Category: Global Regulation

  • Juul Ban Reversal Welcomed

    Juul Ban Reversal Welcomed

    Photo: Juul Labs

    The potential return of Juul to U.S. store shelves would represent a win for consumers and tobacco harm reduction, according to the Consumer Choice Center (CCC).

    On June 6, the U.S. Food and Drug Administration rescinded its 2022 marketing denial order. While the move is neither an authorization nor a denial, it places the company’s premarket tobacco product application back into scientific review, meaning it could potentially be authorized at some point.

    “This is a step in the right direction for consumers who want more nicotine alternatives to combustible tobacco,” said CCC U.S. Policy Analyst Elizabeth Hicks.

    The FDA said in its June 6 statement that it had “conducted additional substantive review of the applications in a number of disciplines, including toxicology, engineering, social science and clinical pharmacology” and that their change of course is based on a “review of information provided by the applicant” plus new case law based on court decisions involving MDOs for e-cigarette products.

    “With over 26 million applications submitted to the FDA, less than 10 e-cigarette devices have been approved by the agency. Vaping is 95 percent less harmful than smoking combustible tobacco, and the FDA has an opportunity to help drastically improve public health by allowing consumers a choice when it comes to alternatives to combustible cigarettes,” said Hicks.

    The FDA decision opens the door for Juul to return to the market in the future and allow U.S. consumers the same choice as those in the U.K. and Canada.

    “We hope the FDA provides a clear and transparent pathway for Juul Labs and the thousands of other companies who submitted product applications to finally gain authorization to offer their products to consumers in a regulated market,” concluded Hicks.

  • FDA Rescinds Juul Marketing Denial Order

    FDA Rescinds Juul Marketing Denial Order

    Photo: steheap

    The Food and Drug Administration Thursday rescinded its 2022 ban on Juul Labs’ e-cigarette products. However, the agency has not yet made a final decision on whether Juul can remain on the U.S. market. The move does open the door for Juul to receive marketing authorization from the regulatory agency.

    In 2022, the FDA ordered Juul to stop its sales, but later paused the order while the vaping company appealed. The agency announced that it would reinitiate a scientific review of Juul’s products, essentially returning them to their regulatory status before the initial ban.

    In the time since the MDOs were administratively stayed in 2022, the FDA has gained more experience with various scientific issues regarding e-cigarette products, and there have been new litigation outcomes in cases about MDOs for e-cigarette products from other manufacturers,” the FDA stated in a release. “Some of these court decisions establish new case law and inform the FDA’s approach to product review to maintain the agency’s commitment to issuing final decisions that are appropriate on both the scientific merits and the law.”

    Rescission of the MDOs is not an authorization or a denial and does not indicate whether the applications are likely to be authorized or denied. Rescission of the MDOs returns the applications to pending status, under substantive review by the FDA. The FDA’s regulations significantly limit what the agency can disclose regarding the content of pending applications.

    Juul Labs welcomed the move. “We appreciate the FDA’s decision and now look forward to re-engaging with the agency on a science- and evidence-based process to pursue a marketing authorization for Juul products, the company wrote in a statement. “We remain confident in the quality and substance of our applications and believe that a full review of the science and evidence will demonstrate that our products meet the statutory standard of being appropriate for the protection of public health.”

     

  • Hong Kong Mulls New Anti-Smoking Measures

    Hong Kong Mulls New Anti-Smoking Measures

    Photo: ChenPG

    Hong Kong announced several new anti-tobacco policies on June 6, reports The Standard.

    Among other measures, the city plans to introduce a new duty-paid labeling system, ban “smoke-and-queue” behavior in public, and prohibit all flavored cigarettes and alternative products including vapes and heated cigarettes.

    The rules are meant to help the government lower smoking prevalence to 7.8 percent by 2025 and ultimately achieve a “Tobacco-free Hong Kong” after the completion of a public consultation exercise launched last year.

    Other measures include raising the maximum penalty for evading tobacco duty to a HKD2 million ($256,082) fine and seven years’ imprisonment; a ban on providing cigarettes to underage teens and children; and continuous reviews on the adjustment of tobacco duty.

    The government will also maximize the area reserved for health warnings on cigarette packaging to 100 percent; expand non-smoking areas and increase fines for violations.

    Secretary for Health Lo Chung-mau said the government strives to table the new policies to the Legislative Council before the end of this year and expects they will be passed within this legislative year.

    More than 90 percent of respondents to the public consultation agreed with further lowering the smoking prevalence.

    There are more than 570,000 daily smokers in Hong Kong and the latest prevalence stands at 9.1 percent, according to Director of Health Ronald Lam Man-kin.

  • Swedish Match MRTP Comments Due July 5

    Swedish Match MRTP Comments Due July 5

    The U.S. Food and Drug Administration posted the final set of application materials related to renewing existing modified-risk tobacco product (MRTP) orders for Swedish Match U.S.A.’s General Snus products.

    The agency announced a deadline for public comments. To ensure they receive consideration by FDA, the applications must be submitted to the docket by 11:59 p.m. EDT on July 5, 2024.

    The application materials, redacted in accordance with applicable laws, can be found on the FDA’s website. “Before making a final determination on an MRTP application, FDA considers all information available to the agency, including public comments and recommendations from the Tobacco Products Scientific Advisory Committee (TPSAC),” a release states.

    The FDA recently announced a TPSAC meeting to discuss these renewal applications, scheduled for June 26, 2024, which the public is able to attend in person at the FDA White Oak Campus or virtually. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

    Written submissions may be made to the contact person on or before June 20, 2024.

  • FDA Updates Vaping Products ‘Red List’

    FDA Updates Vaping Products ‘Red List’

    Photo: xy

    The U.S. Food and Drug Administration has updated its import alert, which includes a “red list” of vapor products that may be detained “without physical examination,” the agency announced.

    The alert authorizes U.S. Customs and Border Protection to detain new tobacco products that do not have the required marketing authorization under the Federal Food, Drug and Cosmetic Act, which gives the FDA the authority to regulate all tobacco products.

    The list of products now includes Chinese manufacturers and distributors as well as U.S. importers and distributors.

    The FDA announced last week that it is taking stronger enforcement actions against unauthorized e-cigarettes. The agency is seeking civil money penalties (CMP) against nine brick-and-mortar retailers and one online retailer for selling unauthorized Elf Bar brand vaping products. The FDA is seeking a penalty of more than $20,000 from each retailer.

    “In order to remove a firm’s product from the red list, information should be provided to the agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation,” the FDA wrote. “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.”

  • Namibia to Regulate E-cigarettes

    Namibia to Regulate E-cigarettes

    Image: sezerozger

    Namibia plans to regulate vapor products and water pipes, reports the Windhoek Observer.

    The country’s Ministry of Health and Social Services wants to amend the Tobacco Act to include those products.

    The goal is to curb the growing use of electronic cigarettes and water pipes across the country. The amendment will also facilitate the development of a comprehensive tobacco strategic plan scheduled for launch later this month.

    Deputy Minister of Health and Social Services Ester Muinjangue stressed the urgency of regulating vaping products, despite existing legal frameworks to combat tobacco use in Namibia. “There is no safe form of tobacco smoke,” she said, rejecting suggestions that vaping and hookah smoking are safer alternatives to traditional cigarette smoking.

    Muinjangue encouraged smokers seeking to quit their habit to utilize existing resources and seek support from health professionals.

  • Philippines: New Vape Rules in June

    Philippines: New Vape Rules in June

    Credit: Adobe Photo

    The new Vape Law in the Philippines will take effect on June 1. The new rules also apply to all next-generation tobacco products, including heat-not-burn and e-cigarettes. The Department of Trade and Industry (DTI) will require all vape products to be registered with the agency on that date, an official said on Tuesday.

    At a forum organized by the Bantay Konsumer, Kalsada, Kuryente (BK3) in Makati, DTI Undersecretary Amanda Nograles said the “importation and manufacturing of vaporized nicotine and non-nicotine products and novel tobacco products must now undergo the DTI certification process.”

    This means that products must have the Philippine Standard (PS) mark and Import Commodity Clearance (ICC) sticker first before they can be sold on the market.

    Nograles said at least 3 companies have already applied for registration, and they urge others to begin the process since the registration may take some time. She clarified that there will be a 6-month transition period to allow all firms to comply.

    “We will allow them to sell all the existing inventory. On January 5, 2025, we will do market clearing. There should be no vape products without a PS license and ICC [sticker],” Nograles said, adding that the agency will continue to monitor shops to ensure that no minors will be allowed to buy vape products. They will also check if the vape has marijuana oil.

  • China Tightens Smoking Restrictions

    China Tightens Smoking Restrictions

    Photo: Taco Tuinstra

    China is ramping up its efforts to control smoking. In 2023, 44 cities introduced or revised regulations, bringing the total number of cities with relevant regulations to 254 nationwide, according to national health authorities.

    According to the Xinhua News Agency, 24 regions at the provincial level in China have rolled out smoking regulations, and the proportion of the population protected by comprehensive smoke-free regulations is continuing to increase.

    Experts from the National Health Commission (NHC) released the data on Saturday ahead of World No Tobacco Day on May 31.

    Meanwhile, as China pledges to protect 80 percent of its population with smoke-free laws by 2030, experts on tobacco control on Sunday called for the country to introduce a national smoking control regulation as soon as possible.

    Smoking control, including preventing smoking and encouraging smokers to quit, is a viable approach for both population-wide disease prevention and individual healthcare, according to Wang Lu, a health expert from the NHC.

    Curbing smoking doesn’t aim to deprive people of their right to smoke, but to free people from being hurt by secondhand fumes, Zhang Jianshu, a senior expert at the Chinese Association of Tobacco Control, told the Global Times on Sunday.

  • Unforeseen Costs

    Unforeseen Costs

    Image: Alexandr Byerdugin

    How the Florida e-cigarette registry will harm nonvapers

    By Peter Clark

    This year, many U.S. states have considered imposing heavy-handed registries that aim to ban most vaping products sold today. In Florida, Governor Ron DeSantis wisely refused to follow along with other states. However, his solution—a sort of reverse registry that gives Florida’s attorney general the authority to ban specific products—will create more problems than it solves.

    It’s understandable how many nonvapers would see this law as being reasonable. But there are many unforeseen costs that they will need to bear.

    This law focuses on the dangers of vaping devices attractive to children, but there are many drawbacks to nonvapers. These include state resources wasted on ligation, unfair benefits to tobacco companies and healthcare costs of smokers imposed on all Floridians. 

    HB1007 will run into legal trouble if not correctly applied. Multiple factors need to be satisfied for a vaping product to be restricted. If Attorney General Moody erroneously finds a vaping device to be illegal, this opens Florida up to lawsuits. 

    This impacts Floridians since it costs tax dollars and ties up the court system. The Florida court system is already stressed. Between March 2022–2023, Florida led the country in the number of lawsuits filed. 

    Plus, the courts would require additional tax revenue to adjudicate the influx of claims. Fiscal year 2023 already saw a 7.2 percent increase in the budget over 2022. That budget has soared to $114.7 billion for fiscal 2024–2025. 

    The government should have a compelling interest in restricting sales of e-cigarettes. The public health justification is flimsy at best. 

    Teen vaping is on the decline. It isn’t flavored products that entice kids to start vaping. They vape to rebel and to reduce stress, using nicotine to self-medicate. Targeting flavored electronic nicotine-delivery systems (ENDs) based on a myth theorizing why kids start vaping will jeopardize the health of adult vapers, leaving us with an ineffective policy that burns tax dollars and overloads the courts.

    HB1007 also advantages the tobacco companies. The influx of non-FDA-approved e-cigarettes has severely eaten into the market share of big tobacco. Analysts suggest the only way to remedy slumping cigarette sales would be to “clamp down on disposable e-cig growth.” The CEO of Altria has even described the market as being “overrun” by these devices. 

    Barring vapes that lack FDA approval benefits tobacco companies in two ways. For one, most of the products granted premarket approval were Big Tobacco-owned. In 2022, all the e-cigarettes greenlighted by the FDA were sold by R.J. ReynoldsAltria, and JTI. By the attorney general blocking Big Tobacco’s competition, they can regain some of the sales lost to popular single-use devices like Elfbar.

    Even Florida voters who don’t vape should be concerned about this outcome. Upholding this law gives precedence to similar approval processes for other products. The legislature could pass additional laws to ban the sale of dietary supplements and even food deemed to be harmful. Much like the choice to vape, adults should have the right to evaluate the harm in what they choose to consume for themselves. 

    Florida restricting single-use ENDs would impose higher healthcare costs on Floridians. A study found that only 12.9 percent of vapers polled would abstain from nicotine if their preferred e-cigarette was banned, leaving many e-cigarette users going back to tobacco. The total healthcare cost to Florida from smoking is $10.04 billion, an annual tax burden of $854 per household. These figures do not include the impact of secondhand smoke or the $21.1 billion in lost productivity. 

    If a policy doesn’t directly impact you, it is easy to be apathetic. Banning popular vaping products hurts more than e-cigarette users. It wastes resources, gives tobacco companies an unfair advantage and costs Florida billions in healthcare costs. Even if you have never picked up a cigarette or vape, this law will still negatively impact you.

  • PMTA Filed for Njoy ACE 2.0 With Age Check

    PMTA Filed for Njoy ACE 2.0 With Age Check

    Njoy, a subsidiary of Altria, submitted a supplemental premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration for the commercialization and marketing of its ACE 2.0 device.

    The new device includes access restriction technology designed to prevent underage use. This is achieved through Bluetooth connectivity, which authenticates the user before unlocking the device. The company has also re-submitted PMTAs for blueberry- and watermelon-flavored pod products, which are exclusively compatible with the Njoy ACE 2.0 device.

    “Altria’s Vision is to responsibly lead the transition of adult smokers to a smoke-free future. We’re excited to build on our existing FDA-authorized products,” said Njoy President and CEO Shannon Leistra in a statement. “Njoy ACE 2.0 includes critical technology features to prevent underage access to flavored Njoy products while also responsibly providing flavored options for adult smokers and vapers.”

    The Njoy ACE is the only pod-based vaping product currently with marketing authorization from the FDA. In the first quarter of 2024, Njoy announced it had broadened distribution to over 80,000 stores and expects to expand to approximately 100,000 stores by year-end.

    Njoy also continued the roll-out of the brand’s first retail trade program, which is designed to help achieve optimal retail visibility and product fixture space.

    “Given the widespread illicit flavored e-vapor marketplace, this product offers the FDA a sound solution for balancing the known risk to youth with an opportunity to offer adults legal, regulated choices,” said Paige Magness, senior vice president of regulatory affairs of Altria Client Services. “We hope the FDA prioritizes the review and authorization of this application given its interest in device access restriction technologies to reduce youth access.”

    The Njoy had previously received marketing denial orders for its blueberry (2.4% and 5% nicotine strengths) and watermelon (2.4% and 5% nicotine strengths) pods.

    Njoy believes its latest applications sufficiently address the FDA’s concerns regarding underage use by incorporating device age and identity-based access restriction and demonstrating that these restrictions are effective at preventing underage access in virtually all cases. Currently, the FDA has not authorized the marketing of any non-tobacco-flavored vaping product.