New regulations for the vaping industry continue to sit on President Rodrigo Duterte’s desk in the Philippines. Again last week, the country’s Department of Education (DoE) urged Duterte to veto the Vaporized Nicotine Products Regulation Act approved by the Senate on third and final reading last December 2021.
“As a government institution championing young Filipinos’ well-being, we are taking a stand against the so-called ‘anti-health’ vape bill, which will weaken existing law and the executive order against electronic nicotine delivery systems (ENDS) or electronic non-nicotine delivery systems (ENNDS) commonly known as e-cigarettes or ‘vapes,’” according to a DoE statement.
Credit: Craitza
If passed into law, the proposed legislation will lower the access restriction age from 21 to 18 years old. The bill also permits online sales, and allows flavors other than plain tobacco and menthol, the only two flavors currently allowed by law.
The bill also prohibits celebrities or social media influencers from endorsing vapor products. Physical and online retailers or distributors must register with the Department of Trade and Industry and the Securities and Exchange Commission.
To underscore the danger it poses to the youth, the DoE stated that for school year 2020-2021, at least 870,000 learners in the basic education sector were 18 years old, while close to 1.1 million learners in senior high school were 18 to 20 years old.
“This is the number of learners who will become legally allowed to be marketed the harmful products once the bill becomes law,” the DoE stated, adding that young people are vulnerable to engage in risky behaviors such as substance abuse.
The governor of Indiana signed a bill last week that included provisions cutting the 25 percent tax that wholesalers were to be charged for closed-system vaping devices to 15 percent.
State lawmakers approved the higher rate last year for Indiana’s first tax on electronic cigarettes to start in July 2022. But the Legislature approved the lower rate with seven lines included in a 118-page bill on mostly technical tax law changes.
Sen. Travis Holdman of Markle, chairman of the Senate’s tax committee chairman, said the vaping device tax change was made to bring it in line with the 15 percent rate set last year for refillable vaping products, according to the Associated Press. Holdman said the intention was to have all vaping devices and products taxed the same.
Bryan Hannon of the American Cancer Society said the vaping device tax should be at least 20 percent to achieve parity with Indiana’s 99.5 cents-per-pack cigarette tax.
The Prevent All Cigarette Trafficking (PACT) Act has caused issues for some businesses trying to navigate the new regulatory landscape. PactAct POS says it now offers a cloud-based software that includes integration with major e-commerce platforms like Shopify, BigCommerce and WooCommerce to help businesses remain in legal operation, according to a company press release.
“Pact Act vape compliance can be an overwhelming process for companies,” explained Terrence Johnathan, vice president of shipping and logistics for PactAct POS. “In some cases, the requirements are causing small businesses to shut down or stop shipping directly to consumers, which is hurting both consumers and manufacturers.”
PactAct POS provides registration, reporting, shipping and logistics, and government relations services.
PactAct POS is also releasing the PACT Act Survival Guide for 2022, a free e-book that focuses on PACT Act planning and strategies for 2022 and beyond.
“There are so many hoops to jump though,” said Johnathan. “We’ve worked with clients dealing with the vape mail ban [and] every kind of scenario, and we’ve been with them every step of the way. These companies don’t have to go at it alone. They just need to ask for help.”
PactAct POS is a cloud-based platform that automates PACT Act compliance for more than 250 businesses.
Denmark plans to ban the sale of cigarettes and nicotine products to anyone born after 2010, the country’s Denmark’s Ministry of Health has announced.
Health minister Magnus Heunicke said the policy change would prevent the next generation from smoking any form of tobacco, according to The Independent.
“Our hope is that all people born in 2010 and later will never start smoking or using nicotine-based products,” Heunicke said. “If necessary, we are ready to ban sales to this generation [born in 2010] by gradually raising the purchase age limit.”
Under current laws in Demark, people under the age of 18 are banned from buying tobacco and electronic cigarettes. But around 31 percent of those aged between 15 and 29 are smokers, Heunicke said.
New Zealand announced plans to outlaw buying cigarettes for anyone born after 2008. The ban is expected to come into force this year.
Additionally, the government plans to introduce major tobacco controls such as reducing the amount of nicotine in products and restricting where cigarettes can be sold.
A patent infringement lawsuit has been filed by Zanoprima Lifesciences against Hangsen International Group for infringement on Zanoprima’s patent to produce synthetic nicotine.
Filed in the U.S. District Court in the Western District of Texas, Zanoprima claims Hangsen violated its patent entitled “Process for Making (S)-Nicotine” (U.S. Patent No. 10,913,962) and Hangsen has been importing products that include a a synthetic nicotine into the U.S. that is produced by using Zanoprima’s patent.
“Over many years, Zanoprima has invested substantial time, resources, intellectual capital, and scientific expertise into developing Zanoprima’s groundbreaking enzymatic patented process for synthesizing an (S)-nicotine that is devoid of tobacco-specific nitrosamines and other impurities,” stated Ashok Narasimhan, CEO of Zanoprima, in a press release. “Zanoprima’s legal action reflects our company’s dedication to vigorously protecting our intellectual property in the U.S. and around the world.”
The complaint alleges that, after publication of Zanoprima’s patent, Hangsen filed a Chinese patent application describing a process that copied the process invented by Zanoprima. However, as alleged in the complaint, Hangsen’s patent application was rejected by the Chinese Patent Office in June 2021 citing Zanoprima’s patent as prior art.
The complaint also alleges Hangsen imports into the U.S. from China and sells products containing “alleged high-purity synthetic (S)-nicotine and nicotine products that are marketed and sold under various names including as MOTiVO Synthetic S-Nicotine,” and that such imported products “are manufactured by a process that practices every step … of the Zanoprima patent.”
In addition to seeking damages for infringement, Zanoprima’s complaint seeks preliminary and permanent injunctive relief to prevent Hangsen from continuing infringing upon Zanoprima’s patent.
Zanoprima is the first company to manufacture and make commercially available an enzymatically synthesized form of pure (S)-nicotine, SynNic, according to the release. The synthetic nicotine is chemically identical to that derived from tobacco but devoid of harmful tobacco-specific nitrosamines, carcinogens, alkaloids, and other impurities that accompany tobacco-derived nicotine.
President Joe Biden on Tuesday signed a bill that gives the U.S. Food and Drug Administration powers over over any nicotine, not just tobacco-derived nicotine. Part of a $1.5 trillion government spending measure, the rider was slipped into the bill with no debate or notification to the vaping industry.
The language of the Tobacco Control Act will now 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.”
“You know, in a moment, I’m going to sign this bipartisan government funding bill,” Biden said. “But with this bill, we’re going to send a message to the American people – a strong message – that Democrats and Republicans can actually come together and get something done.”
Bryan Haynes, a partner with Troutman Pepper, said that the amendment has an effective date 30 days after the bill is enacted (April 14) and gives a manufacturer of a tobacco product with synthetic nicotine (or nicotine derived from a source other than tobacco) 30 days after the effective date to file a premarket tobacco product application (PMTA) with FDA.
“If FDA has not authorized the product within 90 days after the effective date, the product must be removed from the market. This is likely to amount to an effective ban on synthetic nicotine products,” he wrote in the firm’s Tobacco Law Blog. “FDA is highly unlikely to authorize a PMTA in 90 days when other PMTAs for electronic nicotine delivery systems have been pending for more than two years.”
April Meyers, board president for the Smoke-Free Alternatives Trade Association (SFATA), told Vapor Voice that the bill will have little effect on youth vaping, which is already down significantly since highs in 2015. “Although the sponsors of the bill claim the intent was to close the loophole on synthetic nicotine-derived products from large companies now popular among youth, the reality is that this bill – and others like it – aren’t likely to have the intended effect,” she said. “Instead, consumers using these products as a harm reduction option will suffer, as will licensed small businesses in full compliance with federal, state, and local laws.
“The FDA created a problem by overregulating a product used by millions of adults who find vaping a safer alternative to smoking. When a market in high demand is overregulated, grey and black markets emerge where there are no regulations requiring safe products or ID checks.”
A new study concludes that 18 to 24 year old’s that use e-cigarettes did not use vaping as a gateway to smoking combustible cigarettes.
The report, published in the journal Addiction, examined e-cigarette use in England among young adults between 2007 and 2018, according to the Belfast Telegraph.
In the study, a team from University College London reviewed data for England from the Smoking Toolkit Study.
Lead author, Emma Beard, said the “findings suggest that the large gateway effects reported in previous studies can be ruled out, particularly among those aged 18 to 24.
“However, we cannot rule out a smaller gateway effect and we did not study younger age groups.” she said.
“If the upper estimates are true, we would estimate that of the 74,000 e-cigarette users aged 16 to 17 in England, around 7,000 would become ever regular smokers as a consequence of e-cigarette use.
“At the same time, approximately 50,000 smokers are estimated to quit per year as a consequence of e-cigarette use.”
China’s health authorities have locked down Shenzhen to prevent the spread of Covid-19 from Hong Kong, which is experiencing a surge of the virus.
Shenzhen is a significant manufacturer of consumer electronics, including vapor hardware, for the global market. The city houses tech powerhouses, such as iPhone manufacturer Foxconn, and more than 170,000 vaping-related businesses. The local vapor industry employs more than 3 million people and supplies more than 90 percent of the vapor hardware used around the world, according to some estimates.
The Shenzhen lockdown will last for at least seven days. All nonessential workers must stay home, adults must take PCR tests and public transportation is being halted.
A lockdown in Shenzhen might further disrupt global supply chains because Shenzhen has one of the world’s largest ports. An outbreak in Shenzhen in late spring of last year held up port operations and caused a steep spike in global shipping rates that helped drive up prices for imported goods in the United States and elsewhere.
According to The New York Times, Hong Kong has reported nearly 3,780 Covid-19 deaths and nearly 700,000 new cases since late January. Shenzhen reported 66 new cases in a population of 17 million on Sunday.
Synthetic nicotine will now require U.S. Food and Drug Administration marketing approval. The U.S. Senate approved a $1.5 trillion legislation by a 68-31 bipartisan margin that includes language that changes the definition of a tobacco product to include synthetic nicotine. The Senate sent Biden the omnibus appropriations bill, and a separate bill financing agencies through Tuesday in case it takes time to complete the required reprinting and proofreading of the lengthy omnibus measure. Biden has said he will sign the bill into law.
Credit: f11photo
“We thank leaders in the House and Senate for their partnership in getting this bill done, and the President looks forward to signing it into law,” wrote White House spokesperson Jen Psaki in an email. “The bipartisan funding bill proves once more that members of both parties can come together to deliver results for the American people.”
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 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.
Synthetic nicotine—nicotine that is made in a lab rather than derived from tobacco—has long existed in a legal grey area, and many companies started using it after their natural nicotine products were denied market access by the FDA. Public health groups have been warning that synthetic nicotine e-cigarettes, such as Puff Bar, have grown in popularity among teens while skirting FDA oversight.
The House passed the bill late last night. Leaders in both parties have declared the legislation a win. Democrats boast of the almost 7 percent increase they secured for non-defense agencies, increasing that funding to $730 billion. Top Republicans tout the $782 billion they locked in for national defense, a 6 percent hike from current spending, according to Politico.
Proponents of the policy change refer to it as closing a loophole. Meanwhile critics of the rider contend that, given the well documented flaws and deficiencies in the FDA approval process, the budget rider will likely result in the prohibition of products that former smokers have used to quit smoking and stay off cigarettes. Vaping advocates have been working on overdrive the last three days trying to get the nicotine rule removed form the bill.
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.”
The House passed a $1.5 trillion federal spending bill that includes language that gives the U.S. Food and Drug Administration power over synthetic nicotine. The bill now moves to the Senate and, if passed, will require a presidential signature to become law.
Not long after the 2,700-page spending bill was released early Wednesday and just hours before a scheduled vote, a number of Democrats privately registered their dismay with party leaders, raising the prospect that the entire package could collapse for lack of support. The dispute froze activity on the floor for hours as top Democrats rushed to salvage the spending measure, according to the New York Times.
By midafternoon, Speaker Nancy Pelosi of California notified Democrats in a brief letter that the coronavirus money would be dropped.
If the synthetic nicotine language remains in the bill and clears the Senate, Biden is expected to sign the measure. The rule will then 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).
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.”
