Author: Marissa Dean

  • New Resources to Help Amend PMTAs

    New Resources to Help Amend PMTAs

    Credit: Postmodern Studio

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has created two new resources to help applicants prepare and submit amendments to their premarket tobacco product applications (PMTAs): Fact Sheet—Amendment Tips: Completing Form FDA 4057a and Video—Using the CTP Portal.

    The fact sheet provides quick tips for completing Form FDA 4057a—Premarket Tobacco Product Application Amendment and General Correspondence Submission. In most circumstances, the CTP can only accept PMTA amendments for review that include Form FDA 4057a. In general, when submitting amendments for a PMTA, the FDA will review the required Form FDA 4057a first. If required content is missing from the form, the FDA may not continue reviewing the amendment.

    The video provides an overview of the CTP Portal and how to use it, including how to find application submission tracking numbers online.

    Recently, CTP Director Brian King outlined several new actions to enhance the center’s efficiency, effectiveness and transparency. These activities include enhanced communication on scientific issues and practices. By providing these new resources, the CTP is aiming to better support applicants navigating the PMTA process.

  • Zovoo Dragbar Z700 GT Wins Red Dot Award

    Zovoo Dragbar Z700 GT Wins Red Dot Award

    Image: BusinessWire

    Zovoo has won a 2023 Red Dot Award for its Dragbar Z700 GT, which was recognized for its innovative design and exceptional functionality, according to BusinessWire.

    The Red Dot Award is organized by the Design Zentrum Nordrhein Westfalen in Germany, recognizing outstanding products in various categories such as Industrial Design, Communication Design and Product Design.

  • Broughton Joins UKVIA

    Broughton Joins UKVIA

    Photo: Courtesy of the Broughton Group

    Broughton has joined the U.K. Vaping Industry Association (UKVIA) as the 2023 vaping awareness month, VApril, kicks off. Nveed Chaudhary, chief scientific and regulatory officer at Broughton, attended a meeting of industry experts at the Houses of Parliament to encourage more regulatory rigor in applying U.K. vape regulation to protect consumers, according to a press release. The event provided a platform for key stakeholders to discuss the current state of the vaping industry and explore ways to improve public health outcomes.

    “Recent compliance issues with some manufacturers could impact consumer trust in vapes in the U.K.,” said John Dunne, UKVIA director. “Quality control and analytical testing experts Broughton joining UKVIA at this time illustrates the importance of product quality and safety to ensuring the continued transition of smokers away from cigarettes.

    “At UKVIA, we believe vapes have a key role to play in helping reduce death and disease caused by smoking. Ensuring vape safety is of the utmost importance to us and our members, and as a group, we’re advocating for stronger action against noncompliant vapes. This should include faster removal of noncompliant products, complete testing of products and greater penalties for manufacturers and retailers who break the rules.”

    Broughton has also introduced a new U.K. and European Union Vape Compliance Package to help address concerns about vape regulatory compliance. The service will focus on labeling, packaging, nicotine strength, fill volume and banned ingredients.

    Manufacturers, distributors and retailers who use the compliance package will receive a Certificate of Analysis that verifies their products’ compliance with current U.K. or EU regulations.

  • CTP Held Public Hearing on Manufacturing Rules

    CTP Held Public Hearing on Manufacturing Rules

    Image: Tobacco Reporter archive

    On April 12, 2023, the Food and Drug Administration’s Center for Tobacco Products (CTP) held an online public hearing regarding its recently released proposed rule on “Requirements for Tobacco Product Manufacturing Practice.” This public hearing was scheduled when the CTP issued the proposed rule on March 10.

    The hearing began with introductory comments by CTP Director Brian King. In addition to welcoming the participants and audience to the hearing, King noted that the CTP has been designing this proposed rule since 2011. Following King was Matthew Brenner, CTP senior regulatory counsel. Brenner summarized the proposed rule and highlighted the definitions of a “finished tobacco product” and a “bulk tobacco product” with regard to the rule. Emil Wang, senior advisor for manufacturing and regulatory policy at the CTP’s Office of Compliance, concluded the introductory session by detailing the timeline of the proposed rule. The proposed rule’s 180-day public comment period is between March 10 and Sept. 6, 2023. The effective date for the regulation would be two years after the final rule is published in the Federal Register. For small manufacturers (those manufacturers with fewer than 350 employees), the effective date for the regulation would be six years after the final rule is published in the Federal Register.

    The public comment session featured the following scheduled participants (in order):

    • James O’Reilly—professor of public health policy at the University of Cincinnati. O’Reilly called the proposed rule “comprehensive” and noted that the CTP needs to add another $100 million in additional staff to properly enforce this rule. O’Reilly also called on the CTP to coordinate with other federal agencies, such as the Environmental Protection Agency, to handle foreign chemical imports that relate to this rule.
    • Drew Newman—JC Newman. The premium cigar maker representative highlighted four items: flexibility is required as each tobacco product differs from one another; recordkeeping is lengthy and costly; qualifying suppliers such as tobacco leaf growers will be difficult; and batch coding for final products will prove very difficult for the premium cigar industry.
    • Hiuyu Shi—e-cigarette manufacturer from Shenzhen, China. Shi noted that foreign components will be very difficult to regulate and monitor. One example was the difference in water quality between nations.
    • Laura Searcy—National Association of Pediatric Nurse Practitioners. Searcy supports the proposed rule.
    • Gabby Kaife—Boutique Cigar Association. Kaife is against the proposed rule.
    • Jason Hodge—former smoker and current vaper. Hodge is against the proposed rule.
    • Joshua Habursky—deputy executive director of the Cigar Association. Habursky is against the proposed rule.
    • Meredith Berkman—Parents Against Vaping. Berkman supports the proposed rule.
    • Maham Akbar—The Truth Initiative. Akbar supports the proposed rule.
    • Connor Fuchs—Campaign for Tobacco-Free Kids. Fuchs supports the proposed rule and notes that the timeline is too long and should be shortened.
    • Mark Anton—e-cigarette/vapor product manufacturer. Anton believes that sections of the proposed rule conflict with previous statements by the CTP. Also, he believes that the burden has been shifted from the regulator to the manufacturer.
    • Patrick Murphy—vice president of scientific and regulatory affairs at Reynolds American Inc. (RAI). Murphy calls for further refinement and guidance to the proposed rule. He calls for more clarity in several sections and better processes that are product dependent. RAI will forward its notes in a written comment.
    • Michelle Paige—tobacco chemist. Paige discussed storage conditions and stability issues regarding electronic nicotine-delivery system liquids. Further product standards are needed in this area.
    • Sammy Hamdouche—Lucy, manufacturer of oral nicotine products. Hamdouche called the regulation onerous for small manufacturers such as his company. Further labor for his company and their suppliers could eliminate parts or potentially all of their business. Costs could be 10-fold for these processes for his company. Predetermined acceptance criteria could be one solution. The CTP has wide latitude to make this rule more flexible, but Hamdouche is not optimistic.
    • Ron Tully—tobacco industry consultant. Tully believes that the proposed rule should recognize manufacturers of different products and sizes. Small manufacturers could face financial disaster with this rule.
    • Pamela Ling—professor at the University of California at San Francisco. Ling supports the proposed rule. She also calls to strengthen the section of the rule regarding storage procedures and shelf life.
    • Pamela Granger—anti-tobacco activist. Granger supports the proposed rule.

    The public comment session featured the following unscheduled participants (in order):

    • Jason Hodge concluded his earlier
    • Delores Orlando—Florida Smoke-Free Organization, nicotine product manufacturer. Orlando is against the proposed rule.

    On May 18, 2023, the CTP’s Tobacco Product Scientific Advisory Committee will meet the discuss the proposed rule on “Requirements for Tobacco Product Manufacturing Practice.”

  • Public Hearing for Manufacturing Rules

    Public Hearing for Manufacturing Rules

    Credit: Monticello

    The U.S. Food and Drug Administration will hold a public hearing tomorrow, April 12, concerning its proposed guidelines for vaping product manufacturers. When finalizing its rules, the agency weighs the public’s perspective and the perspectives of stakeholders like the vapor manufacturing companies that produce the products.

    The FDA will also bring together its Tobacco Products Scientific Advisory Committee on May 18 to get the opinions of those independent experts. The proposed rules would apply to all FDA-regulated bulk and finished tobacco products, including cigarettes, cigars, chewing tobacco and e-cigarettes.

    The hearing is an opportunity for the public to verbally comment on the agency’s proposed rule “Requirements for Tobacco Product Manufacturing Practice.” The FDA is proposing new requirements for vaping and other tobacco product manufacturers regarding the manufacture, design, packing and storage of their products.

    Registration also includes a “listen-only” option for those who want to attend the session but do not want to request to speak.

    When announcing the hearing, the FDA said speaking spots were limited, and the agency could not guarantee that it would be able to accommodate all requests. The agency asked groups and organizations to select a single spokesperson to help the agency hear as many different perspectives as possible.

    Registration to provide oral comments closed on March 31, 2023. The oral session will be recorded, and a transcript will be added to the docket of the proposed rule.

  • UK to Launch Vaping ‘Enforcement Squads’

    UK to Launch Vaping ‘Enforcement Squads’

    Image: RealPeopleStudio | Adobe Stock

    The U.K. is set to launch “illicit vapes enforcement squads” as part of a crackdown on the illegal sale of e-cigarettes to youth under the age of 18, reports Sky News.

    Led by Trading Standards, the squads will work across the country and share knowledge across regional networks and local authorities.

    The government says its priority is to prevent people from smoking and to support them to quit. It has admitted vaping is a preferable alternative for adults.

    However, it recognizes it has issues with illegal sales to children and illicit vapes being introduced into the market.

    Neil O’Brien, the health minister who will unveil the new plans, said the new illicit vapes enforcement squad will work across the country and clamp down on those businesses that sell vapes to children.

    “Our call for evidence will also allow us to get a firm understanding of the steps we can take to reduce the number of children accessing and using vapes,” he said.

    Smoker rights group Forest welcomed the knowledge-focused approach. “Education is always better than coercion, so we’re pleased the government appears to favor the carrot not the stick approach to smoking cessation,” said Forest director Simon Clark.

    “Vaping is a significantly less harmful alternative to smoking, so it makes sense to encourage smokers to switch to e-cigarettes.

    “If, however, adult smokers still prefer to smoke tobacco, government must respect that choice.”

  • Juul Labs Settles with West Virginia

    Juul Labs Settles with West Virginia

    Image: Roman Motizov | Adobe Stock

    West Virginia has reached a settlement agreement with e-cigarette manufacturer Juul Labs in litigation about the company’s advertising and marketing practices, according to state Attorney General Patrick Morrisey.

    Juul Labs has agreed to pay the state $7.9 million, based on accusations that the company violated West Virginia’s Consumer Credit and Protection Act, according to media reports.

    The company was accused of “engaging in unfair or deceptive acts or practices in the manufacturing, designing, selling, marketing, promoting and distributing of e-cigarettes” in the state, especially promotions targeting underage users, according to Morrisey.

    “This settlement puts companies like Juul in check to not copy Big Tobacco’s playbook and gear marketing strategies toward underage people,” he said. “In Juul’s case, we have alleged it has deceived consumers about its nicotine strength, misrepresented the nicotine equivalency of its products to traditional cigarettes and understated the risks of addiction that occur with such powerful levels of nicotine.”

    The settlement represents “yet another step in Juul Labs’ ongoing commitment to resolve issues from the company’s past,” said Austin Finan, vice president of corporate communications at Juul Labs.

    “The terms of the agreement, like prior settlements, provide financial resources to further combat underage use and develop cessation programs, and they reflect our current business practices, which were implemented as part of our company-wide reset in the fall of 2019,” Finan said. “With West Virginia having the highest cigarette smoking rate in the U.S., we hope that some funds will go directly to interventions to reduce the use of combustible cigarettes and improve public health in the state.”

    Juul has now settled with “40 states and territories, providing hundreds of millions of dollars to the participating states,” according to Finan.

  • UK Smokers Encouraged to Swap Cigs for Vapes

    UK Smokers Encouraged to Swap Cigs for Vapes

    Image: Tobacco Reporter archive

    Up to 1 million smokers will be encouraged to swap their cigarettes for vapes, according to the British government. Pregnant women will be offered financial incentives to switch, reports Reuters.

    “Up to two out of three lifelong smokers will die from smoking. Cigarettes are the only product on sale which will kill you if used correctly,” Health Minister Neil O’Brien will say in a speech later on Tuesday, the government said.

    “We will offer a million smokers new help to quit. We will be funding a new national ‘swap to stop’ scheme—the first of its kind in the world.”

  • Call for Measures to Limit Nicotine Harm

    Call for Measures to Limit Nicotine Harm

    Image: Tobacco Reporter archive

    The Malaysian Council for Tobacco Control (MCTC) has called for the government to look into measures to limit harm and exposure of youth to nicotine after the Health Ministry exempted nicotine liquids and gels from the Poisons Act 1952, reports The Star.

    “We are deeply aggrieved by the decision of the Health Ministry and the government to continue with its move to remove nicotine liquid and gel preparations from the poisons list for the purposes of using it for electronic cigarettes and electric vaporizing devices in the form of liquid or gel,” the MCTC said.

    “This move had been carried out despite exhortations and pleas from thousands of health professionals including those within the MCTC umbrella.

    “We are deeply concerned with the dangerous precedent that this has set where the health of Malaysians, especially children and young people, have been put at risk merely for the idea of raising revenue.

    “There is little transparency available on actual taxation measures, so it is not understood in terms of timelines on when actual tax collection would actually even begin.”

    “We urge the Health Ministry and federal government to ensure the wellbeing of its people are looked into, with short-term, mid-term and long-term measures.

    “For short-term measures, the government needs to put active measures in place to limit the exposure of children and young people to nicotine in vaping and other e-cigarette devices. This may be done via cooperation with other agencies and ministries since there are no significant health legislative tools which may be used to limit harm at this point.

    “Mid-term measures include the need to table the Control of Tobacco Products and Smoking Bill as per its original intent and content as quickly as possible. Prime Minister Datuk Seri Anwar Ibrahim has given his commitment that this will be done in the next Parliament meeting in May, and we implore that this timeline be adhered to. Within the bill are comprehensive measures for vaping and electronic cigarettes—including key measures prohibiting its use to those under 18,” the council said.

    The MCTC said long-term measures should include a comprehensive strategy to contain and control nicotine addiction.

  • Tobacco Used to Create Moth Pheromones

    Tobacco Used to Create Moth Pheromones

    Image: Tobacco Reporter archive

    Scientists have used Nicotiana benthamiana, a species of tobacco, to produce the sex pheromone of two moth species, which could potentially help cut down on pesticides, according to Tech Explorist.

    By using precision gene engineering techniques, scientists at the Earlham Institute in Norwich have been able to turn tobacco plants into solar-powered factories for moth sex pheromones.

    To trap or divert male insects from mating, farmers can place pheromone dispersers in their crops to mimic the signals of female insects.

    “Synthetic biology can allow us to engineer plants to make a lot more of something they already produced, or we can provide the genetic instructions that allow them to build new biological molecules, such as medicines or these pheromones,” said Nicola Patron, the study’s principal investigator and director of the Earlham Institute’s Synthetic Biology Group.

    “As we increase the efficiency, too much energy is diverted away from normal growth and development,” Patron added. “The plants are producing a lot of pheromones, but they’re not able to grow very large, which essentially reduces the capacity of our production line. Our new research provides a way to regulate gene expression with much more subtlety.”

    “We’ve shown we can control the levels of expression of each gene relative to the others. This allows us to control the ratio of products that are made.”

    “Getting that recipe right is particularly important for moth pheromones as they’re often a blend of two or three molecules in specific ratios. Our collaborators in Spain are now extracting the plant-made pheromones and testing them in dispensers to see how well they compare to female moths.”