A lawmaker in Israel wants to tax vaping products the same as traditional tobacco cigarettes. Health Minister Nitzan Horowitz is set to propose legislation to combat smoking addiction in Israel, including disposable electronic cigarettes that he says have become popular among Israeli teenagers.
According to the Isreal Hayom, quoting anonymous sources sources states: “There is concern that in the past the decision-making of the political echelon with regards to e-cigarettes was motivated by unprofessional considerations,” the source states. “Horowitz intends to investigate the matter of disposable electronic cigarettes and government policies and restrictions on smoking products … with the consideration of public health alone.”
Credit: Christoph
As part of his initiative, the health minister is looking to raise the tax on vapors to equal regular cigarettes and tobacco; withdraw the special permit that had been granted to newspapers and other written advertising to print cigarette ads; and adopt graphic warnings on cigarette packages – a measure not yet applied in Israel but used in 120 countries worldwide, according to the story.
“The idea to make electronic cigarettes disposable is a sophisticated and dangerous marketing manipulation,” CEO of nonprofit Smoke Free Israel Shira Kislev said. “Because teenagers then think they are not risking getting addicted to cigarettes because their vapor will only last them one time. But the nicotine content makes these e-cigarettes addictive, and in a cruel way, repeated use makes teenagers smoke them more and more.”
A coalition of 23 organizations have written a letter to the U.S. Food and Drug Administration (FDA) to follow the common-sense recommendations of the Small Business Administration (SBA). The SBA had recommended companies seek a court order to allow vaping manufacturers to keep products on the market while their premarket tobacco product application (PMTA) submissions are being reviewed.
Credit: Tanasin
Due to the large volume of PMTAs submitted—the FDA says it received more than 6 million applications— the FDA has stated publicly that it is unlikely that the agency will be able to process all submissions before manufacturers are required to pull their products off the market. All products must be removed from market on Sept. 9, 2022 without FDA approval, according to a court order.
The coalition letter, organized by the Americans for Tax Reform (ATR) acknowledged that FDA promised to exercise discretion in enforcement, stating that “this does not provide the degree of certainty necessary for businesses who have complied with all relevant regulations and have not received authorization due to processing delays by FDA. If an extension is not granted, there could be devastating consequences for businesses, particularly small businesses. Furthermore, any potential reduction in the supply of safe alternatives to tobacco could have a negative impact on public health across the United States and lead to an increase in tobacco-related mortality.”
The letter also argues that there “millions of consumers who depend on ENDS products for their health and thousands of businesses who depend on these products for their livelihood are threatened by this needless bureaucratic uncertainty.” The coalition states that the only way to avert a disastrous outcome for businesses and consumers is for the FDA to obtain a court order allowing it to extend the existing moratorium on enforcement by another year.
“The vaping industry, unlike many others, was created by small businesses, and these same small businesses continue to drive innovation in the market,” the coalition letter states. “Without these entrepreneurs, the vape industry will be consolidated into a few large corporations, causing prices to rise and consumer choice to decrease.”
The full letter and list of signatories can be read here.
The premarket tobacco product application (PMTA) process has been a struggle for vapor industry companies that took on the time, effort and expense to keep their products on the market. During the Tobacco Plus Expo (TPE), Vapor Voice sat down with Blackbriar Regulatory Services (BRS), a firm specializing in helping small-sized to mid-sized companies navigate the regulatory landscape to bring their FDA-regulated product concepts to market, to discuss the lessons it learned while filing 365 PMTAs for its clients. BRS has helped several clients garner acceptance and filing letters from the FDA.
Credit: Coloures Pic
BRS did not exhibit at the TPE. Don Hashagen, VP of business development, and Kristina Rogers, director of marketing and brand management, attended the show to support its partners that were exhibiting. Some of these partners include the Charlie’s Chalk Dust, The Beard and Humble brands. The pair was also testing the waters for how secure other companies felt about their PMTA submissions.
“If they wait until they get a deficiency letter, that’s too late. That’s 90 days,” said Hashagen. “We want to support the industry whether they have worked with us on their PMTA or not. The more people that make it through PMTA, the better it is for everybody in the industry.”
BRS is offering any company that submitted a PMTA a free gap analysis of their submission. Hashagen said that many companies that submitted PMTAs have yet to complete clinical trials, for example, and the FDA has been clear that it’s a requirement for approval. It’s also time-consuming and expensive.
“The other one is perception and behaviors. We’ve got about 45 people that specialize in PMTAs. Now that we’ve seen enough deficiency letters coming through, we have an understanding of how to respond to those letters,” he said. “Our team can read a PMTA and very quickly say, ‘All right, here’s some major issues you’re going to need to attack. Now, you don’t want to wait too long to get started on a deficiency letter. It’s going to take you more than 90 days to remediate.”
Several manufacturers have received filing letters for their PMTA submissions. This is the stage that the FDA will ask a company to respond to questions the FDA has as well as receive deficiency letters. Because the PMTA is a “living process,” BRS can help a company potentially address a known or found deficiency often before a deficiency letter is even issued.
“Submitting your PMTA is really the first step in a very long, lengthy process. You have multiple audits afterwards with people looking into your manufacturing, into registration, into your PMTA, into post-market surveillance … even after you are authorized for marketing authorization,” explains Rogers. “It’s a long year-to-year process. This is just the beginning of something that’s going to last the length of your product lifetime.”
Having an organization like BRS managing a company’s PMTA allows the client to have access to experts that know what’s coming, says Rogers. BRS knows what’s needed to help take a brand and make it successful in the market while complying with regulatory requirements.
“You spend all this money, you get a market authorization, you’re doing well. But four months later, you trip over your own shoelaces because you did something that could hurt your brand from a marketing standpoint … how you positioned it. Maybe your brand is suddenly considered youth-friendly as FDA guidelines change,” said Rogers. “You can be taken off market almost instantly. As this evolves, you want somebody who’s talking to the [FDA] frequently. We’ve built a working relationship with the agency.” Hashagen says the main reason BRS is offering the free gap analysis is because they really want the industry to not just survive but thrive. “We really want to help people,” he said. “This industry is about helping adult smokers quit combustible tobacco for good. That’s really, really important to us.”
Exhibitors react to the industry’s first trade show since the Covid-19 pandemic struck in March of 2020.
By Timothy S. Donahue
The vaping industry has a lot of trade shows and conferences every year. So, when the Covid-19 pandemic struck in March 2020, it was a big change. Gone were face-to-face meetings and the networking opportunities the events offer to business owners. Many businesses saw sales slump and profits nosedive. Coupled with other regulatory requirements, the pandemic caused many businesses to close.
That’s what made this year’s Tobacco Plus Expo (TPE) trade show so special. After being postponed nearly four months, many retailers said they had surpassed their sales goals for the entire show on the first day. TPE attendees said it was a good feeling being able to fist bump clients and talk about the industry in person instead of through a Zoom conference. The TPE felt like the beginning of a much-needed return to normal.
Held May 12–14, an estimated 2,500–3,000 people visited the TPE on the opening day of the three-day event. According to security staff, approximately 4,000–5,000 attended overall. Every morning, several hundred attendees waited at the entrance to see the more 350 exhibitors. The show was moved to May from its typical January date due to the pandemic and was also the first major trade show to be held at the Las Vegas Convention Center (LVCC) since it closed in March of 2020.
Dan Bilzerian (right), owner of the cannabis company Ignite
Even professional poker player Dan Bilzerian, owner of the Ignite cannabis brand, made an appearance. “Honestly, I’m excited to be back,” Bilzerian said. “This industry is really set to take off again.” When asked about Ignite sales at the show during the second day of the event, Bilzerian said the numbers looked good. “We hit our sales target for the show on our first day,” he said. “We’ve had an excellent response.”
Many exhibitors said that the show had exceeded expectations. Rich Zagari, a sales representative for Bantam Vape, said they were unsure of what the show would be like considering it was the first industry trade show in over a year. “We didn’t know what the response was going to be, but there’s a lot of people here,” he said during the second day of the show. “Yesterday was great and today’s already shaping up to be even better. When you’re seeing customers come up to the booth, having conversations and placing orders, it makes a difference. It’s good to be back doing business face-to-face.”Zachary Kestenbaum, VP of sales for The Beard brand, said that while he was hoping for a bit more foot traffic this year, for his company the TPE was more about getting facetime with distributors, vape shops and other industry players. “I enjoy face-to-face sales more than phone sales, anything of that nature,” he said. “I think it’s much better to conduct business outright. In that regard, the show has been a great success.”
Some exhibitors initially questioned whether the show would be able to bring in foot traffic at all. Andy Lucas, director of sales for Ripe Vapes, said with the influx of restrictions, such as the premarket tobacco product application (PMTA) requirements for the U.S. Food and Drug Administration and the recent placement of electronic nicotine-delivery systems (ENDS) under the Prevent All Cigarette Trafficking (PACT) Act, alongside the issues brought about by Covid-19, he was a little hesitant about exhibiting.
“Actually, it’s been pretty good. It’s been more like a traditional show, especially for a big show like this. You got all these organizations with tobacco and the hemp industry, the e-liquid industry; it has really lived up to the hype surrounding its opening,” said Lucas.
Jakob Gutierrez, product specialist for JustCBD, said he was happy to be back in Las Vegas. The attendees were also ready to spend money. While he had hoped for even more buyers to visit the TPE, JustCBD had received more orders by Day 2 of TPE than the company had gotten at the last couple of shows it attended, according to Gutierrez. “People keep stopping by and loving our products,” he said. “People are absorbing it, taking it and just asking us for more. We keep providing high-quality products, and our customers keep coming back.”
There was a noticeable reduction in the number of nicotine vaping companies showing on the floor. The impact of PMTA and PACT Act regulation was evident. There were only an estimated 16–18 e-liquid vendors, including Coastal Clouds, BLVK E-liquid and Fresh Farms. There were an estimated five to seven hardware manufacturers, including Mi-One Brands, Myle, NJoy and Inspire, and most of them produced their own brands.
There was also a noticeable reduction in international participants, said Tony Riva, CEO of TD Distribution Co., the parent to the Hi-Drip e-liquid brand, which was also exhibiting. Normally, there are at least 20–30 exhibitors from China alone; this year, there were only a few Chinese brands present, and the booths were manned mostly by U.S.-based personnel.
“The international community that is normally present at this show just isn’t here this year. That’s obviously due to the Covid restrictions and complications of international travel,” he said. “That’s having an impact on sales, I think. But business is good. We are just trying to navigate the changing regulatory environment and new policies that have been put in place.”
Regulatory concern
Before the show, exhibitors were concerned about what impact the PACT Act would have on show sales. The rule requires a manufacturer to gather data from customers to file the mandatory monthly reports with native, state and local governments disclosing the identity, address and product received for all customers as well as remit any excise taxes owed.
“As a best practice, it’s our priority to collect licensing information upfront from any new customer and we were glad potential buyers came to the show prepared,” said Zagari. “They had copies of these documents on hand or emailed them right away.”While many companies have already stopped using the United States Postal Service (USPS) because the PACT Act prevents the USPS from mailing ENDS products to customers, the rules have not yet taken effect. At the time of writing, the USPS had yet to publish the finalized rule. Lucas said Ripe Vapes had a large following for online sales. However, Ripe Vapes has ended all direct-to-consumer sales because of the PACT Act and now only conducts B2B sales in the U.S. “It was a difficult decision,” he said. “In the end, it was the right one to make.”
Zagari said Bantam plans to ship through USPS until the final rules go into effect. “We are working to identify alternative shipping options, which will help us continue online consumer sales once the USPS final rule is published,” he said. “It’s our goal to ensure our customers always have access to our high-quality, flavor-filled e-liquids that are in compliance with all regulatory requirements.”The PACT Act’s definition of ENDS is so broad that it includes vape-able hemp cannabis products too. JustCBD only sells cannabis products and felt that they were “suckered in” to the ENDS definition, according to Gutierrez. The company has filed an exemption with the USPS, but that exemption will not be considered until after the final rule goes into effect. “It seems like we are jumping through a lot of hoops to sell a legal product that has nothing to do with nicotine or tobacco,” Gutierrez said.
Beyond the PACT Act, TPE exhibitors and attendees remain concerned about the PMTA process and the full impact of FDA regulation on the vaping industry. Numerous companies, including major industry players like Dura Smoke, My Freedom Smokes, Logic and Vape Wild, have gone out of business, merged with other companies or ended all online sales.
Kestenbaum said that as the market condenses and regulation pushes players from the market, naturally sales to the companies that remain would increase. The recent release of the list of manufacturers that have submitted PMTAs has also served a guidance for vape shop owners. Companies cannot now claim they have submitted a PMTA without having done so.
“So many companies were saying, ‘We’re going through PMTA. We’re doing it. We’re doing it,’ and they weren’t. I think we are starting to see many of those companies drop out of the industry, said Kestenbaum. “We’re trying to run everything by the book … I feel like we’ve gotten burned for doing that because there were a lot of companies that were not. The PACT Act, PMTAs, these aren’t all bad. Let’s clear out the lawless, let’s get a little bit more organized and allow the ones doing the right thing to continue.”
Lucas said Ripe Vapes submitted only one PMTA for its VCT flavored e-liquid. The company has a considerable international business, so its other popular flavors, such as Key Lime Cookie, are still available outside the U.S. “Our attorney said, ‘Look, your best chance … the way this is going to go, looking at it from a cost standpoint, take your No. 1 e-liquid and just roll with it,’” said Lucas. “Some of these guys are trying 10, 15 or 20 flavors. They may get it if they have enough money, and there’s a couple of guys in this industry that probably do have enough money.”
Another concern is that the FDA has been taking its time in reviewing PMTAs, according to Lucas. He doesn’t see a path for the regulatory agency to complete reviews on the more than 6 million PMTAs submitted by the 1-year deadline (Sept. 10, 2021).
“We find it kind of hard to believe they’re going to have this done by next year. That’s what my next question is: What happens? Do they give you an extension? I think the industry is going to force them to make some decisions because you’re putting us through this,” explains Lucas. “The submittal alone for us was huge. So, when you’re spending all this money, you want some results. … It’s going to be an interesting thing as that deadline approaches.”
Bantam Vape has received a filing letter for its submitted products, according to Zagari. He said that the company hopes to hear back from the FDA soon but is preparing for the likelihood that the agency will not complete all reviews come September. “We are working to better understand our options and in the meantime, we are continuing to monitor FDA communications and actions.”
TPE 2022 will be held Jan. 26–28, 2022, in Las Vegas.
E-cigarettes have been banned in India since 2019, but the ‘grey’ market continues to grow.
By Vapor Voice staff
There are more than 100 million cigarette smokers in India. The country suffers from over 1 million tobacco-related deaths each year. But Western-style cigarettes account for only a fraction of tobacco consumption in India. According to data from the Global Adult Tobacco Survey (GATS) of 2016–2017, India has the second-largest tobacco-consuming population in the world (China is first). An estimated 267 million Indians use tobacco in some form.
Tobacco also plays a significant role in India’s economy. More than 4.2 million hectares of farmland in India are dedicated to growing tobacco. The government also owns a 28 percent stake in ITC, India’s dominant tobacco company. Currently, there are only 19 smoking cessation centers for the nearly 270 million tobacco users, and there is no national policy to make telemedicine or other medical support available, according to the CDC Foundation.
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. Ministers at the time said the decision aimed at averting health risks related to e-cigarettes. The Indian vaping ban came amid an updated guidance from the World Health Organization (WHO), which encouraged the prohibition of e-cigarettes. India’s ban does not cover the personal consumption of vaping products, although the rule is ambiguous and doesn’t define personal consumption.
Before the vapor ban, many vapers would purchase their products at tobacco shops, known as paanwalas. These shops sold mostly basic 510-threaded vaping devices, low-quality shisha-flavored e-liquids and cheap closed pod systems, according to sources familiar with vaping in India. Shop owners knew little about tobacco harm reduction (THR) and the role vapor products play. A handful of large importers were supplying the shops, and in 2014, ITC even released its own e-cigarette, Eon, that it marketed through the local shops.
India also had a small fraction of vapers, mostly former smokers, that understood the THR concept of vaping and its purpose as a quit smoking aid. “They opened a few shops and were quality conscious. They wanted to help customers stop smoking combustible cigarettes,” said a former vape shop owner, who asked to remain anonymous due to the illegal nature of vaping products in India. “These shops sold mostly high-end brand devices and e-juices from trusted manufacturers. “Almost all of them had online shops and social media presence and nationwide reach, and a few also had brick-and-mortar stores.”
Then came the ban. India’s legal vaping market abruptly stopped overnight. All websites were shut down immediately, sources said. The law, as written, is strict with severe penalties. Initially, all players in the vaping industry in India were terrified. “After some time passed, with little to no enforcement action, the market began to slowly reemerge,” said another former participant in the Indian vape market. “Vendors returned, although in much smaller numbers. The cheap, low-quality vapes are back at the bigger paanwalas. Often these shops do not care what age a customer is when selling tobacco products.”
Amplifying the issue is that most of the employees running the paanwalas do not possess the knowledge to properly educate customers about the usage and maintenance or the pros and cons of vaping products, according to the former vape store owner. “This market needs restrictions and regulations. The less educated, less privileged masses perceive vapes as just another way to exhale dense clouds,” he said. “Also, this market is less afraid of the law because, in most places, the local police have arrangements with small stalls/shops/kiosks of all kinds, where they collect a weekly fee (called a hafta) to look the other way when they flout rules.”
Vaping products are even being displayed on some store shelves now in India. 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. Most of the specialists are discerning and do not entertain new customers without a reference from a known customer.
“The black market is not large at present. However, as India has a huge population (1.4 billion), even ‘not large’ can be sizable. Unofficial estimates say India had a million vapers before the ban, and there are still approximately 200,000 to 300,000 vapers in the country,” the former market player said. “The penalty for selling vapes to anyone—even an adult—is up to three years in prison and fines up to INR500,000 ($6,700). You will be amazed to know that the penalty for selling [combustible] cigarettes to a minor is only INR200 ($2.75) with no imprisonment. How is this allowed?”
According to Anupam Manur, an assistant professor of Economics at the Takshashila Institution in Bengaluru, banning vapor products has caused the government to lose all controls over the products.
“If a seller is selling an illegal product anyway, what difference would the age of buyer make—whether it is above or below 18 years?” Manur wrote in Business Insider. “Furthermore, since it is illegal, would it make sense for a seller to ensure product quality and safety? There have been numerous reports of substandard and potentially dangerous products being sold in India on the black market,” he said. “It would behoove the government to learn the lessons from the U.K. and the U.S. and choose a harm reduction approach, which would involve developing a regulatory plan for e-cigarettes that maximizes smoking cessation among adults while limiting youth uptake.”
The WHO was more enthusiastic about India’s approach, even giving Indian Health Minister Harsh Vardhan a top award for pushing the policy. Vardhan is a former WHO advisor and was until recently the chair of WHO’s executive board, and hence deeply steeped in the WHO’s anti-THR stance. “His leadership was instrumental in the 2019 national legislation to ban e-cigarettes & heated-tobacco products,” tweeted the WHO secretary-general, Tedros Ghebreyesus, after announcing the award. “Thank you, minister!”
Samrat Chowdhery, director of the Association of Vapers India (AVI) and president of the International Network of Nicotine Consumer Organizations, a global consumer advocacy group comprising 40 national and regional bodies, does not expect anything to change in India’s vapor market any time soon.
Samrat Chowdhery
Politics aside, the negative impact of the ban will become clear in time, he says, adding that the nations that have embraced vaping products as THR tools are reaping the rewards of accelerated smoking declines after allowing (and in some cases encouraging) smokers to make the switch.
Countries that have experienced lower health costs because they have embraced vaping products and invested in THR may one day offer enough evidence to force a shift in India’s policy toward e-cigarettes, according to Chowdhery. “Currently, Thailand is the only other major country in Asia that bans safer nicotine inhalation alternatives, and it is worth noting along with India, it too has a state-run tobacco enterprise which is facing competition from replacement products,” said Chowdhery. “China is moving toward regulation too. This ‘ban group’ is likely to shrink further over time.”
If electronic nicotine-delivery system products continue to be available in some form in India, the number of ex-smokers who have switched will continue to grow, according to Chowdhery. With the ban slowing this transition and potentially even halting it, he believes at some point the vaping ban will create its own critical mass to call for a rethink.
“Another possibility is that the courts intervene and either discard the law altogether or create caveats which render the law infructuous. Such challenges require substantial financial backing, which established commerce in this field can support,” said Chowdhery. “The courts have so far been reluctant to delve into this issue because of the emotional ‘think of the children’ pitch attached to it, but over time, rationality and pragmatism will win over. A country with this large of a tobacco problem cannot for long ignore effective measures to reduce related mortality and morbidity.”
22nd Century Group has signed a definitive agreement to restructure its strategic investment in Panacea Life Sciences in line with the ongoing development of 22nd Century’s strategic partnership network.
Under terms of the agreement, 22nd Century’s existing $7 million note in Panacea will be exchanged for ownership of Needle Rock Farms, located in a Colorado hemp/cannabis growing location and valued at $2.2 million. The company will also receive a new $4.3 million note and $500,000 in Panacea equity. The new note is backed by a mortgage on the Panacea Life Sciences operations building located in Golden, Colorado, appraised at $10.7 million. Panacea will retain certain farm assets under its own nameplate of PANA Organic Botanicals at Needle Rock.
Also under the agreement, $7 million in Panacea Life Sciences Series B Preferred Stock held by 22nd Century will be converted into 91 million shares of Exactus as part of a business combination transaction via share exchange with Panacea under which Panacea will become publicly traded. The transaction is expected to be immediately accretive to 22nd Century.
“This exchange is an exciting leap forward for 22nd Century as we advance our upstream value chain strategy to bring highly disruptive hemp and cannabis plant lines to market. It is also highly attractive to 22nd Century on a financial basis, creating immediate value, asset-backed future value and potential future liquidity from an existing investment,” said James A. Mish, CEO of 22nd Century Group, in a statement.
“Needle Rock Farms is a world-class farming operation in a prime growing location where we already have plants in the ground toward our goal of revenue recognition from our cannabis franchise in the second half of 2021. We will also retain access to Panacea’s extraction, purification and testing equipment located in Golden, Colorado, for the benefit of our customers.”
“Rapidly growing demand means that mass cultivation is quickly becoming the critical challenge in the cannabis industry. Most existing plant lines do not exhibit the stable genetics, predictable yield or specific composition of cannabinoids required to fully unlock the value of the cannabis industry,” said Mish. “22nd Century can provide the stable, predictable plant solutions required to achieve true commercial scale and do so in as little as two years versus 7 to 10 years through traditional processes.”
Harm reduction advocates worry about the effects on vapers when the USPS implements PACT Act requirements for ENDS.
By Vapor Voice staff
The United States Postal Service (USPS) has delayed the implementation of a requirement to place electronic nicotine-delivery systems (ENDS) under the same shipping rules as combustible cigarettes. As of this writing, the USPS has not published its final rule for mailing ENDS products in the Federal Register. The USPS has stated that the rules will take effect immediately when the final rule is published.
The rule has been delayed because the USPS is still determining how it will handle the broad definition of ENDS set by the U.S. Congress and how the USPS will process and determine eligibility for companies seeking an exception to the Prevent All Cigarette Trafficking (PACT) Act rules. For example, CBD vaping devices fall under the ENDS definition, but it is believed that it was not the intent of Congress to ban the mailing of hemp products. No date has been announced for when the USPS intends to publish the final rule.
Emily Burns, of counsel for the Green Light Law Group, noted that while the USPS could have banned vaping products altogether as part of the new rule, the USPS is now taking time to revisit the implications of an all-encompassing prohibition on shipments of vaping products. She wrote in the firm’s blog that the USPS must not exceed its own legal authority under the PACT Act by regulating vaping products that fall outside the definition of tobacco product as such a rule could be subject to challenge by various industry groups.
Credit: Aleksandr Yu
“If lawmakers intended to truly change the way the federal government defines ENDS to include nontobacco and non-nicotine products, it is rational to assume that Congress would have also amended the [Tobacco Control Act] to allow the FDA to regulate these other substances. The strategy moving forward should be to encourage USPS to specifically focus on the ENDS market … anything done in relation to cannabis or hemp should be seriously challenged by the industry.”
The USPS confirms Burns’ concerns and has stated that the process is turning out to be more complicated than just ending all vape mail of vapor products. On April 19, the USPS issued guidance for exemptions to the requirements for mailing all vapor products, including cannabis. The USPS was inundated with exemption applications, none of which will be addressed until the final rule is published, according to the USPS.
The USPS refers to possibly exempting cannabis products in its guidance. Other exceptions include intrastate shipping within Alaska and Hawaii, shipments between businesses engaged in tobacco product manufacturing, distribution, wholesale, export, import, testing, investigation or research, shipments by individuals for noncommercial purposes (including return of goods to manufacturer), limited shipments by manufacturers to adult smokers for consumer testing, and limited shipments by federal agencies for public health purposes.
For cannabis-based product exemptions, the guidance states that “mailers must retain, and prepare to make available upon request, records establishing compliance with all applicable federal, state and local laws pertaining to hemp production, processing, distribution and sales, including the [2014 Farm Bill] and [2018 Farm Bill].” The guidance says such records may include “laboratory test results, licenses and compliance reports.”
Burns stated that the USPS guidance also indicates that cannabis products with greater than 0.03 percent THC would be nonmailable if they are deemed to be drug paraphernalia for purposes outlined under the Controlled Substances Act (CSA), which includes a federal ban on mailing drug paraphernalia that already exists outside of the PACT Act. However, the CSA prohibition on drug paraphernalia does not apply to “any person authorized by local, state or federal law to manufacture, possess or distribute” such items.
“In the case of medical and recreational cannabis states that have removed criminal statutes penalizing drug paraphernalia used to consume cannabis, anyone who is shipping from one legalized state to another would technically fall under the paraphernalia definition exception, thus providing a legal basis for exception from the PACT Act requirements,” Burns states.
The move to place ENDS under the PACT Act has been heavily scrutinized. Several harm reduction advocates say the new rule will bring unintended and deadly consequences. During a seminar sponsored by Hall Analytical in mid-May titled “PMTA and Beyond: A Global Outlook on ENDS Regulatory Requirements,” David Lawson, CEO of Inter Scientific, said that placing vaping products under the PACT Act only serves to benefit large tobacco companies and could push former smokers who shop for vaping products online back to combustible cigarettes.
“If you’re a large tobacco company in the U.S., you most likely sell directly to the likes of Walgreens and these kinds of stores. They then sell them to consumers. Many of the independent vaping companies and manufacturers, they sell online. The PACT Act doesn’t really impact store sales. It only impacts online sales,” explains Lawson. “So a company who relies entirely on online sales may have gone through the [submitting a premarket tobacco product application (PMTA) to the U.S Food and Drug Administration] process. They’re now risking the potential for not being able to ship to their clients at all. I think from that perspective, it’s quite negative and damaging.”
Lawson said that what lawmakers failed to realize when moving ENDS under the PACT Act is that online retail has the advantage of being able to do more thorough ID checks than a local mom-and-pop shop. A credit card is needed for an online purchase, for example, along with a photo ID. At a brick-and-mortar store, a youth simply needs a fake ID and cash. “It’s much easier to do detailed checks on people online than it is to do them in store,” he said. “It is a growing concern for the U.S., the ability of youth to get access to ENDS, but I think, from the experience I’ve had, from what I’ve seen from our clients in the U.S., the kids aren’t getting the products online.”
Credit: Michael Vi
Another consequence of the PACT Act is that when adult consumers who purchase vaping products online can’t get their products anymore, they may go back to smoking combustible cigarettes, which are more readily available in local stores, according to Lawson.
“In the U.S., if you’re buying a specific product online, certainly it’s not going to be available anymore. You have the option there to try and find an alternative brand or risk going back to cigarettes. I think there’s a huge risk impact that will result in adult smokers who are currently vaping going back to smoking again, which is, obviously, not good for public health,” said Lawson. “I don’t personally see the value of the PACT Act. I think it’s kind of a step backwards. It does risk impacting public health negatively.”
While the industry continues to wait for the USPS to publish its finalized rule and what a PACT Act exemption might entail, Burns recommends that concerned business owners “reach out to a regulatory attorney about the compliance process ahead of time in preparation of the forthcoming regulatory changes.”
Coupled with the requirement to submit premarket tobacco product applications to the FDA, the PACT Act and flavor bans, ENDS regulations have become overly stringent, and the complex rules can turn smokers away from the idea of switching to ENDS products, said Lawson, especially when that regulation doesn’t allow for clarification of the science behind vaping products.
“The issue here really is around all this information from the perspective of science, perhaps. When ENDS first entered the market back in 2006 … there was a lot of bad science and bad data generated. When you generate a bad set of data and it becomes publicly available, people don’t necessarily question and interpret how the information has been generated or the validity of that data,” said Lawson. “I think there’s a huge risk with the media and with the interpretation of science that it can certainly switch people away from using ENDS.”
There are other regulatory challenges coming too. The Tobacco Tax Equity Act Of 2021, a bill that would establish the first federal e-cigarette tax, increase the traditional tobacco tax rate and close tax loopholes, is currently making its way through the U.S. Senate. The rule would follow the lead of 21 states, and Washington, D.C., that have set their own state taxes on vapor products by setting a federal tax on ENDS products.
Senator Dick Durbin, who sponsored the bill, said tobacco-related disease accounts for one out of every five deaths in America. He did not mention that there has never been a reported death associated with vaping of legal nicotine products.
“Data shows that the most effective strategy to prevent children from starting this deadly habit is to price it out of their range. This bill would help reduce tobacco and e-cigarette use by ending loopholes that the industry has exploited to target our children,” he said in a statement. “If America can kick its nicotine addiction, it would go a long way to improving our public health for generations to come.”
The repercussions of the USPS vapor mail ban on the vaping industry will not be realized for some time. While the PACT Act requirements have forced many businesses to close, the vapor industry is used to dealing with a great amount of uncertainty. With numerous regulatory hurdles on the horizon, it does not seem like that is going to change any time soon.
The Hemp Industries Association (HIA) announced support for the legal position that Delta-8 THC, along with all other hemp-derived cannabinoids, were federally legalized by the 2018 Farm Bill. The group cites a legal opinion drafted by attorneys Rod Kight and Philip Snow of Kight Law.
Credit: Elsa Olofsson
“It is clear that the 2018 Farm Bill, which removed hemp from the Controlled Substances Registry, directed that hemp be regulated as an agricultural product, and defined hemp to include its cannabinoids and all tetrahydrocannabinols from hemp, is the governing law for the hemp industry,” the HIA states in a release. “History has shown that natural cannabinoid consumption does not present public health and safety risks like those from alcohol and tobacco, but researchers have only begun to explore the full range of potential hemp-extracted compounds and their various properties. What is needed is a regulatory framework for their production that prioritizes consumer safety while being grounded in science.”
The HIA states that prohibition is a failed concept. It only exacerbates the threat to consumers created by unregulated markets, and is antithetical to the spirit of free enterprise. The HIA wants state lawmakers to eschew ineffective bans in favor of partnering with the hemp industry to craft hemp policy that safely opens markets, fosters innovation, spurs investment, and creates valuable jobs.
The HIA calls on industry leaders to build consumer confidence and expand the market for hemp cannabinoids by adopting the highest quality and potency testing standards for Delta-8 THC and similar minor cannabinoids, by marketing those products responsibly through use of transparent and detailed labeling, including potency data and warnings against consumption by minors.
“Businesses, farmers, and consumers all deserve regulations that support the exploration of the hemp plant’s full potential. This isn’t just about one minor cannabinoid —the list is over a hundred already and growing,” said Jody McGinness, HIA’s Executive Director “Fortunately, the industry has all the expertise legislators could need, and those manufacturing leaders and scientists are engaged and ready to help create productive policy solutions.”
The HIA’s Cannabinoids Council, a newly-formed member body focused on national priorities distinct to the cannabinoids sector of the hemp industry, has identified safe market expansion as a core focus for its early efforts. The stance on Delta-8 THC and other hemp-derived cannabinoids is in line with the HIA’s history of vigorously defending the legality of all hemp products, and supporting the growth of industries utilizing all parts of the hemp plant, according to the release.
The group, a trade association composed primarily of businesses and farms in the hemp industry, is currently engaged in two lawsuits in response to the DEA’s Interim Final Rule on the 2018 Farm Bill that was issued in August of 2020, creating a threat to extractors and manufacturers of hemp cannabinoids. This is the fourth time the association has gone to court to protect hemp since forming in 1994.
New research published today in Internal and Emergency Medicine, provides the first real-world evidence that people switching from cigarettes to exclusive use of glo, BAT’s flagship tobacco heating product (THP), can significantly reduce their exposure to certain toxicants and indicators of potential harm related to several smoking-related diseases compared with continuing to smoke.
The results, recorded at six months of a 12-month study, showed that switching completely to glo resulted in statistically significant changes across a range of “biomarkers of exposure” (BoE), and indicators of potential harm, known as “biomarkers of potential harm” (BoPH), compared with continuing to smoke.
For most biomarkers measured, the reductions seen in people using glo were similar to those in participants who stopped smoking completely.
Based on the toxicants measured, glo users showed a:
Significant reduction in a biomarker for lung cancer risk
Significant reduction in white blood cell count, an inflammatory marker indicative of cardiovascular disease risk (CVD) and other smoking-related diseases
Improvement in HDL cholesterol associated with reduced risk of CVD
Improvements in two key indicators of lung health
Improvement in a key indicator of oxidative stress, a process implicated in several smoking-related diseases, such as CVD and hypertension
“These are exciting results as they allow us to understand the potential for reduction of risk that switching completely to glo can deliver,” said David O’Reilly, director of scientific research at BAT, in a statement. “The study shows that smokers switching to glo can reduce their exposure to certain toxicants, which reduces their risk of developing certain smoking related diseases.
“To have shown a significant reduction in measures of BOPH, some comparable to quitting completely, is very encouraging and provides further scientific substantiation of the harm reduction potential of glo and how it supports our ambition to build A Better Tomorrow by reducing the health impact of our business.”
A new study by Queen Mary University of London, published in Addiction, shows that e-cigarettes are more effective in achieving long-term smoking reduction and cessation than nicotine-replacement therapies (NRT).
The study randomized 135 smokers who had been unable to stop smoking with conventional treatments into two groups—one received an eight-week supply of their choice of NRT and the other received an e-cigarette starter pack with instructions to purchase further e-liquids of their choice of strength and flavor. Products were accompanied by minimal behavioral support.
After six months, 27 percent of those in the e-cigarette group had reduced smoking by at least half compared to 6 percent in the NRT group. Of the participants in the e-cigarette group, 19 percent had stopped smoking altogether versus 3 percent in the NRT group.
“These results have important clinical implications for smokers who have previously been unable to stop smoking using conventional treatments,” said Katie Myers Smith, lead researcher and health psychologist, in Eurasia Review. “E-cigarettes should be recommended to smokers who have previously struggled to quit using other methods, particularly when there is limited behavioral support available.”
“This study shows e-cigarettes can be a very effective tool for people who want to stop smoking, including those who’ve tried to quit before,” said Michelle Mitchell, CEO of Cancer Research U.K., which funded the study. “And research so far shows that vaping is far less harmful than smoking. But e-cigarettes aren’t risk free, and we don’t yet know their long-term effects, so people who have never smoked shouldn’t use them.”
