Tag: e-cigarettes

  • Into Indonesia

    Into Indonesia

    Credit: Daxiao Production

    Chinese e-cigarette manufacturers are expanding into Indonesia to better serve markets.

    By Yutong Song and Alan Zhao

    China’s rules for the vaping industry are stringent. They do, however, allow leniency for most exports. There is one rule, though, that can make shipping product to some countries nearly impossible: China’s regulations state that all products produced for export must comply with the regulations and laws in the destination country, according to 2FIRSTS, a vaping industry vertical media firm. If a country does not regulate e-cigarettes, China’s rules for vaping products would apply to those exports, including bans on flavors and synthetic nicotine.

    To better serve countries that have not yet created regulations for electronic nicotine-delivery system products, manufacturers are opening factories outside of China. Many of those companies are moving into Indonesia where there are more than 70 million combustible cigarette smokers. The preference of Chinese manufacturers for Indonesia is also evident from a set of recent news headlines:

    • “Jinjia Group’s manufacturing base in Indonesia to provide integrated e-cigarette services.”
    • “Smoore Technology Indonesia (STI), a subsidiary of one of the largest e-cigarette manufacturers, has invested $80 million to establish e-cigarette factories in Indonesia.”
    • “The Indonesian factory of Zhijing Precision, an e-cigarette assembly supplier, is to be operational by 2022.”

    The cost factors, such as land and labor, make Indonesia the first choice for e-cigarette companies setting up abroad, but the country has more to offer. Garindra Kartasasmita, secretary general of the Indonesian Vapor Entrepreneurs Association, mentioned in his keynote speech at the IECIE Vape Show that the Indonesian vaping market has been growing since 2013, with an annual rate of 50 percent except for the year 2021, when it shrank by 7 percent due to the Covid-19 pandemic. It is expected to rebound to 50 percent growth in 2022.

    Integration of Production and Sales

    Indonesia is ripe for helping to grow vaping businesses and boost the harm reduction potential of vaping products. One major advantage of moving e-cigarette production into Indonesia is the ease of integration and sales offered by the country’s large population. With 280 million people, Indonesia is the world’s fourth most populous country, accounting for 40 percent of all people in Southeast Asia. Moreover, Indonesia has 70.2 million smokers, which translates into a smoking rate of 34 percent.

    The presence of so many nicotine consumers means e-cigarettes produced in Indonesia could also be sold domestically. Indonesia’s regulatory environment is conducive to the marketing of nicotine products that present lower risks than combustible cigarettes. Indonesia is the only country in Southeast Asia that allows tobacco advertising on television and in the media. It also has a place for e-cigarette bloggers and cross-category blogging, such as beauty and skin care. Indonesia has the second-highest number of posts on Instagram sharing vaping and related devices among all countries.

    E-cigarette brands can be imported and sold in Indonesia only if they are recommended by the country’s National Agency of Drug and Food Control (part of the Ministry of Health) and the Ministry of Industry. Additionally, the products must be certified by the Indonesian National Standard. The policies are a positive for Chinese e-cigarette manufacturers.

    Commenting on Smoore’s plant in Indonesia, Bahlil Lahadalia, Indonesia’s investment minister and director of the Investment Coordinating Board, publicly stated, “We need cooperation, we need jobs, we need opportunities that will make our brothers owners of our country.” And Clayton Shen, president of Smoore Indonesia, expressed his gratitude for the support of the Indonesian government, including the tariff-free incentives granted by the Ministry of Investment for the company’s much-needed machinery that needed to be imported.

    Challenges Ahead

    There are some challenges in the Indonesian market, however. Although the Indonesian market represents a large pie for Chinese manufacturers, it is not easy to navigate the market. A well-known Chinese e-cigarette manufacturer intending to build a factory in Indonesia revealed to 2FIRSTS that logistics is a problem for manufacturers, and currently no good solution is available.

    For example, if the end products are filled and assembled in China and then sent to Indonesia, the amount of time the products could be held at customs is unpredictable. “I had a batch of goods that arrived at customs the end of last month, but they are still in customs as of the 20th of this month,” the manufacturer said. “If it was assembled in Indonesia and sent from the Indonesian factory, the time difference in delivery is not much different from if it were delivered from China.”

    There is also a lack of e-cigarette machinery. Another vaping product manufacturer told 2FIRSTS that “there’s a critical lack of tools and machinery to keep pace with the production lines. Should factories be built here, machinery must be transported from China, which is a critical problem to tackle. It’s a misconception that the only shortage we would face is raw materials.”

    Credit: Donvictori0

    There is also a “workers’ gap” that can often create staff training and production concerns. In addition to overcoming cultural and geographical challenges when training local workers, it’s difficult to have the workers adapt to the Chinese style of work, which is very dedicated and focused on teamwork. An insider told 2FIRSTS that some workers have a “casual attitude to being late.” He said that he had to create numerous incentives to discourage employees from being late for work and/or going home early. “This is very different from the Chinese work habits,” he said.

    Migration or Spillover

    Shenzhen is considered the vaping capital of the world. Located just north of Hong Kong, the city designs and manufactures an estimated 90 percent of the world’s vaping and e-cigarette devices. There are more than 1,000 factories and thousands of support companies that form the supply chain throughout Guangdong Province and the rest of China.

    A joint report from the E-Cigarette Professional Committee of the China Electronics Chamber of Commerce and 2FIRSTS anticipates the global e-cigarette market to grow by 35 percent in 2022. The total market is expected to exceed $108 billion. In 2021, China’s total e-cigarette exports were $19.8 billion and were expected to reach $26.7 billion in 2022. The expansion of China’s e-cigarette industry from Shenzhen to Indonesia can more accurately be described as “spillover” rather than “migration.”

    Just because Shenzhen’s e-cigarette manufacturing hub status is unshakable in the short term does not mean that the global manufacturing layout is cast in stone. In fact, over the past five years, the country’s e-cigarette industry has spilled from the city into China’s Greater Bay Area. We have seen spillover from Shajing of the Bao’an District of Shenzhen to the Dongguan area and in between.

    This spillover has not affected the development of China’s electronic cigarette industry, however. During the same time, there was also a period of rapid industrial growth and improvements on the supply chain side of the industry.

    In a recent interview, 2FIRSTS co-founder and Chief Operating Officer Echo Guo said that years of development not only granted the Bao’an District of Shenzhen a number of e-cigarette enterprises but also brought together supporting supply chains, including industrial design, molds, batteries and other essential needs for manufacturing vaping products. “Here to there is a ‘two-hour traffic circle’ within the whole e-cigarette industry, with all of its subbranches cooperating closely,” said Guo. “Even when the manufacturers and customers exchange new ideas, it would take less than two hours to get a prototype ready.”

    The spillover of China’s e-cigarette industry to Indonesia can also be seen as the absorption and utilization of manufacturing resources by China’s e-cigarette industry, which has broken the boundary of China’s Greater Bay Area and extended to a broader region of the Asia-Pacific. The entire region will now have the opportunity to create greater economic success through the growth of the e-cigarette and vaping industry.

  • The Long Road

    The Long Road

    The IQOS heat-not-burn brand remains one of the most popular products in the category.

    By Norm Bour

    For those who have been in the nicotine industry for more than a few years, the IQOS saga is an amazing story of the ups and downs and volatility of the vapor market. If there is a real-life example of a “killer app,” IQOS changed the direction of vaping and introduced the concept of “heat-not-burn.”

    First launched in Italy and Japan in 2016, IQOS was initially shot down by the U.S. Food and Drug Administration, which has been the regulatory agency’s tendency since it received the authority to regulate vaping products. Since the FDA started soliciting and accepting premarket tobacco product applications, a long and arduous approval process, it has approved just a handful of products and cost the industry hundreds of millions of dollars and countless hours of legal work and accounting.

    IQOS didn’t find the process any easier.

    Owned by Philip Morris International, which has billions of dollars to spend on new technologies and employs who knows how many well-connected lobbyists, none of that made a difference. Since the company has an international footprint, PMI could focus on greener pastures and jurisdictions with less challenging regulations, so the company put its efforts on “testing” IQOS outside the U.S., where it was generally well received.

    PMI built its first factory in Italy, and after the initial tests in Italy and Japan proved successful, it introduced IQOS in the U.K. Over the years, PMI has partnered with several international companies and marketed IQOS under a variety of names. However, the U.S. market proved to be more challenging.

    In 2020, however, the FDA agreed that IQOS “significantly reduces exposure to harmful or potentially harmful chemicals,” and PMI launched the product in the U.S. that year. After launching IQOS in a handful of states and gaining a single-digit share of the overall market, PMI suddenly found the door slammed shut on IQOS by a copyright infringement claim by BAT, the U.K.-based parent company of Reynolds American Inc (RAI).

    In September 2021, the International Trade Commission (ITC) upheld an initial determination from May 2021 that IQOS infringed on two RAI patents. The ITC barred PMI’s then-partner, Altria Group, from importing PMI’s IQOS 2.4, IQOS 3 and IQOS 3 Duo products into the U.S.

    Following the ITC ruling, PMI stated, “At the present time, we do not expect to have access to IQOS devices or Marlboro HeatSticks in 2022. However, we remain focused on returning IQOS to the market as soon as possible. Our teams are actively working on reentry plans, and we expect to be ready to bring IQOS back to U.S. consumers when available.”

    In order to get its tobacco-heating device back on U.S. store shelves, in early 2022 PMI announced its plans to manufacture IQOS in the United States. In October 2022, PMI agreed to pay Altria Group approximately $2.7 billion for the exclusive U.S. commercialization rights to the IQOS tobacco-heating system effective April 20, 2024.

    “We remain committed to creating long-term value through our vision,” said Altria CEO Billy Gifford in a statement. “We believe that this agreement provides us with fair compensation and greater flexibility to allocate resources toward ‘moving beyond smoking.’”

    In an interview with Bloomberg, PMI CEO Jacek Olczak said the company had planned to manufacture IQOS in the U.S. all along. “From the very beginning of us going to the FDA, we had in mind that IQOS would one day not only be sold in the U.S. but manufactured there, if you take into consideration the size of the market and the opportunity for IQOS,” he said. “It’s just happening sooner because of the ITC decision.”

    In July 2020, the FDA authorized PMI and Altria to market IQOS with certain modified-exposure claims, giving the company a leg up over its rivals. PMI has not specified where it will be manufacturing IQOS but said it plans to sell IQOS in the U.S. again in the first half of 2023.

    Meanwhile, overseas, specifically in Europe, IQOS stores are some of the most beautifully designed tobacco shops in the world. The products are available in 68 international markets, and PMI claims that “13.5 million adult smokers have made the switch from tobacco.”

    PMI’s heated-tobacco products (HTPs) have been launched in key cities in Albania, Andorra, Armenia, Aruba, Austria, Bahrain, Bosnia and Herzegovina, Bulgaria, Canada, Canary Islands, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Estonia, France, Georgia, Germany, Greece, Guatemala, Hungary, Iceland, Italy, Israel, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, Lebanon, Latvia, Lithuania, Malaysia, the Maldives, Mexico, Moldova, Monaco, Montenegro, Morocco, the Netherlands, New Zealand, North Macedonia, Norway, Palestine, the Philippines, Poland, Portugal, Reunion, Romania, Saudi Arabia, Serbia, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, the United Arab Emirates, the United Kingdom, Uzbekistan, and in some duty-free shops.

    PMI has marketed several HTPs under its IQOS brand, and the most popular versions today use “blade heating technology,” a proprietary system for its HEETS, or HeatSticks. That overall methodology encompasses several versions of IQOS.

    The latest generation of IQOS, ILUMA, was released in 2021 and uses induction to heat the tobacco instead of the blade technology and requires no cleaning. These devices use specific heated-tobacco units called Terea Smartcore Sticks.

    In 2022, PMI launched Bonds by IQOS, along with its compatible tobacco sticks, Blends, in a pilot market in the Philippines. The company intends to further commercialize the product into 2023. Equipped with “bladeless” resistive external heating technology, Bond emits 95 percent less harmful chemicals compared to cigarettes, according to PMI.

    “Bonds by IQOS represents another step forward in our ambition to replace cigarettes with innovative, science-based, smoke-free alternatives,” said Olczak. “We know that no single smoke-free product will appeal to all adult smokers. Providing a range of alternatives to continued smoking—with a variety of taste, technology, usage and price options—is imperative and helps us to address a range of preferences as diverse as adult smokers themselves—ultimately encouraging them to leave cigarettes behind.”

    PMI’s ambition is that by 2025 at least 40 million PMI cigarette smokers who would otherwise continue to smoke will have switched to smoke-free products. Furthermore, the company’s aim is that more than half of its net revenues will come from smoke-free products by 2025.

    In 2018, IQOS opened its first “boutique store” in one of the most fashionable, popular areas of Sofia, Bulgaria.

    “I’ve been here since we opened, and it was a madhouse back then,” said the store manager, who asked to remain unnamed. “Many smokers, and even nonsmokers, had heard about the innovative smoking products and were looking for ways to quit smoking. Here in Bulgaria, we have the worse percentage of smokers in all of Europe, and even though it’s dropped, the numbers are between 30 [percent and] 40 percent depending upon age segmentation.

    “Even now, four years later, many tourists visiting this area are shocked to find a store like this. Most of them are current or past smokers and are used to seeing small, ugly tobacco shops, so seeing such a classy place as this excites them.”

    In November 2002, PMI launched its IQOS Iluma Prime at Dubai Duty Free. The appearance of IQOS Iluma Prime in Dubai International Airport terminals 1 and 3 follows the initial market launch in Japan and Switzerland duty-free in 2021.

    “The launch of the IQOS Iluma Prime, our most refined and advanced device yet, in Dubai Duty Free further demonstrates our constant commitment to delight our legal-age consumers in travel retail with our most premium and stylish product range,” PMI vice president of Duty Free Edvinas Katilius said during the Dubai opening.

    The electronic nicotine-delivery systems road is a rocky one, and it is difficult to predict what innovation may be around the next corner. For IQOS, however, market growth is on the horizon.

    Norm Bour is the founder of VapeMentors and works with vape businesses worldwide. He can be reached at norm@VapeMentors.com.

  • BAT Brings Flavor Ban Fight Against EU to Irish Court

    BAT Brings Flavor Ban Fight Against EU to Irish Court

    Credit: Promesa Art Studio

    One of the largest tobacco companies in the world has initiated High Court proceedings against the health minister and attorney-general in Ireland.

    BAT, the owner of the Irish business PJ Carroll, is seeking to bring a judicial review against a decision by the European Union to ban flavored heated tobacco products (HTPs).

    The ban, first proposed by the European Commission in June, took effect last month. The case is being taken by PJ Carroll and Nicoventures, another BAT subsidiary that produces next-generation tobacco products, according to The Times.

    The European Union on Nov. 3 published the directive officially banning flavors in heated tobacco product throughout the Union.

    The publication followed the end of the scrutiny period on Oct. 29, during which neither the European Council nor the European Parliament raised objections to the ban.

  • U.S. and European Cannabis Laws are Changing

    U.S. and European Cannabis Laws are Changing

    Credit: Fresh Ideas

    By Vapor Voice staff

    Marijuana laws are always changing across the globe. After elections in the United States, more states have had voters decide on the legality of marijuana in their state. Rules in Europe are changing more slowly, but many countries are becoming more accepting of cannabis regulation.

    Several U.S. states had recreational marijuana on the ballot in 2022. Maryland and Missouri became the 20th and 21st states, respectively, to legalize marijuana for adult recreational use in November, but cannabis reform efforts met defeat in Arkansas, North Dakota and South Dakota.

    Maryland voters approved a constitutional amendment that legalizes recreational marijuana for people aged 21 and older. It will go into effect on July 1, 2023, and allow possession of 1.5 ounces or two plants. Possession of small amounts of marijuana was already decriminalized in Maryland. Under the amendment, those previously convicted of cannabis possession and intent to distribute will be able to apply for record expungement, according to media reports.

    Missouri voters ended prohibitions on marijuana in the state and allowed personal use for those over the age of 21. It will allow for personal possession of up to 3 ounces and allow individuals with marijuana-related nonviolent offenses to petition for release from prison or parole and probation and have their records expunged.

    North Dakota voters rejected a citizen-initiated ballot measure that aimed at allowing the use of marijuana in “various forms” for those who are at least 21 years old. It would have allowed marijuana possession of up to an ounce and all marijuana to be tested in a facility “for the potency of products and the presence of pesticides” and subject to random inspection.

    South Dakotans rejected legalizing cannabis in the state too. Legalization for recreational marijuana use had passed in South Dakota in 2020, but the results were nullified by state courts. According to the proposed 2022 ballot measure, marijuana possession of up to an ounce would have been legal. It also would have legalized possession of marijuana paraphernalia, use and distribution.

    Additionally, Arkansas voters rejected a constitutional amendment that would have allowed cannabis possession and recreational consumption by adults as well as the sale by licensed facilities. Had it passed, cannabis possession of up to an ounce would have been legal, and some tax revenue from marijuana sales would have contributed to funding law enforcement.

    In Europe, many experts expect most countries to legalize cannabis in some way over the next 20 years to 25 years. Complicating the process is that Europe, like the U.S., currently has a patchwork of marijuana laws. Italy, for example, requires its army to grow marijuana for the country’s medical program. Switzerland is launching its first legal recreational program in Basel. And the Netherlands is only now authorizing the country’s first legal cannabis cultivation.

    In Germany, Health Minister Karl Lauterbach presented a cornerstone paper on planned legislation to regulate the controlled distribution and consumption of cannabis for recreational purposes among adults. Acquiring and possessing 20 grams to 30 grams of recreational cannabis for personal consumption would also be made legal. The coalition government struck an agreement last year to introduce legislation during its four-year term to allow the controlled distribution of cannabis in licensed shops.

    The Czech Cabinet is considering a draft plan to establish a regulated recreational cannabis market, according to Politico. A final proposal is expected in March, and it would go into effect in 2024 if enacted, Radio Prague International reports. Medical marijuana has been legal in the country since 2017. France has been experimenting with medicinal cannabis since 2021. Malta just passed a law allowing a person to carry 7 grams of cannabis. Finland has also recently taken small steps toward legalization. In 2019, a public initiative collected more than 59,000 signatures in favor of decriminalizing the personal use of cannabis, clearing a threshold that would require Parliament to consider the initiative in its current term that ends in 2023.

  • Analytically Speaking

    Analytically Speaking

    Kim Hesse shares her insights into the comparatively new field of testing ENDS products.

    By Timothy S. Donahue

    In late October, a health regulatory body in Mexico said its scientists had developed a new methodology to analyze the aerosols in electronic nicotine-delivery systems (ENDS) because “no one else has come up with one.” Cofepris chief Alejandro Svarch said that the final results of a new analysis of ENDS products using the new method will be published in scientific journals in the coming months. Svarch added that the “pioneering methodology” developed in Mexico will be of interest to health authorities in other countries.

    The situation is puzzling at best since researchers have had the ability to evaluate aerosols in ENDS products for some time. Additionally, the sale of ENDS products was banned in Mexico in June. This led to many in the vaping industry to wonder how the nation could justify an ENDS ban when it now claims it had no ability to test the safety of the products.

    Every country that regulates vaping products requires that the products be tested for various elements, such as harmful and potentially harmful constituents (HPHCs) and heavy metals. According to Kim Hesse, vice president of sales and marketing for McKinney Regulatory Science Advisors, researchers have used aerosol testing methodologies to evaluate air quality, combustible cigarette smoke and inhaled medical product aerosols for many years, and ENDS aerosol testing has existed for nearly 15 years.

    “This knowledge was then adapted to the ENDS industry. The earliest known third-party tobacco testing laboratory of ENDS products occurred in 2008 by one of the largest tobacco laboratories. Most other third-party labs began testing no later than 2015,” explained Hesse. “Coresta [Cooperation Centre for Scientific Research Relative to Tobacco, an organization that promotes international cooperation in scientific research relating to tobacco] has been working on validating methods for ENDS products for many years. The organization has validated method[s] for smoke collection and instrumentation while continuing to work on many more method needs for the ENDS category.”

    Hesse said that it is important to test ENDS products to ensure the general public is not inhaling unacceptable levels of potentially harmful compounds (e.g., heavy metals or diacetyl). By testing these products, the industry can ensure consistency and provide regulators, such as the U.S. Food and Drug Administration and other government agencies, the data needed to evaluate ENDS products. She sat down with Vapor Voice to answer several questions related to ENDS testing.

    Vapor Voice: What type of experience do you have in testing tobacco and ENDS products?

    Hesse: We published several scientific articles that demonstrate our knowledge, capabilities and experience testing tobacco and ENDS products. For example, we recently published an article that provides instructions on the importance of conventional toxicological metrics when generating and characterizing ENDS aerosols.

    How is testing e-cigarette vapor different from testing combustible cigarettes?

    It depends. Testing combustible cigarette smoke, which contains a particle and gas phase, is a bit more challenging than simply testing an ENDS aerosol.

    However, when you consider product variability, ENDS products present many challenges that cigarettes don’t. ENDS products come in all different shapes and sizes. Some have round mouthpieces while others have square. This alone poses a challenge in connecting the device to the smoking instruments, whose adaptors are round. Some devices have actuators, all of which are in different locations. Some vaping machines have push actuators that do not work well with the various actuator shapes and locations. Cigarettes, on the other hand, are standard size, and 20 cigarettes can be lit at one time with a standardized lighter that is built into the smoking machine.

    Combustible cigarettes are tested to completion, and e-cigs are only tested for a set number of puffs. After the aerosol or smoke collection is accomplished, the remainder of the testing for the various compounds proceeds in essentially the same fashion regardless of whether it is aerosol or smoke. The e-cigs and cigarettes are tested on essentially the same instruments, but the method regimes (number of puffs, interval between puffs and volume) are slightly different.

    Are there different standards for testing, and how does a company know which ones to use?

    Both combustible cigarettes and ENDS products have a standard Coresta regime for ambient (ISO) testing. The Health Canada (intense) method for e-cigarettes [is] determined by the manufacturer’s scientists and is established based on the limitations of the devices (some devices have puff duration limits).

    The analytical methods can also vary slightly between combustible cigarettes and vaping products due to the significant reduction of constituents in the e-cigarettes. The calibration curve is usually much lower in e-cigarette analysis. Other variabilities are the angle in which the e-cigarette devices are tested. The testing angle of the device is based on the model (tank, cigalike, etc.).

    Are there many challenges in e-cigarette testing, and how can those difficulties be overcome?

    You are required to share data with FDA even if the data is not favorable. Several companies simply have their products tested and then send the report to FDA without knowing if the data supports their product as appropriate for the protection of public health.

    There is always room for improvement. We find that most labs are always working on method improvement. As mentioned previously, the various sizes and shapes of the ENDS devices pose a challenge. The lack of standardized testing methods for all the HPHCs and lab variability pose opportunities for improvement.

    How accurate are the testing methods and the results that the tests provide?

    Currently, analytical methods can detect chemicals at extremely low levels. Chemicals are often detected at levels that do not pose a health risk to humans. Some in public health use detected levels of chemicals rather than the more important harmful level of chemicals to create a public panic and thereby negatively impact the goal of harm reduction.

    Coresta has a good working group for ENDS testing and analytical methods. We should focus on having more companies and laboratories actively participate in studies aimed at simplifying and reducing variability of existing methods.

    One area of a standardization focus should be on the creation of a reference ENDS device that may be used with any remaining e-liquids—similar to the reference cigarette (1R6F), which is used to compare combustible cigarette data generated by different labs.

    From your test results, would you say that vaping is less risky than combustible smoking?

    This isn’t about me. What I can say is that Brian King, the director of the FDA’s Center for Tobacco Products, said in the media that he understands that e-cigarettes have “markedly less risk” than a combustible cigarette product. He acknowledged the continuum of risk for tobacco products and where e-cigarettes fall on that continuum. During the recent GTNF 2022 I attended, he said that there are certain products that are lower risk than combustible cigarettes, and that is an important component of the dialogue for the FDA. The FDA acknowledging that e-cigarettes are less harmful than combustible cigarettes is significant.

    Do you have any recommendations for companies looking to have their products tested?

    First, simply sending samples to a lab without understanding the testing requirements or how to interpret the data is a waste of money. Make sure you are working with a credible group of scientists that guide you through the process of generating scientific data.

    I suggest the following: Ensure the laboratory you choose is ISO 17025 certified. It is advisable to use a laboratory the FDA is familiar with. This will make the data review process a bit better and will likely not result in denial of data submission due to laboratory insufficiencies. When choosing a lab, make sure they have filed a tobacco product master file (TPMF) with the FDA and that their methods are validated and validation reports are included in their TPMF.

  • Budding Possibility

    Budding Possibility

    Credit: Victor Moussa

    Issues to be aware of before marketing THCa hemp flower

    By Rod Kight

    As a cannabis lawyer, I represent lots of companies in the U.S. hemp industry, and I am routinely asked legal questions about new and novel products. I am currently receiving lots of calls about “THCa flower.” In this article, I will discuss THCa flower and several legal and practical issues regarding it.

    What is THCa flower?

    THCa flower refers to cannabis buds marketed as hemp. These buds are intended for smoking or vaping. They contain high concentrations of tetrahydrocannabinolic acid (THCa) and low concentrations of delta-9 THC (D9). Specifically, their D9 levels do not exceed 0.3 percent by dry weight, which is the legal limit for hemp under the 2018 Farm Bill. For example, I recently viewed a certificate of analysis of THCa flower that showed 25 percent THCa and 0.18 percent D9. This is remarkable. Despite the fact that this cannabis flower is federally lawful hemp, smoking it will get you very high. In fact, cannabis flowers with high THCa/low D9 ratios are exactly what is being sold as marijuana in states that have legalized it. Although some marijuana strains contain D9 in levels that exceed 0.3 percent, many strains do not. This means that they are technically “hemp” under federal law. In other words, THCa hemp flower is no different from much of the marijuana flower currently sold in medical and recreational marijuana dispensaries in states with regulated marijuana markets.

    Rod Kight

    Is THCa flower legal?

    The short answer is “yes,” at least under federal law and the laws of some states.The idea that there are legal hemp buds that are no different from illegal marijuana buds seems counterintuitive, but proving that this is true involves a very straightforward analysis. The 2018 Farm Bill distinguishes legal hemp from illegal marijuana solely by reference to its D9 levels. Specifically, hemp is cannabis with no more than 0.3 percent D9 by dry weight. A hemp bud with THCa levels of 20 percent and D9 levels of 0.15 percent falls squarely within the 2018 Farm Bill’s definition of “hemp” and is legal under federal law.

    In fact, the Drug Enforcement Administration (DEA) has specifically stated on multiple occasions that cannabis material meeting this definition is lawful. In a Jan. 6, 2022, letter, the DEA stated: “Material that is derived or extracted from the cannabis plant, such as tissue culture and any other genetic material that has a delta-9 tetrahydrocannabinol concentration of no more than 0.3 percent on a dry weight basis, meets the legal definition of ‘hemp’ and is thus not controlled under the CSA.” This was not the first time the DEA confirmed that the sole factor distinguishing lawful hemp from unlawful marijuana is its D9 concentration. In addition to confirming this standard in both a letter to the Alabama Board of Pharmacy and a public statement to the Florida Department of Agriculture and Consumer Services, the DEA’s Interim Final Rule regarding hemp states that marijuana is limited “to only include cannabis or cannabis-derived material that contain more than 0.3 percent delta-9-tetrahydrocannabinol (also known as D9-THC) on a dry weight basis.”

    In summary, harvested cannabis flower with D9 concentrations not exceeding 0.3 percent meets the legal definition of “hemp” and is not controlled under federal law, regardless of its THCa levels. It is important to note that this only applies to harvested cannabis material. The U.S. Department of Agriculture (USDA) controls hemp production, and its regulations require a test that accounts for both THCa and D9 before the hemp can be harvested, commonly referred to as a “total THC” test.

    What are the major legal issues with THCa flower?

    Although THCa hemp flower is lawful under federal law, there are some important issues and considerations to be aware of. The rest of this article will discuss these issues.

    Is it possible to grow compliant THCa flower?

    One issue is whether THCa flower, at least with the high THCa concentrations discussed at the beginning of this article, can come from hemp grown in compliance with the USDA’s pre-harvest testing requirements. Through my research and discussions with clients, I have been made to understand that it is difficult, though possible, to obtain THCa hemp flower from hemp that passed the USDA’s pre-harvest tests. Additionally, it is important to note that the DEA considers all cannabis material with D9 levels not exceeding 0.3 percent by dry weight to be lawful “hemp” regardless of whether or not it was grown by a licensed hemp producer and/or if it passed a USDA total THC pre-harvest test. This conflict between the USDA and the DEA is an unsettled area of law, though it is clear that the USDA’s regulation of hemp terminates upon harvest.

    What about state laws?

    Another issue is whether THCa flower is lawful under state law. The answer depends on the state in question. It is clear that you can lawfully transport THCa flower through a state regardless of its hemp laws. This is because the 2018 Farm Bill states: “[N]o state or Indian Tribe shall prohibit the transportation or shipment of hemp or hemp products produced in accordance with subtitle G of the Agricultural Marketing Act of 1946 (as added by section 10113) through the state or the territory of the Indian Tribe as applicable.” But individual states may restrict or even downright prohibit it. Although THCa flower is lawful in many states, it is prohibited in others. For instance, some states restrict all hemp that is intended for smoking, which includes THCa flower. Some states allow smokable hemp but prohibit THCa flower based on their requirement that hemp pass both a pre-harvest and post-harvest “total THC” test. Additionally, the legal status of THCa flower in some states can be tricky to determine due to the way that their hemp laws and regulations are written.

    In summary, the laws and regulations of a given state determine the extent to which THCa flower is lawful. State laws vary, and the legal status of THCa flower can sometimes be difficult to determine. This leads to a final issue: confusion and misunderstanding of hemp laws.

    What if THCa is lawful in my state but law enforcement disagrees?

    A final issue to consider is confusion by law enforcement and state regulators about the legal status of THCa flower. Many people in the hemp industry contend that hemp flower is only lawful if it passes a “total THC” test, which accounts for both THCa and D9. Although this is correct for hemp that has not been harvested, it is wrong under federal law and the laws of many states for harvested cannabis material. Given that this issue is confusing even to experienced hemp industry participants, you can imagine its misunderstanding is compounded by law enforcement and even regulators, many of whom do not know or care much about (or for) hemp. In practice, this means that someone lawfully selling THCa flower may experience problems, including prosecution, from law enforcement.

    Conclusion

    THCa flower is poised to be the “next big thing” in the hemp industry. Based on the feedback I am receiving, I believe that it will be very popular in much of the country. As discussed above, THCa flower is lawful under federal law and the laws of some states. However, before deciding to participate in the emerging THCa flower market, it is very important to understand the issues and risks involved.

    Important Note: This article is not intended to be legal advice and should not be used as such. The matters discussed are novel and involve complicated and unsettled legal issues. Before making any decisions regarding THCa, you should first consult with an experienced attorney. 

    Credit: Cavan
  • Step by Step

    Step by Step

    Credit: Balint Radu

    Embracing tobacco harm reduction involves more than words, and consumers should be involved.

    By George Gay

    Earlier this year, I received a press note headed, “Recommendation: Seven steps for the new Italian government to reduce smoking”—a note that also carried the subsidiary heading, “World Vapers’ Alliance presents seven steps toward harm reduction in Italy as the new government takes office.”

    This was all very well, but there was something odd about the note because the text gave the first step in the strategy as “embrace tobacco harm reduction.” It seemed that the “seven steps toward harm reduction” had been reduced to one, “embrace tobacco harm reduction.”

    This is not meant as a criticism. I’m certain the people at the Alliance know the new Italian government better than I do, and if they decided it was best to keep things simple, if they deemed the government incapable of following a complex, seven-step strategy, who am I to argue? After all, there is no way that I would propose a seven-stage strategy to the U.K. government. Four would be the upper limit:

    1. Choose a new leader.
    2. Try not to crash the economy.
    3. Oh dear, never mind.
    4. At least try to embrace tobacco harm reduction.

    Okay, I lied. I might have a tiny criticism of the press note. One of the people who sat alongside Michael Landl, the Alliance’s director, when the strategy was announced in Rome, was the Italian MEP (Lega party), Gianna Gancia, who said, in reference to the proposed revision of the EU’s Tobacco Products Directive, that it was necessary for the Italian government to insist on some fundamental points concerning legislation on electronic cigarettes.

    “In particular, Italy should maintain a wide range of flavors, which would help the consumer in the transition from traditional to electronic smoking …,” she was quoted as saying in part.

    To my mind, the reference to “electronic smoking” was unhelpful and unnecessary. It will have played into the hands of the vaping industry’s opponents, who will be whispering into the government’s other ear, “see, they’re both smoking; there is no difference.”

    Why, if she wanted to advance the cause of vaping, did she not say, “… which would help the consumer in the transition from smoking to vaping, and in this way, attempt, rightly, to put clear water between smoking and vaping.”

    After all, the need for that division is well understood by the Alliance. The strategy announced in Rome is part of a Europe-wide campaign presented under the slogan #BackVapingBeatSmoking.

    Words matter. It was unfortunate, though understandable in some respects, that vaping devices were first referred to as electronic cigarettes, but we are where we are. There is no need to hand more ammunition to those opposed to vaping and tobacco harm reduction.

    Although I never write headings, I am fascinated by them to the point where I keep pinned to the notice board above my desk one of my all-time favorites, a heading cut from a years-old issue of the London Review of Books, which simply says: “They treat us like shit.”

    You could complain that this heading isn’t a good one because it’s not obvious who “they” and “us” are, but, my goodness, it makes you want to read the piece. In fact, it was about those in power in an authoritarian state, the “they,” and the ordinary citizens of that state, the “us.” The heading has about it an air of whimsy on the point of turning violent. It seems to pour from the lips of the downtrodden, who are finally plotting revolution. Of course, it is lifted by the final scatological note, but, above all, to my way of thinking, it is blessed with brevity.

    The trouble is that, in going for brevity, you need to be careful not to wind up following the path of reductio ad absurdum, which, I’m afraid, is the route this one from opinion.inquirer.net took: “Harm reduction for tobacco?” When I first read this heading, I was excited because I thought that what was on offer was a forward-looking opinion examining ideas about plant consciousness and whether it is morally wrong to tear leaves off living tobacco plants, process and burn them.

    Surely, at the very least, the heading should have read, “Harm reduction for tobacco users?” because that was what the piece was about. Or perhaps not. After all, many of us constantly use the expression “tobacco harm reduction.”

    One final point. Since when has it become OK to put a question mark at the end of a heading introducing an opinion piece? An opinion writer surely provides her opinion; she doesn’t pose questions and ask for the reader’s opinion.

    It’s little wonder that I’m fascinated by headings. Look at this one from theguardian.com: “Australian teenagers are readily accessing illegal vaping products. Here’s how Christina Watts, Becky Freeman and Sam Egger for the Conversation.”

    This, I assume, was written by somebody who believes that it is not only acts that are illegal, a point of view that has made common the hideous phrase “illegal immigrant,” meaning somebody who by their very existence is illegal. This unfortunate person might, in desperation, have committed illegal acts in order to get to what she hopes is a country that will not persecute her, but she is not illegal.

    Is this sort of heading just a mistake? I hope so, because otherwise, it is purposely trying to shift the blame from the teenagers to the perfectly innocent vaping products. It is the teenagers who are committing the illegal acts, possibly in cahoots with sellers acting in an illegal manner.

    I shan’t comment on the second sentence of the heading, which is simply too awful to contemplate.

    I’ll give the headline writer at ctpublic.org her due because it seems she was embarrassed enough to put the phrase, the more lethal product, inside inverted commas: “New Yale study suggests higher e-cigarette taxes could push vapers to smoke ‘the more lethal product.’”I guess she, but not the person responsible for the quote, is aware that there are no degrees of lethal. Something is either lethal or it is not; just as something is unique or it is not, despite the common use of phrases such as “really unique.” But I must say that I would have been more impressed if the heading had been cut after the word “smoke.”

    Otherwise, it would have been less coy to have replaced “the more lethal product” with “combustible cigarettes,” or have we become so sensitive that we can no longer refer publicly to combustible cigarettes?

    When is a sobriety test not a sobriety test? How about, for instance, when the test is being applied to discover whether you are under the influence of alcohol? That would surely be a drunkenness test.

    I started to wonder about this on seeing a Eurekalert news story entitled “Can vaping cause you to fail a sobriety test?” Talking of a sobriety test seems to me to assume that drunkenness is the default setting of the human animal, who has to be tested whenever she displays signs of sobriety: talking coherently, acting rationally and driving in a straight line on a straight road.

    But this is nonsense. I mean, no matter what the gleaming adverts might want to make you believe, you don’t go along to your local hospital or clinic to have a wellness test. You go along to find out whether you are suffering from some disease or other. Even if you go along for an annual checkup, the tests are looking for early signs of disease, not early signs of wellness.

    The idea of a sobriety test seems to smack of a police state in which people are pulled over for acting in what I would describe as a normal way. And for those people concerned with human rights and the fear generated by slippery-slope theories, it could lead to anxieties over whether people could be pulled over for other normal behaviors: breathing, thinking and being happy.

    The heading is also misleading, in my view, because it implies that the fault lies with vaping whereas it lies with the testing, as is almost made clear in the story’s introduction. “While ethanol [alcohol] is often a hidden ingredient in e-liquids, a new study finds vaping won’t trigger a false positive sobriety test—but only if police employ a proper waiting period [between stopping the driver and testing],” the introduction states. It is important to make clear that the “proper” waiting time referred to is in fact the standard time used in a DUI (driving under the influence) roadside stop.

    Note, too, how we’ve gone from the possibility of vaping’s causing a person to fail a sobriety test, according to the heading, to the possibility of its causing a “false positive sobriety test,” according to the introduction. What is this “false positive sobriety test?” To me, this means that the person being tested has gotten away with it when she should have been charged with DUI, but according to the context, a person who is positively sober is in fact drunk.

    A heading on a recent BBC news story asked the question “Should disposable vapes be banned?” Any thoughts anyone? No?

    As is often the case with stories with headings that end in a question mark, no answer was given, though one person, perhaps two, were quoted as saying “yes.” It makes you wonder whether the person who wrote the heading read the story.

    Still, I mustn’t grumble. I think the BBC did well to give the issue of disposable vapes an airing, even if the story provided little more than an opportunity for people to complain about how carelessly discarded, disposable vaping products were littering the U.K. and an opportunity for everybody to blame everybody else for this state of affairs. This debate has not been encouraged nearly enough.

    There is clearly a need to go back to basics and ask whether vaping devices, disposable or otherwise, are a positive. This means honestly addressing the question of whether we should, in trying to reduce the harm caused to smokers by their consuming combustible cigarettes, allow the further degradation of the environment. Yes, vaping devices might help individual smokers avoid the harms they would otherwise have suffered, but should this be at the expense of the environment and, therefore, everybody?

    The answer to this question probably depends on how many smokers can be switched to vaping devices and what is the level of environmental damage that will be suffered. And, of course, into that equation will have to be factored the environmental gains that will accrue because smokers who switch will no longer be discarding cigarette butts.

    Other factors will have to cover what percentage of vaping devices are likely to be disposed of properly if widespread recycling systems can be put in place and how efficient will be the recycling processes. It has to be remembered that some things cannot be recycled while others might require huge amounts of energy to recycle them.

    A major factor in my view concerns consumer attitudes. The blame for the abundance of cigarette butts that litter our streets and waterways is often heaped on cigarette manufacturers, and I would say that, despite the huge profits they have made over the years, they have never properly got to grips with this problem. But there is no getting away from the fact that it is consumers who drop butts on the ground. If they had been willing to put their butts in designated bins, it would have been a reasonably easy task to have them collected and recycled into pallets and whatever. But too many consumers have never proved amenable to doing this.

    The BBC story quoted one former vaper as saying that she had had no idea disposable vaping products were recyclable, adding that the messaging on the products could definitely be improved. “If the vape companies ran social media ads letting people know how to dispose of them, it would grab our attention,” she was quoted as saying.

    Now I don’t want to be harsh, but this sounds a bit flaky to me. People shouldn’t think it’s OK to consume an e-cigarette without taking some responsibility for doing so. If you Google “can vapes be recycled,” there is no end of information available. I’m not saying that this information will answer all your questions, but it will answer enough to allow you to dispose of your vaping devices in a way that will cut out much of the environmental damage caused by throwing them on the street.

    We should not let consumers get away with not acting responsibly. Otherwise, more people will be answering the heading’s question in the affirmative.

  • FDA Accepts Bantam Vape Non-Tobacco PMTAs

    FDA Accepts Bantam Vape Non-Tobacco PMTAs

    Bantam Vape received acceptance of its premarket tobacco product application (PMTA) submission from the U.S. Food and Drug Administration for its non-tobacco nicotine e-liquids, according to a press release. Bantam’s application now moves to the next step in the PMTA process—a preliminary scientific review to confirm the application contains all required items to permit a substantive review by the FDA.

    Bantam submitted its application for its non-tobacco nicotine e-liquids to the FDA on May 13, 2022, and is seeking marketing orders from the agency.

    “The receipt of this acceptance letter reflects Bantam’s efforts to provide adult consumers with high-quality, science-based e-liquids while upholding our responsibility to restrict youth access and use of these products,” said Bantam spokesperson Anthony Dillon. “Bantam remains supportive of the need for science-based regulation in the e-liquids industry and is proud of the progress of our various PMTAs. We remain confident in the quality and consistency of our products and the science behind them.”

    Prior to its non-tobacco nicotine-focused submission, Bantam submitted a PMTA to the FDA in September 2020 for its tobacco-derived e-liquids. The application entered scientific review in August 2021, and, to date, remains under FDA review.

    Earlier this year, the -liquid manufacturer received an exemption from the United States Postal Service (USPS) that allows the company to ship its e-liquid products to select vape retailers and distributors throughout the United States.

  • Kuwait Pauses 100% E-Cigarette Customs Duty Tax

    Kuwait Pauses 100% E-Cigarette Customs Duty Tax

    Credit: Zero Photo

    The government has decided to defer the application of a 100 percent customs duty tax on e-cigarettes – including flavored products – until further notice. The tax was supposed to go into effect on Jan. 1, 2023 after being postponed from Sept. 1 of this year, reports Al- Anba daily, as reported by the Arab Times.

    “The Acting Director General of the General Administration of Customs, Suleiman Al-Fahd, according to a local Arabic daily, has issued instructions regarding postponing the application of single-use cartridges containing nicotine and packages of liquids or gels containing nicotine, whether flavored or unflavored, and packages of liquids or gels containing nicotine from the 100 percent customs tax,” the story states.

    Al-Fahd had previously issued customs instructions to postpone the imposition of 100 percent tax on electronic cigarettes and their liquids, whether with or without flavor, for a period of 4 months, specifically, but according to the instructions, it is decided to postpone the tax application on four items until further notice.”

    The list of the four items includes – the flavored single-use nicotine cartridges; unflavored disposable nicotine cartridges; liquid or gel packs containing flavored nicotine and liquid or gel containers containing unflavored nicotine.

    The instructions come in addition to other Customs Instructions No. 19 of 2022 issued in Feb. 2022 regarding the application of what was introduced in the Main Clause 2404 of Chapter 24 of the unified customs tariff system for the GCC countries by subjecting cartridges containing single-use nicotine flavored, unflavored and packages of liquids or gels containing flavored or unflavored nicotine for a 100 percent customs duty.

  • California’s Flavored Tobacco Ban Begins Today

    California’s Flavored Tobacco Ban Begins Today

    Credit: 4kClips

    California’s controversial ban on flavored tobacco begins today. A week ago, the U.S. Supreme Court blocked R.J. Reynolds Tobacco Company’s contention that the new state law conflicted with federal law.

    Flavored tobacco products such as e-cigarettes, menthol cigarettes, flavored cigars and more can no longer be sold in stores.

    “If they wanted to ban flavored tobacco or regulate it, I feel they should have selected certain stores to be authorized to retail it. It’s saved so many lives, helped so many people get off cigarettes,” said Carlo Sharmoug, owner of Ziggy’s Smoke Shop at the corner of West Lane and Alpine Avenue in Stockton, speaking with ABC10.

    Sharmoug says in his 14 years in business, his store has never once sold tobacco to a minor.

    Freitas says California’s tobacco rates among teens at one point began to decline until e-cigarettes appeared.

    “They started being sold in flavors like grape and cherry and gummy bear. And all of a sudden, we saw our youth tobacco rates increasing again,” said Freitas.

    Smoke shops like Ziggy’s say California will lose out on millions in tax revenue and believes product will be sold on the black market. However, Frietas disagrees, saying the savings in medical treatment in California alone will be huge.