Tag: regulation

UK Lawmaker to Table Bill to Ban Disposable Vapes

Caroline Johnson
An MP in the United Kingdom is set to introduce a bill into parliament next week that will aim to prohibit the sale of disposable e-cigarettes and vapes.
Caroline Johnson, MP for the Sleaford and North Hykenham constituency which includes Great Gonerby, Barrowby, Marston and Cranwell, wants to introduce this bill after an NHS survey conducted in 2021 and published last year found that nearly one in five (18 percent) of fifteen-year-olds considered themselves e-cigarette users.
Johnson, an NHS children’s doctor and member of Parliament’s Health and Social Care Select Committee, is due to highlight the positive impact a potential ban on disposable vapes and e-cigarettes would have on the country as part of her 10-Minute Rule Bill on Wednesday, February 8.
“Reusable e-cigarettes and vapes remain an important aid to quitting smoking, but I fear that their colorful, child-friendly flavored, disposable counterparts are luring non-smokers into a life of addiction, which risks creating a new generation of nicotine addicts,” said Johnson.
“I look forward to presenting my bill to parliament soon and to highlighting the effects disposable e-cigarettes and vapes are having on our nation’s health and natural environment.”
The Scottish government has officially commissioned an “urgent review of the environmental impacts and management of single-use vapes.”
The review, which comes in response to emerging concerns around the negative consequences of disposable vaping devices, will inform potential policy responses, which could include a ban of the products.
February 4, 2023
Connecticut AG Submits Testimony on Flavor Ban
Connecticut Attorney General William Tong submitted testimony concerning House Bill 6488 stating that he fully supports the state’s proposed ban on flavored vaping and other tobacco products.
He also expressed concern that the “An Act Concerning Cigarettes, Tobacco Products, Electronic Nicotine Delivery Systems and Vapor Products” bill as currently written exempts the most widely used flavor—menthol—which must be included in the ban to deter youth addiction.
“Ending the sale of flavored tobacco products, including menthol, will have an enormous impact in reducing the number of people who die or suffer debilitating preventable illness from tobacco use, significantly reducing the number of young people who become addicted to tobacco products, and reversing the youth e-cigarette epidemic,” Tong states. “A comprehensive flavor ban that includes menthol will save thousands of Connecticut lives, protect public health, and advance health equity. It should be implemented immediately.”
Connecticut Attorney General William Tong
Tong stated that his office has a long history of battling tobacco companies “from negotiating the Master Settlement Agreement in the 1990s to the recently announced settlement with Juul, we have focused our efforts on combatting the insidious ways that Big Tobacco has marketed to children.”
The bill is the most recent effort by members of the legislature’s Public Health Committee to take flavored nicotine products off the market in an effort to reduce smoking and vaping among young people. Similar legislation has failed to make it across the finish line during recent legislative sessions.
In May of last year, for the third year in a row, an effort to ban flavored vaping products in Connecticut couldn’t muster enough support.
Connecticut lawmakers heard testimony on legislation that would ban the sale of flavored tobacco and vape products as well as prohibit the use of vapes while in a vehicle with a child.
Connecticut is one of few states in the region that has not adopted a prohibition on flavored e-cigarettes. New York, New Jersey and Rhode Island have barred the sale of flavored vaping products. Massachusetts banned all flavored tobacco items, including flavored cigars, cigarettes and vaping goods.
February 4, 2023
Bloomberg Commits $420 Million to Fight Nicotine

Bloomberg Philanthropies has committed another $420 million over four years to the Bloomberg Initiative to Reduce Tobacco Use. This fourth investment brings Bloomberg’s total commitment to tobacco control to more than $1.58 billion since 2005.
The Bloomberg Initiative to Reduce Tobacco Use is helping cities and countries implement measures such as smoke-free public places, banning tobacco advertising, increasing tax on tobacco products, requiring graphic warnings on cigarette packaging and mass-media public awareness campaigns.
Currently, the initiative spans more than 110 low- and middle-income countries (LMICs)—including China and India, which together account for nearly 40 percent of the world’s smokers.
Critics of Bloomberg’s agenda say his policies fuel corruption and drive countless people back to smoking combustible cigarettes. In a release, the American Vapor Manufacturers Association (AVM) stated that despite his “pretensions and self-aggrandizement, the tragic reality is that Michael Bloomberg is bankrolling a prohibition campaign that aims to stigmatize and outlaw the single most effective smoking cessation method ever devised, nicotine vaping.”
The AVM states that it has extensively documented that Bloomberg’s money is used to coerce public officials, pay lobbyists, and even install personnel in public institutions. “It funds front groups that have no genuine following but peddle demonstrable misinformation to the public,” the release states. “The money is even used to bribe journalists through dark money grants to rig the news coverage of this crucial public health issue. It is thoroughly corrupt and happening at a scale that shocks the conscience.
From the new $420 million in funding, $280 million will be aimed at reducing tobacco use in LMICs and $140 million will target reducing e-cigarette use among teenagers in the United States.
“Over the past two decades, we’ve made major progress in reducing tobacco use and the death and disease connected to it, but it continues to take a devastating toll, and it remains the leading cause of preventable death,” said Michael R. Bloomberg, founder of Bloomberg Philanthropies and WHO Global Ambassador for Noncommunicable Diseases and Injuries, in a statement.
“This latest investment will help to spread strategies that have proven so effective at saving lives — including smoke-free laws and advertising restrictions—to more nations and communities around the world.”
February 3, 2023
PMI, BAT Recognized Again for Gender Equality

Philip Morris International and BAT were included in the 2023 Bloomberg Gender-Equality Index (GEI).
PMI made the index for the third year running, achieving an overall score of 80.6 percent.
“Achieving gender balance at all levels of the company is one of our top priorities, and I am delighted that our efforts are recognized again in this year’s index,” said Silke Muenster, chief diversity officer at PMI. “While we are making significant progress, we know we need to keep our foot on the acceleration pedal. An inclusive workplace that leverages the full talents of both women and men is crucial to our smoke-free vision, making our organization more innovative, resourceful and engaged.”
In 2022, PMI achieved its target of ensuring at least 40 percent female representation in managerial roles and announced a new target to achieve 35 percent of women in senior roles by the end of 2025, among other targets.
BAT, which participated in the index for the first time, received a score of 75 percent. BAT was recognized for creating an inclusive culture for women via its recruiting initiatives, adoption of family-friendly policies, sponsoring programs dedicated to educating women, and support of community programs. Inclusion in the index follows BAT being named as a Global Top Employer for a sixth successive year.
“Recognition in this year’s Bloomberg Gender-Equality Index demonstrates our commitment to addressing gender diversity and highlights our concerted global efforts to provide transparent reporting,” said Hae In Kim, BAT’s director of talent, culture and inclusion. “With more than 50,000 employees worldwide, our diversity and inclusion strategy is truly global, and I continue to be incredibly proud of the collective efforts made by all our employees.”
The GEI measures gender equality performance globally across five pillars as set by Bloomberg: leadership and talent pipeline, equal pay and gender pay parity, inclusive culture, anti-sexual harassment policies, and external brand. The 2023 Bloomberg GEI comprises 485 companies from 45 countries and regions.
February 1, 2023
Milwaukee, Wisc. Wants to Ban New Vape Shops

Credit: FellowNeko
Leaders in the U.S. city of Milwaukee, Wisconsin, debated a proposal for an ordinance Tuesday that would prevent some electronic cigarette sales across the city in the future.
“The explosion of vape shops, particularly when concentrated in a small geographic area, may have harmful impacts on the public health, safety, and welfare of our residents,” said Milwaukee’s District 3 Alderman Jonathan Brostoff, according to CBS58.
Part of the Milwaukee Zoning, Neighborhoods & Development Committee meeting Tuesday morning discussed a plan to prevent new vape shops from doing business in the city.
The proposal would prevent new shops from selling e-cigarettes for six months.
During this trial period, officials would also prevent other businesses from opening if they plan on selling e-cigs.
“Part of the goal of this is going to be, ultimately, to look at both concentration and location–for example, proximity to schools, things of that nature,” added an Alderman.
Neighborhood Services Commissioner Erica Roberts said this request would be complicated for a number of reasons.
“There are many different types of uses that would sell this type of product, everything from grocery stores to gas stations, convenience stores…” Roberts expressed.
February 1, 2023
Cannabis Regulators Could Learn From Nicotine

Photo: Darren415
Nicotine’s lessons for cannabis regulation
By Cheryl K. Olson and Willie McKinney
From the industry perspective, regulation of tobacco products by the U.S. Food and Drug Administration went from impatient foot-tapping to a lurching roller-coaster ride. The recently released “operational evaluation” of the FDA’s tobacco program, requested by Commissioner Robert Califf, lays out in sedate but clear terms some causes of industry’s frustrated exhaustion: years of delay in establishing requirements. Sudden major shifts in policy. Cycles of litigation and reprieve.
Based on feedback from FDA employees, and people from industry and public health, the independent Reagan-Udall Foundation for the FDA made recommendations to start repairing the regulatory mess. After “observ[ing] that CTP [Center for Tobacco Products] has been forced to operate primarily in a reactive mode, moving from one challenge to the next,” the first recommendation to the agency is to get proactive. The Reagan-Udall panel encouraged the CTP to make time now to “think strategically about where it is today and where it needs to go in the next several years.”
This advice might apply equally to whatever future the FDA faces with regulation of cannabis products. The FDA has authority over cannabis and its dozens of biologically active chemical compounds, including CBD and THC. Although marijuana falls under the federal Controlled Substances Act, the 2018 Farm Bill removed hemp (a low-THC cannabis plant and its derivatives) from that definition.
Principal Deputy Commissioner Janet Woodcock recently announced in a press release that existing regulatory frameworks for food and supplements are not appropriate for CBD. “The agency is prepared to work with Congress” on a new pathway, she stated.
What might we take from the U.S. tobacco experience to ease headaches for future cannabis regulation? Below are some points to ponder in three areas: regulatory structure, medical versus recreational use, and the effects of misinformation on regulation.
What Should a New Structure Look Like?
First, what regulatory structure makes sense: Should the FDA create an all new one for cannabis products, or should it employ some existing channels? Consider the tobacco parallel.
“Safe and effective” is the FDA’s traditional standard for evaluating drugs and medical products. In the 1990s, then Commissioner David Kessler tried to assert the FDA’s authority to regulate nicotine as a drug—intended by industry to affect the body’s structure or function—and cigarettes as delivery devices. A 2000 Supreme Court ruling found that the “s and e” standard left no room for regulation of tobacco.
In 2009, when Congress chose to place tobacco under FDA jurisdiction, a novel department was created. But this promising, fresh science-based regulatory approach for tobacco faced headwinds. This Center for Tobacco Products was largely staffed by people rotated from elsewhere in the FDA. The “appropriate for the protection of public health” (APPH) tobacco standard was a difficult departure from their accustomed ways and views. The combination of suspicion from past industry misbehavior and the political uproar over youth vaping fostered an “us versus them” mindset. The founding legislation’s focus on cigarettes, the most deadly of tobacco products, affected attitudes toward emerging alternative nicotine products with the potential to greatly reduce disease risks for people who smoke.
Perhaps there is light at the end of the tunnel. The FDA appears to recognize that shoehorning cannabis into existing structures has its own problems. Each type of intended use must find a fit in an existing department, such as human food, veterinary products, cosmetics or drugs. Under the Federal Food, Drug and Cosmetic Act, a drug is any product (including marijuana or hemp) intended to affect the structure or function of the body or intended to diagnose, cure, mitigate, treat or prevent disease.
What factors will influence staff mindset about cannabis in these various departments? How will that affect regulation?
Medical vs. Recreational Pathways
Another issue: How best to regulate cannabis for medical versus recreational use? Like tobacco, cannabis has been used historically for medical purposes, such as treating pain. Both nicotine and cannabis are reportedly used to self-medicate for mental health disorders. Use of marijuana to manage mood disorders is reportedly higher in states with medical marijuana laws. But there currently is no such thing as “medical” marijuana. (This is not unlike the confusion over what constitutes “natural” food.) The FDA drug pathway would create medical cannabis. A standardized product would be evaluated for quality, safety and efficacy for a particular medical indication.
We lack randomized, controlled clinical trial data on whether cannabis effectively treats disorders such as depression. However, such studies could be done by industry and submitted to the FDA’s Center for Drug Evaluation and Research. Several specialty products containing THC or CBD (e.g., for chemotherapy-related nausea or severe forms of epilepsy) have emerged from this path.
But what regulatory pathway might recreational cannabis take? And what complications arise from product format and route of administration: smoked, vaped, applied to skin or eaten? Where would combusted flower fit?
Nicotine is regulated by the FDA as a drug and as a recreational product. Two paths for cannabis also make sense. Although there is overlap (to get technical: Gum bases that contain nicotine are regulated as both pharmaceuticals and recreational tobacco products), combusted tobacco products that contain nicotine are only regulated by the Center for Tobacco Products.
We propose that Congress modify the 2009 Tobacco Control Act to give the CTP authority over combusted and vaped cannabis. Such products are very unlikely to pass the “safe and effective” drug standard, but the APPH standard may be applicable to recreational cannabis. And the CTP has built up expertise in combusted and vaped products.
Keep Moral Panic Out of Regulation
A third issue deserving of thought is how to prevent moral panic and misinformation from derailing the potential benefits of cannabis. One lesson from nicotine is how these can fog the ability of regulators, politicians and the public to see data clearly.
Research shows that youth use of nicotine and cannabis (as well as alcohol and other substances) overlap. A 2022 analysis of Population Assessment of Tobacco and Health study data found that more than half of e-cigarette users aged 15 to 24 had vaped cannabis. At the population level, teen cannabis youth has been fairly stable for the last quarter century. However, there will be concerns that the spread of state laws legalizing cannabis for adults could ease access for youth.
Once it takes hold, misinformation is hard to uproot. Witness stubborn rates of misbelief that the outbreak of vaping-related lung injuries (e-cigarette or vaping product use-associated lung injury, or EVALI) were caused by e-cigarettes instead of THC vapes adulterated with vitamin E acetate.
We see signs of a potential moral panic over cannabis. When the Centers for Disease Control and Prevention noted that marijuana vaping was most often linked to EVALI, the Wall Street Journal editorial board decried the “risky social experiment [of] legalizing and especially destigmatizing cannabis”—a drug that “could be damaging young brains for a lifetime.” News reports tout studies suggesting higher potency cannabis could mean higher risks of addiction and health harms.
Research to clarify the specific nature of cannabis risks to youth is needed. We also need research on the current state of cannabis misinformation, including overly rosy views of risk that could create a backlash when problems are publicized. Using the results of this research for outreach ASAP, before the pot panic gets rolling, could soften the impact.
Scrutinize and Enforce
To avoid repeating mistakes of the past, we also need rigorous oversight. The FDA has been criticized for reluctance to use its powers to remove illegal nicotine vapes from the market. Some companies continue to sell despite warning letters. We need to study what cannabis products drive youth use and proactively target those makers and distributors.
Products likely to attract underage users deserve particular scrutiny. Although no deaths were reported, a study in the journal Pediatrics² documented a worrisome increase in child poisonings from edible cannabis products. To protect both adult access and child well-being, it’s common sense to require that edibles come in clearly marked, child-resistant packaging with no resemblance to candy.
We have tools to unmask the bad actors. Youth will tell us in surveys what products they buy. The FDA’s own National Youth Tobacco Survey identified products not legally on the market, such as Puff Bar and Hyde, as favorite brands (Hyde was identified through write-in responses).
With nicotine, regulatory delays and gray areas (such as regulation of synthetic nicotine) were abused by companies willing to skirt the law for quick profit. We see analogous situations with cannabis. One example is hemp-derived delta-8 THC products, said to produce a milder high similar to that from marijuana-derived delta-9 THC. Sales are rising fast. So are concerns. There are safety risks from impurities created during delta-8 manufacturing. And public confusion over delta-8’s legal status could complicate marijuana legalization efforts.
The Reagan-Udall Foundation review of the CTP highlighted the need for “truthful and accurate information to help adult consumers make informed decisions about the role of nicotine” and product-specific risks. This applies equally to cannabis.
This article first appeared in Vapor Voice‘s sister publication Tobacco Reporter.
Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors via McKinney Regulatory Science Advisors. She spent 15 years on the faculty of Harvard Medical School.

Willie McKinney is the founder of McKinney Regulatory Science Advisors. He’s held senior regulatory roles at major tobacco product companies and served for three years as the industry representative on the FDA’s Tobacco Products Scientific Advisory Committee.

February 1, 2023
Hong Kong Begins Ban on CBD, Same Penalty as Heroin

Credit: Proxima Studio
Once legal in the city, Hong Kong began enforcing its ban on CBD, labeling it as a “dangerous drug” and imposing harsh penalties for its possession on Wednesday. The move is forcing fledging businesses to shut down or revamp.
THC, the psychoactive ingredient of marijuana has long been illegal in Hong Kong.
CBD was once legal in the city, and cafes and shops selling CBD-infused products were popular among young people, according to AP.
But all that has changed with the prohibition, which took effect Wednesday but had been announced by the government last year. CBD-related businesses have closed down while others have struggled to remodel their businesses. Consumers dumped what they saw as a cure for their ailments into special collection boxes set up around the city.
The new rule reflects a zero-tolerance policy toward dangerous drugs in Hong Kong, a semi-autonomous southern Chinese business hub, as well as in mainland China, where CBD was banned in 2022.
In contrast. the U.S. Food and Drug Administration recently 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.
February 1, 2023
CTP to Release Reagan-Udall Response in February

The Head of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) said in a perspective released today that the Center recently received the findings from the Reagan-Udall Foundation’s independent evaluation of its program and is in the process of closely reviewing the feedback. In February, the Center will provide an update on its planned actions in response to the evaluation.
When the Reagan-Udall Foundation submitted its recommendations to Robert Califf, commissioner of the FDA, in December, the report concluded that vaping industry stakeholders observed a lack of “consistent implementation” of what the industry understood to be the policies of the CTP, particularly with respect to tobacco harm reduction and the requirements needed to navigate the PMTA process.
CTP Director Brian King also announced the Center has accepted for review more than 8,600 marketing applications for synthetic products. In a recently released perspective, King said the center received more than 1 million premarket tobacco product applications (PMTAs) from 200 companies by May 14, 2022.
“FDA has also issued refuse-to-accept (RTA) letters for more than 925,000 products in applications submitted by May 14 that do not meet the criteria for acceptance,” King wrote. “The RTA letters state that it is illegal to sell or distribute the product in the U.S. marketplace without a premarket authorization.”
Brian King / Credit: FDA
He also stated that in 2022, CTP participated in 52 meetings with stakeholders – averaging one per week – including 25 meetings since King became director. King also stated that starting when the FDA was given the authority by Congress to regulate non-tobacco nicotine products in April 2022, the CTP has issued more than 75 warning letters to manufacturers through Jan. 20, 2023, including manufacturers of brands popular among youth, such as Puff Bar.
“We have also issued over 585 warning letters to retailers for the sale of non-tobacco nicotine products to underage purchasers as of December 2022. In October 2022, the U.S. Department of Justice (DOJ), on behalf of the FDA,” filed complaints for permanent injunctions in federal district courts against six e-cigarette manufacturers that failed to submit PMTAs and continued to sell products,” wrote King.
In a court filing last week, the FDA stated it will take until possibly December 31, 2023, before it completes the PMTA review process for some of the most popular vapes on the market.
Much like an earlier op-ed this year, King does not address memos recently submitted to the U.S. Court of Appeals for the Third Circuit that show King reversed a recommended marketing approval of Logic Technology’s menthol vaping products, ignoring the advice of FDA scientists, according to Logic’s lawyers.
King also failed to address the conclusion of a recent investigation conducted by the U.S. Office of Special Counsel that found the CTP had relaxed its standards of review for certain tobacco products and stifled attempts by its scientists to raise concerns.
January 31, 2023
German Industry Group Blasts Call for Vaping Ban

Jan Muecke
(Photo: German Association of the Tobacco Industry and Novel Products)
Recent calls to ban e-cigarettes lack a scientific basis, according to the German Association of the Tobacco Industry and Novel Products (BVTE).
In a recent interview with Deutsche Presse-Agentur, Manne Lucha, minister of social affairs, health and integration for Baden-Württemberg, said that e-cigarettes should be treated the same as combustible cigarettes and that flavored vapor products should be banned.
“It is a scientific consensus that the intake of harmful substances when vaping e-cigarettes is much lower than when smoking tobacco. With his ‘post-factual’ statements, the minister is causing consumer uncertainty with counterproductive consequences for health policy,” said BVTE CEO Jan Muecke in a statement.
Muecke cited a 2020 statement by the German Cancer Research Center, which acknowledged that a complete switch from smoking to vaping reduces the consumer’s exposure to harmful substances. He also quoted Public Health England’s finding that e-cigarettes are at least 95 percent less harmful than smoking.
According to the BVTE, e-cigarettes are the most frequently used smoking-cessation tool in Germany, ahead of less effective methods such as medical nicotine replacement products. The wide choice of flavored liquids, meanwhile, is a significant factor for adult smokers to switch to vaping, the organization wrote.
“Instead of fueling fears with false claims and misguided demands for bans, e-cigarettes should finally be promoted in Germany as an opportunity to minimize risks for smokers,” Muecke said.
January 31, 2023
FDA Says PMTA Reviews to Take Until End of Year

Credit: F Armstrong Photo
In a court filing this week, the U.S. Food and Drug Administration stated it will take until possibly December 31, 2023, before it completes a premarket tobacco product application (PMTA) review process for some of the most popular vapes on the market.
Upon being informed of the delay, Senator Dick Durbin of Illinois began demanding the FDA act immediately in removing e-cigarettes and vaping products from store shelves saying the agency has ignored a court order requiring them to take action by September 2021.
“On Tuesday, in a stunning filing to the federal judge, the Food and Drug Administration disclosed that it will take another six-month delay in fulfilling the public health duty announced by the court years ago. That the Food and Drug Administration will not finish reviewing applications for the most popular e-cigarettes until the end of 2023, is another outrageous delay,” said Durbin. “How can this federal agency knowingly, willingly ignore this court order to protect America’s children?”
Durbin, who has repeatedly urged FDA to complete the premarket review of e-cigarettes, called on FDA to use its authority to swiftly remove any and all unreviewed vaping products from store shelves for the safety of American consumers.
“While the FDA has dithered, dallied and delayed, more than one million of America’s kids have started vaping,” Durbin stated this week calling on the agency to obey the court order. “Not next year. Not next month. Immediately. Today,” Durbin stated in a release.
January 28, 2023