Category: Regulation

  • NZ Bans Smoking in Cars with Minors

    NZ Bans Smoking in Cars with Minors

    Photo: thodonal

    New Zealand will ban smoking in cars with minors effective Nov. 28, reports The New Zealand Herald. The rule defines children as any person under the age of 18 and applies to moving and stationary vehicles alike.

    The measure is part of the government’s commitment to achieve its “Smokefree 2025” goal and follows moves such as including plain packaging of cigarettes, a retail display ban and progressive vaping legislation that supports vaping use as a quit-smoking tool.

     A 2018 Youth Insights Survey found that about 15 percent of 14- to 15-year-olds were exposed to secondhand smoke in vehicles, while 26 percent of Māori and Pacific students were exposed to it.

    While welcoming the new law, Action and Smoking and Health (ASH) said more needs to be done to achieve the country’s target of being smokefree by 2025.

    About one in eight New Zealand adults smoke cigarettes daily and this rises to one in three among Māori.

    “We are not on track to get to the Smokefree 2025 goal,” said Ash Director Deborah. “What is needed immediately is greater investment in community-led initiatives to help people quit and mass media campaigns that support quit efforts.”

  • Synthetic Nicotine May be Subject to Regulation

    Synthetic Nicotine May be Subject to Regulation

    Photo: Tobacco Reporter archive

    Synthetic nicotine could be considered a component of e-cigarettes, which would allow for the product to be regulated by the U.S. Food and Drug Administration. Mitch Zeller, director of the FDA’s Center for Tobacco Products, said the agency was concerned about the use of synthetic nicotine to avoid regulation and enforcement and is considering its options in dealing with its use.

    On Nov. 17, the first day of TMA’s “From Chance to Change” webinar, Zeller said that the Tobacco Control Act defines tobacco products as anything that is made or derived from tobacco and is intended for consumption. The FDA believes that it also includes components and parts (such as coils and batteries) and all the ingredients included in producing e-liquids (such as flavorings and vegetable glycerin) even if the product does not contain nicotine.

    “That’s an assessment that we need to make on a case-by-case basis based upon the totality of all the information that we have,” said Zeller.

    According to Zeller, synthetic nicotine represents a challenge for the agency because it is increasingly difficult to differentiate from naturally derived nicotine. “Historically, that hasn’t been a problem,” he said. “It’s not a problem now, but it could become a challenge for us going forward.”

    Zeller explained that nicotine is comprised of two isomers: R and S. Tobacco-derived nicotine is 99 percent S, and early synthetic nicotine had a 50-50 split between R isomers and S isomers. However, newer versions of synthetic nicotine have much higher proportions of S isomers (as high as 99.9 percent pure), making it harder to tell synthetic nicotine apart from natural nicotine. Tobacco-derived nicotine is also becoming higher in quality.

    “Tobacco-derived nicotine is now being made available at a higher quality … pharmaceutical grade from a purity standpoint. And with that, it may be harder for us to see that chemical fingerprint, if you will, whether it’s tobacco DNA or tobacco-specific nitrosamines,” he said. “We could see this as a problem going forward. Coupled with the clear intent of certain companies to do this to evade FDA regulation … We are concerned about what this means for product regulation, for the public health, and a product like Puff Bar proudly proclaiming its use of synthetic nicotine [and] being the No. 1 brand used by youth.”

    In the short term, Zeller said the FDA is talking internally about how to best address the growing number of products that are using synthetic nicotine to skirt FDA regulation. He said the agency is also responding to questions from Congress about synthetic nicotine and providing technical assistance to members when asked.

    “There are a lot of companies out there that pride themselves on playing by the rules. They have every right to expect that the playing field is going to be level. That’s where we come in with our compliance and enforcement authorities,” Zeller said. “We agree that one of the most important things that we can do, using our compliance and enforcement tools, is to level the playing field and to have our actions [in the e-cigarette space], hopefully, serve as a deterrent. There’s nothing that I can say from a compliance enforcement standpoint on synthetic nicotine other than we have ongoing investigations.”

  • FDA Rescinds Marketing Denial for Humble Juice

    FDA Rescinds Marketing Denial for Humble Juice

    Photo: AliFuat

    The U.S. Food and Drug Administration has rescinded the marketing denial order (MDO) issued Sept. 15, 2021, for Humble Juice Co.’s flavored e-liquid products, the company announced on Nov. 5.

     Humble had filed a petition in October with the U.S. Court of Appeals for the Ninth Circuit, challenging the FDA’s decision and seeking to have the MDO vacated. Following the receipt of the rescission letter, Humble withdrew its petition as FDA’s rescission of Humble’s MDO places the brand’s flavored e-liquids back into the PMTA review process and provides Humble with a pathway to market its products while its PMTAs are pending.

    FDA’s rescission letter states that upon further review it identified information contained in Humble’s PMTA that requires additional evaluation such as “randomized controlled trials comparing tobacco-flavored ENDS to flavored ENDS as well as several cross-sectional surveys evaluating intentions to use or likelihood of use in current smokers, current ENDS users, former tobacco users, and never users.”

    The agency also stated that due to the unusual circumstances, it “has no intention of initiating an enforcement action” against any of Humble’s flavored e-liquid products with pending PMTAs. Humble will continue to market its products while its application remains in the review process.

    “FDA’s decision to rescind the MDO re-instills our faith in this challenging but science-based regulatory process,” said Humble CEO Daniel Clark. “We remain confident in and proud of our extensive PMTA submission. We are committed to working with the FDA to obtain marketing orders for the products submitted in our initial PMTAs in order to provide Humble’s adult consumers with flavor-filled and affordable e-juice long into the future.”

  • Filter: Some PMTAs Not Evaluated on Merits

    Filter: Some PMTAs Not Evaluated on Merits

    Photo: Ronstix

    Confronted with an unexpected large volume of premarket tobacco applications, the U.S. Food and Drug Administration subjected some premarket tobacco product applications (PMTAs) to only a superficial review, according to documents obtained by Filter.

    The report follows the FDA’s denial of more than 1,167,000 marketing applications since Sept. 9, 2021.

    The PMTA review process comprises three phases: Phase I (Acceptance), which essentially means an application has been received; Phase II (Notification or Filing), which entails acknowledging a company had enough information for its applications to be formally filed; and Phase III (Review), which involves a substantive scientific evaluation, followed by a marketing granted order or marketing denial order (MDOs).

    Overwhelmed by the large number of PMTAs and facing a court-ordered deadline of Sept. 9, 2021, the FDA in effect opted for a shortcut, according to Filter.

    The publication cites a memorandum signed on July 9 by Matthew Holman, the director of FDA Center for Tobacco Products Office of Science (OS). “Considering the large number of applications that remain to be reviewed by the September 9, 2021, deadline, OS will conduct a Fatal Flaw review of PMTAs not in Phase III for non-tobacco-flavored ENDS products,” it reads.

    The Fatal Flaw review is a simple review in which the reviewer examines the submission to identify whether or not it contains the necessary type of studies. “The Fatal Flaw review will be limited to determining presence or absence of such studies; it will not evaluate the merits of the studies,” the memorandum states.

    Filter suggests that CTP reviewers created what’s probably a new method to get through a backlog of millions of PMTAs, searched those applications for longitudinal cohort studies and randomized clinical trials without evaluating any other evidence, and for applications lacking them, did not advance them beyond Phase II and just sent out templated MDOs.

  • FDA Stays Bidi Vapor MDO Pending Review

    FDA Stays Bidi Vapor MDO Pending Review

    The U.S. Food and Drug Administration has issued an administrative stay of its marketing denial order (MDO) for nontobacco flavored bidi sticks, pending the agency’s review of Bidi Vapor’s request that the MDO be rescinded based on product-specific scientific evidence in its premarket tobacco product applications (PMTAs).

    Bidi Vapor’s flavored Bidi Sticks may remain on the market without the threat of enforcement while the FDA reviews the company’s request.

    Bidi Vapor, which is part of Kaival Brands, submitted PMTAs for all 11 flavor varieties of its Bidi Stick. The applications ran over 285,000 pages and contained information supporting the products as appropriate for the protection of the public health.

    On Sept. 29, 2021, Bidi Vapor filed a Petition for Review with the U.S. Court of Appeals for the 11th Circuit, seeking judicial review of the MDO under the Tobacco Control Act, the Administrative Procedure Act as well as the U.S. Constitution.

    “We appreciate FDA’s decision to stay, or put on hold, the MDO as it reconsiders its denial,” said Bidi Vapor Niraj Patel in a statement. “As we explained to the agency, Bidi Vapor submitted scientifically rigorous PMTAs that contained product-specific evidence demonstrating that the added benefit of our flavored Bidi Sticks to adult smokers outweighs any potential risks to youth, especially considering our stringent youth-access prevention measures and commitment to mature, adult-focused marketing.”

    “That said, we are still seeking a formal, judicial stay from the appellate court pending the outcome of the lawsuit,” Patel noted.

    The company has now filed a Motion for Stay Pending Review with the 11th Circuit Court of Appeals citing the “irreparable harm” it continues to suffer from the MDO.

    Multiple companies have challenged their MDOs in recent weeks. In early October, the FDA rescinded MDOs it has issued to Turning Point Brands and Fumizer, placing their products back under review.

    According to Filter, Triton, Bidi and Gripum recently received some temporary form of stay, and My Vape Order has demanded a recission due to the fact its PMTA includes some of the same data and studies that also appears in TPB’s applications.

  • FDA Authorizes Product Not on the Market Since 2019

    FDA Authorizes Product Not on the Market Since 2019

    Photo: Altria Group

    The U.S. Food and Drug Administration has authorized the marketing of four oral tobacco products that are no longer on the market—Verve Discs Blue Mint, Verve Discs Green Mint, Verve Chews Blue Mint, and Verve Chews Green Mint, manufactured by Altria subsidiary U.S. Smokeless Tobacco Co.

    “We are pleased that FDA has determined that Verve oral nicotine products are appropriate for the protection of public health,” said an Altria spokesman. “While we discontinued selling Verve on Feb. 2, 2019, we applied learnings from this successful application to our on! submissions, which remain under review by FDA. Oral nicotine products play an important role in our vision of moving beyond smoking and remain an important part of our portfolio of products to transition adult smokers away from cigarettes.”

    In a press release dated Dec. 17, 2018, Altria said it would stop the production and distribution of Verve oral nicotine products based upon the expected financial performance of these products and the regulatory restrictions that burdened the company’s ability to quickly improve these products. “We do not see a path to leadership with these particular products and believe that now is the time to refocus our resources,” wrote Chairman and CEO Howard Willard at the time.

    It its Oct. 19, 2021, marketing order, the FDA said it had determined the marketing of Verve products would be consistent with the statutory standard, “appropriate for the protection of the public health.” This includes a review of data showing that youth, nonsmokers and former smokers are unlikely to initiate or reinitiate tobacco use with these products.

    “Ensuring new tobacco products undergo a robust premarket evaluation by the FDA is a critical part of our mission to protect the public—especially kids,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products, in a statement.

    “While these are mint flavored products, data submitted to the FDA show the risk for youth uptake of these particular products is low, and stringent marketing restrictions will help prevent youth exposure. Importantly, evidence shows these products could help addicted smokers who use the most harmful combusted products completely switch to a product with potentially fewer harmful chemicals.”

  • FDA OKs Tobacco-Flavored Vuse Solo

    FDA OKs Tobacco-Flavored Vuse Solo

    Photo: R.J. Reynolds Vapor Co.

    The U.S. Food and Drug Administration has issued marketing orders to R.J. Reynolds (RJR) Vapor Co. for its Vuse Solo closed electronic nicotine-delivery system (ENDS) device and accompanying tobacco-flavored e-liquid pods.

    The orders allow RJR to legally sell its Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8 percent G1 and Vuse Replacement Cartridge Original 4.8 percent G2 in the United States. This marks the first set of ENDS products ever to be authorized by the FDA through the premarket tobacco product application (PMTA) pathway.

    “Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust scientific premarket evaluation,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products, in a statement. “The manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products—either completely or with a significant reduction in cigarette consumption—by reducing their exposure to harmful chemicals.”

    Zeller said the FDA would monitor the marketing of the products, including whether the company fails to comply with any regulatory requirements or if credible evidence emerges of significant use by individuals who did not previously use a tobacco product, including youth. “We will take action as appropriate, including withdrawing the authorization,” said Zeller.

    The manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products—either completely or with a significant reduction in cigarette consumption—by reducing their exposure to harmful chemicals.

    Mitch Zeller, director, FDA CTP

    Under the PMTA pathway, manufacturers must demonstrate to the agency that, among other things, marketing of the new tobacco product would be appropriate for the protection of the public health. The FDA found RJR’s products to meet this standard because, among several key considerations, the agency determined that study participants who used only the authorized products were exposed to fewer harmful and potentially harmful constituents from aerosols compared to users of combusted cigarettes.

    The toxicological assessment also found the authorized products’ aerosols are significantly less toxic than combusted cigarettes based on available data comparisons and results of nonclinical studies.

    Additionally, the FDA considered the risks and benefits to the population as a whole, including users and nonusers of tobacco products, and, importantly, youth. This included review of available data on the likelihood of use of the product by young people. For these products, the FDA determined that the potential benefit to smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth, provided the applicant follows post-marketing requirements aimed at reducing youth exposure and access to the products.

    While authorizing the marketing of tobacco-flavored Vuse Solo e-liquid pods, the FDA issued 10 marketing denial orders (MDOs) for flavored ENDS products submitted under the Vuse Solo brand by RJR. Due to potential confidential commercial information issues, the FDA is not publicly disclosing the specific flavored products. These products subject to an MDO for a premarket application may not be introduced or delivered for introduction into interstate commerce.

    The agency is still evaluating the company’s application for menthol-flavored products under the Vuse Solo brand. 

    BAT welcomed the marketing orders. “We are pleased that, today, Vuse Solo received the first of its kind U.S. Food and Drug Administration marketing authorization for vapor products, authorizing the sale of our U.S. subsidiary Reynold’s Vuse Solo product in Original flavor,” the company wrote in a statement following the FDA announcement. “FDA’s orders confirm that Vuse Solo products are appropriate for the protection of the public health, underscoring years of scientific study and research dedicated to ensuring that adult nicotine consumers aged 21-plus have access to innovative and potentially less harmful alternatives to traditional tobacco products.”

    The company said it was studying the MDOs for five flavors currently not on the market.

    FDA has turned its back on the public health by approving a high-nicotine e-cigarette.

    Raja Krishnamoorthi, chairman of the House Oversight Committee’s Subcommittee on Economic and Consumer Policy

    Anti-tobacco activists expressed disappointment with the FDA’s decision. “While it is a positive step that FDA denied applications for 10 flavored Vuse e-cigarettes, it is concerning that a product that has three times the nicotine concentration as legally permitted in Canada, the U.K. and Europe was authorized,” wrote Matthew Myers, president of the Campaign for Tobacco-Free Kids, on the organization’s website. “Vuse products with this level of nicotine leave our nation’s youth at an undue risk of addiction.”

    “FDA has turned its back on the public health by approving a high-nicotine e-cigarette,” said Raja Krishnamoorthi, chairman of the House Oversight Committee’s Subcommittee on Economic and Consumer Policy. “Many countries around the world have capped the amount of nicotine allowed in e-cigarettes, which allowed them to avoid a youth vaping epidemic.”

  • TPB’s Marketing Denial Order Rescinded

    TPB’s Marketing Denial Order Rescinded

    Photo: momius

    The U.S. Food and Drug Administration has rescinded the marketing denial order (MDO) it issued for some Turning Point Brands (TPB) e-liquids. The products that had been denied are now back under review.

    In a letter addressed to TPB’s senior vice president of external affairs, Brittani Cushman, the FDA said it had found relevant information that was not properly assessed.

    “Specifically, your applications did contain randomized controlled trials comparing tobacco-flavored ENDS to flavored ENDS as well as several cross-sectional surveys evaluating patterns of use, likelihood of use and perceptions in current smokers, current ENDS users, former tobacco users and never users, which require further review,” wrote Matthew Holman, the director of the Office of Science at the FDA’s Center for Tobacco Products.

    The agency indicated that it would not initiate enforcement action against the TPB products under review.

    The move comes after TPB challenged the MDOs in court. TPB has now withdrawn its appeal.

    “We are encouraged by the FDA’s decision to reconsider our product applications and look forward to engaging the agency as our PMTAs are reviewed,” said TPB President and CEO Larry Wexler in a statement. “It is important that the PMTA process is transparent, purposeful and evidence-based. Our organization dedicated significant time and resources in filing our applications in accordance with agency guidance.

    “We remain hopeful that the depth and range of our studies and data will persuade the FDA that the continued marketing of our vapor products is appropriate for the protection of the public health and that the agency will ultimately preserve a diverse vapor market for the more than 30 million American adult smokers who may wish to transition from combustible cigarettes to lower risk alternatives.”

    Industry representatives suggest the clerical error is a result of the rush with which the FDA was forced to decide on premarket tobacco product applications. The Sept. 9 deadline was ordered by a court in response to litigation by anti-vaping groups, including the Campaign for Tobacco-Free Kids.

    The MDO withdrawal has left some speculating as to whether the rejected applications of other companies would also receive a second look. Several companies, including Triton and Bidi Vapor, are currently awaiting court decisions on their MDO challenges.

  • Fierce Opposition to Legalizing E-Cigarettes

    Fierce Opposition to Legalizing E-Cigarettes

    Photo: 1STunningART

    A proposal to legalize e-cigarettes in Thailand has run into fierce opposition, reports the Bangkok Post.

    Digital Economy and Society Minister Chaiwut Thanakamanusorn said on Tuesday he is exploring ways to permit the sale of e-cigarettes, citing economic opportunities and their potential to help people quit smoking.

    At least 67 countries have approved e-cigarettes as a less harmful alternative to smoking while Thailand still refuses to accept them, Chaiwut noted. More importantly, if it is possible to turn tobacco grown in Thailand into e-cigarette products and export them, both the Tobacco Authority of Thailand and tobacco growers will benefit, he said.

    The National Alliance for a Tobacco-Free Thailand (NATFT) responded by calling on the government to increase efforts to protect the public from all forms of tobacco products. “Various elements of society, both government and nongovernment, have been working hard to reduce the number of smokers, so legalizing e-cigarettes will only exacerbate the situation,” said NATFT chairwoman Somsri Pausawasdi.

    E-cigarettes are not safer choices for people who want to quit smoking while knowledge about their long-term effects on health remains limited for now, echoed Ronnachai Kongsakon, director of the Tobacco Control Research and Knowledge Management Center.

    The Medical Association of Thailand, too, has come out strongly against Chaiwut’s proposal.

    The organization sent an open letter to Prime Minister Prayut Chan-o-cha asking him to caution the minister. The letter was signed by Amorn Leelarasamee, president of the Medical Association of Thailand, and supported by heads of other organizations, including 14 royal colleges and the National Alliance for Tobacco-Free Thailand.

    The president of the Royal College of Surgeons of Thailand, Pramuk Mutirangkura, also voiced his opposition.

    Responding to the minister’s assertion that at least 67 countries had approved e-cigarettes as being less harmful than smoking tobacco, Pramuk said that each of those countries had allowed the sale with conditions attached. They were not sold without restrictions, he noted. 

    Many other countries still banned e-cigarettes because they wanted to protect the people’s health, preferring the “prevention is better than cure” principle, he added.

    There are at least 10 million smokers in Thailand.

  • FDA Issues Two Final Rules for Applications

    FDA Issues Two Final Rules for Applications

    Photo: Araki Illustrations

    The U.S. Food and Drug Administration has issued two final rules for the premarket review of new tobacco products. These foundational rules provide additional information on the requirements for the content, format and review of premarket tobacco product applications (PMTAs) and substantial equivalence (SE) reports—two of the most commonly used pathways through which a manufacturer can seek marketing authorization for a new tobacco product from the FDA.

    According to the agency, the finalization of these rules helps ensure that all future submissions contain the basic information needed to determine whether the new tobacco products meet the relevant premarket requirements to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act.

    “These final rules are important components of the FDA’s comprehensive approach to tobacco product regulation, which includes premarket application review, science-based use of the product standard authority and prioritized compliance and enforcement actions,” said acting FDA Commissioner Janet Woodcock in a statement. “The FDA is committed to protecting Americans from tobacco-related disease and death by ensuring that new tobacco products undergo appropriate regulatory review to determine if they meet the public health standards set by law. If new tobacco products do not meet the standards for these pathways, they cannot be marketed or sold in the United States.”

    “Conducting review of new tobacco products before they can be legally marketed is a critical responsibility of the FDA,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “These final rules will provide greater clarity and efficiency in review of new tobacco products by describing information that any company must provide if they seek to market a new tobacco product in this country.”

    On Jan. 19, 2021, the PMTA and SE final rules were displayed in the Federal Register but did not publish. On Jan. 20, 2021, a memo from the White House Chief of Staff ordered the withdrawal of any rules that did not publish in the Federal Register by noon on that day. Therefore, these final rules were withdrawn at that time. The rules displaying today reflect clarifying changes made from the previous versions but no significant substantive changes. Both final rules will publish on Oct. 5 and are effective Nov. 4. Beginning on the effective date, applications submitted through these pathways must meet the requirements described in these final rules.