Many states are seeking to limit local governments from passing restrictions beyond state vaping and tobacco laws such as flavor bans. A Kentucky lawmaker, however, has filed a bill to give cities and counties more power to pass their own rules dealing with smoking and vaping.
According to WKYT.com, Senate Bill 166 would allow cities, counties or other local governments to adopt tougher rules or restrictions than the state allows when it comes to smoking or vaping products.
Credit: Andreykr
Tony Florence, the owner of four Lexington vaping stores, told the news agency that the bill would be extremely damaging to because business owners and other vaping advocates would have to fight regulation in every city or county, causing problems for thousands of mom-and-pop style businesses.
Florence says vaping products generate a lot of tax revenue for the state and he says this bill would be hurtful to a product that he says is less harmful than cigarettes.
SB 166 is sponsored by Senator Wil Schroder and would impact the use, sale, or distribution of tobacco or vapor products. The bill has been assigned to the Senate Health and Welfare Committee but has not yet been called up for a vote.
A new bill introduced in Nebraska would limit localities in how they regulate electronic smoking devices under a bill heard Feb. 17 by the state senate’s Health and Human Services Committee. LB954, introduced by Omaha Sen. Justin Wayne, would prohibit counties and municipalities from adopting ordinances or resolutions regarding electronic smoking devices that are more restrictive than the provisions of the Nebraska Clean Indoor Air Act.
This would include banning certain smoking devices or flavors, according to state’s legislative website. Wayne said the bill would prevent a “patchwork” of vaping regulations across the state. “It would make it easier for the industry to provide their services to their customers,” he said.
Credit: Niro World
Sarah Linden, president of the Nebraska Vape Venders Association, testified in support of the bill. She said the Nebraska Clean Indoor Air Act allows vape shop customers to sample products, but Lincoln and Grand Island have ordinances banning indoor vaping in all circumstances.
LB954 would standardize the law across the state and enable customers to try out various products before they purchase them. “There’s nothing worse than buying something and deciding you don’t like it once you get home,” Linden said.
Dave Watts, president of the Nebraska Medical Association, spoke in opposition to the bill. He said state law should apply equally to vaping and cigarettes. “Vaping devices don’t simply emit harmless water vapor … heating the substances in the chamber of a vaping device creates an aerosol,” Watts said. “Unlike water vapor, that aerosol contains nicotine — ultra-fine particles that can worsen asthma — and toxins that are known to cause cancer.”
Maggie Ballard of Heartland Family Service also testified in opposition to LB954. She said nicotine is a “pilot light” for other addictions and that individuals with substance abuse disorders are better off without it. “Community members want to see less vaping, not more,” Ballard said.
Also in opposition was Lash Chaffin of the League of Nebraska Municipalities. He said the bill would take away a municipality’s ability to regulate vaping as it sees fit. The committee took no immediate action on LB954.
He’s back. The U.S. Senate on Feb. 15 narrowly confirmed Robert Califf as commissioner of the U.S. Food and Drug Administration, reports The New York Times.
The vote was 50-to-46, with six Republicans crossing the aisle to support him while five senators who caucus with Democrats opposed him. One senator voted present.
Credit: Bill Clark/CQ Roll Call
A cardiologist who has served as the deputy commissioner of the FDA’s Office of Medical Products and Tobacco, as President Barack Obama’s FDA commissioner and as the head of medical strategy at Alphabet, Google’s parent company, Califf takes over the position from Janet Woodcock, the acting commissioner since President Joe Biden assumed office more than a year ago.
According to Vaping360, Califf has been generally antagonistic toward vaping as a consumer product. He was at the FDA helm in 2016 when the agency rolled out the Deeming Rule, which gave the FDA authority over e-cigarettes and other tobacco-free nicotine products.
Tellingly, the Campaign for Tobacco-Free Kids (CTFK) enthusiastically welcomed Califf’s appointment. “Dr. Califf is highly qualified and prepared on day one to address the enormous challenges facing the FDA, including the most significant decisions on tobacco in the agency’s history,” wrote CTFK President Matthew L. Myers in a statement.
Califf is expected to be sworn in this week. He faces a looming flurry of decisions, including reviews of premarket tobacco applications from leading e-cigarette companies, such as Juul Labs. He will also have to contend with litigation from vapor companies over marketing denial orders (MDOs).
After issuing MDOs to hundreds of manufacturers for hundreds of thousands flavored product, the agency has been challenged in court by more than 30 companies that claim their PMTAs were denied based on a standard that was not in place when the applications were submitted.
One of the new commissioner’s first tasks will be working with Health and Human Services Secretary Xavier Becerra to find a replacement for Center for Tobacco Products Director Mitch Zeller, who plans to retire in April.
Many countries continue to limit access or have outright banned vaping and e-cigarette products.
By Norm Bour
As much as we would like to think that vaping and the sale of vape products is universally accepted, that is not the case. The world has changed a lot over the past 10 years, and the medical community’s support has carried some weight, but old customs and rituals die hard. Here is an overview of where the status of vape remains iffy.
Turkey
You can use vape products where tobacco is permitted, but the Turkish government is vehemently anti-vape—regardless of the medical documentation that shows the advantages of vaping over combustible cigarettes. Since 2009, President Recep Tayyip Erdogan has led the campaign against all tobacco products, including cigarettes, regardless of their popularity.
Turkey banned the import of e-cigarettes and related products on Feb. 25, 2020. The ban covers e-cigarettes, accessories, spare parts and solutions (e-liquids) as well as e-cigarette products that use heating or incineration, like electronic hookahs. The country had already banned the sale of electronic cigarettes.
Erdogan’s aggressive posture has resulted in the seizure of almost 18 million packs of cigarettes in 2020 and 140,000 e-cigarettes. The government offers a hotline for people to call and blow the whistle on illegal products, and 1,500 teams scour the country doing random inspections. For vapers, the online channel remains open, and there are many foreigners who vape in the street without concern.
India
With a population of 1.38 billion, India has banned vaping products since 2019. With an estimated 120 million people lighting up, India has the dubious honor of having 12 percent of the world’s cigarette smokers. The country loses about 1 million people per year to tobacco-related illnesses.
India’s aggressive anti-smoking posture has proven successful as the number of smokers has dropped significantly over the past 20 years. In 2000, it was estimated that one-third of the male population smoked, with 5.7 percent of the female population smoking. A decade later, those numbers had dropped to 23 percent for men and 2.5 percent for women. Currently, an estimated 14 percent of the country’s population smokes.
With a 28 percent luxury tax on tobacco, there are huge incentives to quitting smoking in India. The bad news is that vaping products are lumped into the tobacco pile, but evidence for the relative safety of e-cigarettes is gaining ground. The anti-vape campaign was geared toward the young smokers, but there may be light at the end of this tunnel.
Under the guise of preventing potential health risks to the country’s youth, India banned the “import, manufacture, sale, advertisement, storage and distribution” of e-cigarettes in September 2019. However, according to Research and Markets, the Indian e-cigarette market reached a value of $7.8 million in 2018, and it is further predicted to witness a CAGR of 26.4 percent during the forecast period (2019-2024) even with the ban in place.
There is very little regulatory enforcement for vaping products in India. Vaping products are even being displayed on some store shelves. A few of the biggest paanwalas in the cosmopolitan cities reportedly sell Juul and other high-end hardware. It’s not plainly obvious everywhere, and the specialist “vape only” vendors are all clandestine, according to several sources. Most of the specialists are discerning and do not entertain new customers without a reference from a known customer.
Australia and New Zealand
Australia has been a teeter-totter in terms of vapor regulations. In October of 2021, it declared all nicotine products illegal without a doctor’s prescription. The prescription is intended only for the patient and may not be shared or sold. The sole light at the end of this this tunnel is that nicotine- free products are excluded from this heavy-handed ban.
Devices and liquids can be sold in all eight territories, though advertising and promotion is legal in some but illegal in others. Spotty monitoring and enforcement have resulted in a lively online trade in vapor products.
Compared to many countries, the perceived “problems” of youth smoking are modest with percentages of vapers and smokers under 20 percent among different age groups. According to 2021 research from the Australian National University, about 16 percent of current e-cigarette users in Australia are non-smokers who have never inhaled tobacco, while the remaining third are ex-smokers. There are about 400,000 e-cigarette users in Australia.
While often lumped in with Australia by outsiders, New Zealand has followed its own, more reasonable, path in vapor regulation. The small island country of just 5 million people estimates that 11.6 percent of its population smokes. Its priority is on reducing underage vaping and smoking.
The Middle East
Excluding the North African countries sometimes included in the Middle East, this part of the world is home to almost 0.5 billion people and encompasses about 20 percent of the Muslim world. While Islam frowns on tobacco use, many Muslim countries have high smoking rates. While tobacco use has been grudgingly tolerated, vaping was initially disdained, with some countries banning the practice. That is changing, as was evidenced in September 2021 when the World Vape Show was held in Dubai, which has now legalized vaping.
Tim Phillips, managing director of ECigIntelligence, says the United Arab Emirates is leading the Middle East in vape product sales and access, but considering it started from scratch, the numbers are still small. As tobacco-oriented as this part of the world is, buyers prefer flavored liquids with three out of four sales being sweeter fruit flavors followed by menthol flavors.
Across the Middle East, the rules are in constant flux. Currently, Kuwait, Jordan, Egypt, Saudi Arabia and Bahrain offer legalized vape, but Qatar and Oman do not. Market intelligence company Mordor Intelligence projects a growth rate of almost 10 percent through 2025 in the regional vapor market.
In late 2020, a Euromonitor International study found only a very small minority of smokers used e-cigarettes to quit smoking in the Middle East region. Analysts found just 1.8 percent of smokers in the region took up alternatives to conventional cigarettes in 2020. The figure is up from 1.4 percent in 2017 but it remains significantly low when compared to other parts of the world.
South America/Latin America
On the other side of the globe, South America’s 433 million people also face an ever-changing landscape of vaping laws. The largest country, Brazil, allows vaping, with some restrictions in enclosed areas. Sales are highly regulated by the Health Surveillance Agency, which closely monitors underage sales, though enforcement of sales and production is weak.
No. 2 by population, Argentina has banned vaping for a decade and shows no sign of changing its policy. The ban extends to nicotine-free products, and there are virtually no sales, production or importation of e-cigarettes. Ironically, Argentina reportedly accounts for as much as 15 percent of total tobacco consumption in South America.
Contrary to some of its neighbors, Peru has been open-minded about vaping—to the point where the government appears to turn a blind eye to the practice. With an estimated 2.3 million smokers—just under 10 percent of the population—Peru has no official numbers on the vapers and vape products. It seems the country has higher priorities and has decided to leave vapers alone.
According to Mordor Intelligence, as enforcement of e-cigarette laws are often open to local authorities, vape shops are often found in places where they are technically illegal in the region. In the entire region only five countries allow the legal sale of e-cigarettes: Chile, Ecuador, Honduras, Paraguay, and Costa Rica.
Following the recent enactment of smoke-free laws in Paraguay, every South American country has now banned vaping and smoking in most public places. Under Decree No. 4624, approved by Paraguay’s presidency on Dec. 29, consuming lit, heated, or electronic tobacco products is permitted only in uncrowded open air public spaces that are not transit areas for nonsmokers.
Norm Bour is the founder of VapeMentors and works with vape businesses worldwide. He can be reached at norm@VapeMentors.com
The FDA is expected to have a new leader today. Robert Califf will likely be confirmed as the next commissioner of the U.S. Food & Drug Administration (FDA) by midday Tuesday.
On Monday night, the Senate voted 49-45 to advance his nomination as part of a cloture vote, a key procedural hurdle that can also show whether or not Senate leadership has enough votes to succeed. Technically, cloture simply streamlines the vote by limiting down the time a matter can be discussed and also restricting Senators from certain actions such as amendments that are unrelated to the vote.
Robert Califf / Credit: Modern Healthcare
While this vote was close—five Republicans and one Democrat did not vote—Senate leadership typically does not call for cloture unless it believes it has the votes to pass a measure, writes Charlie Minato, an editor with Halfwheel.
He garnered the support of five Republicans, while simultaneously having five members of the Democratic caucus vote against his nomination.
Thousands of vaping products in New Zealand started being removed from store shelves Friday as new regulations on packaging come into effect.
The move is part of the amended Smokefree Vaping Act rolled out 15 months ago, which includes it only being legal to sell vape products registered with the Ministry of Health, according to 1News.
Action for Smokefree 2025 director Deborah Hart on Friday told Breakfast the new regulations mean manufacturers need to be more transparent about what’s in their products.
“The Government has been rolling out regulations right from the very start of the (Smokefree Environments and Regulated Products) Act. So from the start of the Act until today, one of the things we’ve been doing is around the safety of the product,” she said.
“Six months ago importers and manufacturers had to start notifying what was in their products – had to notify labels, packaging and what’s in the products.
“And today they had to do all that, they can only sell what’s been notified, and to notify they had to adhere to the safety regime that had been set up by the Government. So that’s fantastic.”
“Countries which have chosen to legalize and regulate e-cigarettes have seen a fall in overall smoking rates and have much better control over youth vaping. It’s exciting for Thailand, and in fact the world, that the government is now set to overturn its ban on the sale of vape products,” says Asa Saligupta, director of ENDS Cigarette Smoke Thailand (ECST).
According to Saligupta, Thailand’s harsh ban and penalties on vape sales has meant too many smokers have been stuck with cigarettes, while young people buy e-cigarettes in the underground economy with no control over the purchase age or product safety standards.
“We’ve seen the legalization and regulation of vaping in places like the United States, United Kingdom and New Zealand work very well. I’m delighted the Thai government is now listening to the science with the adoption of effective tobacco harm reduction (THR) policies now increasingly imminent,” he says.
The ECST director says Digital Economy and Society Minister Chaiwut Thanakamanusorn, government officials, public health experts and advocates have all been key to finally addressing Thailand’s failed tobacco control policies.
He says that, despite the minister adopting an evidence-based approach, local conservative health groups continue to unfairly target him and publicly scaremonger.
“It was a big breakthrough last year when the minister told local media that vaping is safer for people trying to quit smoking. Since then, he has walked the talk—looking at ways vaping can be legalized. He fully understands it offers smokers a less harmful alternative to deadly cigarettes and protects non-smokers from the dangers of second-hand smoke.
“Consumer groups like ours have worked hard to encourage our politicians and officials to follow the significant international public health evidence. It has been a long journey, but we’re pleased with the progress the government’s working group continues to make on legalizing e-cigarette sales,” says Saligupta.
Nancy Loucas
International research also shows countries which have adopted progressive policies around vaping have seen their smoking rates fall twice as fast as those countries that haven’t.
Nancy Loucas, executive coordinator of The Coalition of Asia Pacific Tobacco Harm Advocates (CAPHRA), says that by lifting its long ban on vape sales, Thailand will join about 70 countries that have legalized vaping.
“Around the world, vaping is saving millions of ex-smokers’ lives and can save many more if safer nicotine products are embraced, not demonized,” says Loucas. “Thailand’s 10 million smokers have long deserved a readily and legally available alternative to cigarettes. The country’s sky-high smoking rate is totally unacceptable but thanks to the work of ECST and others, it’s about to be seriously addressed.”
According to Loucas, Thailand has become increasingly isolated internationally with its harsh policies. Vapers currently risk arrests, sanctions and even imprisonment.
“By legalizing that sale of vapes, Thailand will join countries like the Philippines and Malaysia which are also waking up to the fact that vaping bans inevitably fail, leading to unnecessary smoking-related illnesses and deaths,” says Loucas.
The U.S. state of Mississippi’s House of Representatives Thursday passed legislation that would require sellers of any type of alternative nicotine and marijuana products and package retailers to have a third-party age verification service.
Nick Bain
HB 976, authored by State Rep. Nick Bain (R), revises the provisions of law that regulate alternative nicotine products such as an electronic cigarette, any other product that consists of or contains nicotine that can be ingested into the body by chewing, smoking, absorbing, dissolving, inhaling or by any other means, according to Y’All Politics. The rules would include synthetic nicotine products.
The bill also amends Section 67-1-81 of Mississippi Code to, “require holders of a package retailer permit to have an independent, third-party age verification service available on the property of the location in which alcoholic beverages are sold; and for other related purposes.”
The legislation says that before selling alternative nicotine products, the person or business must verify that the individual is at least 21 years of age by performing an age verification through a third-party verification service that obtains the purchasers full name, date of birth, and residential address and compares the information available from public records to the personal information entered.
In accordance with national standards, the third-party verification system used must have at least a 95% accuracy rating in order to be in compliance with the identification requirements listed in the bill.
An amendment was added that would require medical marijuana dispensaries to be included in this bill.
The 11th Circuit Court of Appeals granted the stays to Diamond Vapor, Johnny Copper and Vapor Unlimited. The ruling was in conjunction with Bidi Vapor’s stay. The 11th Circuit handles petitions for review from vaping businesses based in Florida, Georgia and Alabama. All four companies are based in Florida.
The decision allows the companies to continue selling their tobacco harm reduction products while the lawsuits remain active. A three-judge panel heard motions from the businesses and granted the stays by a 2-1 vote. The stays don’t guarantee that the companies will succeed in their challenges to the FDA denials, but they are an encouraging sign, according to Azim Chowdhury, a partner with Keller & Heckman law firm. He said courts usually grant stays only if the plaintiff’s case has a good chance of “succeeding on its merits.”
More than 30 companies have now sued the FDA and many of those appeals will be heard in federal courts over the next few weeks. No decisions have yet to be handed down, and early decisions could affect later ones, according to several attorneys. If there are conflicting decisions in multiple courts, the FDA’s PMTA process could eventually wind up being sorted out by the Supreme Court, according to Chowdhury.
In a highly anticipated case for the vapor industry, Triton Distribution made its opening arguments Monday in its battle with the U.S. Food and Drug Administration over how the regulatory agency conducted it premarket tobacco product application (PMTA) reviews. Triton’s lawyer urged a three-judge panel of the 5th U.S. Circuit Court of Appeals in Houston to conclude the FDA could not force manufacturers to provide studies that the agency had previously stated would not be required.
“The question before the court concerns how exactly the FDA ended up denying Triton’s PMTA—with potential implications for comparable applications by many other denied companies,” said Triton’s attorney Eric Heyer, a partner at Thompson Hine.
Credit: Sergign
In August, the FDA rejected applications to market 55,000 flavored e-cigarettes, including Triton’s, and said applicants would likely need to conduct long-term studies establishing their products’ benefits to win approval, according to Reuters. The new requirement for long-term studies differed from earlier FDA guidance and was a “surprise switcheroo,” a 5th Circuit panel concluded in October when it allowed Triton to keep selling e-cigarettes until another panel could hear its appeal.
In recently released internal FDA correspondence, the agency’s scientific staff conducted “fatal flaw” reviews that only looked for the presence of the newly required long-term studies, and if those studies were not present the agency issued a marketing denial order (MDO). During oral arguments, Heyer said the FDA’s new requirement was “arbitrary and capricious, a position conservative U.S. Circuit Judge Edith Jones appeared to agree with.
“It seems to me that’s the height of arbitrariness and capriciousness, to say we are the FDA, trust us, which I might say some of us are becoming skeptical about in light of recent vaccine experiences,” she said, alluding to COVID-19 vaccines.
Heyer argued that the process the FDA established set Triton up for failure because the new requirements were only conveyed after the deadline for when PMTAs needed to be submitted (Sept.9, 2020) had passed. It was only then that the FDA indicated that applicants would likely need randomized controlled trials (RCTs) and longitudinal cohort studies to demonstrate “comparative efficacy.”
The other two judges questioned Triton’s case. U.S. Circuit Judge Gregg Costa asked whether Triton’s products, such as one called Jimmy the Juiceman Strawberry Astronaut, were really targeted to adults. “That’s supposed to be appealing to a 40-year-old?” he asked.
U.S. Circuit Judge Catharina Haynes questioned why companies like Triton did not have enough time to develop such support for their products’ health benefits for adults given the years they have had to prepare for FDA regulation. The FDA in 2016 deemed e-cigarettes to be tobacco products like traditional cigarettes subject to agency review under the Tobacco Control Act. Manufacturers were ultimately given until 2020 to seek approval to market them.
If the court disagrees with Triton’s argument, Heyer has requested that the judges “enjoin FDA from taking further adverse action on the Petitioners’ PMTAs for 18 months to allow Petitioners to conduct the necessary studies to prove comparative efficacy,” according to legal documents.
There is no timeline for a decision in the Triton lawsuit. Judges are expected to take at a minimum weeks, if not months, to make a decision.
Excluding the North African countries sometimes included in the Middle East, this part of the world is home to almost 0.5 billion people and encompasses about 20 percent of the Muslim world. While Islam frowns on tobacco use, many Muslim countries have high smoking rates. While tobacco use has been grudgingly tolerated, vaping was initially disdained, with some countries banning the practice. That is changing, as was evidenced in September 2021 when the World Vape Show was held in Dubai, which has now legalized vaping.
On the other side of the globe, South America’s 433 million people also face an ever-changing landscape of vaping laws. The largest country, Brazil, allows vaping, with some restrictions in enclosed areas. Sales are highly regulated by the Health Surveillance Agency, which closely monitors underage sales, though enforcement of sales and production is weak.
