Tag: regulation

Juul2 Wins UK Retailer’s Product of the Year Award

Taking Retail’s Product of the Year 2023 for the Vaping and Heated Tobacco Products category has been awarded to Juul Labs’ new Juul2 system following an independent nationwide survey of 8,000 adult consumers.
Juul2 was launched in April 2022 following a successful pilot launch on the brand’s website, according to Talking Retail. The rechargeable pod-based system was updated from previous versions with new technologies and features, which the brand said includes the capability to combat potentially harmful and compatible pods.
“We are extremely proud that our commitment to product quality and innovation has been recognized by the voters who awarded Juul2 this accolade,” said Efe Abebe-Heywood, senior director of communications and brand at Juul Labs UK. “Our new Juul2 system has marked a step change in vapor technology, providing adult smokers with a product that more closely resembles the consistency and experience of combustible cigarettes to support them on their switching journey.
“Smoking remains the leading cause of preventable death and disease in the UK, and we remain committed to our mission at Juul Labs to transition even more adult smokers from cigarettes, while combating underage use.”
The award also coincides with the launch of a new Juul2 Blackcurrant Tobacco variant – a classic tobacco flavor with ripe blackcurrant notes, which further extends the Juul2 portfolio in the UK.
The new Blackcurrant Tobacco Juul pods launched on the brand’s website in January and will be rolled out across all major retailers nationally from early February.
In the U.S., Juul2 is under review by the U.S. Food and Drug Administration.
January 27, 2023
FDA Authorizes Three New Heated Tobacco Products

The U.S. Food and Drug Administration today authorized the marketing of three new tobacco-flavored heated tobacco products included in Philip Morris Products S.A.’s supplemental premarket tobacco product applications (PMTAs).
The products receiving marketing granted orders are Marlboro Sienna HeatSticks, Marlboro Bronze HeatSticks, and Marlboro Amber HeatSticks.
The three HeatSticks products are “heated tobacco products” (HTPs) used with the IQOS device.
Based on FDA’s review of the supplemental PMTAs, the agency determined that the marketing of these products should be authorized because, among other things, the net population-level benefits to adult smokers outweigh the risks to youth.
In 2019, FDA authorized the marketing of IQOS and several other Marlboro HeatSticks products through the PMTA pathway. Philip Morris pursued marketing authorization for these new Marlboro HeatSticks by submitting supplemental PMTAs for modified versions and line extensions of the tobacco-flavored product for which the company had previously received a marketing granted order.
A supplemental PMTA can be submitted in situations where an applicant is seeking authorization for a new tobacco product that is a modified version of a tobacco product for which they have already received a marketing granted order.
“Following FDA’s rigorous scientific evaluation of the applications, the agency determined that Marlboro Sienna HeatSticks, Marlboro Bronze HeatSticks, and Marlboro Amber HeatSticks are comparable to the previously authorized tobacco-flavored product,” according to FDA. “Like the previously authorized products, FDA has placed stringent marketing restrictions on the new products in an effort to prevent youth access and exposure.”
January 26, 2023
U.S. FDA to Seek Congress’ Help in CBD Regulations
“FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward”
The U.S. Food and Drug Administration has concluded that a new regulatory pathway for cannabidiol (CBD) is needed. The regulatory agency states it will seek guidance from the U.S. Congress. The new rules would need to balance individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks, according to a press release.
The FDA is also denying three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.
“A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products,” the release states. “Some risk management tools could include clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children. In addition, a new pathway could provide access and oversight for certain CBD-containing products for animals.”
FDA Principal Deputy Commissioner Janet Woodcock stated that a working group she chaired on the subject of CBD regulations closely examined studies related to the CBD-based drug Epidiolex, published scientific literature, information submitted to a public docket, as well as studies both conducted and commissioned by the agency.
“Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives,” she stated. “For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods.
“CBD also poses risks to animals, and people could be unknowingly exposed to CBD through meat, milk and eggs from animals fed CBD. Because it is not apparent how CBD products could meet the safety standard for substances in animal food, we also do not intend to pursue rulemaking allowing the use of CBD in animal food. A new regulatory pathway could provide access and oversight for certain CBD-containing products for animals.”
Woodcock said the FDA will continue to take action against CBD and other cannabis-derived products to “protect the public, in coordination with state regulatory partners,” when appropriate.
The U.S. House Oversight Committee plans to grill U.S. Food and Drug Administration Commissioner Robert Califf about why the agency still hasn’t developed CBD regulations.
The FDA has said it is planning to release CBD guidance this year.
January 26, 2023
Juul Labs Seeking new Partners, Potential Buyers

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Juul Labs is in talks with leading cigarette manufacturers about a partnership, alliance or sale of its business, reports The Wall Street Journal.
Juul executives have had separate discussions with Philip Morris International, Japan Tobacco and Altria Group, according to the newspaper.
The talks are at an early stage and might not result in a sale of partnership, The Wall Street Journal’s sources pointed out. Altria, which owns one-third of Juul, valued the vaping company at $1 billion in October.
Once the undisputed leader of the U.S. vape market, Juul reached the brink of bankruptcy last year after the Food and Drug Administration denied its marketing applications and ordered the company to remove its products from the market.
The order has been stayed pending appeal but the still-unresolved dispute made it difficult for Juul to raise money to cover its legal liabilities. In December Juul agreed to pay $1.7 billion in a broad legal settlement covering more than 5,000 lawsuits accusing the company of marketing its products to teens and children. Juul denies targeting underage consumers.
To pay for the deal, Juul secured an equity investment from a group including two Juul directors. The settlement and financing put Juul on firmer ground and allowed the company to begin talks with potential strategic partners.
On Sept. 30 Altria announced it was ending its noncompete agreement with Juul. The decision gave Juul the freedom to sell itself—or a significant stake—to one of Altria’s competitors.
Altria can’t buy Juul outright because of antitrust concerns: The Federal Trade Commission is seeking to unwind Altria’s 2018 investment in Juul. Altria and Japan Tobacco in October formed a partnership to develop and sell heated-tobacco devices in the U.S. and other new tobacco products abroad.
If the FDA ultimately halts Juul’s sales, Juul could seek U.S. authorization for a newer version of its vaporizer that has been released in Canada and the U.K. Juul also has other products under development.
January 26, 2023
U.S. Court Grants Stay of Reynolds Menthol MDOs

Credit: Sang Hyun Cho
The U.S. Court of Appeals for the Fifth Circuit has granted an administrative stay of a U.S. Food and Drug Administration marketing denial order (MDO) for two R.J. Reynolds Vapor Co. menthol flavored refill pods.
The order was granted as a temporary stay pending a motion to file a stay with the court by Feb. 1, 2023.
On Jan. 24, the FDA denied marketing applications for two menthol refills used in Vuse Vibe and Vuse Ciro vaporizers, which are sold in the U.S. by BAT subsidiary R.J. Reynolds. According to the agency, Reynolds’ applications presented insufficient evidence to show that the potential benefit to adult smokers outweighs the risks of youth initiation and use.
British American Tobacco said on Jan. 25 that it intended to appeal the MDO for its Vuse Vibe Tank Menthol 3.0% and Vuse Ciro Cartridge Menthol 1.5%, the company announced in a statement.
January 26, 2023
FDA Issues Final Guidance on Clinical Cannabis Research
Credit: Nocturnal
The U.S. Food and Drug Administration today issued the final guidance on clinical cannabis research. The “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Guidance for Industry” guidance provides the agency’s current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis and cannabis-derived compounds, according to a press release.
FDA considered comments received on the draft guidance, issued in July 2020, as the agency worked to finalize the suggested rules. Changes from the draft to the final guidance include clarifying sources of cannabis for clinical research (including Schedule I sources), adding resources explaining expectations for investigational new drug (IND) applications in various stages of drug development, and providing guidance on quality considerations for INDs.
The final guidance also:

Lists applicable United States Pharmacopeia chapters on quality testing, including the assessment of leachables from packaging and delivery systems.

Identifies relevant International Council for Harmonisation guidelines, FDA guidances, and considerations for devices used in combination with a drug.

Addresses the calculation of delta-9 THC content, which is relevant to determine control status for cannabis and cannabis-derived compounds.
“It is critical FDA continues to support robust scientific research needed to develop new drugs from cannabis,” the release states. “FDA believes the drug development and approval process represents the best way to ensure that safe, effective, and high-quality new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy.”
Earlier this month, The FDA said it is planning to make recommendations on how to regulate the use of the popular cannabis compound cannabidiol (CBD) in food and supplements.
January 23, 2023
U.S. House Oversight Committee to Grill FDA on CBD

Credit: Dogora Sun
The U.S. House Oversight Committee plans to grill U.S. Food and Drug Administration Commissioner Robert Califf about why the agency still hasn’t developed CBD regulations.
The FDA has said it is planning to release CBD guidance this year.
Rep. James Comer, chair of the Oversight Committee, said during an interview with the U.S. Hemp Roundtable advocacy group that his panel wants to ask Califf about the FDA’s “lack of action” on issues including hemp-derived CBD that fall under the agency’s regulatory jurisdiction, according to MJBiz Daily.
“I want to bring the FDA commissioner in front of the committee, and this is one of the things that we want to talk about,” Comer, a Republican from Kentucky, told the U.S. Hemp Roundtable.
“It’s not just their lack of action with respect to CBD and other types of hemp – it’s their inaction regarding a lot of areas of their jurisdiction.”
Comer said he believes the FDA’s focus on Covid-19 and vaccines might have prevented the agency from addressing other issues.
According to Hemp Today, the FDA has focused on enforcement rather than clarifying what the rules are.
In March, for example, the FDA and Federal Trade Commission sent letters to several CBD companies warning them about making health claims related to Covid-19.
January 23, 2023
Oregon Lawmakers Introduce Vape Flavor Ban Bill

Credit: David Kruger
Lawmakers in Oregon introduced a new bill that would end the sale of flavored vaping and other tobacco products across the state.
House Bill 3090 aims to end the sale of menthol cigarettes and all other flavored tobacco products. This includes hookah, e-cigarettes, cigars, and smokeless tobacco, reports KATU.
“We have been setting ourselves up for success through the legislature for the last seven years, to get to the point now where we can finally have a huge impact on reducing the pipeline of new customers,” said Jamie Dunphy, the Oregon director of government relations for the American Cancer Society.
Dunphy said the bill is the next step in reducing the number of people who vape.
Washington County, Oregon’s flavored vaping and tobacco ban was struck down by a judge who stated that counties in Oregon do not have the authority to enact such measures and that they must come from the state legislature.
January 22, 2023
AVM to Hold Public Forum With CTP Director King

Brian King / Credit: FDA
The U.S. Food and Drug Administration’s Center for Tobacco Products Director Brian King will participate in an open discussion with the vaping industry in late February.
The virtual event will be moderated by American Vapor Manufacturers Association (AVM) legislative director Gregory Conley and newly-named AVM vice president Allison Boughner.
“The Future of Vaping in the US: A Conversation with FDA’s Dr. Brian King” will be held on Feb. 24 at 1:00 p.m. EST, and is open to the public. Participants must register in advance, and AVM has provided an opportunity to submit questions for King.
King has been quiet since memos recently submitted to the U.S. Court of Appeals for the Third Circuit show that he reversed a recommended marketing approval of Logic Technology’s menthol vaping products, ignoring the advice of FDA scientists, according to Logic’s lawyers.
January 20, 2023
Philippines: Group Wants Crackdown on Illegal Vapes

Credit: Tupungato
The Philippine Tobacco Industry (PTI) has called on the Philippines’ Bureau of Internal Revenue (BIR) to crack down on illicit vapor products, reports The Manilla Times.
In a letter sent recently to BIR Commissioner Romeo Lumagui Jr., the group emphasized that the full implementation of the Vaporized Nicotine and Non-Nicotine Products Regulation Act “will ensure that the public is protected against the dangers of using illicit products as well as the collection of appropriate taxes aimed at helping our economy.”
The Act, which became law in July 2022, regulates the importation, manufacture, sale, packaging, distribution, use and communication of vaping products such as e-cigarettes and heated tobacco products.
Under the laws implementing rules and regulations (IRR), e-commerce platforms, e-marketplaces and other similar online platforms are mandated to allow only Department of Trade and Industry and BIR-registered distributors, merchants or retailers of vape products, devices and novel tobacco products to sell on their website or platform.
To ensure vape products are made inaccessible to minors, the IRR also requires vapor product refill receptacles to be tamper- and child-resistant. Products packaged or labeled with flavor descriptors appealing to minors are prohibited.
“We are also hoping that the BIR will closely work with enforcement agencies such as the Philippine National Police, The Armed Forces of the Philippines as well as relevant anti-illicit trade groups from the Bureau of Customs to make sure the law and its IRR are effectively implemented,” the PTI said.
The PTI members include Japan Tobacco International Philippines, Associated Anglo-American Tobacco Corp. and Philip Morris Fortune Tobacco Co.
January 20, 2023