FDA Archives - Green Market Report

StaffJanuary 26, 2023
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4min3650

The Daily Hit is a recap of the top financial news stories for January 26, 2023.

On the Site

Curaleaf Closes Book on Legacy West

Curaleaf Holdings, Inc. (CSE: CURA) (OTCQX: CURLF) is exiting a trio of legacy western states in search for better profits. The exodus will begin this month with the “proactive closure of the majority of its operations” including its production and cultivation facilities in California, Colorado, and Oregon, the company said on Thursday. Read more here.

FDA Says CBD Still Can’t Be Dietary Supplement

The U.S. Food and Drug Administration this week announced that it would deny a trio of petitions that requested authorization for cannabidiol (CBD) to be used as a dietary supplement. The agency also advised that Congress needs to establish a better regulatory framework before such a classification is allowed. Read more here.

Mississippi Kicks Off Medical Cannabis Sales

Mississippi launched its medical cannabis program one year after the Mississippi Medical Cannabis Act was signed into law. Southern-based medical operator Good Day Farm sold flower to an Oxford, Mississippi medical patient. The company said that the flower was cultivated at Good Day Farm’s 130,000-square-foot facility, and became the first legal medical cannabis purchase in the state. Read more here.

TGOD is Now BZAM

The Green Organic Dutchman Holdings Ltd. (CSE: TGOD) (US-OTC: TGODF) is changing its name from “The Green Organic Dutchman Holdings Ltd.” to “BZAM Ltd.” In addition to changing the company name, the ticker symbol will also switch from TGOD and TGODF to “BZAM” on the CSE and “BZAMF” on the OTCQX. TGOD acquired the shares of BZAM in November 2022 resulting in one large shareholder owning 49.5% of the company. Read more here.

In Other News

Village Farms International

Village Farms International Inc. (Nasdaq: VFF) entered into definitive agreements with certain institutional investors for the purchase and sale of 18,350,000 of its common shares together with warrants to purchase up to 18,350,000 common shares, pursuant to a registered direct offering. Read more here.

St. Andrews Pharmacy LLC

A California state judge has ordered an early cannabis entrepreneur to pay $3.8 million after she was found to have cheated the successor of her dispensary by falsely claiming ownership of a legacy license, blocking him from securing a recreational marijuana business. Kathy Smith was ordered to pay the multimillion-dollar judgment to Cobby Pourtavosi, the operator of cannabis dispensary St. Andrews Pharmacy LLC. Read more here.


StaffJanuary 24, 2023
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4min4480

The Daily Hit is a recap of the top financial news stories for January 24, 2023.

On the Site

FDA Releases Cannabis Industry Research Guidance

The guidance document from the U.S. Food and Drug Administration follows the 2018 federal legalization of hemp via that year’s federal farm bill, which removed cannabis with less than 0.3% THC by dry weight from the list of controlled substances. Read more here.

Mississippi Medical Marijuana Sales May Start Friday

But over the weekend, state regulators began activating patient cards and notifying cardholders, so they could visit dispensaries and get the rest of mandated info uploaded to the state in advance of the sales launch. Read more here.

SMACKED Social Equity Dispensary Opens in NYC

New York’s first social equity applicant dispensary opened its doors today. Roland Conner, the owner of SMACKED Village located in Greenwich Villag, had been incarcerated for cannabis but prefers to be called an entrepreneur, not an ex-con. Watch video from the opening event here.

Cannara Biotech Expands, But Makes Just $2,200 in Q1 2023

Montreal-based Cannara Biotech Inc. (TSXV: LOVE) (OTCQB: LOVFF) (FRA: 8CB) was slightly profitable for its first financial quarter of 2023, with $2,209 in net income against $7.7 million in revenue, the company reported. The vertically integrated Canadian marijuana company also spent $2.7 million to expand its footprint, increase headcount, and bring 14 new product lines to market during the quarter, which ended Nov. 30 last year. Read more here.

In Other News

22nd Century Group

22nd Century Group, Inc. (Nasdaq: XXII), a biotechnology company dedicated to improving health with reduced-nicotine tobacco, hemp/cannabis, and hops advanced plant technologies, acquired privately held RX Pharmatech Ltd (RXP), a United Kingdom distributor of cannabinoids with 1,276 novel food applications with the U.K. Food Standards Agency (FSA). Terms of the agreement include an up-front payment of $650,000 in cash and stock and a three-year equity earn-out based on revenue milestones. Read more here.

Curaleaf

Curaleaf Holdings, Inc. (CSE: CURA) (OTCQX: CURLF) announced the expansion of its Grassroots brand in New Jersey with the launch of premium cannabis flower and pre-rolls. Available now at all Curaleaf locations across the state, New Jersey is the eighth market to offer Grassroots products. Read more here.


Debra BorchardtNovember 23, 2022
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9min7520

On Monday, the FDA issued Warning Letters to five companies that produce products with CBD (cannabidiol) and specifically zeroed in on products that would appeal to children. The FDA noted in some of the letters that it was concerned about Delta-8 THC products that may be consumed by children, as some packaging and labeling may appeal to children.

11-11-11 Brands, Naturally Infused LLC, Newhere Inc., Infusionz LLC, and CBD American Shaman LLC were all issued letters.

The letters from the FDA stated, “There is no food additive regulation which authorizes the use of CBD. We know of no basis for general recognition of safety for CBD based either on scientific procedures or common use in food prior to January 1, 1958. Based on our review of published, scientific literature, existing data and information do not provide an adequate basis to conclude that the use of CBD in food meets the criteria for GRAS (generally recognized as safe) status.”

U.S. Hemp Roundtable General Counsel, Jonathan Miller, told Food-NavigatorUSA: “It’s become ever more apparent that Congress needs to act expeditiously to require FDA to establish a regulatory pathway to govern food and beverage products where CBD is an additive.”  The Hemp Roundtable issued a statement saying, “This recent action by the FDA indicates the agency’s lack of urgency and reluctance to regulate CBD products, making it clear that Congress must act on behalf of our industry.”

Lollipops & Gummies

Naturally Infused was cited for its candy and coffee products. Its letter said, “For example, your CBD Lollipops, CBD Gummies, and Delta-8 THC Gummies are in forms that would be attractive to children and could easily be mistaken for traditional foods that are commonly consumed by children. Furthermore, you market other products that consumers may confuse with traditional foods for humans, including CBD Infused Sugar and CBD and Delta-8 THC Infused coffees. Therefore, there is a risk that consumers of these products, including children, will unintentionally consume CBD or Delta-8 THC ingredients. Additionally, we note that the CBD coffee products appear to contain caffeine. Evidence suggests that CBD may affect caffeine metabolism and may increase and/or prolong caffeine’s effects.”

Newhere was also cited for its products having an appeal to children. That letter stated, “FDA is particularly concerned that some of your products are in forms that are appealing to children. For example, your CBDFx Mixed Berry Gummies 1500mg, CBD Cookies with Protein 20mg, including Chocolate Chip, Oatmeal Raisin, and Peanut Butter flavors, products are all in forms that would be attractive to children and could easily be mistaken for traditional foods that are commonly consumed by children.” Newhere was also called out for making medical claims about its CBD products on its websites and in blog posts.

Infusionz was also called out for its CBD gummies, CBD fruit snacks, CBD gum, CBD candy, CBD oil/tinctures, and CBD lollipops products. Its letter said, “The use of untested drugs can have unpredictable and unintended consequences, especially in vulnerable populations, such as children. For example, children may be at greater risk for adverse reactions associated with certain drug products due to differences in the ability of children to absorb, metabolize, distribute, or excrete such drug products or their metabolites.”

CBD American Shaman’s letter also stated, “Your CBD Suckers, CBD Hard Candies, various Cookies [with] 10mg CBD per Serving, and various CBD Gummies products are all in forms that would be attractive to children and could easily be mistaken for traditional foods that are commonly consumed by children. Furthermore, your products have not been evaluated by the Agency for safety, effectiveness, and quality.”

11-11 Brands wasn’t cited for having products that appealed to children, however, the FDA had determined that the company’s Mood33 Hemp Infused Herbal Tea products were “adulterated under section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 342(a)(2)(C)(i), because they bear or contain an unsafe food additive. Furthermore, it is a prohibited act to introduce your Mood33 Hemp Infused Herbal Tea products into interstate commerce under sections 301(ll) and 301(a) of the FD&C Act, 21 U.S.C. 331(ll) and 331(a).” FDA was particularly concerned that the products are in a form (herbal tea or beverage) that consumers may confuse with traditional foods.

Legislation

The Hemp Roundtable noted that there are currently two bills that would empower the FDA to regulate CBD as a food and beverage. H.R. 6134 would ensure foods and beverages containing CBD derived from hemp conform with the current FDA requirements for food additives or be generally recognized as safe “GRAS,” while S. 1698 permits hemp-derived CBD in both dietary supplements and foods.

Hemp food products that don’t advertise CBD content have been on the shelves for years. The Hemp Food Association recently wrote, “Hempseed, hempseed oil, and hemp protein powder are Generally Recognized As Safe (GRAS) to the U.S. FDA, exempt from Novel Food registration in the European Union, and hemp products, in general, are exempt from the U.N. Single Convention Treaty on Drugs. They need no further approvals or certifications from any government in the U.S., Canada, or E.U. In other words… legal!” However, when CBD gets pulled into the mix that’s when the FDA steps in with its warning letters.


Adam JacksonAugust 10, 2022
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7min1370

Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE) posted positive results as the company continues to further its research and development goals — with signs of a FDA approval looming in the distance. The cannabis biotech company reported financial results for the second quarter ending June 30, 2021,

Research and development expenses were $5.4 million for the second quarter of 2022, the company said, including stock-based compensation of $0.5 million. General and administrative expenses were $3.7 million in the second quarter this year, including stock-based compensation expense of $0.6 million. As an emerging biotech company, Zynerba does not have revenue at this time as it develops drugs.

The company said that it has continued to focus resources toward developing treatment for two orphan neuropsychiatric disorders, Fragile X syndrome and 22q Deletion Syndrome.

“During the second quarter, we were pleased to announce positive top-line results from our Phase 2 trial of Zygel in patients with 22q,” said CEO Armando Anido. “In addition to further progressing 22q, we are focused on completing the Phase 3 RECONNECT trial for children and adolescents with Fragile X syndrome, with top-line results expected in the second half of 2023.”

With a cash runway extending past expected availability of top-line results from our RECONNECT trial, we remain well-positioned on achieving our goal of bringing the first pharmaceutical product indicated for the treatment of behavioral symptoms of Fragile X syndrome to market.”

This echoes Zynerba’s belief that the results from RECONNECT, if positive, will be sufficient to support the submission of a New Drug Application (NDA) for Zygel in patients with Fragile X syndrome.

The company also said it plans to meet with the U.S. Food and Drug Administration (FDA) to discuss the data and the regulatory path forward for its open label Phase 2 INSPIRE trial of Zygel in children and adolescents with 22q Deletion Syndrome — also called DiGeorge syndrome, a chromosomal disorder with no known cure that results in poor development of several body systems.

The company said it plans to move forward in 22q as an orphan indication and has previously received orphan drug designation from the FDA for cannabidiol, the active ingredient in Zygel, for the treatment of 22q.

While data from the company’s ASD clinical development program to date are compelling, given the difficult financing market, the company has deferred the start of the Phase 3 development program in ASD as it has prioritized its resources on FXS and 22q in the near term.

Net loss for the second quarter of 2022 was $9.9 million, with basic and diluted loss per share of $0.24 cents. Cash and cash equivalents were $62.5 million, versus $67.8 million as of December 31, 2021.

In May, the company entered into a Controlled Equity Offering Sales Agreement — with Cantor Fitzgerald & Co., Canaccord Genuity, LLC, H.C. Wainwright & Co. LLC and Ladenburg Thalmann & Co. Inc. as sales agents — in which the company may sell, from time to time, up to $75 million of its common stock.

Zynerba then sold and issued 488,892 shares of its common stock in the second quarter under the agreement in the open market — resulting in gross proceeds of $0.9 million and net proceeds of $0.8 million, after deducting commissions and offering expenses.

After that, from July 1, 2022 through August 8, 2022, the company sold and issued 1,469,714 shares of its common stock under the agreement in the open market resulting in gross proceeds of $1.8 million, and net proceeds of $1.6 after deducting commissions and offering expenses.

Zynerba also struck an equity purchase deal last month for up to $20 million with Chicago-based firm Lincoln Park Capital Fund (LPC).

Lincoln Park Capital is expected to provide financial flexibility and is aligned with Zynerba’s long-term strategy for value creation, the company said.

Zynerba said it plans to use any net proceeds from the sale of its common stock to LPC for working capital and general corporate purposes, including research and development expenses and capital expenditures.

Management believes that the Company’s cash and cash equivalents are sufficient to fund operations and capital requirements through the end of 2023 or into early 2024, after the expected availability of top-line results from its confirmatory pivotal Phase 3 RECONNECT trial of Zygel in patients with FXS.


Dave HodesJuly 28, 2022
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9min2800

Among the four Food and Drug Administration (FDA) pathways for developing new drugs faster are Fast Track, created in 1997, designed to expedite the review of drugs to treat serious conditions and fill an unmet medical need; and Breakthrough Therapy, created by the FDA in July 2012, a process designed to expedite the development and review of drugs that are intended to treat a serious condition, where “preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).”

There have been no psychedelic compounds listed on the FDA’s fast-track approval list (but oxycodone made the list in 2016), and just a few listed on the FDA’s breakthrough therapy list, such as the Compass Pathways’ (NASDAQ: CMPS) psilocybin therapy for treatment-resistant depression in October 2018, and the Janssen Pharmaceuticals’ Spravato in March 2019.

All four FDA expedited drug development pathways are designed to overcome the problems of the long process of drug development, in part fueled by the AIDS epidemic when researchers had called for quicker review and development of drugs by the FDA.

In the 1960s and 1970s, clinical development of a new compound through marketing approval took respectively 7.9 years and 8.2 years, on average, according to one study.

Real World Evidence

While the development process is designed to ensure efficacy and safety, there is a new and growing acceptance of a new process of advancing drug development based on the rapid accumulation of data, which may soon be working with the randomized clinical trial (RCT) process—it’s called real-world evidence, or RWE.

The FDA promoted the use of RWE for a faster pathway to developing Covid vaccines beginning in September 2021 in a process that continues today.

Another example of RWE effectiveness was demonstrated in a recent study of the outcomes of ketamine from patients treated in 178 participating independent community ketamine practices across the U.S.—a setting that offers significantly different outcomes compared to patients in randomized trials.

The outcomes were measured on 9,016 outpatients with symptoms of depression who received ketamine intravenous therapy (KIT) between 2016 and 2020.

It was the largest published analysis to date examining the real-world effectiveness of a standard KIT induction protocol for depression using data from patients treated at community clinics across the United States.

One of the critical findings of the study is that a richer data set from RWE can form the basis of predictive models that directly inform clinical care. One example is how data about how medications, taken daily or as adjuncts to KIT, can modify the response. “More broadly, point of care data collection and personal sensing streams (e.g. actigraphy, or “wearables”) can establish links between self-report measures and functional health outcomes,” the study reported.

So RWE can help inform clinical care going forward. But what is the relationship now between real-world evidence and clinical trials?

The outcomes of RWE today usually get a lower credibility assignation by researchers working on RCTs. But RWE research is a practice that does not need to be done like a random clinical trial research for it to be reliable, according to another study.

Some of the advantages of RWE include less time and cost compared to RCT; research that can’t be done with RCT, such as safe research on high-risk groups; rapid access and easier information and data retrieval; and more.

The FDA sees the advantages and published draft guidance for working with RWE in September 2021. According to the FDA, RWE can be generated by different study designs or analyses from randomized trials, including large simple trials, pragmatic trials, and observational studies—all built on such real-world data (RWD) as electronic health records, product and disease registries, patient-generated data including in-home use settings, and data gathered from other sources that can inform on health status, such as mobile devices.

As more RWD is collected, RWE is being gradually expanded, with a developing need to be more structured and use the new silos of health data being generated every day. RWE and RCT research are not in a mutually competitive relationship, a study noted. “Presently, RWE research cannot substitute RCT research. However, RCT research, bestowed the highest reliability, and RWE research, perceived to reflect the actual clinical aspect, can be proven to share a mutually supplementary relationship to become the most powerful resource in evidence-based medicine.”

Today, as spelled out in a “Forbes” article by Dr. Dan Riskin, the founder of Verantos, health systems, insurers, and pharmaceutical firms have all created RWE divisions. Insurance companies use RWE to analyze whether high-cost therapies provide sufficient benefit.

But there are still many questions to answer. For example, would an identical RCT trial and an RWE study reach the same conclusions? The FDA is looking into that in more detail, hoping to make RWEs more valid by conducting additional RCT/RWE trial emulations to add to the ten already done.

Meanwhile, progress on RWEs for psychedelics research continues. Compass Pathways is searching for an RWE manager as it further investigates the process. And one company that hopes to make headway in using RWE for developing psychedelics is Albert Labs in British Columbia. “RWE studies are a much faster and vastly less expensive way to conduct and take medicine through regulatory approval to commercialization compared to RCT trials, as evidenced in bringing Covid 19 vaccines to market,” said Malcolm Barratt-Johnson, chief medical officer for Albert Labs in a blog featured on their website.


Joanne CachaperoJuly 19, 2022
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7min4500

Cannabis research firm Brightfield Group released its CBD: FDA Impact and the Path Forward/ 2022 Mid-Year US CBD Report, which found that growth in the CBD industry is “heavily dependent” on Food and Drug Administration (FDA) regulation, though there has been little progress on federal regulation for cannabidiol (CBD) since provisions removing hemp and hemp derivatives from prohibition were passed in the Farm Act of 2018. 

“If federal regulation were to be implemented by 2024, sales are expected to reach $11.0 billion by 2027, driven by accelerated growth of ingestible products like capsules and gummies as well as increased acceptance by mainstream retailers,” the Brightside report said. “Without such guidance, the CBD market is expected to remain decidedly lower.”

CBD Needs FDA

Currently, the U.S. CBD market is expected to reach $5 billion by 2022, according to Brightside. The report then offered two scenarios – projections with FDA guidance in place by 2024, or without. Their analysis predicted more than $4 billion in growth for the CBD industry by 2027, to $11 billion with the implementation of a regulatory scheme. However, without regulation, the report predicted relatively stagnant growth over the same time period to just over $6 billion. 

Lack of FDA guidance, Brightside pointed out, presented challenges for CBD industry businesses by allowing a market environment with “a shifting product mix and competition from other hemp-derived cannabinoids, though price compression has begun to subside, and the industry is increasingly attracting attention from large firms.”

“While waiting for increased oversight, companies have been seeking to define CBD’s place in the wider wellness landscape and using tactics like creating non-CBD products that can be sold through mainstream outlets and partnering with retailers who do not sell CBD to increase distribution and reach a novel base of consumers,” the report surmised.

Charlotte’s Web CBD Gummies

Brightside said CBD product companies Charlotte’s Web (OTC: CWBHF) and Your CBD Store (SunMed) were the two top leaders in company shares for the second year in a row. Charlotte’s Web saw the largest portion of industry online sales and was third in brick-and-mortar sales behind Your CBD Store (SunMed) and American Shaman. Companies that saw significant gains in Q1 2022 included High Tide and Heavenly Rx/Simply Better Brands. 

Grocery store sales of CBD products grew 18 percent since 2021, with $131 million in sales predicted for 2022. Brightside called grocery companies “risk averse” in regards to CBD products, resulting in marketing challenges for ingestible CBD products. Topicals will account for more than 41 percent of grocery store CBD product sales in 2022, with tinctures a distant second place at just over 19 percent. With FDA guidance, the report said, the ingestible CBD product market was set to boom.

Hope Fades

Pundits and industry experts are not hopeful for any federal regulations to come from the agency any time soon. Though four years have passed since the hemp provisions were approved in the Farm Bill, only one CBD-based pharmaceutical application has been approved by the FDA; Epidiolex, which was developed to treat seizures associated with a severe form of pediatric epilepsy. 

The FDA has said there is not enough data or research on CBD (or other cannabinoids) to allow comprehensive guidance for the industry. The COVID-19 pandemic also apparently slowed progress for the agency, as it prioritized vaccine approval over the last two years. 

An open day-long meeting in mid-June was held by the Science Board to the FDA to discuss the challenges to evaluating cannabinoids as dietary supplements or food ingredients, as well as safety reviews and concerns regarding toxicity possibly associated with consistent consumption of large amounts of CBD. The agency claims concerns are based on data gathered during the approval of Epidiolex. CBD industry leaders said the meeting provided only more delaying tactics from the FDA. 

In February, the appointment of new FDA Commissioner Robert M. Califf, M.D., gave attorney Blair Gue of Rogoway Law, a glimmer of hope for progress. Comments from Califf, though, were nonspecific regarding when FDA guidance on CBD may be forthcoming. Gue pointed out that continued pressure on the agency was needed from CBD industry companies. 

“Though Commissioner Califf could not provide a plan or timeline for the adoption of hemp or CBD regulations, he did express a strong desire to work with Congress on the subject moving forward.  Given Commissioner Califf’s comments about his willingness and desire to make real progress on the FDA’s industrial hemp product and derivative regulations, now is the time for the industrial hemp community to apply pressure to ensure that he actually does so,” she said. 


Debra BorchardtJune 24, 2022
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9min10310

The Food & Drug Administration (FDA) decided to ban the popular vape product Juul and issued a marketing denial orders (MDOs) to JUUL Labs Inc. for all of its products currently marketed in the United States. That’s a long-winded way of saying the products are now banned. The company must stop selling and distributing these products. The ban doesn’t mean that people who continue to use Juuls or have them in their possession will get into trouble, the product just can’t be sold. 

In addition, those currently on the U.S. market must be removed, or risk enforcement action. The products include the JUUL device and four types of JUULpods: Virginia tobacco flavored pods at nicotine concentrations of 5.0% and 3.0% and menthol-flavored pods at nicotine concentrations of 5.0% and 3.0%. 

“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” said FDA Commissioner Robert M. Califf, M.D. “The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.”

What trigged the FDA response was the company’s lack of data regarding the toxicological profile of the products. “In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data – including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods – that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications.”

Cannabis Industry Worries

Vaping products in the cannabis industry are hugely popular, so the ban has attracted a great deal of attention among producers. Seattle-based data-analytics firm Headset recently reported that vapes were the second-largest category by revenue behind flower in the U.S. cannabis market during 2020 and 2021. The category logged nearly $2.6 billion in retail sales across six adult-use markets last year. Vape pens are also growing with sales rising 28% in 2021. Despite the sustainability issues, disposable vapes are proving to be very popular as well growing by 64%. Likely because disposable vape products tend to be cheaper. 

Arun Kurichety, chief operating officer and general counsel of Petalfast said, “ While the FDA’s decision to prohibit Juul from marketing its products in the US does not directly impact the cannabis industry, it suggests we may continue to expect scrutiny on all vaping products — nicotine and cannabis alike. For licensed businesses in the highly regulated cannabis industry, this shouldn’t be huge news. Rather than prohibition, this further highlights the need for consumer education regarding the risks of obtaining vape products in the illicit markets where product testing for safety is non-existent.”

E-cigarettes were originally hailed as an effective way for nicotine-addicted consumers to inhale with fewer terrible side effects. Tobacco companies all created versions for their tobacco-smoking customers with limited success. Yet, when Juul began marketing cotton candy flavored nicotine vapes, teens and young adults swarmed the products. Instead of helping already addicted adults, it created a whole new generation of Juul-addicted consumers. Parents complained and the FDA jumped in to address the situation. At first, it was just a clamp down on the flavors, but now it is banning the entire product line. 

Cannabis vapes also proved to be a nice option for consumers who didn’t want to smoke regular flower. Cannabis vapes were discreet, easy to carry, and didn’t create the distinct smell that burned flower did. They could be expensive, but cannabis consumers were willing to spend money for the convenience of being able to pop a vape in their pocket and ramble on. 

Arnaud Dumas de Rauly, CEO and co-founder of the Blinc Group said, “If the FDA took the time to look at the science surrounding vaping instead of having knee jerk reactions to statistics over youth consumption, they would see that vaping has been beneficial to countless individuals looking to quit smoking. For years, the European markets have embraced vape as such a necessary tool for the cessation of smoking that they offer health insurance breaks to those who vape.”

He went on to add, “If you look down the road to what this decision could mean for the cannabis vape industry, the federal illegality of cannabis will keep the space safe for now since the FDA is unwilling to regulate the industry while it remains a schedule one drug. However, this doesn’t mean that will be the case forever. I would hope when that time comes that the FDA will recognize that vape is considered one of the safest consumption methods, particularly for medical patients who are looking for the purest stream of cannabinoids and terpenes, and the absence of combustion means less hazardous substances and it’s easier on the lungs.”

A Post Juul World

One company that the trouble has already impacted in the Juul market is Greenlane (NASDAQ: GNLN). At one point in 2019, Greenlane was selling almost $50 million worth of Juul products. With the first ban on flavored products, sales fell over 30% to $33 million in 2020. Just this week, Greenlane noted that it was selling off assets in order to generate cash. The company has been weaning itself off its Juul dependence, but $50 million is a big number to make up elsewhere. 

In Closing

Juul has said it will appeal the ban and try to keep its products on the shelves while it fights the ban. Cannabis vapes may luck out purely due to the fact that the FDA can’t decide what to do about the federally illegal product.  Since the FDA can’t seem to make a decision on CBD products, tackling cannabis vape pens seems unlikely. Cannabis consumers haven’t been complaining about the product as evidenced by the growing sales. Like Dumas noted, the FDA was mostly reacting to angry parents of Juul-addicted teens. In the cannabis industry, not many people are complaining and that seems to have kept the product off the radar for now.


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