Author: Staff Writer

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

VV Archive
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
Juul MDL Paused for Review of Class Certifications

Credit: Piter2121
The California federal judge presiding over multidistrict litigation regarding Juul vaping products has agreed to postpone a trial that would have parent company Altria Group Inc. facing RICO claims, allowing the Ninth Circuit to first review the trial court’s certification of four classes of plaintiffs who brought the suit, according to Law360.
Last week, A U.S. district judge handed Juul Labs Inc preliminary court approval of a $255 million settlement resolving claims by consumers that it deceptively marketed e-cigarettes, as the company seeks to resolve thousands of lawsuits.
The class action settlement resolves claims by people who say they would have paid less, or not bought the e-cigarettes at all, if Juul had not downplayed the products’ addictiveness and appeal to teenagers through social media campaigns and other means.
The settlement is part of a larger, global agreement by Juul to resolve thousands of lawsuits by school districts, local governments and individuals accusing it of contributing to a youth vaping epidemic.
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
UKVIA Publishes Annual Vaping Industry Report

The U.K. Vaping Industry Association (UKVIA) has published its 2022 annual report.
Among the highlights of 2022 was the launch of the UKVIA-commissioned Economic Impact Report from the Centre for Economics and Business Research, which—for the first time—detailed the national and regional contribution that the U.K. vape industry made to the economy, according to the UKVIA.
“Our industry is under scrutiny like never before, and we must tackle the big issues, such as underage vaping, the environmental impact of disposable devices and the massive influx of fake and illegal imports,” said John Dunne, director general of the UKVIA. “Any one of these issues has the potential to see regulators clamp down hard on vaping, and the fact that they are all happening at once demonstrates that it is crucial that we get our house in order without delay.”
January 26, 2023
Reynolds to Appeal FDA’s Denial of Menthol PMTAs

British American Tobacco will appeal the U.S. Food and Drug Administration’s marketing denial orders for its Vuse Vibe Tank Menthol 3.0% and Vuse Ciro Cartridge Menthol 1.5%, the company announced in a statement.
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.
“Reynolds intends to seek a stay of enforcement immediately and will pursue other appropriate avenues to allow Vuse to continue offering its innovative products to adult nicotine consumers age 21+ without interruption,” the company said.
“We believe that menthol vapor products are critical to helping adult smokers migrate away from combustible cigarettes. FDA’s decision, if allowed to go into effect, will harm, not benefit, public health.
“We remain confident in the quality of all of Reynolds’ applications, and we believe that there is ample evidence for FDA to determine that the marketing of these products is appropriate for the protection of public health.”
Anti-tobacco campaigners countered that menthol e-cigarettes appeal to underage consumers. “Existing evidence demonstrates that non-tobacco-flavored e-cigarettes, including menthol flavored e-cigarettes, have a known and substantial risk with regard to youth appeal, uptake and use; in contrast, data indicate tobacco-flavored e-cigarettes do not have the same appeal to youth and therefore do not pose the same degree of risk,” said Matthew Myers, president of the Campaign for Tobacco-Free Kids in a statement.
Morgan Stanley said it expected the rejected products to remain on the U.S. market for the duration of BAT’s appeal, with minimal impact on the company’s operations. “Longer term, should today’s denial order reflect a broader effort by the FDA to ban menthol e-cigarettes, BAT’s U.S. cigarette business could benefit given its menthol mix as it might discourage some smokers from quitting or switching to reduced risk products,” the bank wrote in a note to investors. Reynolds’ Newport brand represents about 40 percent BAT’s U.S. cigarette dollar sales, according to Morgan Stanley.
The Jan. 24 rejection of the Vuse refills underscores the FDA’s ongoing reluctance to approve menthol e-cigarette flavors. To date, the agency has approved only tobacco-flavored e-cigarettes.
However, the FDA has granted both a premarket tobacco product application and modified risk tobacco product designation to IQOS’s menthol variant, which may eventually leave Philip Morris International’s heat-not-burn product as one of the few menthol reduced-risk alternatives on the market.
The FDA is targeting publishing a final rule to ban menthol cigarettes in August 2023, but considering expected industry litigation, final implementation could be five to six years away, according to Morgan Stanley.
January 25, 2023
FDA Denies Marketing of 2 Vuse Menthol Products

Unsurprisingly, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) for two menthol e-cigarette products currently marketed by R.J. Reynolds Vapor Company.
In a release today, the regulatory agency said that the products include the Vuse Vibe Tank Menthol 3.0% and the Vuse Ciro Cartridge Menthol 1.5%. Reynolds is now banned from marketing or distributing these products in the U.S. or they risk FDA enforcement action.
The company may resubmit applications or submit new applications to address the deficiencies of the products that are subject to these MDOs. The company may also file a lawsuit against the agency’s denial.
“Consistent with the authorities granted by Congress, the FDA remains committed to evaluating new tobacco product applications based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole,” said Brian King, director of the FDA’s Center for Tobacco Products, wrote. “The applications for these products did not present sufficient scientific evidence to show that the potential benefit to adult smokers outweighs the risks of youth initiation and use.”
The FDA isn’t expected to approve any flavored vaping products in the near future.
Memos recently submitted to the U.S. Court of Appeals for the Third Circuit show that the U.S. Food and CTP King, reversed a recommended marketing approval of Logic Technology’s menthol vaping products, ignoring the advice of FDA scientists, according to Logic’s lawyers. The new documents were made available to Logic after it had filed its motion for a stay of its marketing denial order (MDO) for its menthol vaping products.
The Vuse products cannot be legally introduced into interstate commerce in the U.S. without risking FDA enforcement. In addition to ensuring that the manufacturer complies with this order, as with unauthorized products generally, the FDA intends to ensure compliance by distributors and retailers. Retailers should contact R.J. Reynolds Vapor Company with any questions about products in their inventory.
“Today’s decision pertains to the specific application submitted for review by FDA,” said King. “It is the responsibility of the applicant to provide sufficiently robust scientific evidence to demonstrate that the necessary public health standard has been met. In this case, the presented evidence did not meet that standard.”
January 24, 2023
In Memoriam: Kay O’Neill
Kay O’Neill
Tobacco Reporter (Vapor Voice‘s sister publication) will be celebrating its 150th anniversary next year, and, understandably, no one today was present for its beginning. However, for Tobacco Reporter’s “modern era”—that is, when its headquarters moved to Raleigh, North Carolina, USA, in 1982—the magazine has been fortunate to enjoy an extraordinarily consistent existence in terms of its personnel. In fact, though many people have contributed over the years, we can easily point to a small handful who have been fundamental and foundational to the evolution of what Tobacco Reporter has today become. Our Mount Rushmore, if you will.
One of those people, without question, was Evelyn O’Neill. She was better known to the industry, her colleagues and friends simply as Kay. Kay joined Tobacco Reporter in 1991 and served numerous roles for the magazine and its family-like parent companies. On Jan. 17, 2023, after battling illness for far too long, Kay passed away surrounded by her loving family.
In her professional life, Kay did everything you can imagine on the sales side, developing relationships and fostering partnerships around the globe. She eventually earned the title of associate publisher, but to those who worked with her, her most important role was always being the “sales coordinator.” To translate that term, Kay was the buffer between the editors and designers back at the office who cared way too much about when the magazine was scheduled to go to the printer and the salespeople out on the road who were unfamiliar with the concept of deadlines. Kay handled each side with a magical blend of charm, humor and force as only she could, kept the peace and helped everything move forward with the big picture in mind.
As her former colleagues shared stories, it became apparent that Kay was the true definition of dichotomy. On one hand, she was a Carolina girl—that is to say, she came off as small-town country with the beautiful Southern twang in her voice—but she was as sharp and worldly as they came. She was equally comfortable networking with industry executives at five-course dinners as she was sharing a plate of Carolina barbecue with tobacco farmers at local extension meetings.
She wasn’t shy about mincing words and wouldn’t hesitate to kick you in the butt when needed but would protect you like a mother lion in her next breath. Each September, she would travel to one of the world’s great cities as part of the Global Tobacco and Nicotine Forum, staying in lush accommodations, then just a few weeks later, she would be in a giant tent standing over a space heater trying to stay warm as she worked a booth at the fairgrounds for the North Carolina Farm Show. Each of those moments was pure Kay. She was a professional, and she was a friend.
Those who knew her will not only miss her generous personality and infectious laughter but also her ability to disarm the moment and bring perspective. While Kay appreciated the value of hard work, she never lost sight of what truly matters: health, friends and family.
Kay is survived by her husband, Don Michael “Mike” O’Neill; her daughter and son-in-law, Laura and Erin Douna; her son and daughter-in-law, Ryan and Meghan O’Neill; her stepson and daughter-in-law, Don Michael and Marie O’Neill; her brother and sister-in-law, David and Regina Peebles; and her grandchildren, Abigail, Finley, Webb, Aubrey, Regan and Michael Wayne—along with a group of grateful friends from more than three decades at Tobacco Reporter.
January 24, 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