Tag: regulation

  • Vietnam Mulls Ban on Next-Generation Products

    Vietnam Mulls Ban on Next-Generation Products

    Photo: Michele

    Vietnam’s health ministry has proposed a ban on next-generation tobacco products (NGPs), reports VN Express International. the country’s current law on tobacco harm prevention lacks provisions for e-cigarettes and heated tobacco products.

    According to Tran Thi Trang, deputy head of the Ministry of Health’s legislation department, a trial allowing the distribution of NGPs revealed potential negative impacts, including on youth behavior.

    The percentage of people using e-cigarettes in Vietnam increased to 3.6 percent from 0.2 percent during 2015-2020, according to the health ministry.

    With 15.6 million smokers, Vietnam ranks 15th in the world in terms of combustible cigarette users, the Legal Affairs Department at the Ministry of Information and Communications said. People in Vietnam spend an estimated at VND49trillion ($2 billion) per year.

  • FDA Warns 5 Companies for Marketing CBD Edibles

    FDA Warns 5 Companies for Marketing CBD Edibles

    Credit: Simone

    The U.S. Food and Drug Administration today posted warning letters to five companies for illegally selling products containing cannabidiol (CBD).

    These companies are accused of selling products containing CBD that the FDA states some people may confuse for traditional foods or beverages that do not contain CBD. This could result in unintentional consumption or overconsumption of CBD.

    “CBD-containing products in forms that are appealing to children, such as gummies, hard candies and cookies, are especially concerning,” the FDA stated in a release.

    Warning letters were sent to the following companies:

    The FDA has not found adequate information showing how much CBD can be consumed, and for how long, before causing harm, according to the agency.

    “This is particularly true for vulnerable populations like children and those who are pregnant. People should be aware of the potential risks associated with the use of CBD products,” the agency states.

    The warning letters also outline additional violations of the Food, Drug & Cosmetics Act, including that several of the companies are illegally selling unapproved CBD products that claim to cure, mitigate, treat or prevent various diseases, and adding CBD to animal foods, such as pet treats.

    “The FDA has requested responses from the companies within 15 working days stating how they will address the issues described in the warning letters or providing their reasoning and supporting information as to why they think the products are not in violation of the law,” the agency wrote. “Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.”

  • Calls for Australia to Adopt Plain Package for Vapes

    Calls for Australia to Adopt Plain Package for Vapes

    Credit: Von ifeelstock

    Anti-vape advocates are calling for e-cigarette packaging to be under the same rules as tobacco packing, including warnings that include the dangers involved with using the product.

    In December 2012, Australia became the first country to require tobacco companies to sell their products in drab olive-brown boxes stripped of branding but featuring large pictures of smoking-related diseases.

    Tobacco companies challenged the move in various courts, saying it not only breached trademark laws and intellectual property rights but would also boost black market sales. Libertarians characterized plain packaging as a “nanny state” measure.

    Now, 20 countries, including the U.K., Turkey, France, Sweden, Belgium, the Netherlands and Ukraine, have brought in their own versions of plain packaging legislation.

    Mal Washer, told 6PR Mornings that what worked best in the past was by making smoking anti-social.

    “You looked like a half wit if you smoked, and that did more than any medical advice as people tend to ignore that but vaping has now become a big problem,”

    “The biggest thing in my opinion is making vaping anti-social and to make people realize this product is dangerous.”

  • Video: TGA Boss Admits Issues With Australian Rule

    Video: TGA Boss Admits Issues With Australian Rule

    The head of the Australia’s Therapeutic Goods Administration (TGA) has acknowledged shortcomings in the country’s vaping regulations, according to tobacco harm reduction activist Colin Mendelsohn.

    Writing on his website, Mendelsohn says TGA boss John Skerrit “has finally admitted the disastrous and predictable failure of Australia’s vaping regulations,” which among other things require vapers to obtain a doctor’s prescription to buy nicotine-containing e-cigarettes

    During questioning in Australia’s Senate, Skerrit acknowledged not only that there has been a dramatic increase in youth vaping, but also that large numbers of low-quality products are entering the country and are being sold on the black market, according to Mendelsohn.

    In addition, Skerrit noted that only 1,353 out of 130,000 registered doctors have applied to be authorized e-cigarette prescribers and less than 10 percent of adult vapers have a prescription for nicotine.

    According to Mendelsohn, Skerritt had previously promised a review of the regulations, which were introduced on Oct. 1, 2021, at three, six and 12 months. Instead, he wrote, the TGA and government had a secret meeting of unnamed vaping experts.

    Mendelsohn said it is likely that further restrictions and enforcement will be recommended by “the experts” to double down on their de facto prohibition. “This will only lead to greatly reduced legal vaping and more deaths from smoking,” he wrote.

  • Minimum Market Prices Set for Vapes in Philippines

    Minimum Market Prices Set for Vapes in Philippines

    The Philippine Bureau of Internal Revenue (BIR) has set a floor price for heated, vapor and other electronic nicotine-delivery systems (ENDS), reports ABS-CBN News. 

    The floor price for a 0.7 ml pod of nicotine is PHP131.04 ($2.29). For 1.8 ml and 1.9 ml nicotine salts, the minimum prices are PHP306.88 and PHP318.08, respectively.

    Meanwhile, the floor price for a 15-ml bottle of conventional freebase nicotine is PHP207.2. A bottle that contains 30 ml of classic nicotine has a PHP352.8 minimum price. 

    According to BIR East NCR director Edgar Tolentino, the new guidelines will help the economy and protect the health of minors. 

    “BIR will have exclusive jurisdiction over taxpayer registration, setting the products’ floor price, drafting and publication of revenue regulations covering vape items,” Tolentino said. 

    He also said the newly appointed BIR Commissioner Romeo Lumagui Jr. has a mandate to crack down on illicit vape traders. 

    “We need to support the plans of the commissioner; one thing is to focus on illegal vape sellers because if smuggling persists we will be losing huge revenues from vape products,” he said. 

    Since 2019, the government has collected about PHP15.3 billion in vape taxes. 

  • Marijuana Research Bill Heads to U.S. President’s Desk

    Marijuana Research Bill Heads to U.S. President’s Desk

    Credit: Jose

    For the first time, a standalone piece of marijuana reform legislation has been sent to the U.S. president’s desk. The “Medical Marijuana and Cannabidiol Research Expansion Act” is just one signature away from historic enactment.

    Just weeks after President Joe Biden issued a mass marijuana pardon and directed a review of the drug’s scheduling status, the U.S. Senate approved a House-passed bipartisan cannabis research bill on Wednesday.

    Senate Majority Leader Chuck Schumer said he is continuing to have “productive talks” about a broader package of cannabis reforms. He hopes to pass them before the end of Congress’ lame duck session, according to Marijuana Moments.

    The bill “would eliminate the red tape that hinders cannabis research, opening the door for new innovative treatments derived from cannabis,” Schumer said ahead of the vote. “If you’re one of the millions of Americans who deals with conditions like Parkinson’s or epilepsy or post-traumatic stress, or any number of other conditions, cannabis might hold promising new options for managing these diseases.”

    “We need to do the research first,” he said. “And the federal government, sadly, has been woefully behind the times on this front. This bill will help fix that.”

    Numerous marijuana measures have been filed and advanced in each chamber in recent sessions, however, reform has consistently stalled before reaching the president.

    The bill was filed in July and quickly moved through the House before being taken up by the Senate, which approved the legislation under unanimous consent.

  • Solons Must Seize Potential of Safer Nicotine Products

    Solons Must Seize Potential of Safer Nicotine Products

    Knowledge-Action-Change (KAC) has published The Global State of Tobacco Harm Reduction 2022: The Right Side of History. The Global State of Tobacco Harm Reduction (GSTHR) publication charts the history of tobacco harm reduction and considers the future of a strategy that can hasten the end of smoking and drastically reduce smoking-related death and disease worldwide.

    According to the report’s authors, the emergence of new safer nicotine products has caused substantial disruption to nicotine use, public health and tobacco control institutions and the traditional tobacco industry. However, mistrust and ideological opposition is hampering widespread adoption of a strategy that could help 1.1 billion adult smokers failed by existing tobacco control interventions.

    “Technology helped smoking become one of the world’s biggest health problems,” said Harry Shapiro, author of The Right Side of History, in a statement. “Now, technological innovations from beyond both the tobacco industry and public health have combined to produce safer nicotine products, and millions of people who smoked have already chosen to switch. Yet progress is being hampered. Although disruption is not always comfortable, the genie is out of the bottle—these new technologies demand the development of new policies and new thinking.”

    “A failure to recognize and exploit the potential of tobacco harm reduction will mean millions more avoidable deaths each year.”

    Gerry Stimson, project lead, GSTHR

    “A failure to recognize and exploit the potential of tobacco harm reduction will mean millions more avoidable deaths each year and contribute to an ever-growing burden of disease that disproportionately affects the most vulnerable countries and communities,” said Gerry Stimson, GSTHR project lead and emeritus professor at Imperial College London.  

    “Tobacco control’s lack of evolution, despite its very limited gains, means that many aspirational targets to achieve smoke-free status by 2030 or within the next generation are no more likely to be met than former aspirations for a drug-free world. Tobacco harm reduction offers us an historic opportunity. We must not let it slip away.”

    The Right Side of History is the third in the biennial series of GSTHR reports, following No Fire, No Smoke in 2018 and Burning Issues in 2020. The GSTHR project is produced with the help of a grant from the Foundation for a Smoke-Free World.

  • Snowplus Tech Obtains Production License in China

    Snowplus Tech Obtains Production License in China

    Snowplus has obtained a production license from China’s State Tobacco Monopoly Administration, which grants the company a quota to produce 80 million pods annually, according to a press release. The company stated that it will now takes on the “challenge and responsibility to help lead the development of a healthy and sustainable vaping industry.”

    While the U.S. government has strict regulations for vaping products, there has been a rise in fake or counterfeits of popular brands in the country, which has led to an increase in incidents relating to poorly manufactured variations, according to Snowplus. This highlights the importance of using a reputable, tested and certified vape product.

    For Snowplus Tech, a China-based e-cigarette manufacturer, equipment safety and quality are top priority. Snowplus products are designed in-house, developed by experts in specialist R&D centers, and manufactured in one of the largest, most advanced e-cigarette facilities in the world, according to the release.

    Established in Jan 2019, backed by investors such as Zhen fund and Sequoia, Snowplus has more than 60 criteria for testing, ensuring highest standards of safety and quality. With three CNAS certified research laboratories, its safety protocols are recognized and interoperable by 65 institutions in 50 countries, according to the release.

    “There is an increasing trend for cheap counterfeit vapes on the market, which we find deeply concerning,” said Derek Li, Snowplus co-founder and head of overseas markets. “That is why we have invested heavily in product research to create products that enhance the vaping experience while ensuring it is as safe as possible.” 

    Snowplus has invested over $2 million in quality and safety research and to help prevent e-liquid from leaking out of products, it conducts impact tests in variable temperature, humidity and pressure conditions, according to the release. In addition, Snowplus’ batteries pass two tests before assembly to “guarantee that devices can operate in different environments.”

  • Chowdhury: Implementation of Tobacco Control Act Flawed

    Chowdhury: Implementation of Tobacco Control Act Flawed

    Azim Chowdhury

    The U.S. Food and Drug Administration’s implementation of the 2009 Tobacco Control Act, which gave the agency authority to regulate tobacco products, has been fundamentally flawed from the beginning, according to Azim Chowdhury, a partner in the Keller and Heckman law firm.

    Writing in Filter, Chowdhury explains that the premarket authorization requirements for “new” products subjects potentially reduced-harm products to nearly insurmountable hurdles while allowing preexisting products, including combustible cigarettes, to mostly escape FDA scrutiny.

    In his article, Chowdhury suggests several ways in which the FDA can more effectively implement the Tobacco Control Act.

    For example, rather than conducting reviews in a silo, the FDA should consider the totality of evidence in a premarket tobacco product application, according to Chowdhury.    

    “It is also critical that the FDA hamper the spread of counterfeit products, which may be riskier for consumers and are drowning out the small businesses and vape shops that continue to bear the brunt of FDA enforcement,” he writes.

    “Finally, the FDA should shift more resources to developing reasonable safety, quality and marketing product standards.”

  • Bidi Parent Inks Deal for Marketing, Sales Strategy

    Bidi Parent Inks Deal for Marketing, Sales Strategy

    Kaival Brands Innovation Group, parent to Bidi Stick vaping products, today announced it has reached a three-year extension agreement with QuikfillRx, the third party vendor responsible for executing Kaival Brands’ marketing and sales strategies.

    As part of the agreement, QuikfillRx will be rebranded as Kaival Marketing Services (KMS) to more properly reflect the commitment of KMS to the success of Kaival Brands, according to a press release.

    “We are happy to continue our service with Kaival Brands and its commitment to responsible marketing,” Russell Quick, president of KMS, stated in the release. “Our combined efforts at preventing underage use of vaping devices and focus on the needs of legal-age smokers looking for an alternative to combustible cigarettes, stands as a model for the industry.”

    In February 2022, the U.S. Court of Appeals for the Eleventh Circuit stayed a marketing denial order (MDO) issued by the U.S. Food and Drug Administration to Bidi Vapor in September 2021 for its non-tobacco flavored Bidi Stick products. The FDA had previously issued an administrative stay to Bidi Vapor, however, the agency rescinded that stay in December 2021.

    Kaival Brands reported revenues of $3.8 million for the third quarter of fiscal year 2022, up from $3.2 million for the same period of 2021. Gross profit was $442,100 compared to a loss of $84,300 for comparable 2021 period.

    Kaival attributed its improved revenues in part to an August court ruling that set aside a marketing denial order issued by the U.S. Food and Drug Administration to the company’s nontobacco flavored Bidi Stick e-cigarettes.

    The three-year extension with KMS was executed in preparation to support the anticipated improved sales volumes arising from this decision and the increase of Bidi Stick sales and marketing activities.

    In addition to monthly cash payments, which will be lower than during the initial term of the agreement, and a one-time upfront vested common stock option award, KMS will be eligible to receive performance-based common stock option awards from Kaival Brands.

    Eric Mosser, president and chief operating officer of Kaival Brands, stated that KMS has been an integral part of the Kaival story since its inception.

    “Their industry knowledge and expertise, experience working with our team, and unmatched around-the-clock service is best in class,” he said. “As part of ongoing corporate efforts in anticipation of increasing sales activity following Bidi Vapor’s merits case win, it became clear that reaffirming our relationship with KMS was an important step to manage growth.”