Tag Archives: Curaleaf

New Jersey Gives Curaleaf A Second Chance

On April 13, 2023, The New Jersey Cannabis Regulatory Commission (CRC) announced that Curaleaf would not be able to renew their cultivation and retail licenses for adult use cannabis for violating labor rules under the state’s cannabis regulations. In a surprise reversal, the NJ CRC voted to approve the license renewals with some caveats during an emergency meeting on April 17.

According to Commissioner Krista Nash with the NJ CRC, Curaleaf did not abide by the law when it failed to recognize workers’ vote to unionize in a timely manner. She says evidence includes testimony from workers and the union. “In my opinion, Curaleaf, in several of its locations, have not complied with the mandatory labor provisions set forth in the law,” says Nash. “And that alone was reason to deny their application for renewal.”

In a press release published by Curaleaf following the reversal, the company say they will be complying with the demands set by the NJ CRC to provide documentation of its labor practices, confirm ongoing compliance and provide evidence of good faith efforts to negotiate collective bargaining agreements. “Today’s decision by the CRC Board to vacate their unprecedented action last week is an incredible victory for our 500 NJ team members and vindication for what we knew all along: Curaleaf is in good standing with the CRC and has fulfilled every requirement necessary for the renewal of our licenses,” says Matt Darin, CEO of Curaleaf in the same statement.

While the second chance comes with a number of caveats, the decision reversal is definitely unprecedented. The Board at the NJ CRC said that if Curaleaf does not comply with those demands, they have the ability to take further action at the next meeting. “Either we hold true to the law and protect the hard-working men and women of New Jersey who want fair wages and working conditions, or we can reward bad behavior and ignore these mandates for the sake of money and profits,” says Nash. “The conditions contained in these resolutions presented today offer Curaleaf a second chance to course correct.”

One Month In: New Jersey Market Starts Growing

By Cannabis Industry Journal Staff
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Just over a month ago, a handful of dispensaries in New Jersey began selling cannabis to adults over the age of 21. The state issued licenses for adult use sales to seven alternative treatment centers (ATCs), otherwise known as medical cannabis businesses already established in the state. In total, thirteen dispensaries in the state started selling cannabis to adults over 21.

The seven companies awarded adult use licenses were Ascend, Curaleaf, GTI, Acreage, Verano, Columbia Care and TerrAscend. The state’s roll out created a lot of controversy over allowing already established, larger medical cannabis businesses and multi state operators to begin adult use sales before smaller businesses and social equity applicants get licensed.

Sales totals in the first month of New Jersey’s adult use market

Earlier this week, the New Jersey Cannabis Regulatory Commission (CRC) held a public meeting where regulators discussed progress, sales totals so far, conditional license applications and more. According to the meeting notes, between April 21 and May 21, retailers in New Jersey did $24,201,875 in cannabis sales with 212,433 transactions. During the meeting, regulators considered 46 conditional license applications and four testing lab license applications.

According to NJ.com, six new dispensaries were awarded licenses to begin adult use sales. Of the six new retail locations, Curaleaf opened their Edgewater location to adult use customers and Ayr Wellness received approval to begin adult use sales at all three of their medical locations in Eatontown, Union and Woodbridge. Ascend and TerrAscend also received approval to begin adult use sales act their locations in Montclair and Lodi, respectively.

About two weeks ago, the CRC testified before the state’s Senate Judiciary Meeting to share progress on the legal cannabis market, just over a year after the CRC was established. Jeff Brown, executive director of the CRC, discussed the agency’s goals and some challenges ahead of them. Brown says the CRC will be focusing on additional rules for adult use, modernizing the medical rules, enforcing regulatory compliance and information sharing in the near future. He also mentioned a couple challenges the industry is currently facing that they wish to address, including: expanding access to capital for entrepreneurs , removing impediments to finding real estate, educating municipalities to open up opportunities for applicants and ensuring medicinal cannabis access is unimpeded by recreational sales.

“We have made great strides in all of these efforts, and when we look at how New Jersey compares against other states, we fair pretty well,” Brown told lawmakers. “Beginning recreational sales on 4/21/22 was an important milestone. But it doesn’t mark the end of the process, it marks an important step in a multi-year effort to establish New Jersey as the premier cannabis market on the East Coast.”

Curaleaf Expands in Pennsylvania

By Cannabis Industry Journal Staff
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According to a press release published last week, Curaleaf Holdings, Inc. announced the opening of two new dispensaries in Pennsylvania. Their newest location in State College opened its doors to patients this week and the company is expecting to open an new dispensary in Erie next month, pending regulatory approval.

With those two additions to the Curaleaf portfolio, the company will have 127 retail dispensary locations across the United States, with sixteen of them being in Pennsylvania. In addition to their new locations in State College and Erie, Curaleaf also has dispensaries in Altoona, Bradford, Brookville, City Avenue, DuBois, Gettysburg, Greensburg, Harrisburg, Horsham, King of Prussia, Lebanon, Morton, Philadelphia and Wayne

Just last month, they acquired Bloom Dispensaries, adding four dispensaries in Arizona, in addition to the 44 locations they already had in Florida.

“Curaleaf is excited to begin serving our newest patient communities in State College and Erie through our premium medical products and inclusive retail experiences,” says Joe Bayern, CEO of Curaleaf. “Expanding our presence within Pennsylvania enables us to further support our patients by providing them with quality products and service to make confident and informed decisions about their medical marijuana journeys.”

Curaleaf Acquires Bloom, Opens New Florida Dispensaries

By Cannabis Industry Journal Staff
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Curaleaf Holdings, Inc., a Florida-based cannabis company operating in 23 states and Europe, made two big announcements earlier this morning. First, they acquired Bloom Dispensaries for $211 million. As part of the acquisition, Curaleaf is purchasing Bloom’s four dispensaries in Phoenix, Tucson, Peoria and Sedona. They also acquired Bloom’s cultivation and processing facilities outside of Phoenix.

Bloom’s revenue last year was near $66 million, with EBITDA margins above 40%. Boris Jordan, executive chairman of Curaleaf, says the Bloom acquisition is huge for the company’s position in Arizona, a state with a billion-dollar-market. “Bloom is an excellent strategic fit for Curaleaf as it further expands our capacity and retail footprint in Arizona with an attractive set of assets, enabling us to better serve the state’s US$1.4 billion-plus annual market opportunity,” says Jordan. “Adding to these benefits, Bloom will be immediately accretive to our adjusted EBITDA margins.”

Now that they have 121 retail locations across 23 states and over 5,000 employees, Curaleaf is on a path to become one of the largest cannabis companies in the world.

On a more local level, Curaleaf also announced the launch of two new dispensaries in Tampa Bay and Largo, Florida. They now have 44 retail locations in Florida.

According to Matt Darin, president of Curaleaf, their growth strategy is continuing well into 2022. “We are excited to kick off this year continuing our momentum of expansion and growth in Florida,” says Darin. “Throughout this year our patients can expect to see Curaleaf continue to lead the Florida market with new innovative products and convenient new locations.”

Cannabis M&A in the Post-COVID Era

By Jose Sariego
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After a slow start following a disappointing 2019, M&A in the cannabis space closed 2020 with a bang, with more than $600 million in deals announced immediately following the November elections. Prospects for the New Year are expected to continue the explosive year-end trend with a backlog of nearly $2 billion in deals heading into 2021. The COVID-19 pandemic boosted sales of cannabis products, and election results opening up five new states to legal cannabis use and possible federal regulatory reform are further boosting prospects. Analysts now predict the U.S. cannabis market is poised to double by 2025.

Growth is expected to be led by multi-state operators who have achieved scale, cleaned up their balance sheets and stockpiled dry powder for roll-up acquisitions. Cannabis companies raised nearly $134 million in the two weeks before Election Day, a 185% increase over the same period last year. Most of the money flowed to multistate operators. In addition, the biggest stocks by market capitalization saw a roughly 20% bump ahead of the election and now are trading at record volumes, providing plenty of stock currency for further acquisitions.

Among the headline acquisitions last year:

  • Curaleaf continued its multi-state expansion with two of its largest acquisitions – the all-stock purchases of its affiliated cannabis oil company Select and of Grassroot, another MSO player. Curaleaf is now the largest cannabis company in the world based on annualized revenues, with annualized sales of $1 billion and operations in 23 states and 96 open dispensaries. Curaleaf also raised $215 million privately last year end for further expansion.
  • Close behind, Aphria and Tilray announced in December that they will merge, creating what they say will be the largest cannabis company in the world with an equity value of roughly $3.8 billion. The combined entity will have facilities and offices in the U.S., Canada, Portugal and Germany. The deal is expected to close during the second quarter of this year.
  • Also in December, Illinois-based Verano Holdings LLC unveiled plans to go public at a $2.8 billion valuation through a reverse takeover of a Canadian shell company. That deal followed the announcement that Verano will merge with Florida-based AltMed.
  • In addition, publicly traded New York cannabis firm Columbia Care signed a definitive agreement last month to acquire Green Leaf Medical, a privately held Maryland-based cannabis manufacturer and retailer, for $45 million in cash and $195 million in stock. The acquisition is expected to close this summer. Including Green Leaf’s inventory, the Columbia Care will operate 107 facilities, including 80 dispensaries and 27 cultivation and manufacturing facilities. Columbia Care also took advantage of cannabis fever last year by raising $100 million privately.
  • Also in December, Ayr Strategies announced it would acquire Liberty Health Sciences, one of the largest cannabis companies in Florida, for $290 million in stock, as well Garden State Dispensary, a New Jersey marijuana company for $41 million in cash, $30 million in stock and $30 million in the form of a note. This follows Ayr’s $81 million acquisition of an Arizona medical marijuana operator in November. Voters approved marijuana use in Arizona and New Jersey in November.  Ayr has completed a string of acquisitions in Nevada, Massachusetts, Pennsylvania, Arizona, Ohio and, upon the closing of December’s deals, New Jersey and Florida.

Not all cannabis companies will rely on acquisitions, however. Trulieve, as an example, has focused its efforts on Florida and organic growth. It remains to be seen whether a multi-state approach fueled by acquisitions or a single-state organic growth model will prove the more lasting. Growth and profitability in the short term likely will continue to be hampered by limits on economies of scale due to federal restrictions and differing state laws.

In light of the maturing industry and the 2019 bust, the valuation model for acquisitions in the cannabis space is evolving from one based on sales, typically associated with emerging growth industries, to a more mature industry model based on profits or Earnings Before Interest, Taxes, Depreciation, and Amortization (EBITDA). Most cannabis MSOs have stabilized and generate positive EBITDA, which justifies the evolution away from a sales-driven model.

From a legal standpoint, the same limitations that have vexed the cannabis industry for years will continue to challenge deal makers until there is greater clarity on the federal front. Institutional investor reluctance, financial industry constraints, haphazard state regulation and the unavailability of federal forums such as national copyright and trademark registration will continue to be issues for acquirers and their lawyers in the space.

Acquisition agreements will continue to have to address the federal Damocles’ sword should expected relaxation of federal enforcement under the Biden administration and further legislative relief does not materialize as expected. Although the U.S. House in December passed the “Marijuana Opportunity Reinvestment and Expungement Act” (MORE) to remove cannabis from the Controlled Substances Act, the Senate did not take up the bill in 2020 and it will have to be re-introduced in 2021. Notably, the MORE Act does not affect existing federal regulation of cannabis, such as the Food, Drug and Cosmetics Act, under which the FDA has limited the use of CBD in certain products despite hemp being removed from the Controlled Substances Act in 2018.

The cannabis M&A market is moving into a more mature phase, as MSOs will be choosier in their approach rather than continuing the land-grab mentality of years past. Due to improved financial strength, 2021 should see these MSOs continuing to expand their footprints either within existing states or new ones. Although uncertainties abound, further consolidation and expansion through add-on acquisitions is likely to continue apace in 2021, providing plenty of opportunities for deal makers and their lawyers.

The Brand Marketing Byte

The Hottest U.S. Cannabis Brands Right Now

By Cannabis Industry Journal Staff
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The Brand Marketing Byte showcases highlights from Pioneer Intelligence’s Cannabis Brand Marketing Snapshots, featuring data-led case studies covering marketing and business development activities of U.S. licensed cannabis companies.

In this week’s Byte, we’re taking a look at the hottest non-retail U.S. cannabis brands right now. Using a scoring methodology that factors in a wide variety of data sets, Pioneer’s algorithm tracks brand awareness, audience growth and engagement. Using more than 80,000 relevant data points per week, they analyze business activity across social media, earned media and web-related activities.

Keep in mind though, these brands are not the best in class or the strongest selling. The brands listed below have the strongest marketing performance and web activity, for better or worse. Here are a few insights that explain why some of these companies appear on the list:

  1. Curaleaf closed their acquisition of Grassroots. They also own Select, which is one of the largest wholesale brands in the United States. The official completion of Curaleaf acquiring Grassroots makes them the world’s largest cannabis company by revenue.
  2. Ignite Brands, founded by Instagram playboy and controversial figure Dan Bilzerian, made headlines for all the wrong reasons in early July. The company lost $50 million last year and is still hemorrhaging money. News stories in early July detail his lavish lifestyle funded by the company, including paying $2.4 million in rent per year and paying for dozens of models to travel with him, among other absurd expenses.
  3. Tyson Ranch: The cannabis brand owned by Mike Tyson, generated considerable web activity due to some press the boxer received recently. Tyson announced that he is coming back to boxing, stepping back in the ring to fight Roy Jones Jr. in September.
  4. Baked Bros, an edibles company based in Arizona, grew its social media outreach considerably in the month of July. Through a giveaway contest on Instagram, the company generated 3,584 comments on one post alone. That kind of activity directly increases their audience reach, thus boosting their marketing performance.

Without further ado, here are the top 15 hottest U.S. cannabis brands for July 2020:

  1. Kiva Confections
  2. Wyld
  3. Select
  4. Rove
  5. Ignite
  6. Papa & Barkley
  7. Cresco Labs
  8. Old Pal
  9. Lowell Herb Co
  10. Coda Signature
  11. Tyson Ranch
  12. Baked Bros
  13. 1906
  14. Bloom Farms
  15. Kush Queen
FDA

FDA Warning Letter to CBD Company Provides Many Lessons for Burgeoning Market

By Seth Mailhot, Emily Lyons, Steve Levine
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FDA

The U.S. Food and Drug Administration (FDA) issued a warning letter to Curaleaf Inc., a multi-billion-dollar market cap company that is publicly traded on the Canadian Securities Exchange. The FDA determined, based upon a review of the company’s website and social media accounts (Facebook and Twitter), that several of Curaleaf’s cannabidiol (CBD) products are misbranded and unapproved new drugs sold are in violation of the Federal Food, Drug, and Cosmetic Act(FD&C Act). The FDA also determined that Curaleaf’s “Bido CBD for Pets” products are unapproved new animal drugs that are unsafe and adulterated under the FD&C Act2. This action by FDA holds many lessons and cautions for companies already in or looking to break into the CBD market.

Unapproved New Human Drug Claims and Misbranding
The FDA identified a variety of statements in its review of the Curaleaf website and social media accounts that it said established the CBD Lotion, CBD Pain-Relief Patch, CBD Tincture, and CBD Disposable Vape Pen products as drugs. It is important to highlight that these claims were not made on the products’ label and, in some instances, referred to CBD generally. The FDA characterized these claims as demonstrating an intent to market the products for use in the diagnosis, cure, mitigation, treatment or prevention of disease, as well as to affect the structure or any function of the body. For example, FDA asserted that Curaleaf made a variety of drug and disease-related claims that its products or CBD in general could be used:

  • To treat chronic pain;
  • To reduce the symptoms of ADHD, anxiety, depression, post-traumatic stress disorder, and schizophrenia;
  • As a natural alternative to pharmaceutical-grade treatments for depression and anxiety;
  • To address eating disorders;
  • To reduce the severity of opioid-related withdrawal;
  • To deter heart disease;
  • As an effective treatment for Parkinson’s disease and Alzheimer’s; and
  • To kill breast cancer cells and counteract the spread of cancer.

The FDA stated that the Curaleaf products are not generally recognized as safe and effective for the uses described on their website and social media accounts and, therefore, the products are new drugs under the FD&C Act3. The FDA stated that, because the products have not received approval from the FDA, they may not be legally introduced or delivered for introduction into interstate commerce.

FDAlogoThe FDA further declared that the Curaleaf products are misbranded within the meaning the FD&C Act, because their labeling fails to bear adequate directions under which a layperson can use a drug safely and for the purpose for which it is intended. The FDA will frequently add this charge when citing a product marketed as an unapproved new drug. In its warning letter, the FDA noted that Curaleaf’s products are offered for conditions that are not inclined to self-diagnosis and treatment by individuals who are not medical professionals (e.g. Parkinson’s, Alzheimer’s, etc.). Therefore, the products would need to bear adequate directions for use, as well as obtain appropriate new drug approvals from FDA prior to being marketed as human drugs.

Unapproved Dietary Supplement Labeling 
The FDA further concluded that Curaleaf intended to market their CBD products as dietary supplements. For example, under the disclaimer section of the Curaleaf products the FDA noted that it says that “Cannabidiol (CBD) . . . is a dietary supplement.” However, the warning letter reiterated the FDA’s longstanding position that CBD products do not meet the definition of a dietary supplement because they contain an active ingredient in a drug product that has been the subject of public research and drug approval by FDA. While the warning letter states that FDA is not aware of any evidence that counters the agency’s position that CBD products are excluded from the definition of dietary supplement, Curaleaf may present the FDA with any evidence that is relevant to the issue.

Further, the FDA noted that the Curaleaf products do not meet the definition of dietary supplement because those products are not “intended for digestion”. The CBD Lotion and the CBD Pain-Relief Patch products’ labeling states that they are intended to be applied directly to the skin and body, while the CBD Disposable Vape Pen is intended for inhalation. In addition, the CBD Tincture products contain a “Suggested Use” section on labeling that includes both edible and topical uses. According to the FDA, the addition of the topical use to labeling established that the tincture products are not intended for ingestion and therefore do not meet the definition of a dietary supplement.

Unapproved New Animal Drugs 
The FDA also concluded that Curaleaf’s “Bido CBD for Pets” products are unapproved new animal drugs as statements on Curaleaf’s website show that the products are intended for use in the mitigation, treatment or prevention of diseases in animals. For example, the company’s website states that its products will decrease dog separation anxiety, distressed feelings, anxiety and seizures, as well as reducing or stunting the growth of cancer, relieve muscle spasms and treat arthritis issues. The FDA stated that the products are “new animal drugs” because they are not generally recognized among experts qualified by scientific training and experience as safe and effective for use under the conditions prescribed, recommended or suggested in the labeling. In order to be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing. As these products are not approved or index-listed by the FDA, these products are considered unsafe and adulterated.

What This Means to You 
The FDA is paying close attention to companies marketing CBD products with unapproved drug claims for both human use and animal use. It is important for companies that currently market or are considering marketing CBD products to ensure that their marketing materials and labeling generally comply with FDA requirements and avoid making unapproved human or animal drug claims.  Additionally, it underscores the fact that FDA will review more than just the label of the product, and will scrutinize statements made about the product on the company’s website and social media accounts to determine the product’s intended use. Even though the FDA is in the process of determining how to regulate CBD products, the agency will not withhold enforcement actions against companies that make unapproved drug claims, particularly those that FDA believes will steer patients from receiving approved treatments.

The receipt of an FDA warning letter may also potentially result in class action lawsuits based on state consumer protection laws or lawsuits by competitors under the Lanham Act or state competition laws. While the FD&C Act does not include a private right of action, publicly issued warning letters may form the basis of a claim that statements are false and misleading and actionable under state or other federal laws.


References to the Federal Food, Drug, and Cosmetic Act (FD&C Act).

  1. Sections 502(f)(1), 505(a) and 301(d)
  2. Sections 501(a)(5) and 512(a)
  3. Section 201(p)

Curaleaf Fined Big Time in Massachusetts

By Aaron G. Biros
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According to Masslive.com, the Massachusetts Cannabis Control Commission fined Curaleaf $250,000 “for failing to disclose a change of ownership and ask permission from state regulators before completing the transaction.” The news comes just weeks after the US Food & Drug Administration (FDA) sent a warning letter to Curaleaf President Joseph Lusardi for making unsubstantiated health claimsand for misbranding their products as drugs.

Steven Hoffman, Chairman of the Massachusetts Cannabis Control Commission

Curaleaf, one of the largest cannabis companies in the United States, has dispensaries in a handful of locations across Massachusetts, with plans to open more locations. Curaleaf Massachusetts went from being a non-profit to being a for-profit business, then merged with a Canadian company to access the Toronto Stock Exchange.

The $250,000 fine is the largest penalty assessed by regulators to a state-licensed cannabis business to date. Curaleaf and the Cannabis Control Commission came to an agreement, signed in early August. “In assessing this fine against Respondent, the Commission acknowledges that Respondent’s violation was the result of Respondent’s good-faith but mistaken interpretation of the Commission’s regulations, that Respondent has fully cooperated with the Commission’s investigation, and that the Respondent has accepted responsibility,” reads the agreement.

Steven Hoffman, Chairman for the Cannabis Control Commission told the public that he thinks the company has been “very constructive and collaborative” in working with the Commission. “I think they were wrong, but I can understand they were acting in good faith,” says Hoffman.

CBD Health Claims Spur FDA Warning & Product Seizure Threats

By Greg Boulos
3 Comments

The 2018 Farm Bill gave cannabis businesses around the country a legal path to market and sell hemp and hemp-derived products. Despite the groundbreaking law, several regulatory uncertainties remain. The FDA has been a source of many of those uncertainties, but recent action suggests that the agency plans to impose heavy burdens on companies selling CBD products that claim to provide health benefits. Recently, the FDA held a public hearing during which it signaled that health claims associated with cannabis-related products was a primary concern. Congress subsequently pressured the FDA to develop a regulatory framework for the cannabis industry and the agency announced that it was expediting its efforts to do so, promising an update on its progress by this fall.

FDAThen, on July 22, the agency issued a warning letter to Curaleaf regarding its claims that several of its products provide specific health benefits. The agency included a threat to seize Curaleaf’s products if the issues raised in the letter are not resolved. How the FDA ultimately regulates cannabis products going forward will have a significant impact on the industry as a whole. Indeed, the agency has significant powers over product manufacturers, including the ability to seize products through the U.S. Marshalls. This article will delve into the specifics on the FDA’s warning letter and address how manufacturers can limit the risks associated with making health-related claims.  

The FDA’s Warning: Beware of “Unsubstantiated” Health Claims

The FDA’s letter explained that it determined several of Curaleaf’s CBD products “are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FDCA).” The letter goes on to say that one of Curaleaf’s pet CBD products “are unapproved new animal drugs that are unsafe.” Curaleaf has 15 days to respond to the agency’s letter. The agency cited the following health claims as problematic, among others.

  • “CBD has been demonstrated to have properties that counteract the growth of [and/or] spread of cancer.”
  • “CBD was effective in killing human breast cancer cells.”
  • “CBD has also been shown to be effective in treating Parkinson’s disease.”
  • “CBD has been linked to the effective treatment of Alzheimer’s disease ….”
  • “CBD is being adopted more and more as a natural alternative to pharmaceutical-grade treatments for depression and anxiety.”
  • “CBD can also be used in conjunction with opioid medications, and a number of studies have demonstrated that CBD can in fact reduce the severity of opioid-related withdrawal and lessen the buildup of tolerance.”
  • “CBD oil is becoming a popular, all-natural source of relief used to address the symptoms of many common conditions, such as chronic pain, anxiety … ADHD.”
  • “What are the benefits of CBD oil? …. Some of the most researched and well-supported hemp oil uses include …. Anxiety, depression, post-traumatic stress disorders, and even schizophrenia …. Chronic pain from fibromyalgia, slipped spinal discs . . . Eating disorders and addiction . . ..”
  • “[V]ets will prescribe puppy Xanax to pet owners which can help in certain instances but is not necessarily a desirable medication to give your dog continually. Whereas CBD oil is natural and offers similar results without the use of chemicals.”
  • “For dogs experiencing pain, spasms, anxiety, nausea or inflammation often associated with cancer treatments, CBD (aka cannabidiol) may be a source of much-needed relief.”

The letter explicitly warned, “Failure to correct the violations promptly may result in legal action, including product seizure and injunction.” The FDA has a history of seizing products it deems non-compliant with its regulations. Recently, the U.S. Marshals, at the direction of the FDA, seized 300,000 units of a cosmetic company’s product. The impact of such a seizure on a business’ profits and operations is staggering. FDA action also has a direct impact on publicly traded cannabis companies’ stock price. When news of the FDA’s Curaleaf letter circulated, Curaleaf shares plunged 8%.

Balancing Regulatory Risk and Business Objectives

While the FDA’s letter appears to create a new risk for the cannabis industry, the stock market’s reaction is arguably overblown. The fact that the FDA would question a product’s ability to kill cancer cells is not surprising. I am not familiar with Curaleaf’s research efforts and it is not my goal to pass judgment on their claims. Rather, my point is that manufacturers need to make sure legitimate scientific studies underpin all of their health claims, regardless of the industry. Manufacturers will never be able to avoid regulatory scrutiny or even litigation regarding their health claims entirely. Instead, cannabis companies should take steps to ensure that they can credibly respond to regulatory scrutiny or present strong defenses in potential litigation. Establishing a robust research department is a start. But manufacturers must develop institutional knowledge of the most cutting-edge research regarding their products.Developing in-depth institutional knowledge regarding the state-of-the-art scientific research on your product is a must. 

Manufacturers that market products primarily for their health benefits should consider working with clinical researchers to study their products. There should be written policies and guidelines, as well as employee training, for conducting these studies and dealing with researchers in order to protect the quality of the study. For purposes of mitigating regulatory and litigation risks, the perceived quality of these studies can be just as important as their actual quality. Regulators and plaintiff’s attorneys can easily misinterpret (sometimes intentionally) written communications between a manufacturer and researcher in ways that suggests a particular study was outcome-driven and not a legitimate scientific undertaking. Manufacturers should consult with attorneys experienced in defending product liability and mass tort litigation so that their labeling and research practices are based on historical examples of successful (and sometimes, unsuccessful) product manufacturers.

Key Takeaways

Manufacturing consumer products comes with substantial litigation and regulatory risks. There are several historical and current examples of product labels, health claims, and warnings leading to thousands of lawsuits filed simultaneously across the country against a single manufacturer. Fees associated with defending against even meritless claims can force a manufacturer into bankruptcy. The regulatory risks can also have devastating effects on the day-to-day business operations of any manufacturer. Eliminating these risks is impossible, but addressing them upfront before a product launch, regulatory crackdown, or lawsuit is considerably less expensive than dealing with costly litigation or government seizure of entire inventories. Developing in-depth institutional knowledge regarding the state-of-the-art scientific research on your product is a must. Also, consider working with a clinical researcher to support any claimed health benefits or even discover new health benefits associated with your product. Finally, consult a lawyer with experience in product liability and mass tort litigation to strengthen your policies and procedures regarding research, develop credible health claims, and craft strong warnings.

FDAlogo

FDA Sends Warning Letters to Curaleaf

By Aaron G. Biros
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FDAlogo

Curaleaf Hemp, a well-known and publicly traded cannabis company, made headlines this week for all the wrong reasons. The US Food & Drug Administration (FDA) sent a warning letter to Curaleaf President Joseph Lusardi for making unsubstantiated health claims and for misbranding their products as drugs.

FDAThe health claims in question appear to be removed from their website and social media accounts. In the warning letter, the FDA cites numerous claims made on Curaleaf’s website, Twitter and Facebook accounts. You can check out the health claims they found here, but it’s essentially a list of instances where Curaleaf said their products can be used to treat specific conditions. They claimed their CBD vape pen can be used for chronic pain and said another one of their products is a “[S]oothing tincture for chronic pain.”

For most of the health claims the FDA cited, it appeared they were articles or blog posts on Curaleaf’s website. Take a look at some examples of statements that should not be posted on a CBD products website (taken from the warning letter found here):

  • “CBD has also been shown to be effective in treating Parkinson’s disease.”
  • “CBD has been linked to the effective treatment of Alzheimer’s disease . . ..”
  • “CBD is being adopted more and more as a natural alternative to pharmaceutical-grade treatments for depression and anxiety.”
  • “CBD can also be used in conjunction with opioid medications, and a number of studies have demonstrated that CBD can in fact reduce the severity of opioid-related withdrawal and lessen the buildup of tolerance.”
  • “CBD has been demonstrated to have properties that counteract the growth of spread of cancer.”
  • “CBD was effective in killing human breast cancer cells.”
  • “Heart disease is one of the leading causes of death in the United States each year, and CBD does a number of things to deter it. The two most important of these are the ability to lower blood pressure, and the ability to promote good cholesterol and lower bad cholesterol.”

While the FDA is expediting their push to roll out hemp and CBD regulations, companies should still be cautious when marketing their products for interstate commerce. Dr. Amy Abernathy, Principal Deputy Commissioner and Acting CIO, said in a series of tweets earlier this month that the FDA is eager to get to work and plans to report on their progress by the end of summer. The public hearing they held back in May helped jumpstart their efforts to begin investigating regulation of the market.

Still, companies need to be careful when marketing CBD products. The FDA has made it abundantly clear in a lot of warning letters that drug claims are not allowed. Here are two articles that give advice on how companies should proceed with marketing and how to go about properly labeling their products.