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Feds Send Warning Letter To Another CBD Company Over Medical Claims

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The Food and Drug Administration (FDA) and Federal Trade Commission (FTC) sent a warning letter to a Florida-based CBD company on Tuesday, alleging that the business made several unsanctioned claims about the therapeutic benefits of their products.

The federal agencies accused Rooted Apothecary of unlawfully asserting that their cannabidiol products could treat symptoms of conditions such as ADHD, Parkinson’s disease, ear aches, ADHD and autism. Those claims appeared on the company’s website and social media accounts, they said.

Certain products appeared to be marketed as dietary supplements, which FDA currently prohibits as it works to develop an alternative regulatory scheme for CBD.

“Cannabis and cannabis-derived compounds are subject to the same laws and requirements as FDA-regulated products that contain any other substance,” Acting FDA Commissioner Ned Sharpless said in a press release. “We are working to protect Americans from companies marketing products with unsubstantiated claims that they prevent, diagnose, treat, or cure a number of diseases or conditions.”

“We’ve sent numerous warning letters that focus on matters of significant public health concern to CBD companies, and these actions should send a message to the broader market about complying with FDA requirements,” he said. “As we examine potential regulatory pathways for the lawful marketing of cannabis products, protecting and promoting public health through sound, science-based decision-making remains our top priority.”

FTC’s complaint with the company is that it violated a law that requires businesses that advertise medical claims about their products to have “competent and reliable scientific evidence” to back them up, which could include human clinical trials. Making or exaggerating such claims through “a product name, website name, metatags, or other means” without proper evidence is also prohibited.

Rooted Apothecary must respond to the agencies within 15 working days to explain what steps it’s taking to resolve the issues. If the company fails to do so, it is subject to legal action, including the possible seizure of its products or an injunction. It may also have to compensate customers.

FDA emphasized that CBD products—other than the prescription medication Epidiolex, for the treatment of intractable epilepsy—are not currently allowed. But it also reiterated that the agency is in the process of developing rules that could allow for the lawful marketing of the compound.

In April, FDA sent warning letters to three other CBD companies that it said was making unauthorized claims about the medical benefits of their products. FTC also submitted warning letters to three separate CBD companies for allegedly advertising misleading statements about their products last month.

These letters are examples of the agency’s use of enforcement discretion. Former FDA Commissioner Scott Gottlieb, who recently suggested that the federal government should be involved in regulating state marijuana programs, clarified in March that the agency is only going after companies that make especially misleading claims about their products.

Senate Majority Leader Mitch McConnell (R-KY), who championed a provision of the 2018 Farm Bill federally legalizing hemp and its derivatives, has urged FDA to clear a path for the lawful marketing of CBD products by using enforcement discretion while it develops an interim final rule. A bipartisan group of lawmakers made a similar request in a letter sent to the agency last month.

“The FDA is working quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD while using all available resources to monitor the marketplace and protect public health by taking action as needed against companies,” FDA Principal Deputy Commissioner Amy Abernethy said.

“We recognize that there is significant public interest in cannabis and cannabis-derived compounds; however, we must work together to fill in the knowledge gaps about the science, safety and quality of many of these products,” she said. “We are committed to advancing our regulation of these products through an approach that, in line with our mission, prioritizes public health, fosters innovation and promotes consumer confidence.”

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Photo courtesy of Kimzy Nanney.

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.

Kyle Jaeger is Marijuana Moment's Los Angeles-based associate editor. His work has also appeared in High Times, VICE and attn.

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Number Of Banks Working With Marijuana Businesses Levels Off, Federal Data Shows

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The number of banks and credit unions that service the marijuana industry largely leveled off in the last quarter, according to new federal data released late last week. And that market trend could reflect shifting expectations among financial institutions about the likelihood of Congress approving cannabis banking legislation.

While the House did eventually pass the Secure and Fair Enforcement (SAFE) Banking Act, which would shield banks that accept marijuana business clients from being penalized by federal regulators, that vote happened just five days before the end of the fourth quarter of the federal fiscal year and not prior to the summer recess weeks earlier, as had previously been expected.

Marijuana Moment first reported that a vote was imminent about two weeks prior to the House action.

It’s possible that banks were waiting to see the congressional action before further servicing the market and were disappointed that the Democratic-controlled chamber did not act on the legislation before lawmakers broke for the summer break. Previous quarters have seen significant upticks in the number of banks and credit unions working with marijuana businesses, especially since the end of 2018.

But this last quarter, the Financial Crimes Enforcement Network (FinCEN) reported that 563 banks and 160 credit unions were serving cannabis companies as of September 30, compared to 553 banks and 162 credit unions at the end of the previous quarter. That’s a small increase for banks and a slight dip for credit unions, signaling a shift in pace as lawmakers work to get the bipartisan banking bill to the president’s desk.

Via FinCEN.

But now that the House has acted, and signals point to the Senate following suit, industry watchers are bullish about getting the key reform across the finish line this Congress.

“I get the sense that people in the financial community are optimistic about the chances of cannabis banking reform happening in the near future from our work with groups like the [American Bankers Association] and [Credit Union National Association] on the SAFE Banking Act,” Morgan Fox, media relations director for the National Cannabis Industry Association, told Marijuana Moment.

FinCEN also said that short-term declines in these numbers “may be explained by filers exceeding the 90 day follow-on Suspicious Activity Report (SAR) filing requirement,” a process that banks are mandated to follow in accordance with 2014 cannabis banking guidance issued under the Obama administration.

“Several filers take 180 days or more to file a continuing activity report,” the agency said. “After 90 days, a depository institution is no longer counted as providing banking services until a new guidance-related SAR is received.”

Those caveats were also included in previous quarterly reports that had shown increases in the number of financial institutions working with the cannabis industry, however.

The latest update also contains data on the number of marijuana-related SARs that have been filed, which exceeded 100,000 for the first time as of the quarter’s end. (There appears to be a mistake in the narrative of FinCEN’s report, as it states the numbers reflect SARs filed by the end of June instead of September.)

FinCEN also placed the SARs in one of three categories: marijuana limited, marijuana priority and marijuana termination.

Via FinCEN.

As usual, most (76,203) were considered “marijuana limited,” which refers to cannabis businesses that seem to be operating in compliance with state law, and therefore meet the agency’s standard for being serviceable under existing federal guidelines.

The second largest category was for “marijuana termination” SARs, or marijuana businesses that violated at least one federal enforcement priority or state regulation and so “the financial institution has decided to terminate its relationship with” the firm.

About 7,800 SARs fit the definition of “marijuana priority,” which is defined as a business that “may raise one or more of the red flags” under federal guidelines, or they “may not be fully compliant with the appropriate state’s regulations” and so they’d be under investigation.

Whether the leveling off trend will continue is yet to be seen. However, if the Senate does advance the SAFE Banking Act and it is enacted, advocates expect a surge in banks embracing the cannabis industry. The chair of the Senate Banking Committee has said that his panel will vote on marijuana banking legislation before the year’s end, though he suggested he’d like certain changes from the House-passed version.

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Head Of Nation’s Only Federally Legal Marijuana Farm Develops THC Eye Drops

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The head of the nation’s only federally approved marijuana farm has revealed that he is developing cannabis eye drops to treat glaucoma.

In a podcast interview, pharmacologist Mahmoud ElSohly, director of the University of Mississippi’s Marijuana Research Project, discussed the history of how an eye doctor discovered that cannabis can relieve the interocular pressure associated with glaucoma. But while the THC in the plant treated the symptoms, it also means patients experience the high.

“The best way to treat glaucoma is not to take a drug that will affect your brain, affect your ability to function, the whole rest of your body just to lower the pressure inside the eyes,” ElSohly argued. “The way to do this is to develop, let’s say, eye drops, eye drops from marijuana.”

Both his lab and a separate, unnamed company that licensed the idea are looking into the eye drop possibility, with the company having already begun clinical trials, ElSohly said. It’s a notable advancement because THC is lipophilic, acting like an oil, and so “it doesn’t penetrate into the inner compartments of the eye to lower the pressure.”

“Therefore, only if you take systemically—meaning if you inhale it or swallow it or something—but then you deal with all the side effects of THC,” he said in the interview, which was recorded in February and published this month. “Now we’re developing a pharmaceutical product, and it’s been licensed by the way now, that we take the THC molecule and we modify it in a certain way to allow it to go inside the eye, and once inside, it breaks off and releases THC just in the eye to lower the pressure.”

“You don’t feel any psychological activity, it doesn’t even get into your blood. It’s all localized in the eye,” he said. “We have this product now that is being licensed and being developed as an eye drop.”

Listen to the conversation about the THC eye drops, which begins around 15:40, below: 

“That’s the way to develop pharmaceuticals based on cannabis but not cannabis, based on marijuana but not marijuana,” he added during the appearance on the podcast of anti-legalization organization National Families In Action, for which ElSohly serves as a scientific advisory board member. “That’s the way to do it and develop the medicine.”

The targeted treatment of glaucoma using the novel delivery method that ElSohly described is noteworthy, but it also underscores the potential for the development of other valuable treatment options derived from marijuana that’s being inhibited under prohibition. One barrier that researchers and lawmakers alike have identified is the substandard quality of cannabis produced at ElSohly’s farm.

Currently, the University of Mississippi is the only federally approved source of research-grade marijuana, but scientists have complained about the cannabis supply, which one study found is genetically closer to hemp than products available in state-legal markets. That raises questions about the validity of studies that rely on the government’s marijuana.

The Drug Enforcement Administration said in September that it is taking steps to approve additional marijuana farms beyond ElSohly’s Mississippi operation, three years after the agency initially invited applications for such facilities.

In an earlier podcast segment released in September, ElSohly made a series of remarks that some viewed as reflective of a fundamental misunderstanding of marijuana issues.

The director characterized cannabis containing eight percent THC as “extremely high potency” and expressed confusion as to why individuals would seek out varieties in the commercial market that contain “20 percent or 15 or 18 or any of those high amounts.”

But ElSohly was thinking about marijuana consumption in the context of standardized clinical trials, where individuals would have to consume an entire joint in one sitting in order to compare the effects of a controlled dose with other subjects. Others have pointed out that consumers might prefer higher concentration products because they can achieve the desired effect without having to smoke as much.

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SXSW Announces Two Dozen Marijuana Panels For 2020 Festival

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South by Southwest (SXSW) revealed the festival’s 2020 lineup this week, and it includes 24 panels dedicated exclusively to cannabis issues.

The sessions are part of SXSW’s “Cannabusiness” convergence track, which will invite attendees to learn about “the technological, cultural, financial, legal and political ecosystems that are defining the cannabis-focused enterprises of both today and tomorrow,” according to a description on the event site.

In July, the Austin-based festival announced that it was soliciting panel ideas from the public. More than 150 marijuana-related panel proposals were submitted—more than double the submissions for this year’s event—and SXSW invited individuals to vote on their top choices throughout August. Ultimately, 24 cannabis-focused panels made the final cut, including one that isn’t in the Cannabusiness Track.

Here are some examples that stand out: 

Descheduling Cannabis: Be Careful What You Wish—Leading cannabis industry stakeholders discuss how removing cannabis from the list of federally banned substances could be destructive to the market as it exists today by allowing for a corporatized marijuana model. Panelists including The Arview Group CEO Troy Dayton will address how descheduling could “decimate the dispensary system and see the destruction of millions of dollars of investment.”

Duty Bound: Why the DoD Should Embrace Cannabis—Active duty military members and veterans stand to greatly benefit from marijuana, this panel argues, by “alleviating both mental and physical traumas” while at the same time saving tax dollars. “During our panel we’ll dive into the specific individual, national, and even global benefits of allowing for active duty cannabis use in the US military,” a description states.

Featured Session: Cat Packer—Top Los Angeles marijuana regulator Cat Packer will talk about her role in the “licensing and regulation of commercial cannabis activity” as well as managing “the implementation of the City’s cannabis related policies and programs.”

Cannabis in Canada: What We’ve Learned—Panelists from Leafly, Spiritleaf, Tilray, 48North and Hill+Knowlton will discuss the impacts of marijuana legalization in Canada, including talks about the impact on local economies and industry innovation.

Can Social Equity Help Heal The War On Drugs?—This panel will look at the disproportionate impact of cannabis prohibition on disadvantaged communities, efforts to enact restorative justice policies and how those measures have affected the business community.

The Future of the Cannabis Industry is Colored—Another social justice-focused panel, this event will look at actionable things that people can do to ensure that the legal marijuana market is equitable. “The right and just thing to do for racially equity industry is also the profitable thing to do in business,” a description of the panel states. Kris Krane of 4Front Investments, Simply Pure CEO Wanda James and representatives of the People’s Dispensary will participate.

Frenemies: Cannabis Activists & Cannabis Industry—Krane, who also previous served as executive director of Students for Sensible Drug Policy (SSDP), will also lead a session that explores the complicated relationship between the reform advocacy world and the marijuana industry. He will take a “deep dive into this relationship, examining how the two can support each other, where they clash” and why he thinks “the industry is obligated to support the drug policy reform movement.”

Boutique Cannabis Needs Appellations—Individuals fighting to get a designation for cannabis products that reflect where they were produced will discuss the importance of the business move.

Forbidden Territories: Women & Children First!—This panel will focus on the use of cannabis in the treatment of conditions that afflict women and children. “This session will explore this taboo topic, explore the science that supports the use of cannabis for these populations as well as what we as physicians have learned from our patients about cannabis.”

Hemp: Game Changers—Representatives from Canopy Growth, Vincente Sederberg LLP and outdoor apparel company Patagonia will discuss marijuana’s non-intoxicating cousin, hemp, as part of a panel centered on the “rapidly evolving new industry.”

Is Cannabis Media Coverage Fair or Biased?—Panelists including Business Insider reporter Jeremy Berke and Rolling Stone contributor Amanda Chicago Lewis will look at the media landscape for marijuana coverage. “They’ll delve into how media coverage has changed for cannabis companies and discuss the high bar companies need to achieve to gain media attention,” as well as addressing “how misinformation persists and how the careful art of semantics—such as using the word dope vs. cannabis—changes reader perceptions.”

Marijuana Today: Live Podcast Recording—The weekly podcast Marijuana Today will record live for a segment that “will focus on the status of efforts to reform federal law and to promote equity in the cannabis industry.” SSDP Executive Director Betty Aldworth will participate in the event.

Medical Cannabis: From Rogue to Recovery to Riches—A Texas state senator will join a panel to discuss the evolution of the cannabis reform movement as well as future “business and social opportunities” for the industry. The panel of “government, medical and family activists will uncover the unexpected alliances formed—and strategies for collaboration for commercial success in a complex marketplace.”

Navigating an Emerging Cannabis Beverage Market—While federal regulators are playing catchup, a market for cannabis-infused beverages has exploded. This panel will explore the business and “share insights and lessons learned as they navigate the rapidly changing landscape in hopes of bringing world-class cannabis beverages to market.”

“Cannabusiness Track includes content that will appeal to more experienced professionals in this rapidly evolving industry, as well as to newcomers who are just starting to enter this space,” SXSW said.

At this year’s SXSW event, in March, social equity activists protested an appearance by former House Speaker John Boehner (R-OH), who opposed legalization while in Congress but now sits on the board of a large cannabis company.

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Photo courtesy of Mike Latimer.

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.
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