettes,” the group wrote in part. “For the FDA to meet its harm reduction goals, it must have a functioning authorization process.

    “Since 2009, more than 26 million [PMTAs] have been submitted for new tobacco products in the U.S. Of those 26 million applications, the CTP has authorized fewer than 50… The availability of scientifically substantiated, authorized-PMTAs or MRTPs could potentially improve health outcomes for smokers currently using riskier products.”

    For the FDA to meet its harm reduction goals, it must have a functioning authorization process, the Senators state, adding that the agency’s authorization rate is not in keeping with CTP policy acknowledging that tobacco products fall on a continuum of risk.

    “The CTP has previously attributed its backlog to staffing shortages, but CTP’s staff has more than doubled over the past decade, from 426 employees in 2013 to more than 1,100 today,” the Senators state. “Since 2009, the FDA has also had the authority to assess and collect user fees from tobacco manufacturers and importers, with those fees being $712 million annually since 2019.

    “Given these significant resources, there is no reason why the CTP should be so drastically out of step with the [Food, Drug and Cosmetic] Act’s requirements.”

  • More Warning Letters for Unauthorized Products

    More Warning Letters for Unauthorized Products

    Photo: Adobe

    On Dec. 13, the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) issued warning letters to 11 online retailers selling unauthorized e-cigarette products marketed under the brand names Lost Mary, Funky Republic/Funky Lands, Elf Bar/EB Design, Kangvape, Cali and Breeze. Warning letter recipients are given 15 working days to respond with the steps they’ll take to correct the violations discussed in the warning letter and to prevent future violations. Failure to promptly correct the violations can result in FDA enforcement actions such as an injunction, seizure and/or civil money penalties.

    “It is illegal to sell, import, distribute or offer for sale or distribution to U.S. consumers any e-cigarette that has not been authorized by FDA,” said CTP Director Brian King in a statement. “The products identified in these warning letters are being marketed without the required authorization. We can issue, and have issued, warning letters for products for which an application has been submitted and is pending review. For unauthorized tobacco products, the pendency of an application does not create any sort of a safe harbor to sell that product.”

    As of December 2023, the FDA has issued more than 400 warning letters to retailers for the sale of unauthorized e-cigarettes and filed civil money penalty complaints against more than 65 retailers and manufacturers for the manufacture or sale of unauthorized products.

    To date, the FDA has authorized 23 e-cigarette devices and tobacco-flavored e-cigarette products.

  • Mexico President to Push Forward Anti-Vape Bill

    Mexico President to Push Forward Anti-Vape Bill

    Mexican President Andres Manuel Lopez Obrador stated his intentions to introduce a law forbidding the use of e-cigarettes and vapes before he finishes his term in 2024.

    This comes after the Supreme Court overturned his previous attempt to ban their sale.

    Mexico already has one of the most stringent anti-tobacco laws globally, as evidenced by their implementation of a bill in January that prohibits smoking in all public spaces – including outside on the street, according to media reports.

    Mexico has already banned the import of e-cigarettes.

  • Imperial Calls for Better Targeted Vape Regulation

    Imperial Calls for Better Targeted Vape Regulation

    Photo: Casimirokt | Dreamstime.com

    Imperial Brands has called for a ban on vapes that are deliberately marketed to young people. In its response to the U.K. government’s consultation on “creating a smoke-free generation and tackling youth vaping,” the company argued for stronger enforcement of existing regulation.

    Among other provisions, the government’s plan includes a provision that would make it illegal for anyone born on or after Jan. 1, 2009, to ever legally buy cigarettes, and a ban on disposable vapes.

    “As the owner of the blu vape brand, we share the government’s concerns about the rise in youth vaping and call for a reform of vape flavor names and a ban on packaging that deliberately appeals to under-18s,” Imperial Brands wrote on its website.

    However, Imperial also noted that vaping has played a key role in reducing U.K. smoking levels to the lowest on record, referring to Public Health England’s finding that e-cigarettes are around 95 percent less harmful than normal cigarettes.

    “If a ban on disposable vapes is introduced—which more than half of adult vapers use—it could easily drive some nicotine users to return to cigarette smoking and reverse the positive downward trend,” Imperial wrote.

    The proposed generational tobacco ban, meanwhile, would be unworkable and unenforceable, according to the company. “The prohibition of tobacco products won’t deter tobacco users from smoking; rather, it will increase the already flourishing illicit trade—as was the case in South Africa when the government outlawed the sale of tobacco products during Covid—and lead to a decline in government revenues. Last year, receipts from tobacco duty contributed £10 billion [$12.52 billion] to the public purse,” Imperial wrote.

    “The government’s intention to put the U.K. on a path to a smoke-free future is one we all share; however, a generational smoking ban, coupled with a ban on disposable vapes, risks undermining the country’s progress,” said Oliver Kutz, general manager U.K. and Ireland at Imperial Brands. 

    “It is clear that prohibition does not reduce tobacco consumption; rather, it creates an illicit market, fuels organized crime and presents a real danger to retailers. Removing disposable vapes, the most widely used harm reduction alternative in the U.K., at the same time as prohibiting legitimate tobacco sales is illogical and counterproductive. 

    “If the U.K. wants to continue on its journey to reduce smoking whilst preventing the rise of youth vaping, greater enforcement of the current regulations at the point of sale is imperative. The introduction of a retailer licensing scheme, alongside Fixed Penalty Notices for breaches, would deter retailers from selling to under-18s, ensuring a crackdown on youth vaping that does not risk existing vapers reverting to smoking.”

  • Argentina Urged to Repeal Recent E-cigarette Ban

    Argentina Urged to Repeal Recent E-cigarette Ban

    Image: simonmayer

    The Argentinean vapers’ association, Asovape Argentina, and the World Vapers’ Alliance have sent an open letter Argentina’s recently elected president, Javier Milei, calling for the repeal of the National Administration of Medicines, Food and Medical Technology Provision 3226/2011 banning the commercialization of e-cigarettes.

    The provision banned the import, distribution, marketing, advertising and promotion of e-cigarettes. It went into effect May 6, 2011.

    The letter explains that numerous studies conducted since the ban took effect have demonstrated the significantly lower risk profile and the usefulness of e-cigarettes for smoking cessation as well as the low health risk of nicotine. The signatories also argue that the ban is incompatible with respect for the individual freedom of Argentinian adults and the rights to free development of personality, information and health of users and smokers. 

    “The ban violates the rights and freedoms of Argentine adults and should be repealed,” said Juan Facundo Teme, president of Asovape Argentina, in a statement. “The state is not the one to tell Argentines how to consume nicotine and should respect the decisions of individuals who choose to vape in order to consume it in a less harmful way. Moreover, all the arguments on which the ban was based have been disproved.”

    Argentina has a smoking rate of 24.5 percent, the second highest in Latin America and one of the highest in the world.

    “Smoking is a huge problem for Argentina, and the ban has only exacerbated it,” said Teme. “It spreads the misconception that vaping is the same or worse than smoking, makes it difficult for millions of smokers to switch to a safer alternative and has pushed thousands of vapers back to tobacco. With clear information and proper regulation of vaping, we could reduce smoking rates quickly and significantly.”

    Argentina should respect smokers who choose to consume nicotine in a less harmful way.

    “Argentina is one of the most restrictive countries on vaping in the whole region and consequently has one of the highest smoking rates,” said Alberto Gomez Hernandez, policy manager of the World Vapers’ Alliance. “It is second only to Chile, which has just passed a law regulating vaping to allow adults to use it to quit smoking, as Brazil is also working to do. Argentina should not lag behind and should respect smokers who choose to consume nicotine in a less harmful way.”

    Michael Landl, director of the World Vapers’ Alliance, added, “Argentina’s approach to vaping is outdated and irreconcilable with upholding the individual freedom of consumers. Argentina now has a great opportunity to take the lead and adopt the approach of countries like Sweden or the U.K., which respect users’ right to choose while improving public health. Sweden is on the verge of becoming the first smoke-free country thanks to this approach, and the U.K. is reducing its smoking rate rapidly. We encourage President Milei and his government to follow these examples. Vaping is not a crime and should be legalized immediately.”

  • FDA Says Next PMTA Update to Come in January

    FDA Says Next PMTA Update to Come in January

    Credit: F Armstrong Photo

    The U.S. Food and Drug Administration stated in prior status reports for its premarket tobacco product applications (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.

    The regulatory agency is under court order to file regular status reports on the agency’s review of pending PMTAs for new tobacco products that were on the market as of Aug. 8, 2016.

    For such new tobacco products to be lawfully marketed in the United States, the Family Smoking Prevention and Tobacco Control Act requires the FDA to complete a substantive review of the PMTA for each new tobacco product and issue a marketing granted order authorizing the sale of the product.

    The court order stems from litigation filed by health groups against the FDA seeking a court-imposed deadline for finalizing the review of the PMTAs that were filed with the agency by Sept. 9, 2020.

    The court-imposed deadline to complete the agency’s review was originally Sept. 9, 2021, which the FDA was unable to meet due to the extremely large number of PMTAs filed by manufacturers.

    The most recent and FDA’s seventh status report was filed on Oct. 23, 2023, according to media reports. Specifically, in these reports, the FDA provides an update on the progress to finalize the agency’s review of pending PMTA “covered applications.”

    A “covered application” is for new electronic cigarette/vapor products that were on the market as of Aug. 8, 2016, which had a PMTA filed with the FDA by Sept. 9, 2020, are sold under the brand names of Juul, Vuse, Njoy, Logic, Blu, Smok, Suorin, or Puff Bar, and reach 2 percent or more of the total retail sales volume in NielsenIQ’s various retail e-cigarette sales reports.

    According to the FDA’s Oct. 23 status report, the agency has completed its review of 69 percent of the 186 pending covered applications.

    The FDA states that it will file the next status report with the court by Jan. 22.

  • UK Labour Party Wants ‘Prescription-Only’ Vapes

    UK Labour Party Wants ‘Prescription-Only’ Vapes

    Credit: IR Stone

    The British Labour Party told media representatives it may implement a prescription-only policy for vaping products if they win the upcoming general election, which must take place by January 2025.

    The Labour Party has been consistently leading in polls for the past two years.

    Wes Streeting, shadow health secretary for the Labour Party and potential choice for health secretary if the party gains a majority in Parliament, is closely monitoring Australia’s recent decision to regulate vaping as a prescription product.

    Streeting believes that this policy is partly based on evidence from Australia showing that vaping can lead to smoking.

    He also criticizes the vaping industry for promoting itself as a helpful tool for quitting smoking while simultaneously addicting young people to nicotine.

    In regards to the industry’s marketing tactics, Streeting says, “We will take strong measures against targeting children, but I also want the vaping industry to return to its initial purpose as a legitimate method for quitting smoking.”

  • FDA Files Civil Money Action Against 25 Retailers

    FDA Files Civil Money Action Against 25 Retailers

    Credit: FDA

    The U.S. Food and Drug Administration announced it has filed civil money penalty (CMP) complaints against 25 brick-and-mortar and online retailers for selling unauthorized Elf Bar, EB Design and other e-cigarette products.

    In a press note, the FDA stated that it had previously warned each retailer in the form of a warning letter to stop selling unauthorized tobacco products. During follow-up inspections, the agency observed the retailers had not corrected the violations, resulting in civil money penalty actions. 

    The complaints seek the maximum civil money penalty of $19,192 for a single violation from each retailer. 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 the complaint risk a default order imposing the full penalty amount.  

    Today’s actions bring the total number of CMPs filed against retailers for the sale of unauthorized e-cigarettes up to 67.

    Previously, in September, and then again in November, FDA sought CMPs for similar amounts against 42 brick-and-mortar retailers across 18 states for the sale of unauthorized Elf Bar products. Today’s actions include retailers from 14 states and, for the first time, include cases against online retailers.

  • DOJ Injunction Filed Against Vape Junkie for Illicit Vapes

    DOJ Injunction Filed Against Vape Junkie for Illicit Vapes

    Credit: Egokhan

    The U.S. Department of Justice (DOJ) today filed a complaint for a permanent injunction against Jessica M. Fitzgerald and Michelle L. Allen doing business as Vape Junkie Ejuice (Vape Junkie Ejuice) for “manufacturing, selling, and distributing unauthorized e-cigarette” products.

    The injunction was filed on behalf of the U.S. Food and Drug Administration.

    The move represents the seventh time FDA has initiated injunction proceedings to enforce the Federal Food, Drug, and Cosmetic Act’s (FD&C Act) premarket tobacco product review requirements for new tobacco products.

    The FDA previously warned Vape Junkie Ejuice that they were in violation of the FD&C Act’s premarket review requirements for new tobacco products by manufacturing, selling, and distributing new tobacco products without first obtaining marketing authorization from FDA, according to the FDA.

    The agency’s warning noted that continued violations could lead to further action, including an injunction. However, Vape Junkie Ejuice continued to manufacture, sell, and distribute unauthorized e-cigarette products to consumers, according to the FDA.

    “FDA has been abundantly clear that we will not stand by as bad actors choose to blatantly disregard the law, especially after being duly warned. This manufacturer continued to break the law, and that behavior has consequences.”

    Brian King, director of the FDA’s Center for Tobacco Products (CTP)

    DOJ institutes judicial enforcement actions under the FD&C Act in court. DOJ filed the injunction complaint on behalf of the FDA against Vape Junkie Ejuice in the Middle District of Florida, the manufacturer’s respective U.S. District Court.

    If the injunction is handed down, it would require Vape Junkie Ejuice to stop manufacturing, selling, and distributing their e-liquids. The injunction would also require the manufacturer to obtain marketing authorization from the FDA before marketing such products.

    “Today’s injunction action should be a clear reminder to all manufacturers: If you continue to sell illegal products, we are equipped to use the full force of the law. FDA is committed to working with federal partners, including the Department of Justice, to enforce the law.”

    Ann Simoneau, director of CTP’s Office of Compliance and Enforcement.

    Today’s action is part of the FDA’s comprehensive approach to enforcing the law, according to the agency. Within the past year, the FDA has acted against manufacturers, distributors, importers, and retailers of illegal e-cigarette products.

    As of Nov. 2023, the FDA has issued approximately 640 warning letters to firms for manufacturing and/or distributing illegal e-cigarette products and devices, issued more than 400 warning letters to retailers for the sale of unauthorized e-cigarettes, filed civil money penalty complaints against 36 e-cigarette manufacturers and 42 retailers for manufacture and/or sale of unauthorized products.