More than three months ago, China’s Tobacco Monopoly Administration started to solicit opinions from the public on regulating e-cigarettes after the vaping industry was brought under tobacco’s supervision last November. On Friday, the Chinese government published a revised draft of standards for the vaping industry that has sent vaping stocks tumbling.
In the original proposal, it seemed China was set to allow flavors. However, the new draft underlines the importance of reducing the appeal of e-cigarettes to youth, stating: “Flavors other than tobacco taste shall not be offered in products.” To be specific, 21 additives, referring to tastes like plum, rose and orange, are removed from the list.
As the some U.S. state and European countries already have flavor bans in place, industry experts believe the new regulations may have a greater impact on domestic market rather than exports, according to Li Qian, writing for Shine.cn.
In an interview with Securities Times, an unnamed industry insider said sales volumes of tobacco-flavored e-cigarettes in the domestic market are dwarfed by other flavors. So it would be “subversive” for the domestic market, he said.
After the draft was published, shares of RLX Technology, China’s leading e-cigarette maker listed on the New York Stock Exchange, dropped more than 36 percent and closed at $1.49 on Friday.
The draft is now available on the administration’s website. The administration is asking for public feedback until March 17. If the current draft rule is passed, there will be an end to flavored vaping products in China.
President Biden on Tuesday is expected to sign a $1.5 trillion spending bill that funds the government through September and includes a rider that places synthetic nicotine products under the authority of the U.S. Food and Drug Administration. The Senate passed it late Thursday night by a 68-31 margin. Biden signed a stopgap measure Friday that averts a partial government shutdown that would otherwise have occurred midnight Friday.
The rule will become law 30 days after the bill’s signing date. Manufacturers of currently marketed synthetic products would have an additional 60 days to file a premarket tobacco product application (PMTA) without being subject to FDA enforcement—unless the FDA has already denied a non-synthetic version of the same product (meaning those manufacturers would be subject to enforcement 30 days after the passage of the bill).
Azim Chowdhury, a partner with the law firm Keller and Heckman said that the way he interprets the rule is that all synthetic products already on the market or newly marketed within 30 days after the enactment date can continue to be marketed during the 60-day period following the enactment date.
The language of the Tobacco Control Act would change to define a tobacco product as “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption,” when Biden signs the bill into law.
Products subject to timely submitted PMTAs can remain on the market for 90 days after the effective date, which is 120 days after enactment. Any product not authorized by FDA within 120 days of enactment must come off the market, according to Chowdhury.
“We do not anticipate FDA authorizing any synthetic nicotine products by the end of the 90-day period, though they may take another fatal flaw approach to quickly deny applications,” said Chowdhury. “Significantly, the rider in its current form indicates that a synthetic nicotine version of a product that already went through the PMTA process and is subject to a Refuse-to-Accept (RTA), Refuse-to-File (RTF), Marketing Denial Order (MDO), or withdrawal of a marketing order would have to come off the market as of the effective date – i.e., after 30 days of the law’s enactment.
“In simpler terms, for products that were previously formulated with tobacco-derived nicotine (and the only change was a switch to synthetic nicotine) and whose PMTAs have already been refused or denied, those products will effectively be banned on the effective date (30 days after enactment) with no opportunity to submit a new PMTA. (This is Congress’ way of punishing companies whose PMTAs were denied and then, in their view, sought to circumvent the law by switching to synthetic nicotine).”
Beyond the PMTA conditions, manufacturers of synthetic nicotine products would be subject to ‘all requirements of the regulations for tobacco products. Chowdhury said he and his team interpret this to include all additional Tobacco Control Act requirements, including tobacco product establishment registration and product listing, ingredient listing, ensuring that labeling is compliant including required warning statements, and health document submissions, among other.
April Meyers, board president for the Smoke-Free Alternatives Trade Association (SFATA), wrote in a release that her organization is disappointed by the Biden administration’s use of earmarks in a omnibus appropriations bill without giving an adequate amount of time for interested parties to review and discuss the rule.
She stated that the vaping industry has helped millions of American adult consumers that have relied on flavored vapor products for over a decade to successfully remain combustible tobacco-free.
“Sadly, it is those consumers who will pay the ultimate price of this legislation,” she said. “Over the last decade of SFATA’s existence, we have fought diligently to keep flavored products accessible to smokers. Any battle lost means consumers are potentially driven back to deadly combustible cigarettes, and therein lies the real tragedy.
“It is shameful that public health officials prefer to carve legislation with a butcher’s knife, rather than with the skill and precision of a scalpel better served to ensure the nation’s public health.”
Youth cigarette smoking rates in the United States are at historically low levels, with just 1.9 percent of high school students reporting current use of cigarettes, according to the National Youth Tobacco Survey 2021.
The NYTS found 2.55 million middle-school and high school students in the United States used tobacco products in 2021, according to figures released Thursday by the Centers for Disease Control and Prevention. In the 2020 results, the agency estimated 4.5 million tobacco users among middle school and high school students nationally, down from 6.2 million in 2019.
If the report is accurate, tobacco use among teens nationally declined by more than 40 percent from 2020 to 2021. That would be largest decline in the history of the NYTS.
E-cigarettes were the most popular tobacco product among middle school and high school students in 2021, with an estimated 2 million users, the report found. Puff Bar was the popular brand. That is expected to change next year after Congress passed a rule the same day the study was released that gives the U.S. Food and Drug Administration authority over synthetic nicotine products. That rule requires manufacturers of synthetic nicotine products to file a premarket tobacco product application (PMTA) with the FDA within 90 days.
An estimated 400,000 of students in the middle-high school age range smoked traditional cigarettes, while approximately 380,000 used cigars. Roughly 240,000 used smokeless tobacco, while 220,000 used hookahs and 200,000 tried nicotine pouches, according to the report.
Although the CDC and the Food and Drug Administration “remain confident in our study results,” the survey was conducted online, the agencies have again said that this year’s results cannot be compared to previous years. However, both the 2019 and 2020 surveys were conducted primarily on school campuses, the agencies said.
An industry-leading risk assessment laboratory for compliance of the European Union Tobacco Product Directive (TPD) has been launched by one of China’s largest vapor manufacturers. Shenzhen-based Smoore has become China’s first company capable of providing vaping products with a one-stop TPD risk assessment service, according to a company press release. A division of Smoore’s fundamental research center, the laboratory will be a hub to empower more vaping brands to comply with the safety standards of TPD.
“This laboratory has begun operation in the first half of 2021, and already completed 52 product tests for several world-leading vape brands. As China’s first corporate TPD-compliant risk assessment laboratory, it can generate test reports within 5 working days,” the release states. “Its laboratory equipment is benchmarked against those in world-class analytical testing laboratories, such as Labstat and Enthalpy.”
Smoore’s fundamental research center has developed a comprehensive analytical testing and risk assessment system, covering PMTA non-clinical testing and health risk assessment. Accredited by China National Accreditation Service for Conformity Assessment (CNAS) in 2019, the lab is capable of up to 149 CNAS tests, involving the chemical analysis of e-liquids and aerosols, electrical safety, material safety and battery safety.
With only one e-cigarette approved by the U.S. Food and Drug Administration through the premarket tobacco product application (PMTA) pathway to date, more and more vape brands are aiming for expansion in the European market. Smoore states that the EU is a “relatively friendly regulatory environment and significant market potential.”
“As the industry’s harm reduction and quality benchmark, Smoore complies with its in-house Smoore 3.0 safety standards. Based on the risk assessment guidance of U.S. Environmental Protection Agency and PMTA, Smoore 3.0 covers all of the PMTA vapor safety tests and Harmful and Potentially Harmful Constituents (HPHCs) listed by U.S. FDA,” the release states. “In addition to vapor safety, Smoore 3.0 also involves extractable and leachable substances of medical-grade atomization materials.”
Since FEELM, Smoore’s flagship atomization technology brand, entered the EU market in 2018, Smoore has been in partnership with several leading vape brands in this EU region, including Vuse, HEXA, Innocigs and Alfapod. To date, vaping products loaded with FEELM technologies have been exported to Belgium, Netherlands, Estonia, and Romania, with market leadership in the UK, Germany and France, the release states.
Update: At 2:56 pm the House went into recess, to presumably make amendments to the bill. Media outlets have reported it is to remove some Covid-19 related measures (30 states at risk of losing Covid relief funding previously promised). Currently, the vote on the omnibus appropriations bill is expected to occur this evening or late tonight.
It is possible that the omnibus appropriations bill vote is delayed. In case Congress does not complete work on the omnibus by the end of the week, the House is also expected to vote on a CR through March 15 today to allow time for Senate passage and signing by the President.
If the synthetic nicotine language remains in the bill, the rule will become law 30 days after the bill’s passage date. Manufacturers of currently marketed synthetic products would have an additional 60 days to file a premarket tobacco product application (PMTA) without being subject to FDA enforcement—unless the FDA has already denied a non-synthetic version of the same product (meaning those manufacturers would be subject to enforcement 30 days after the passage of the bill).
The U.S. House of Representatives is expected today to vote on an omnibus appropriations bill (page 1,870) that includes language that would give the U.S. Food and Drug Administration the power to regulate synthetic nicotine . Lawmakers have said some add-ons have already been agreed to, such as a package of health care provisions including Medicare program extensions and eliminating the synthetic nicotine loophole.
The House is planning to vote sometime today before going to Philadelphia for its annual issues conference. The bill must clear the Senate before stopgap funding expires at midnight Friday. GOP objections to a unanimous consent agreement to speed consideration in the Senate could delay final passage into the weekend, lawmakers warned, but both sides expect the process to be complete in time to avoid a partial government shutdown when federal agencies open Monday.
House Appropriations Chair Rosa DeLauro was adamant after a private House Democratic Caucus meeting Tuesday morning the omnibus would be ready for the House to pass on Wednesday, according to RollCall.
“It’s not going to get delayed. We’re going to vote tomorrow,” she said.
If the spending bill currently under consideration passes, the language of the Tobacco Control Act would change to define a tobacco product as “any product made or derived from tobacco, or containing nicotinefrom any source, that is intended for human consumption.”
Amanda Wheeler, president of American Vapor Manufacturers association, said the of banning synthetic products is going to drive millions back to combustible cigarettes.
“At a time when FDA is under scrutiny from multiple federal courts for unlawful regulatory overreach on nicotine, handing the agency even more powers to prevent Americans from switching to vaping is like handing car keys and a bottle opener to your drunk uncle,” she said. “It’s already lunatic that FDA is prohibiting adult American smokers from switching to vaping but this legislation is so absurd that it will extend FDA’s reach to products that have no actual, physical connection to tobacco whatsoever. This bill ought to be called the Cigarette Protection Act, because the indisputable outcome will be countless more Americans pushed away from nicotine vaping and back into combustible smoking.”
Amanda Wheeler
Yaël Ossowski, deputy director of the Consumer Choice Center, said the legislation will actively harm adults who want to quit smoking. He says that the method of “fattening up continuing resolution bills with laws that benefit special interests, without broader democratic debate or analysis of the costs and benefits,” is shameful in a modern American Republic.
“The byzantine process of asking permission to sell harm reducing vaping products in the 21st century is asinine in itself. But using sleight of hand during an emergency government funding bill to castigate millions of vapers and the entrepreneurs who make and sell the products they rely on is the definition of active harm,” said Ossowski. “Only the largest and most powerful vaping and tobacco companies can afford the lawyers and the time necessary to complete the paperwork necessary to pass the FDA’s process, meaning thousands of hard-working American business owners will now be forced to close, depriving millions of adult consumers of harm reducing options. Many will be forced back to cigarettes.
“Synthetic nicotine is an innovative method of providing nicotine independent of tobacco, and millions of American adults now use these products as a less harmful method of consuming nicotine. A back door bureaucratic power move like this represents a sledgehammer to the men and women of our country who have sought out vaping devices to kick their cigarette habit.”
Yaël Ossowski
Ossowski said he hopes elected representatives reject the synthetic nicotine inclusion and “go back to the drawing board” to offer a more permanent policy.
Congress has tried numerous times over the past year to give the FDA authority over synthetic products. The FDA said last year that synthetic nicotine could be considered a component of e-cigarettes, which would allow for the product to be regulated by the agency. Many states have already begun banning synthetic products.
Sens. Richard Burr, Dick Durbin and Patty Murray, along with Rep. Frank Pallone led the effort to get the language into the omnibus, according to two Senate sources familiar with the discussions. “This is an enormous win for public health and American consumers,” Pallone said in a statement. “I’m grateful to members on both sides of the aisle for working with me to close this loophole in the omnibus.”
The flavor ban bill introduced in Illinois would also ban flavored THC vaping devices. Senate Bill 3854, introduced in January, is currently in committee. Any flavored flavored vaping product, including heat-not-burn systems and tobacco chew, would be banned.
Credit: Kurgu 128
The bill provides “that (1) “tobacco product” includes products containing tetrahydrocannabinol and products containing a mixture of tetrahydrocannabinol and nicotine, and (2) “tobacco retailer” includes dispensing organizations and dispensing organization agents, as those terms are defined in the Cannabis Regulation and Tax Act. Creates a presumption that a tobacco product, related tobacco product, alternative nicotine product, or solution or substance intended for use with electronic cigarettes is a banned product, solution, or substance intended for use with electronic cigarettes if it has or produces a characterizing flavor.”
A consumer advocacy group says the measure could do more harm than good. Elizabeth Hicks, U.S. Affairs analyst with the Consumer Choice Center, said enacting a flavor ban for vaping products will push adult consumers to switch back to smoking combustible tobacco at a time when smoking cigarettes has been trending down in Illinois, according to KPVI.
“About 12% of adults in 2020 reported smoking, however, if this bill passes, we can certainly expect that number to increase,” Hicks said. “This ultimately will lead to increases in smoking-related healthcare costs, which are already costing Illinois taxpayers over $1.9 billion annually,” Hicks said.
The state of Illinois passed two laws last year aimed at making it harder for minors to access vaping products. The first law (Senate Bill 512) prohibits the use of cartoon characters, video game characters, and popular children’s media from advertisements for e-cigarettes. It also makes it harder to buy vaping products online. Buyers will now have to use a credit card or check in the buyer’s name.
The second law (Senate Bill 555) amends the Substance Use Disorder Act to include vape shops. Adding vape shops allows the Illinois Department of Human Services to do compliance checks on the sale of e-cigarettes according to the minimum purchasing age of 21.
Thirty U.S. states plus the District of Columbia began the new year on Jan. 1 with taxes on vaping products and e-cigarettes in place. In 2015, only three states and the District of Columbia imposed taxes on vaping products.
Credit: Splitov27
According to the Federation of Tax Administrators, the states without vape taxes as of February 2022 are: Alabama, Arizona, Arkansas, Florida, Hawaii, Idaho, Iowa, Michigan, Mississippi, Missouri, Montana, Nebraska, Oklahoma, Rhode Island, South Carolina, South Dakota, Tennessee, and Texas.
Bubba Lange, writing for Avalara, states Indiana doesn’t have a state vape excise tax as of this writing, but one will take effect on July 1 of this year. Alaska doesn’t have a statewide vape excise tax, but certain municipalities within the state collect a local tax, including Anchorage and Juneau.
“More states are likely to start collecting excise tax on vape products soon. Our last count had 12 additional states considering adding specific vape taxes,” Lange writes. “In addition, two states currently have local jurisdictions collecting additional excise taxes on vape products: Cook County and the city of Chicago in Illinois, and Montgomery County in Maryland.”
There are a lot of challenges in keeping up with excise taxes, states Lange. Most importantly, “you have to invoice your customer correctly to ensure you collect the right tax money.”
A new study claims that people who use vaping devices are 22 percent more likely to have high blood sugar – known as prediabetes – compared with those who have never used them. However, traditional cigarettes increase a combustible smokers risk of developing type 2 diabetes by 40 percent.
Researchers from Bloomberg School of Public Health at Johns Hopkins University in the U.S. analyzed data from 600,000 people. They looked for links between e-cigarette use and prediabetes – a serious but reversible health condition in which blood sugar levels are higher than normal but not high enough to be diagnosed as type 2 diabetes.
To determine the association between e-cigarette use and prediabetes, the investigators analyzed 2016–2018 data from the Behavioral Risk Factor Surveillance System (BRFSS). It said to be the largest annual nationally representative health survey of U.S. adults with data on health outcomes, health-related risk behaviors, preventive services, and chronic medical conditions.
“Our study demonstrated a clear association of prediabetes risk with the use of e-cigarettes. With both e-cigarette use and prevalence of prediabetes dramatically on the rise in the past decade, our discovery that e-cigarettes carry a similar risk to traditional cigarettes with respect to diabetes is important for understanding and treating vulnerable individuals,” said Shyam Biswal, the study’s lead investigator.
The researchers state that the possible link between combustible cigarettes, e-cigarettes and prediabetes is not understood. However, nicotine, which is in both traditional cigarettes and e-cigarettes, has long been linked to a rise in blood sugar levels, according to news reports.
The results, published in the American Journal of Preventive Medicine, showed that current e-cigarette users are 22 percent more likely to have prediabetes compared with those who those who had never used them, while former vapers still had a 12 percent higher risk.
Prediabetes is reversible with lifestyle management, according to reports.
Kenya has struggled in regards to helping combustible cigarette smokers quit. According to recent research by Dr. Michael Kariuki, an epidemiologist, two-thirds of the country’s smokers want to quit but lack alternatives to replace traditional cigarettes.
Credit: Zero Photo
In an interview with TUKO.co.ke, Kariuki stated that as much as smoking is an addictive habit, most smokers expressed a desire to quit but admitted that they find it difficult. “The addictive product in cigarettes is nicotine, however, what kills people are the other carcinogenic products that are medically referred to as Group 1 human carcinogens,” he told Hillary Lisimba.
Kariuki added that his research was aimed at offering solutions that would make it easy for smokers to quit. He said offering them alternative products that have nicotine but are not combustible. “You see, smoking [cigarettes] gives a calming effect due to the nicotine, yet the majority of smokers who want to quit find it difficult because of the addiction,” he said.
Vaping products are not regulated in Kenya. There is no law addressing the use of e-cigarettes in indoor public places, workplaces, and public transport. The desire of cigarette smokers to stop smoking are complicated because nicotine replacement therapies, such as e-cigarettes, are too expensive for most smokers, according to Kariuki.
He also stated that, as a country, Kenya is not doing enough to help smokers quit. The country needs to offer products that can gradually assist struggling smokers.
The state Senate of Idaho narrowly passed a bill meant to clarify the legal age for vaping and tobacco product purchases with a 19-15 vote Tuesday.
Under federal law, people must be 21 or older to legally purchase or possess tobacco or vaping products. Congress raised the age limit from 18 to 21 in 2019. Idaho law, however, still lists 18 as the legal age for tobacco purchases.
Senate Bill 1284 changes that to 21, bringing Idaho law into symmetry with federal law, according to news reports.
Sen. Fred Martin, the bill’s sponsor, said the disparity between state and federal law causes confusion for Idaho retailers. Although they’re required to comply with the federal age limit, the signs they have to post indicate that 18 is the minimum age under state law.
