Category: Regulation

  • Duterte Asked to Cut Regulator’s Foreign Funding

    Duterte Asked to Cut Regulator’s Foreign Funding

    Tobacco harm reduction advocates have urged Philippine President Rodrigo Duterte to revoke the foreign funding received by the Food and Drug Administration (FDA), reports The Manila Times. The groups are concerned that the funds will unduly influence the drafting of the guidelines for the regulation of heated tobacco products (HTPs).

    “We appeal to President Duterte to rescind the foreign grants received by the Philippine Food and Drug Administration, which cast a dark cloud on the agency’s role as an independent regulator and protector of public health,” said Anton Israel, president of the Nicotine Consumers Union of the Philippines.

    The FDA has admitted that it received grants from foreign anti-tobacco groups The Union and Bloomberg, which advocate prohibition for all tobacco products, including e-cigarettes and heated tobacco products (HTPs)

    Israel said the FDA receiving money from the said groups was a violation of the Code of Conduct and Ethical Standards for Public Officials and Employees.

    Clarisse Virgino, the Philippines’ representative to the Coalition of Asia Pacific Tobacco Harm Reduction Advocates, said the funds received from anti-vaping groups would jeopardize FDA’s treatment of tobacco harm reduction products such as e-cigarettes and HTPs.

    “E-cigarettes and heated tobacco products are not pharmaceutical products and should not be regulated as such. What we need is a fair and risk-proportionate regulation that will encourage smokers to reduce their exposure to smoke which is the one that causes all these diseases,” she continued.

    The groups called for impartial and reasonable regulations based on scientific evidence.

  • Taiwan Considers Ban on Flavored Vapor Products

    Taiwan Considers Ban on Flavored Vapor Products

    city in Taiwan
    Credit Remi Yuan

    Flavored e-cigarettes and vapor products could be banned in Taiwan in an effort to curb youth use. Taiwan health officials stated that there were over 1,200 registered tobacco (and e-cigarette) flavorings in Taiwan in 2019, with the 10 most common being vanilla, floral and fruity flavors, candy, menthol, almond, caramel, butter, cherry, cinnamon, and rose.

    The Health Promotion Administration (HPA) claims four out of 10 juvenile smokers (includes vapers) used flavored cigarettes in 2019, and the products appear to be more popular among girls.

    The HPA said youths tend to believe such products pose lesser health risks and that they underestimate the addictive properties of nicotine. The agency has thus included restrictions on floral, fruity, chocolate, menthol, and other additives in the proposed amendment to the Tobacco Hazards Prevention Act, according to the Taiwan News.

    The amendment, which is currently being reviewed before its legislative reading, will also regulate traditional cigarettes and other tobacco products.

  • Vaporesso First CRC-Compliant Brand in Canada

    Vaporesso First CRC-Compliant Brand in Canada

    Credit: Vaporesso

    Vaporesso is the first refillable vapor product to pass Canada’s Child Resistant Certified (CRC) regulation. The rule was imposed by the Canada Consumer Product Safety Act (CCPSA).

    Vaporesso, which is owned by the world’s largest vapor company Smoore International, received certification for its ZERO and XROS CRC devices. The GTX TANK 22 CRC version compatible with the GEN S, GEN Nano, LUXE II, and SWAG II mods, was also approved.

    Similar to the premarket tobacco product application (PMTA) in the United States, Canada’s CRC-compliance is a federal requirement for all vaping manufacturers who want to continue advertising and selling their vaping products in Canada. The regulation serves to prevent children and teenagers from using vaping products, according to a press release.

    “Working closely with the official authorities, Vaporesso is committed to leading the industry into strictly complying with all vaping-related regulations,” the release states. “The brand’s purpose is to prevent people who haven’t reached the legal age from using vaping products while maintaining the industry’s healthy development.”

    The brand’s ZERO refillable pod system was compliant with the ISO8317 child-proof standard certification before the CRC Act took effect in the vaping industry. As a result, Vaporesso quickly redesigned the GTX TANK 22 into a new CRC-compliant version launched in 2020.

  • New U.S. FDA Draft Guidance for Perception Studies

    New U.S. FDA Draft Guidance for Perception Studies

    fda

    The U.S. Food and Drug Administration (FDA) has released a draft guidance for tobacco product perception and intention (TPPI) studies. The studies must be submitted as part of a modified risk tobacco product application (MRTP), a premarket tobacco product application (PMTA) or a substantial equivalence report (SE Report).

    The guidance is aimed at helping applicants design and conduct the studies that can be used to assess, among other things, individuals’ perceptions of tobacco products, understanding of tobacco product information (e.g., labeling, modified risk information), and intentions to use tobacco products.

    It is possible for a TPPI study to also include an actual use component (e.g., an actual product utilized in a simulated use setting or a real environment of use); however, a discussion of actual use research is beyond the scope of this draft guidance, according to the FDA.

    This draft guidance addresses the following scientific issues for applicants to consider as they design and conduct TPPI studies to support tobacco product applications:

    • Developing TPPI study aims and hypotheses
    • Designing quantitative and qualitative TPPI studies
    • Selecting and adapting measures of TPPI study constructs
    • Determining TPPI study outcomes
    • Selecting and justifying TPPI study samples
    • Analyzing TPPI study results

    The administration is accepting public comments related to the draft guidance through Dec. 28. The application deadline was Sept. 9 for deemed new tobacco products that were on the market as of Aug. 8, 2016, and the FDA said it intends to make a public list of what products were submitted on time. 

  • Australian C-Stores Want Ability to Sell E-Cigarettes

    Australian C-Stores Want Ability to Sell E-Cigarettes

    Shell gas station in Australia
    Credit: Simona Sergi

    Retailers in Australia want the government to allow small businesses that sell cigarettes and other nicotine products to also be allowed to sell less harmful alternatives such as vaporizers and e-cigarettes.

    The Australasian Association of Convenience Stores (AACS) and the National Retailers Association (NRA) both claim that the federal Government’s decisions regarding the sale of smoke free tobacco products will hurt Australian retailers.

    NRA Chief Executive Officer Dominique Lamb said that after the government’s reversal on its previous ban on vapor products, its policy position was getting weirder by the day, Convenience and Impulse Retailing.

    “Last month, smoke-free tobacco products were deemed so harmful that the government decided they could only be sold at a chemist, by prescription, with visits to a doctor every three months,” Lamb said. “The same government says it will reverse its looming ban on importing vaping products, so individuals will be free to buy them from overseas dealers and have them shipped into Australia.”

    Lamb said that the laws confuse consumers by regulating e-cigarettes and vaping products as controlled substances, yet anyone one can purchase them online from overseas retailers. “The only people who will be banned from selling smoke-free tobacco products will be the tens of thousands of mum-and-dad retailers who currently rely on cigarette sales but are desperate to offer their customers a less harmful alternative,” he said. “This government clearly supports overseas retailers as much as it supports big-box corporate pharmacy. It’s just a shame that it won’t support small, local Australian businesses.”

    AACS has also pointed towards a growing black market for e-cigarettes and has highlighted the urgent need for Government to regulate the sale of these products through legitimate and responsible channels, according to the story.

    “There are positive health outcomes available to Australians through the regulated, legal sale of e-cigarettes, given they are significantly safer for people to use than traditional tobacco. Unfortunately, by restricting the legal sale of products which are clearly in demand, the health impacts of the Government’s approach are decidedly negative,” AACS CEO Jeff Rogut says. “This refusal to catch up with the rest of the world in making safer choices easier for consumers has allowed the black market for vaping products of unknown ingredients and from dubious sources to grow in Australia.”

    “Clearly, consumers are looking for safer alternatives to smoking. If health authorities are serious about helping people quit tobacco, they need to make vaping products legally available through responsible retailing channels urgently.

    The recent interim decision by the Therapeutic Goods Administration (TGA) to make vaping products only available to people from pharmacies with a prescription is both dangerous to health and a missed opportunity for responsible retailers, the AACS says.

    “Australia’s approach of making it harder for our citizens to access products that are safer for them is unique in a global context,” Rogut says.

  • Consumer’s Wants Charges Against Philippines FDA

    Consumer’s Wants Charges Against Philippines FDA

    Credit: Ye Jinghan

    The Food and Drugs Administration (FDA) continues to face backlash from stakeholders who are now threatening to file corruption charges before the Ombudsman following the regulatory agency’s admission of receiving funds from foreign vested interest groups.

    The FDA conducted virtual public consultations on the general guidelines for e- cigarettes and heated tobacco products (HTPs) on October 6 and 8, 2020, where a ranking FDA official admitted that the agency received grants from The Union and Bloomberg Initiative after questioning from Nueva Ecija Rep. Estrellita Suansing who noted the potential conflict of interest, according to the Inquirer.net.

    The public consultation described by some stakeholders as “moro-moro” was suspended upon the request of Deputy House Speaker Deogracias Victor Savellano who also moved to conduct a full-blown House of Representatives investigation on the FDA.

    Nicotine Consumers Union of the Philippines (NCUP) president Anton Israel said: “If the FDA ignores the views of legitimate and impacted stakeholders and proceeds with the adoption of an administrative order lifted from the playbook of their anti-tobacco patrons, we would be constrained to file an anti-graft case with the Ombudsman.”

    Philippine representative to the Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA) Clarisse Virgino said they were “shocked and aghast by the admission of the FDA that they received money from the Union and Bloomberg Initiative. These groups are known advocates of prohibition for all forms of tobacco products including better alternatives to cigarettes like e-cigarettes and heated tobacco products.”

    Philippine E-Cigarette Industry Association president Joey Dulay said during the last FDA public hearing that, “We are saddened to hear that the proposed FDA Guidelines on the regulation of vapor products was based on the recommendations of only the public health NGOs, we (vapers and industry) are the ones most affected with these guidelines and should be heard and considered also.”

    “Upon questioning by Congress representatives present in the hearing, it came out that the FDA has been receiving financial grants of Bloomberg, basing guidelines on medical NGO’s who are known anti-vapor groups, shows partiality. We would like to humbly request the FDA for more fair and impartial conduct of the drafting of the guidelines. That is all we ask, so we may work things together hand in hand please,” Dulay added.

    Virgino reminded the FDA that the solicitation or acceptance of gifts is prohibited under Republic Act No. 6713, or the Code of Conduct and Ethical Standards for Public Officials and Employees, especially if it involves a piece of regulation: Section 7 of RA 6713 prohibits public officials and employees from soliciting or aaccepting, directly or indirectly, any gift, gratuity, favor, entertainment, loan or anything of monetary value from any person in the course of their official duties or in connection with any operation being regulated by, or any transaction which may be affected by the functions of their office. It is clear that funds received from anti-vaping groups would jeopardize FDA’s treatment of tobacco harm reduction products such as e-cigarettes and HTPs,” she said.

    FDA’s acceptance of the grant is a clear case of conflict of interest driven solely by financial considerations, according to Israel. “We know this government is uncompromising with corruption and President Duterte will not tolerate this abuse of authority,” he said.

    Virgino said the FDA as a regulatory agency should be an independent body free from the influence of any foreign or local institution that tries to push their own interests.

    “It is supposed to safeguard public health, and not become a subordinate to moneyed foreign groups,” she said.

  • MIchigan to Again Try Banning Flavored E-liquids

    MIchigan to Again Try Banning Flavored E-liquids

    Credit: Sahand Babali

    The Michigan Governor’s administration is working on another statewide ban on flavored nicotine vaping products without legislative approval after Gov. Gretchen Whitmer’s first emergency order was struck down by courts.

    The Michigan Department of Health and Human Services (MDHHS) held a virtual public hearing on Tuesday to solicit public comments on its proposal to permanently ban the sale and distribution of flavored nicotine vaping products. MDHHS is accepting comments until Friday.

    The hearing is the first step required to impose a ban, which state officials support to crack down on the rise in youth vaping, according to the Metro Times.

    “MDHHS is proceeding with permanent administrative rules preventing the sale and advertisement of flavored nicotine vapor products in the state to protect the health and safety of Michiganders, particularly our youngest residents,” MDHHS spokeswoman Lynn Sutfin tells Metro Times. “The explosive and unprecedented rise in youth vaping continues to be a public health emergency and a nationwide epidemic.”

    Whitmer issued an executive order to ban flavored Michigan in September 2019, becoming the first state to ban flavored nicotine vaping products. But a Michigan Court of Claims judge issued an injunction requested by vape shop owners, who argued Whitmer overstepped her authority by imposing a ban without the approval of state lawmakers. The Michigan Supreme Court last month denied the state’s request to reconsider the lower court’s ruling.

  • U.S. Senator Asks FDA to Release List of PMTA Filers

    U.S. Senator Asks FDA to Release List of PMTA Filers

    Dick Durbin
    Credit: Durbin.gov

    U.S. Senator Dick Durbin urged the U.S. Food and Drug Administration (FDA) to strongly enforce its own regulations “to protect kids from addictive e-cigarettes” by publishing a list of products that submitted premarket tobacco product applications (PMTAs). The Illinois senator wants to remove products that did not submit PMTAs from store shelves.

    “After years of delayed regulatory oversight, which fueled the explosion in youth e-cigarette use, FDA finally required e-cigarette PMTAs to be submitted for review on September 9. It has now been more than one month, and the agency has yet to publish a comprehensive list of products that submitted applications,” according to a press release.

    Durbin said he was concerned that the delay to publish the list of products that have submitted applications will allow products that remain out of compliance and illegally on the market to proliferate.

    “In order to protect public health and uphold the duty to enforce against products on the market that are out of compliance, I urge FDA to immediately publish a comprehensive product listing of all relevant e-cigarette applications received by FDA. While I appreciate the sheer volume of applications submitted to FDA, and the agency’s intention to prioritize review of those with the greatest market share and public health impact, we know from recent years that youth shift patterns of e-cigarette use based upon what products are available to them,” Durbin wrote in a letter to FDA Commissioner Dr. Stephen Hahn.

    Vapor and e-cigarette products can remain on the market while the FDA determines whether to approve or reject PMTA applications. The agency has up to one year to make these determinations.

  • USA Vape Lab Gets Filing Letter From FDA for PMTA

    USA Vape Lab Gets Filing Letter From FDA for PMTA

    Credit: Naked 100

    USA Vape Lab, one of the largest e-liquid manufacturers in the world, announced that it received its filing letter from the U.S. Food and Drug Administration (FDA). The filing letter acknowledges that the company’s premarket tobacco product applications (PMTAs) for their Naked 100 products are sufficiently complete, advancing the brand’s application forward to the substantive review phase.

    During the substantive review phase, the FDA evaluates the scientific studies and data presented in the applications submitted to ensure that the products are appropriate for the protection of the public health (APPH).

    “We are excited to be advancing further through the PMTA process. Our team has dedicated time and resources to ensure we have the data, research, and necessary components needed for our applications,” said Huy Nguyen, CEO of USA Vape Lab. “We are optimistic that our applications will continue to advance and result in the FDA granting USA Vape Lab with marketing orders.”

    The company says it continues to maintain the highest standards of regulatory compliance and is committed to working with the FDA as its applications undergo review.

  • Air Factory, Charlie’s Chalk Dust Get PMTA Filing Letters

    Air Factory, Charlie’s Chalk Dust Get PMTA Filing Letters

    My Vape Order, Inc. (MVO) announced that on October 9, 2020, the U.S. Food and Drug Administration (FDA) issued a Filing Letter notifying MVO that the Air Factory’s premarket tobacco product application (PMTA) met the FDA’s requirements and was moving forward into the regulatory agency’s substantive scientific review phase.

    Charlie’s Chalk Dust e-liquids have also received a filing letter and moved on to substantive review. “It is with great pleasure that we can announce to our customers that the FDA’s Center for Tobacco Products has informed us that our PMTA is sufficiently complete to enter the Substantive Review phase of the process,” wrote Brandon Stump, CEO of Charlie’s Chalk Dust. “This news is worthy of celebration as it highlights our progress towards achieving full regulatory compliance and providing our customers with a trusted product portfolio. It is a reflection of our relentless hard work and meticulousness in the pursuit of precision. We are confident that during the Substantive Review process the FDA will recognize that our submission is both distinguished and suitable for approval.”

    Kyle Godfrey, MVO’s CEO, said the FDA will review the extensive scientific data and research submitted with the PMTA to determine whether the Air Factory products are appropriate for the protection of public health. “The Air Factory PMTA was the culmination of years of planning and extensive toxicological testing and scientific research,” he said. “We look forward to working with FDA on its review of the Air Factory products, with the ultimate goal of obtaining FDA marketing orders for the products.”