Innokin, a leading vape brand since 2011, has announced its strategic partnership with Bahrain Duty Free, a prestigious retailer in the Middle East.
The collaboration will see the introduction of Innokin’s popular INNOBAR vaping products to Bahrain Duty Free’s premium stores, catering to the increasing demand for e-cigarettes in the region, according to a press release.
The new partnership began with a pilot project launched in April 2023. Within two weeks, the entirety of the trial stock had sold out.
“Building on this remarkable success, the collaboration has now expanded to provide customers with greater access to Innokin’s award-winning vaping solutions,” the release states. “Innokin’s INNOBAR devices, in particular, have garnered significant interest for their exceptional performance and flavors which are tailored to suit the preferences of the Bahrain market.”
Currently INNOBAR 3500, 6000 and V7000 models are available at Bahrain Duty Free locations. A key element of the partnership has been the knowledge-sharing and training provided by Innokin’s experts to the management of Bahrain Duty Free.
“We are thrilled about our partnership with Bahrain Duty Free. This collaboration signifies not only our dedication to the growing Middle East market but also our commitment to fostering responsible practices in the industry,” said George Xia, co-founder of Innokin. “With our decade-plus experience and the shared values of both organizations, we are confident that this partnership will set new standards of excellence for vaping.”
The U.S. Food and Drug Administration has posted a new webinar to help online retailers respond to warning letters from regulatory agency’s Center for Tobacco Products (CTP).
The webinar provides an overview of warning letters and outlines the process for responding to a warning letter, such as corrective action taken by the firm to address any violations and its plan for maintaining compliance, according to an FDA release.
In the webinar, you will learn about:
FDA’s internet and publication surveillance of tobacco products
Examples of violations cited in warning letters sent to online tobacco product retailers
Actions to take after receiving a warning letter
Regulators in the United States began cracking down on online retailers selling vaping products that are attractive to youth. The Food and Drug Administration last week issued warning letters to 16 (the agency reported 15, but lists 16) online retailers for selling and/or distributing unauthorized e-cigarette products packaged to look like cartoon characters, school supplies, toys, and drinks.
The U.S. Court of Appeals for the D.C. Circuit yesterday found that the Food & Drug Administration failed to conduct the proper analyses before rejecting some vaping product applications.
This is the second circuit court of appeals to accuse the FDA of a “surprise switcheroo” when reviewing vaping product applications.
Fontem, the company behind the Blu and myBlu vaping brands, argued that the FDA had not conducted the proper analysis prior to rejecting their applications. The D.C. Circuit Court agreed with Fontem in regards to their unflavored products, ruling that the FDA had “neglected to conduct the overall public health review specified by law.”
Judge Rao’s opinion for the court (joined by Judge Walker and Senior Judge Ginsburg), stated that with respect to Fontem’s unflavored products, the FDA also denied Fontem’s applications on the public health ground.
“While the FDA identified multiple ‘deficiencies,’ it failed to analyze the tradeoffs necessary to make a public health finding. Nor did the agency explain how the specific deficiencies relate to its overall conclusion that Fontem failed to demonstrate its unflavored products were appropriate for the protection of public health,” the opinion states. “The agency’s denial therefore failed to comport with the requirements of the Tobacco Control Act.”
In denying Fontem’s unflavored products, the FDA relies solely on the public health ground. The FDA could have promulgated regulations imposing consistent requirements on the composition and manufacturing of tobacco products, according to the order.
“Had the agency done so, Fontem’s failure to meet those standards would be an independent and sufficient ground for denying the applications, regardless of the overall public health consequences of Fontem’s products,” the order states. “But the agency has not exercised its regulatory authority. Because the FDA has chosen to proceed application by application under the public health ground, it must undertake the holistic inquiry required by the statute.”
Instead of making an overall assessment that Fontem had not shown its products were beneficial to the public, the agency identified five highly technical deficiencies, according to the order. But nothing in the denial order explains how the deficiencies relate to the overall public health consequences of Fontem’s unflavored products.
The FDA’s failure to correctly apply the public health inquiry to Fontem’s unflavored products led it to make another serious error, according to the order. In its initial deficiency letter, the FDA requested certain information from Fontem, thereby indicating such information would be sufficient for the agency to approve Fontem’s products.
“Cf. 21 U.S.C. § 387j(c)(3) (providing an application denial “be accompanied by a statement informing the applicant of the measures required to remove such application from deniable form”),” the order states. “But in several instances, the FDA changed its tune in the denial order, reproaching Fontem for failing to provide information the agency had never explicitly sought.
“Shifting the regulatory goalposts without explanation is arbitrary and capricious. By indicating in its deficiency letter that Fontem could resolve issues with its applications by providing specific information, the FDA represented such information would be sufficient to secure approval.”
Kaival Brands Innovations Group has promoted Stephen Sheriff to chief operating officer.
Sheriff succeeds Eric Mosser, who was recently promoted to CEO, and joins Mosser and recently appointed Chief Financial Officer Thomas Metzler as a part of Kaival Brands’ expanded senior management team.
“Promoting Stephen to the role of chief operating officer was a natural and logical next step given his contributions to the success of Kaival Brands to date and his experience helping businesses navigate through rapid periods of growth and change,” said Mosser in a statement. “He has a strong entrepreneurial spirit and will be instrumental in helping us take our business to the next level. With a deep understanding of our operations, the capital markets and what it takes to develop and execute a strategy with proven results, he is a great addition to our C-suite leadership team.”
Sheriff brings more than a decade of finance and entrepreneurial leadership to his new role. Most recently, he served as the director of administration and communications at Kaival Brands. In this role, he managed the company’s investor and public relations and human resource programs in addition to overall responsibility for the development and implementation of key programs and initiatives, including customer and vendor relations.
Prior to Kaival Brands, Sheriff co-founded Riverhill Group, a capital markets advisory and consulting firm.
A man used 80 discarded vape batteries to power his e-scooter to make a point about the wasteful nature of the disposable products. Tobiasz Stanford, from Trowbridge, Wiltshire, England, says he wired the lithium-ion batteries up to a scooter he bought for £30 on eBay.
The scooter is now fully functioning and “very reliable”, said Tobiasz. “The amount of vapes I see on the street is really upsetting. These vape batteries have the potential to power a scooter. They’re very active still yet they’re marketed as disposable. It needs to stop.”
Tobiasz discovered vapes used a lithium-ion battery after taking several apart. He began recharging the batteries and found after one cycle they could function “almost like a brand new battery,” according to media reports.
Tobiasz says manufacturers and vape consumers need to think about e-waste with greater importance. “The amount of vapes I see on the street or in ponds – which have the potential to power a scooter – is so bad. They’re very active still. When those chemicals break down lithium will start to spill out,” he explains. “The consequences of that will be ridiculous. It will happen over time. We need to do what we can to stop this from happening and that includes banning disposable vapes.”
FDA is extending the proposed rule’s comment period by an additional 30 days to allow people additional time to submit comments. Comments on the proposed rule will now be accepted through Oct. 6, 2023.
The proposed TPMP rule would place new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of their products.
These proposed requirements would help protect public health by, among other things, minimizing or preventing contamination and limiting additional risks by ensuring product consistency.
The Irish music festival Electric Picnic has banned the use of single-use disposable e-cigarettes ahead of the event this weekend.
The music and art festival taking place in Stradbally, County Laois, from September 1 to 3. It issued a statement warning attendees that single-use disposable e-cigarettes will be confiscated if found in their possession as they enter the festival this Friday, according to the Independent.
Taking to social media, the organizers of the festival said the ban was made in order to “protect the land” where the festival is being held.
“Disposable vapes are made of a mixed compound of materials making them very difficult to recycle and hazardous if not placed in the correct waste stream,” the statement said. “Please do not bring single-use disposable vapes as they may be confiscated on entry. They pollute the environment and incorrect disposal of these can be hazardous at waste centers.”
After a two year gap due to the pandemic, Electric Picnic resumed last year with almost 70,000 people who attended the event.
The festival announced on social media that Irish rock band The Script will be performing over the festival weekend, making this their first performance in Ireland following the death of their guitarist Mark Sheehan in April this year.
This year’s sold out event will be headlined by Billie Eilish, The Killers, Niall Horan and Fred Again.
The U.S. DEA says cannabis-derived delta-9 THCA does not meet the definition of hemp under the CSA.
By Rod Kight
The U.S. Drug Enforcement Administration (DEA) issued a letter1 on June 9, 2023, in response to a request about information regarding, among other things, tetrahydrocannabinolic acid (THCA). Note that I was only able to locate a copy of the letter on Reddit. I had to compile a series of PNG images of it into a single document. I believe, but cannot confirm, that the letter is in response to an inquiry by Vice Media Group.
In the letter, the DEA states the following about THCA:
“In regard to delta-9 THCA, Congress has directed that, when determining whether a substance constitutes hemp, delta-9 THC concentration is to be tested ‘using post-decarboxylation or other similarly reliable methods.’ 7 USC § 1639p(a)(2)(A)(ii)2; 7 USC § 1639q(a)(2)(B).3 The “decarboxylation” process converts delta-9 THCA to delta09 THC. Thus, for the purposes of enforcing the hemp definition, the delta-9 THC level must account for any delta-9 THCA in a substance…. Accordingly, cannabis-derived delta-9 THCA does not meet the definition of hemp under the Controlled Substances Act because upon conversion for identification purposes as required by Congress, it is equivalent to delta-9 THC.”
Rod Kight
Is the DEA right?
The answer is “it depends.” If the DEA is addressing the legal status of hemp that is in production (i.e., pre-harvest hemp), then it is correct. As I have previously discussed,4 all hemp must pass a “post-decarboxylation” test, commonly known as a “total THC” test, in order for it to be harvested. However, for hemp that is postproduction, i.e., hemp that has passed a post-decarboxylation test and been harvested, the sole legal metric for determining its legal status is its delta-9 THC levels. In other words, if we read the DEA’s letter to contend that postproduction hemp is subject to a post-decarboxylation test, then it is wrong.
The post-decarboxylation test does not apply to postproduction hemp. The two statutes cited by the DEA in its letter are the only two places in the Agriculture Improvement Act of 2018, commonly known as the 2018 Farm Bill, that the term “post-decarboxylation” appears. They both apply solely to hemp production.
In the first statutory provision, 7 USC § 1639p(a)(2)(A)(ii), Congress sets forth the criteria that states and Indian tribes must comply with in order to “have primary regulatory authority over the production of hemp” within their jurisdictions. The second statutory provision, 7 USC § 1639q(a)(2)(B), is similar in that it sets forth the criteria that the U.S. Department of Agriculture (USDA) shall use to “monitor and regulate [hemp] production” in states that do not have an approved hemp plan and thus do not have primary authority over hemp production within their jurisdictions (state and tribal hemp plans are available at www.ams.usda.gov/rules-regulations/hemp/state-and-tribal-plan-review).
The key word in the above provisions is “production.” In law, we refer to a word with a specific and defined legal meaning as a “term of art.” In the context of hemp, “production” is a legal term of art. Under 7 CFR § 990.1,5 to “produce” means “To grow hemp plants for market, or for cultivation for market, in the United States.” Additionally, 7 CFR § 718.26 defines a “producer” as “an owner, operator, landlord, tenant or sharecropper who shares in the risk of producing a crop and who is entitled to share in the crop available for marketing from the farm or would have shared had the crop been produced. A producer includes a grower of hybrid seed.” To produce hemp means to grow it.
Since the post-decarboxylation test clearly applies to producers, the DEA is correct when it states that “for the purposes of enforcing the hemp definition, the delta-9 THC level must account for any delta-9 THCA.” A hemp producer’s crop must not have total THC concentrations exceeding 0.3 percent by dry weight in order to harvest it. However, once that crop passes the test and is harvested, no additional test is required under federal law.
“At that point, meaning post-harvest, the sole statutory metric under federal law for determining whether harvested cannabis material is lawful hemp or illegal marijuana is its delta-9 THC levels. In fact, the DEA stated this very clearly in a letter dated January 6, 2022:7 “[T]issue culture or any other genetic material that is derived or extracted from the cannabis plant such as tissue culture and any other genetic material that has a D9-THC concentration of not more than 0.3 percent on a dry weight basis meets the definition of “hemp” and thus is not controlled under the CSA.”
This was not the first time the DEA said that Delta-9 was the sole factor. During a video webinar8 called a “Town Hall with USDA and DEA” conducted by the Florida Department of Agriculture and Consumer Services on June 24, 2021, the DEA representative stated: “I’ll be very, very deliberate and clear. At this time, I repeat again, at this time, per the Farm Bill, the only thing that is a controlled substance is delta-9 THC greater than 0.3 percent on a dry weight basis.”
The 9th Circuit Court of Appeals has also weighed in on this issue, stating: “[T]he only statutory metric for distinguishing controlled marijuana from legal hemp is the delta-9 THC concentration level.” 9
So, the DEA is right that Congress requires a post-decarboxylation test for hemp production. But, once hemp has been deemed to be compliant and allowed to be harvested, the “post-decarboxylation” test no longer applies. You may reasonably ask how a crop that passed a total THC compliance test could be harvested and have flowers with no more than 0.3 percent delta-9 THC but with high concentrations of THCA. I discuss that in a companion article.10
In summary, this DEA pronouncement is bound to create more confusion in an already confusing area of law; however, it should properly be read as simply restating the fact that hemp producers must comply with the total THC test in order to harvest their hemp. Post-harvest (i.e., postproduction), the 2018 Farm Bill’s definition of hemp clearly states that the delta-9 THC levels are what matter, not the levels of THCA.
Finally, I should note that the DEA also addressed other cannabinoids in its letter, including hexahydrocannabinol (HHC), which it finds to be an illegal synthetic form of THC that does not naturally occur in the cannabis plant. There is contrary evidence to this position, namely that HHC is naturally produced in cannabis seeds,11, 12 but that issue is for a future discussion.
Based in Asheville, NC, Rod Kight is a renowned attorney in the cannabis industry.
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.
Suriname has banned the sale of all vaping products. The small South American country has been named among eight countries that are adopting measures in line with the World Health Organization’s (WHO) Framework Convention on Tobacco Control (FCTC) to protect the health of their populations from novel tobacco products.
The Republic of Suriname, a country in northern South America, borders the Atlantic Ocean in the north, French Guiana in the east, Guyana in the west, and Brazil in the south.
The WHO said Friday that with the recent ban on the use and marketing of electronic cigarettes in Venezuela, currently, 21 countries in the Americas regulate electronic nicotine delivery systems (ENDS), such as e-cigarettes and vapes.
“The resolution that regulates new and emerging nicotine and tobacco products in Venezuela is an important step forward for the country and for the region,” said Anselm Hennis, director of Non-Communicable Diseases Mental Health at the Pan American Health Organization (PAHO/WHO).
“We hope that this measure motivates other countries to take action on these products, which are addictive, harmful and aggressively advertised towards the youngest,” he added.
The eight new countries to join the initiative are Argentina, Brazil, Mexico, Nicaragua, Panama, Suriname, Uruguay and Venezuela and PAHO said these countries prohibit their sale altogether, and the other 13 countries have partially or totally adopted one or more regulatory measures.
The PAHO report states that 14 countries in the Americas, including the Caribbean, lack any regulation of vaping products.
The vape industry in Slovenia has quickly gone through several cycles over the past decade.
By Norm Bour
Slovenia is known for its diverse landscapes, giving it its nickname of “Little Europe.” The country, one of the smallest in Europe, is nudged between Italy and Croatia to the south, Austria to the north and Hungary to the east. It is part of the European Union and therefore abides by the all-inclusive Tobacco Products Directive (TPD).
On a recent visit to Slovenia, I visited two vape shops, one in the capital city of Ljubljana and the other in the second-largest city, Maribor, to the north. “Disposables are about the only practical option in Slovenia right now,” said the gentleman at Vape On Shop vapes in Ljubljana, “and taxes have pretty much killed the market for mods.”
Eighteen cents per milliliter equates to about €4.50 ($5.01) for one nicotine shot. To increase the pain, the same tax applies to non-nicotine vape products as well. When you add the value-added tax, that makes smoking a luxury in any form. A package of standard cigarettes is about €4.50, which is reasonable compared to some other countries.
Vape On opened about nine years ago and has ridden the rising tide of taxation in Slovenia as well as competing with outfits in neighboring countries that may be more proximate for some of its customers. Those taxes are scheduled to increase incrementally through the end of the year. Aside from taxes, it is also facing flavor bans, and the regulators want just one flavor—tobacco—to be offered.
“I think the government loses money on combustible cigarettes, and they are trying to get it back through our vape shops,” the shopkeeper confided. “We have some of the highest nicotine taxes in Europe, so that makes it hard to make money.”
During our conversation, a customer came in looking for THC, which is illegal in Slovenia. HHC is acceptable, however. Vape On offers it as a smokable herb as well as in gummy form, but, like many vape shop operators, the shopkeeper was reluctant to sell it, and he kept it hidden.
“I started in vape to help people stop smoking, just like I did,” the shopkeeper said. “I really don’t want to sell products just to get the customer high, which is a common sentiment among the vape shop crowd. He was a lifelong smoker and a 10-year vape converter.”
Moving up to Maribor, I stumbled across one of the coolest vape shops I’d seen in a while—a real crossover since it was a coffee shop as well as a bar.
“We’re pretty new here in this location, and we started as a bar, then added vape,” said Jure Strasek of the Vape and Puff Shop. “All together, we have 14 shops in Slovenia and one in Zagreb, Croatia. The name of the bar is Belidim Bar, and some people come in for one thing, maybe coffee, and now we can offer them choices.”
Walking in was almost a step back in time since many shops I have seen over the years have been low-key affairs. Whereas vape shops from a decade ago were sometimes opulent and impressive, most today are small and more functional. In the entry is the bar area with a curving staircase in the rear, with a crystal chandelier hanging above! If the bar was going for a Victorian look, they succeeded—but I think they were intending to create an air of classiness in the shop, which they achieved too.
“All our products must remain hidden,” shared Strasek. “We open up the display doors or turn on the lights only when we know we have a legal customer. The display cases are softly lit so you can barely see anything, and we are very careful to avoid selling to minors.”
When I asked about favorite flavors or brands, he replied, “We sell our own called Egoist and Exotic Oxygen, and we sell many different flavors. We also have a few lines that fit under those brands, but overall, those two cover most of them.”
Vape and Puff Shop is bucking the trend since disposable sales are secondary to their liquid sales, which is old school and different from most shops today. Its prices are quite affordable—a 60 mL bottle of the shop’s house brand retailed for €19, but that is without nicotine and without a base flavor. The shop adds nicotine and flavor separately.
Due to regulations that prevent them from selling pre-mixed flavors, this provides a special niche unlike most other vape shops.
I asked Strasek if he thought the government might succeed in banning flavors, and he responded with an empathetic “no.” “Maybe in disposables, but I don’t think they will ban individual flavoring,” he said. “That would pour over into flavors for candies, cookies and other treats, so where do you draw the line?”
Nic shots are limited, per the TPD, but he believes that they will continue to grow their shops.
The vape industry has gone through several cycles over the past decade. In the heyday from 10 years ago, many also went the multipurpose route as Vape and Puff did in Maribor. It would be a trend I would love to see continue.
Meanwhile in Croatia, two big events happened on Jan. 1, 2023. Even though the country was already part of the European Union, it not only adopted the euro as its currency that day but also became part of the Schengen Zone, which means it now shares passport controls with the other 26 countries that are part of the agreement. In Split, Croatia, I returned to VAPEX, a shop that I profiled in December 2021, to ask about changes in its model.
“Business has been good,” said Igor Eberhardt, the owner of the shop. “We just opened another shop in Dubrovnik. But, like everywhere, we are dealing with increasing taxes, which are currently €0.16 per milliliter—and that is for pure base even without nicotine.” Those numbers are staggered to increase for the next several years, and that has been giving Eberhardt pause since he desires to open a higher profile vape bar in Split.
It seems that Croatian vape laws, aside from the TPD, follow those of Germany. So if Germany decides to limit or regulate flavors, Croatia will probably follow suit.
I asked if there had been any changes in Eberhardt’s business since the first of the year, when the euro replaced the kuna as the country’s legal tender.
He laughed and said, “We miss the kuna, and we do not like having to deal with euro coins since before, we didn’t use change!”
And if that is his biggest problem, he is a lucky man!
Norm Bour is the founder of VapeMentors and works with vape businesses worldwide. He can be reached at norm@VapeMentors.com.
