MjLink Cannabis Business News and Press

CHICOPEE, Massachusetts, September 27, 2021 - PRESS RELEASE - This year marks the 50th anniversary of the War on Drugs. Racial inequality has been a pervasive theme in these policies resulting in disproportionate persecution of minorities for decades. The "Reimagining Community Days" event seeks to bring transformative justice to those who have been affected by it most. 

Today, in the commonwealth, where cannabis is legal, nearly $2 billion has been generated through cannabis sales. However, none of those funds are allocated towards sealing criminal record information (CORI) records or expungements for those disproportionately affected by the War on Drugs. With the support of Theory Wellness, the Massachusetts Recreational Consumer Council (MRCC) is working to change that with their "Reimaging Community Days" event.

The event will be held at Theory Wellness' Chicopee dispensary on Sept. 30. It will offer free legal counseling for expungements, sealing CORI records, wraparound services, and cannabis health consultations for registered attendees previously subject to cannabis-related crimes.

In today's industry, expungements and CORI sealing are critical to healing the past woes of the War on Drugs, especially here in Massachusetts. Those who still have these records are prohibited from obtaining a license to work in the cannabis industry, prolonging systemic racial inequality. The event will help bridge that gap by bringing much-needed education and awareness to support those who need it. 

The event is open to those with past or present criminal cases filed against them in court or a criminal record CORI relating to a cannabis-related offense. Theory wellness will be offering free Uber services to and from their location for all who wish to attend. Those who are interested should pre-register for the event using the following link. 

Date: Sept. 30, 2021Time: 12:00 p.m. - 3:00 p.m.Registration: Attendees are encouraged to sign up in advance hereFree Ubers will be provided via the link following registrationLocation: Theory Wellness, Chicopee Dispensary (672 Fuller Rd. Chicopee, MA 01201)

 

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After running pre-employment cannabis tests for years—and going so far as to terminate employees for cannabis use—the online retail giant Amazon has been on a sudden tear of support for the industry over the past few months. Beginning with applause for the Cannabis Administration and Opportunity Act (CAOA), the company is now getting behind the industry and doing away with its prohibitive policies.

Assistant Editor Andriana Ruscitto reports this week: While the company has begun to remove pre-employment cannabis screenings, it has also decided to “reinstate employment eligibility of both former employees terminated due to receiving a non-negative Tetrahydrocannabinol (THC) result during random drug tests, as well as applicants that were deferred for the same reason during standard pre-employment screenings.”

As the industry knows, however, embracing former opponents with open arms is not an automatic response to this sort of about-face. Amazon is a powerful private business with its own interests, some of which may indeed intersect with cannabis in the coming years (particularly following the passage of some federal reform like the CAOA). Until then, a bit of cautious optimism and low-key intrigue is warranted with news like this.

We’ve rounded up some of the key cannabis headlines from the week right here.

Canadian cannabis giant Aurora Cannabis is grabbing headlines this month due to a class-action lawsuit and news that the company will shutter its Aurora Polaris facility in Edmonton, Alberta. Senior Digital Editor Melissa Schiller reports on the news. Read more Amazon has publicized its continued support to refine the nation’s cannabis policy. The organization declared its support for the Cannabis Administration and Opportunity Act (CAOA), a federal draft bill that would end cannabis prohibition, as it “makes a number of important changes” the company stands by. Read more In week three of “Operation Hammer Strike,” the San Bernardino County Sheriff’s Department (SBSD) Marijuana Enforcement Team (MET) and deputies from several other patrol stations arrested 31 suspects last week that were tied to illegal cannabis grows. Read more Among the 185 cannabis dispensary licenses recently awarded by the Illinois Department of Financial and Professional Regulation (IDFPR), 75 were reserved for top-scoring applicants in what was intended to be a competitive licensing process. That presents a dilemma. Associate Editor Tony Lange has the story. Read more 

And elsewhere on the web, here are the stories we’ve been reading this week:

KOMO News: “Washington requires a criminal background check for applicants who want a license to sell or grow cannabis. Under current rules, anyone with a felony or a few misdemeanor convictions is ineligible. That changes next month.” Read more Mississippi Today: “Legislative negotiators and leaders have agreed on a draft of medical marijuana legislation, and are anticipated to ask Gov. Tate Reeves … to call the legislature into special session.” Read more News on 6: “About 300 Oklahoma medical marijuana businesses, all with the same co-owner, suddenly lost their licenses recently, prompting numerous legal battles.” Read more KOCO: Also in Oklahoma, “multiple law enforcement agencies dismantled a large outdoor marijuana grow operation in Major County.” Read more Voice of San Diego: The San Diego Country Board of Supervisors will consider “the full scope of a countywide cannabis ordinance that got the greenlight this past January in a 4-1 vote. The details of what that will look like in practice are still being hammered out, but there is an expectation that there will be a social equity provision in the ordinance.” Read more 

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When Wanda James was working to open her first cannabis dispensary over ten years ago, she was poised with many stressors, such as raising capital and worrying about not going to jail in the midst of it.

In 2009, James and her husband, Scott Durrah, opened the first Black-owned dispensary in Denver, Colo., the Apothecary of Colorado. And in 2010, the couple launched Simply Pure edibles and became the first African Americans in the state "licensed to own a dispensary, a grow operation and an edibles company," Cannabis Dispensary previously reported.

The cannabis industry was in a "very different place back then," James said. Not only did she have to stress about acquiring funding, but she also had to worry about the negative comments she would get from others on how she was making a wrong decision.

"In 2009, I remember The Denver Post wrote an article called 'Coming Out of The Cannabis Closet,’ and I got so many phone calls from all of the politicians that I work with and business people telling me that life as I knew it was over, [and] I ruined my reputation," James said. "And that was a real thing."

James expressed that the money involved in opening a dispensary in 2009 was first and last month's rent payment, a security deposit, and whatever extra money owners wanted to put into the business.

 Simply Pure Dispensary in Denver, Colo.

"We've always been able to have outside investors," she said. "We just had to go through a bunch of ridiculous gymnastics to make it happen, which means we had to take money in as a personal loan to the owners of the dispensary. Then, the owners could put that money into the dispensary and then pay back the investors through a personal loan or a lien on their house. So, we've always had that ability, but now we just have the legal, straight-up ability to be able to take that money."

New rules that take effect in Washington Oct. 2 will allow those with past convictions to pursue cannabis licenses, according to a local KXLY.com report.

Under the existing regulations, a felony conviction in the past 10 years disqualifies applicants seeking cultivation, processing and retail licenses, the news outlet reported.

Recent misdemeanor convictions, as well as not disclosing misdemeanor or felony convictions on the application, also count against applicants under the current set of rules.

When the new regulations take effect next month, a serious felony conviction in the past decade will still spark an in-depth review of the application, but it will no longer be a non-starter in the licensing process, according to KXLY.com.

In addition, one Class C felony on an applicant’s record, or less than three misdemeanor convictions in the past three years, will not prompt a deeper review of the application under the new rules, the news outlet reported.

Mississippi lawmakers have been working on legislation to legalize medical cannabis to restore the will of their constituents after the state’s Supreme Court overturned a voter-approved medical cannabis ballot measure in May.

After a summer of negotiations, legislative leaders have reached a deal on a medical cannabis bill, according to a Mississippi Today report, and plan to ask Gov. Tate Reeves to call the Legislature into a special session to consider the proposal.

Reeves has said in the past that he would call a session for a medical cannabis bill as long as he and lawmakers agree on the legislation, the news outlet reported.

House Speaker Philip Gunn said during a Sept. 23 interview on a Supertalk radio show that he believes the House and Senate have the votes to pass the legislation, according to Mississippi Today.

Under the current proposal, cities and counties could opt out of allowing medical cannabis businesses within their jurisdictions, the news outlet reported, but voters could then gather 1,500 signatures or signatures of 20% of voters—whichever is less—to get a referendum on the issue and potentially opt back in. If the referendum ultimately fails, voters could try again in two years. Once a referendum to opt in to the medical cannabis market is approved by voters, a municipality could not ban it again, Mississippi Today reported.

Governor Phil Murphy said he believes New Jersey adult-use cannabis sales will begin next year in the first or second quarter. https://headynj.com/governor-murphy-says-new-jersey-adult-use-cannabis-sales-start-winter-or-spring-2022/ 

Canadian cannabis giant Aurora Cannabis is grabbing headlines this month due to a class-action lawsuit and news that the company will shutter its Aurora Polaris facility in Edmonton, Alberta.

The suit, originally filed in late 2019 and amended in a U.S. District Court in New Jersey on Sept. 7, alleges that Aurora employed a fraudulent scheme to inflate one of its 2019 quarterly earnings results. This scheme, the plaintiffs claim, involved Aurora selling millions of dollars’ worth of cannabis back to itself through Radient Technologies, an Edmonton-based cannabis extraction company that Aurora had “significant influence over,” according to the complaint.

Aurora has a 12% ownership stake in Radient Technologies, as well as a seat on its board, as noted in the complaint.

In a June 2019 deal with Radient Technologies that “lacked commercial substance,” according to the complaint, Aurora allegedly sold $21.7 million worth of dried cannabis to Radient Technologies and then repurchased that same amount of product back from the company in a scheme that the plaintiffs claim artificially inflated Aurora’s 2019 fourth quarter adjusted earnings.

The lawsuit claims that Aurora then continued to misrepresent the true condition of the business, “causing the prices of Aurora’s common stock to be artificially inflated,” according to the complaint.

North Carolina lawmakers have indicated that a vote on the NC Compassionate Care Act, a medical cannabis legalization bill, may be postponed until 2022 as the Legislature focuses on the state budget and redistricting process during the final months of this year, according to a local WNCN report.

The legislation, Senate Bill 711, cleared the Senate Judiciary Committee in June, and then passed the Senate Finance Committee before heading back to the Judiciary for a second review.

After addressing an amendment containing several technical changes to the legislation, the Senate Judiciary Committee passed the bill a second time before sending it to the Health Care Committee, which signed off on the legislation at the end of August.

Despite the building momentum, some of the lawmakers behind the bill have said there are still some issues they are trying to resolve before bringing the legislation to the Senate floor for a vote, WNCN reported.

“There’s far more moving parts to this thing than I thought there was when we began,” Sen. Paul Lowe (D-Forsyth), one of the bill’s sponsors, told the news outlet. “We want to make sure we get it right.”

A host of new laws will take effect in Connecticut Oct. 1, including some that include new rules for the state’s existing medical and forthcoming adult-use cannabis markets.

Gov. Ned Lamont signed an adult-use legalization bill in June, and the new cannabis law includes several changes to the state’s smoking restrictions for cigarettes, cigars and vaping, according to the Hartford Courant.

New rules prohibit smoking within 25 feet of buildings that serve the public, such as restaurants and retail stores, the news outlet reported. The new law also prohibits smoking in hotels, motels, prisons and psychiatric facilities.

In addition, communities with more than 50,000 residents must designate an area for cannabis use, such as a section of a park, according to the Hartford Courant.

While the new law allows people to smoke cannabis anywhere that they are permitted to smoke cigarettes, towns can draft their own rules based on local zoning regulations, the news outlet reported.

NEW YORK, Sept. 21, 2021 – PRESS RELEASE – Dispense, a leading digital dispensary management platform, announced the completion of its $2 million seed funding. The round of investment is led by NextView Ventures with NextView co-founder, Lee Hower, joining the Dispense board. Leading cannabis VC's Poseidon Asset Management and Achari Ventures participated, along with Arrive, a Roc Nation company, and Wayne Chang.

Dispense is one of the fastest growing software companies in the cannabis space. The platform is currently used by dispensaries in five states, including Illinois, Michigan, Ohio, New Jersey and Massachusetts. Since its beta launch in August 2020, Dispense has processed over 1.5 million orders, with an order value of over $200 million with only two employees. Co-founders Kyla Moore and Tim Officer plan to use the funding to hire top talent, continue developing and enhancing their product, and scale their sales and marketing efforts.

Prior to launching Dispense, Moore and Officer founded Tablelist and TablelistPro, an online ticketing, reservations and venue management software for nightlife and events. When nightlife and in-person events stopped due to the pandemic, the team pivoted and repurposed the software to help cannabis dispensaries manage their customer purchases and pick-ups.

"What makes Dispense unique is that our software is built to empower our dispensary partners, giving them simple-to-use tools to not only take online orders but to build and maintain direct customer relationships, optimize their sales, and streamline their operations," said Moore, who serves as the company’s CEO. "This new funding will allow us to grow our team, expand into more states and continue to build features that align with the needs of the dispensaries and their customers."

Dispense differentiates itself from other online dispensary management platforms by giving retailers 100% ownership of their customer data, online orders and order details. Dispense gives business owners the tools to connect, build, and nurture relationships to create loyal and lasting customers. The platform is used by some of the country's top dispensaries, including Ascend Wellness, a leading retailer in the Midwest and East Coast.

"Our experience using Dispense so far has been great," Ascend Wellness founder and CEO Abner Kurtin said. "Their hospitality and customer-centric approach to building the software has made it both intuitive and easy to use. Dispense e-commerce and order management software is an important part of our customer service experience at Ascend."

Portland, OR -- PRESS RELEASE -- The Oregon Liquor and Cannabis Commission has issued a mandatory recall for a product labeled as a hemp tincture that can get consumers “high” because the product contains undisclosed levels of THC. Consumers using this mislabeled product may become unexpectedly impaired.

The recall is for an item labeled as a hemp CBD tincture produced by Cura CS, LLC, and sold under its Select brand. The specific batch of this product Select CBD Drops “Broad Spectrum” Unflavored 1000 MG CBD was only available for purchase through OLCC licensed retailers. Photos of the recalled product and packaging are at the bottom of this press release.

The OLCC has notified cannabis retailers about the recall, and has put a hold on the product in the OLCC cannabis tracking system to prevent further sales from OLCC licensed retailers.

The recall affects this specific product produced on May 14, 2021. The OLCC estimates approximately 500 units have been sold starting June 19, 2021 and about 200 units remain in the inventories of OLCC retailers and those items are required to be quarantined.

Customers who have purchased this product can either return it to the OLCC licensed retailer they purchased it from or destroy the product.

As cash pertains to cannabis, the supermajority consensus in the U.S. House of Representatives is that federal regulators should not penalize depository institutions for providing banking services to legitimate cannabis-related businesses.

That consensus was unveiled during a 321-101 vote in April, when the Secure and Fair Enforcement (SAFE) Banking Act cruised to bipartisan passage in the lower chamber, which has indicated time, and time again, that the federal government has a responsibility to provide safe harbor to financial institutions servicing the industry.

But that was a standalone bill, which has yet to make progress in the Senate.

The question on Sept. 21 in the House was whether SAFE Banking should be attached as an amendment to the National Defense Authorization Act (NDAA) spending package for fiscal 2022.

While Rep. Mike Rogers, R-Ala., supported SAFE Banking as a standalone bill five months ago, he said Tuesday night it had no business hitching a ride with NDAA. Rogers is the ranking member of the House Armed Services Committee, which works hand in hand with NDAA.

“This is a fine piece of legislation in a standalone fashion,” Rogers said. “In fact, I voted for the gentleman’s standalone bill. I think what he’s trying to accomplish is admirable and should be accomplished, but not in the National Defense Authorization Act.”

Amazon has publicized its continued support to refine the nation’s cannabis policy.

In a recent press release, the organization declared its support for the Cannabis Administration and Opportunity Act (CAOA), a federal draft bill that would end cannabis prohibition, as it “makes a number of important changes” the company stands by.

RELATED: Industry Experts, Stakeholders Offer Their Takes on Cannabis Administration and Opportunity Act

"First, we support removing cannabis from the Controlled Substance Act,” said Brian Huseman, Amazon vice president of public policy. “Doing so will open significant new economic opportunities for millions of capable individuals while beginning to restore some of the damage done to highly affected communities.”

Huseman said the company believes Congress should eradicate non-violent cannabis convictions and grant resentencing for individuals currently convicted on such charges. 

"For far too long, criminal marijuana provisions have been unequally enforced upon people of color, perpetuating over-incarceration, poverty, health conditions and other barriers to economic opportunity,” Huseman said. “We believe it’s necessary to expunge these crimes that our society has borne on the shoulders of communities of color. And as the nation’s second-largest employer, we support expungement to ensure that all capable individuals have a fair opportunity to seek and secure employment wherever they choose. Finally, we support community reinvestment grants, which can have a positive impact in pursuit of social justice.”

In week three of “Operation Hammer Strike,” the San Bernardino County Sheriff’s Department (SBSD) Marijuana Enforcement Team (MET) and deputies from several other patrol stations arrested 31 suspects last week that were tied to illegal cannabis grows.

As previously reported by Cannabis Business Times, Operation Hammer Strike is “an investigation to attack the existing unlawful cannabis cultivation in San Bernardino County, Calif.”

In week one of the investigation, officials served warrants for four California cities, arrested 12 individuals, and discovered more than 10,000 illegal cannabis plants and roughly 1,335 pounds of processed cannabis. 

In week two of the operation, from Sept. 6-10, deputies served 23 search warrants throughout various Southern California cities. They found “21,002 [illegal] marijuana plants, 5,628.5 pounds of processed marijuana, nine guns [and] over $9,000 in cash.” The department also liquidated 113 greenhouses found throughout the locations, according to a press release from the SBSD headquarters.

In week three of the investigation, law enforcement served 31 search warrants after receiving “numerous complaints about large outdoor marijuana cultivations in these areas,” the SBSD headquarters said in a press release.

The department seized nearly 30,000 illegal cannabis plants, 6,000 pounds of processed cannabis, about $19,000 in cash and decimated 138 greenhouses found throughout the locations.

If there is such a thing as a perfect business plan in adult-use cannabis retail, it involves teams that are majority owned by military veterans—at least that’s the standard in Illinois. 

Among the 185 cannabis dispensary licenses recently awarded by the Illinois Department of Financial and Professional Regulation (IDFPR), 75 were reserved for top-scoring applicants in what was intended to be a competitive licensing process.

The dilemma?

KPMG, the global accounting firm that IDFPR bestowed a no-bid contract worth $4.2 million to grade the applications, awarded 21 groups perfects scores. In turn, the 75 licenses reserved for the top-scoring applicants were to be divvied up among those 21 groups. Overall, 937 candidates submitted 4,518 applications seeking those 75 licenses, according to the Chicago Sun Times.

While there was a cap on how many licenses applicants could win, which was 10, there was no cap on how many times applicants could apply. The 21 groups with perfect scores collectively submitted more than 300 applications.

The kicker?

San Juan Capistrano, Calif., Sept. 21, 2021 – PRESS RELEASE – Packwolves, an on-demand cannabis packaging platform, announced its public launch, unveiling a collaboration with Mohave Cannabis Co., an Arizona and California-based cannabis brand with quality cultivation and premium indoor flower products. In addition to designing and manufacturing custom packaging and products, Packwolves also allows manufacturers to purchase pre-designed, child-resistant packaging for faster deployment of their cannabis products.

The company’s collaboration with Mohave Cannabis Co. came through a jointly designed custom-produced glass jar inspired by the design and feel of fine spirit bottles. The rounded square jar features embossed letters and convex inner glass which magnifies the jar's contents, providing a deeper look at the nuances of the product. The jar also features a dark, oak-pattern, child-resistant lid with an air-and-water-tight “twist and seal” feature that keeps cannabis more potent, longer than other products in the industry.

View photos of the collaboration and Packwolves' work here.

“There is frankly nothing else like this on the market,” said Curtis Devine, owner and founder of Mohave Cannabis Co. “Our collaboration with Packwolves delivers an experience that’s as curated, nuanced and sophisticated as the product itself.”

Packwolves was founded by Tom Vickers, who left product design in the advertising world to pursue his passion of helping cannabis companies grow and market themselves. The company brings a design-forward approach to the cannabis industry, helping both newcomers and established companies quickly create high-quality packaging, swag and other products.  
 
“With more and more states legalizing the use of cannabis, too many entrepreneurs must resort to a piecemeal approach to deploying their branded products, such as buying packaging, boxes and product stickers from various vendors on Amazon,” Vickers said. “We are confident that our distinctive, one-stop solution will be a welcome resource for many manufacturers.”

In addition to custom packaging solutions, Packwolves offers pre-designed pouches for quick deployment of products. The company also offers packaging programs for products, such as: Jar & Box, Jar & Paper Tube, Pouch & PET Insert, and Pouch & PET Insert for Pre-Rolls, among other options. They also have an expert internal design team that can aid customers in launching a brand.
 
In addition to pre-designed products, Packwolves offers customizable pouches, jars, folding boxes, magnetic boxes, paper tubes and shipper boxes as well as swag items such as customizable rolling trays, ashtrays and carabiners.

“Design can elevate the image of cannabis,” Vickers said. “We’re building a design-forward platform that can positively influence and educate the public about the often-stigmatized cannabis plant.”
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Black-owned cannabis brand Viola has launched its own education platform to bring a “new wave of talent” to the cannabis industry, according to CEO Al Harrington.

The Harrington Institute, powered by the Cleveland School of Cannabis, another Black-owned business in the space, aims to remove a common barrier to entry for Black individuals looking to enter the cannabis industry: education.

“We just don’t have the fundamental education to understand the industry,” Harrington tells Cannabis Business Times and Cannabis Dispensary. “We see how negatively it impacted our communities for so long, [and] people just can’t really wrap their head around [the fact] that [they] can actually do this legally and make a career out of it.”

The Harrington Institute’s curriculum aims to help students learn both the technical aspects of growing, processing and selling cannabis, as well as the business side of the industry, so they can ultimately decide how they can best participate in the growing marketplace.

“I just felt like this was something that was really needed, and the fact that I could work with people who look like me was something I was really, really excited about,” Harrington says. “When I think about the opportunity to really usher in the next wave of talent in the cannabis industry, I really feel like we haven’t been tapped into it yet.”

The New Jersey Cannabis Regulatory Commission (CRC) adopted its first set of rules for the state’s adult-use cannabis industry last month and had 30 days to begin accepting and processing business license applications—a deadline that came and went Sept. 18 without the agency taking action.

The CRC approved a new licensing platform to help regulators process applications from potential cultivators, manufacturers and retailers at a Sept. 14 meeting, according to an NJ.com report, but the statutory deadline for the agency to actually launch the application process passed Saturday without the agency releasing the applications to entrepreneurs.

A CRC source told NJ.com that although officials did not meet the deadline—and will not open the application process in the coming days—the commission plans to publish a notice in the New Jersey Register with the start date for application filing and the necessary materials that an applicant needs to submit to comply with a process outlined in the CRC’s adult-use regulations.

RELATED: First Set of Adult-Use Cannabis Rules Approved in New Jersey

New Jersey’s adult-use cannabis law requires the CRC to set a date within 180 days of adopting its final regulations for the first sales to launch, and according to NJ.com, the delay in the start of the state’s business licensing process exacerbates doubts already in place that newly-licensed adult-use operators could open their doors—let alone get plants in the ground—by early next year as planned.

California Gov. Gavin Newsom survived a statewide recall vote by a wide margin, but now the hard work of building a successful, accessible cannabis industry only continues for him and his administration. We spoke with attorney Jared Schwass on “Beyond the Show” this week about what that means—and what we should be watching in the months ahead. https://www.cannabisbusinesstimes.com/article/beyond-the-show-jared-schwass-cannabis-conference-episode-14/

The issues that Schwass highlights—tax rates and retail licensing, among others—are things that we’ve written about at length in Cannabis Business Times and Cannabis Dispensary. They are the important tentpoles of regulation that states across the U.S. are continuing ato dial in, getting closer in some cases to a more equitable industry. The recall election, in the context of the cannabis space, only serves to remind us how important it is to hold powerful politicians accountable when the health of the industry is on the line, whether it’s Newsom or anyone else.

We’ve rounded up some of the key cannabis headlines from the week right here.

Dark Heart Nursery found that upwards of 90% of California cannabis growers are contending with hop latent viroid (HpLVd). We took a close look at what that means. Read more A bipartisan group of state lawmakers introduced the Michigan Cannabis Safety Act Sept. 14 to fine-tune testing, tracking and labeling regulations in the state’s medical cannabis market. Read more South Dakota lawmakers approved the majority of regulations for the state’s medical cannabis program Sept. 13, while rejecting a handful of rules proposed Gov. Kristi Noem’s administration. Read more The Alabama Medical Cannabis Commission has appointed its executive director and unveiled plans to begin cultivation next year. Read more The FDA and CDC released advisory statements on hemp-derived products containing delta-8 THC. Read more 

And elsewhere on the web, here are the stories we’ve been reading this week:

CBS News: “The World Anti-Doping Agency (WADA) executive committee announced on Tuesday it will review cannabis' status as a banned substance. The announcement came two months after U.S. sprinting star Sha'Carri Richardson was disqualified from the Tokyo Olympics for using marijuana after she had learned that her mother died.” Read more BBC: “Three men who ran what police described as the biggest marijuana-growing operation ever found in Lincolnshire [in England] have been jailed.” Read more WEWS: “Ohio is watching two separate paths to adult-use legalization develop, one through the traditional legislative process and the other through an initiated statute by a group called Coalition to Regulate Marijuana like Alcohol.” Read more Petoskey News-Review: “A vote by the Gaylord City Council has settled a dispute between two organizations that have devoted resources to building a brand involving the word ‘rise’ — at least for the moment.” Read more KOB4: “Growers across the state are ramping up for the anticipated demand coming April 1 with the legalization of recreational marijuana sales [in New Mexico].” Read more ]]>

In August, the U.S. Food and Drug Administration (FDA) maintained its position that CBD in any ingestible form is subject to the drug preclusion language in the federal Food Drug and Cosmetic Act via refusal letters posted regarding New Dietary Ingredient Notifications (NDIN) filed by Charlotte’s Web and Irwin Naturals, respectively. In addition to the drug preclusion position, which refers to the prohibition on an ingredient that was first studied as a drug from being a food or a dietary supplement, the FDA also expressed concern that the NDIN submissions did not adequately establish that the extracts can be safely consumed by the intended users, nor did they respond to concerns that the FDA has previously identified relative to CBD safety, including liver toxicity.

NDIN notifications are submissions intended to satisfy the FDA that the dietary ingredient—full spectrum hemp extract, in this instance—is safe for the intended use, typically based on a demonstrated history of safe use or clinical studies relevant to the ingredient. An NDIN notification must be submitted to the FDA for a dietary ingredient that was not marketed in the U.S. as a dietary supplement, prior to October 15, 1994, the date that the Dietary Supplement Health and Education Act became law.

Charlotte’s Web took the unusual step of issuing a public response to the refusals, available here, with a link to the company’s also public letter to the FDA here, which responds directly to the agency’s criticisms of the data provided and alleging factual inaccuracies in its response.

For anyone wondering what the practical implications of these refusals are, consider these highlights.

Still About Safety

The FDA has relied on the drug preclusion rationale consistently since the very early CBD warning letters but has also expressed an interest in working with the industry to explore a non-drug pathway. Two and a half years since the passage of the 2018 Farm Bill, the FDA’s recent refusals make clear that the agency has unresolved safety concerns.