LMCC Welcomes Leaders from Ulta Beauty, Adweek, New York State Cannabis Control Board, Merida Capital Holdings, Adweek, NYC Mayor’s Office, Food & Wine, Standard Dose, Women’s Health, and Bon Appétit

NEW YORK:  Luxury Meets Cannabis Conference (LMCC) today announced the complete program for its Fall 2022 Edition, which returns on October 20 & 21 in Hudson Yards, New York City.

Launched in 2018 as a first-of-its-kind B2B trade event, LMCC has grown into the go-to resource and venue for product discovery and extensive category education, connecting visionary CBD and Cannabis brands across the beauty/wellness, food/beverage, and technology/lifestyle accessory categories to mainstream retailer buyers, luxe dispensaries, media, and investors.

As an indication of the excitement around the emerging New York legal Cannabis market and the official brand showcase mix at LMCC, 100+ A-tier retail outlets – LMCC’s highest rate to date – have registered to attend the show including KITH, Standard Dose, Curaleaf, Bloomingdale’s, Rise Cannabis, Etain, The Vitamin Shoppe, Shen Beauty, and many others.

LMCC’s inaugural infused Food & Beverage Hall will also debut, which will feature the finest food/culinary, beverage, consumables, and confectionery brands in the space — especially timely as alcohol sales in the U.S. continue to decline. This Harrods-esque, immersive (and delectable) experience will spotlight leading brands such Cann, Kiva Confections, oHHo, Cycling Frog, Cloud 11, Black Dahlia, L8, Sass, Chef For Higher, and many more.

More than 700 business attendees from around the world will explore the LMCC Official Brand Showcase — a pre-vetted, store-ready exhibition — paired with a full schedule of keynote talks, brand presentations, and business networking.

For the most up-to-date information on partners, exhibiting brands and speakers, visit lmccshow.com.

LMCC FALL 2022 OFFICIAL BRAND SHOWCASE DIRECTORY

LMCC SPEAKER SCHEDULE NOW LIVE

See 50 leading executives on stage from Ulta Beauty, Adweek, New York State Cannabis Control Board, Merida Capital Holdings, Adweek, Different Leaf, NYC Mayor’s Office, Food & Wine, Standard Dose, Women’s Health, and Bon Appétit and many others:

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.

TORONTO–(BUSINESS WIRE)-11/23/2021- Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (“Cybin” or the “Company”), a biopharmaceutical company focused on progressing “Psychedelics to Therapeutics”, today announced it has awarded a grant for the first psychedelic treatment clinic at Lenox Hill Hospital, part of Northwell Health, to serve marginalized and underserved communities on the Upper East Side of Manhattan, New York. The program aims to become one of the first hospital-based clinical sites to offer psychedelic medicine in the United States.

Lenox Hill Hospital is a 450-bed, acute care facility on Manhattan’s Upper East Side and the flagship Manhattan hospital of Northwell Health – the largest healthcare system in New York State. Highlights of the program include:

• Founded by Kimia Pourrezaei, DO, and Gregory Mendoza, LCSW-R, of the Lenox Hill Hospital Outpatient Center for Mental Health, the clinical program is dedicated to addressing health inequities by prioritizing care for marginalized and underserved populations;
• The program will increase accessibility by offering treatment with no out of pocket cost for individuals who would otherwise be unable to afford this service;
• The clinic plans to also provide psychedelic treatments to frontline healthcare workers affected by COVID-19;
• Clinicians will receive training in MDMA-, ketamine-, and tryptamine-assisted psychotherapy.

Clinicians will also receive training in EMBARK, a transdiagnostic psychedelic psychotherapy model that can be adapted to address a range of clinical indications and populations. EMBARK is Cybin’s psychotherapy model created by Dr. Alex Belser, Cybin’s Chief Clinical Officer and Bill Brennan, Ph.D. (cand.).

“Lenox Hill Hospital is excited by the potential of these modalities for the treatment of previously intractable conditions such as severe depression, chronic PTSD, and OCD,” said David Roane, MD, Chairman of Psychiatry at Lenox Hill Hospital. “With this grant from Cybin, Lenox Hill Hospital aims to become one of the first hospital-based clinical sites offering psychedelic medicine in the country and is dedicated to addressing health inequities by prioritizing care for marginalized and underserved populations. In particular, people of color are greatly underrepresented in psychedelic research studies and our team is committed to inclusive recruitment of patients.”

“It’s time for psychedelic medicine to climb down from the ivory tower and into the community. We are honored to support this program at Lenox Hill Hospital to start a low-cost/no-cost psychedelic-clinic for marginalized and underserved communities in New York,” said Dr. Alex Belser, Chief Clinical Officer of Cybin.

About Cybin
Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally-recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in the USA, UK and Ireland. The Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.

About Lenox Hill Hospital
Lenox Hill Hospital, a member of Northwell Health, is a 450-bed, fully accredited, acute care hospital located on Manhattan’s Upper East Side with a national reputation for outstanding patient care and innovative medical and surgical treatments. U.S. News & World Report has ranked Lenox Hill among the nation’s best for cardiology and heart surgery; diabetes and endocrinology; ear, nose and throat; geriatrics; gynecology; neurology and neurosurgery; and orthopedics. In addition, the hospital received “high performing” designations from U.S. News for its performance in cancer, gastroenterology and GI surgery, pulmonology and lung surgery, and urology. For more information, go to www.lenoxhill.northwell.edu.

Cautionary Notes and Forward-Looking Statements
Certain statements in this press release constitute forward-looking information. All statements other than statements of historical fact contained in this press release, including, without limitation, statements regarding Cybin’s future, strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words “believe”, “expect”, “aim”, “intend”, “plan”, “continue”, “will”, “may”, “would”, “anticipate”, “estimate”, “forecast”, “predict”, “project”, “seek”, “should” or similar expressions or the negative thereof, are forward-looking statements. Forward-looking statements in this news release include statements regarding the Company’s proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens to potentially treat psychiatric disorders.

These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the COVID-19 pandemic on the Company’s operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in the Company’s management’s discussion and analysis for the period ended September 30, 2021 and the Company’s listing statement dated November 9, 2020, which are available under the Company’s profile on www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin’s performance and operations.

Neither the Neo Exchange Inc. nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.

Source: Cybin Inc.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.

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After months of debate and negotiations, New York’s bill to legalize marijuana has reached a dead end for the time being. There had been increased pressure by lawmakers and marijuana advocates to pass the bill in this legislative session which came to an end on Wednesday.

There had been no consensus regarding the details of the bill, even though the broad aspect of legalized cannabis had gained quite a number of supporters. The lawmakers had a slightly different idea than that of Gov. Andrew Cuomo’s proposed regulatory framework. The decision was stalled on Sunday night due to stubborn negotiations. They reached an impasse on the distribution of marijuana generated tax revenue.

Wednesday Saw End Of Legislative Session As Well As Of The Bill’s Run

There was also a disagreement on the provision allowing retail sales. The lawmakers opted for a provision that would allow localities to opt for the retail selling of cannabis. If this provision is not added, the chamber might withdraw its support. However, Cuomo is firm on an opt-out provision allowing cannabis sales all over the state.

Even after being a priority for Cuomo and continuous pressure by lawmakers, the bill failed to get passed. New Jersey’s effort to pass the marijuana bill also faced a roadblock. After no mention of the bill in the budget presented in April, just last week, new bills were introduced. However, these cannabis bills have higher tax rates and a lower quantity amount that can be used by adults.

The legalization of the bill would have brought forward clear and definite regulations around the cannabis industry. Also, it would have brought in tax revenue for the state. Furthermore, it could have obliterated the criminal charges against those previously convicted for dealing marijuana. Even though this might be a victory for those opposing legalization, it is not permanent, as claimed by Sen. Liz Krueger. The opposition is equally resilient in not letting these policies and regulations through. They are claiming them to be hazardous to the health and safety of the public at large. The battle to legalize cannabis is on, and the road ahead is long.

This post is part two of two on how New York is regulating CBD. 

On Monday, I wrote about the New York City Department of Health’s (“DOH”) recent crackdown on Hemp-CBD in food and how it was consistent with the New York State Department of Agriculture’s (“Department”) FAQs on hemp-derived CBD (“Hemp CBD”). In summary, the Department’s FAQs state that any Hemp-CBD product sold in New York state must be labeled and manufactured as a dietary supplement. Today’s post focuses on the Department’s Template CBD Processor Research Partner Agreement (“CBD Agreement”) which elaborates on the dietary supplement classification.

The CBD Agreement is a research contract between Hemp-CBD processors, referred to as “Research Partners” in the Agreement, and the Department. Its provisions would not bind other actors including Hemp-CBD sellers or Hemp-CBD processors legally operating in other states. However, the CBD Agreement does shed light on what the Department is going to require for Hemp-CBD.

Research Partners cannot process or sell Hemp-CBD as food. A Research Partner must also obtain written approval from the Department if it intends to sell or distribute Hemp-CBD dietary supplements in a form other than “pill, capsule, caplet, tablet, tinctures, droplets or elixir, chewable, or isolate form[.]”

The CBD Agreement expands on how Research Partners, or CBD processors in other states hoping to sell products in New York, can comply with FDA’s dietary supplement standards:

For the purposes of this Research Agreement, products and production methods used shall comply with FDA law, regulation and guidance concerning dietary supplements with respect to the standards for: personnel, facilities, production, process control systems, quality control measures, record retention, packaging, holding and distribution, supply chain management, recalls, returns, complaints and training associated with dietary supplements.

The dietary supplement standards are in addition to THC testing for CBD products. Hemp-CBD intended to be consumed or absorbed into the human body must also be tested under New York’s medical marijuana program for “cannabinoid profile, solvents, pesticides, heavy metals, bacteria and molds.”

The CBD requirements requires that Research Partners must also provide a serving size and applicable warning on the label. According to the CBD Agreement, CBD products shall also include the following information:

• The list of all pharmacological active ingredients, including and not limited to THC, CBD, and other cannabinoid content over .05%;
• The CBD product must set forth the servings per bottle/package, the amount of CBD in milligrams per serving and the total CBD content, in milligrams per package, and the maximum recommended daily amount;
• The list of all solvents (pesticides) used in the cultivation/extraction process;
• The manufacture date and source;
• The batch number;
• The product expiration date, and
• The following warning, along with an appropriate warning to consult with a physician concerning the product use:

“This product is neither reviewed nor approved by the State of New York; and has not been analyzed by the FDA. There is limited information on the effects of using this product. Keep out of reach of children.”

The CBD agreement also covers reporting, approved extraction methods, and sourcing hemp.  According to the CBD Agreement, the Department may eventually require registration from entities selling Hemp-CBD.

Recently, I wrote about the FDA’s stated position is that Hemp-CBD is not a dietary supplement. As such, the Department’s position is contrary to the FDA’s. The following language in the CBD Agreement requires Research Partners to acknowledge the FDA’s position:

The Research Partner represents that it has sought whatever legal or other advice it believes to be appropriate and is not relying upon the Department’s approval of its research proposal or any other statement or conduct by the Department in connection with the Research Partner’s evaluation of any legal or other risk to which the Research Partner may be exposed in undertaking the project, including, without limitation, the FDA’s position with respect to CBD and dietary supplements.

For CBD Processors in New York, the CBD Agreement must be carefully observed. For CBD Processors operating in other states who wish to sell products in New York, the Department’s position makes things a little more complicated. For example, the FDA has different standards for cosmetic products. CBD Processors may want to argue that they are selling a CBD cosmetic not a dietary supplement. However, if that CBD cosmetic is sold in New York, it must be labeled as a dietary supplement. This may mean that the CBD cosmetic distributor may need to avoid New York or adopt labeling and manufacturing requirements as if the product was a dietary supplement.

Though it may be hard to comply with the Department’s regulations, the FAQs and CBD Agreement at least provide guidance. If you want to sell Hemp-CBD in New York, it must be sold as a dietary supplement, at least for now.

This post is part one of two on how the State of New York is regulating CBD. 

Last week, New York City’s Department of Health (“DOH”) quarantined a number of edible products that contained hemp-derived CBD (“Hemp-CBD”) and announced that Hemp-CBD would not be allowed in food products in the City. Eater first broke the story, but the crackdown made national news with the Wall Street Journal, the New York Times, NBC, and Fox all publishing stories on the event. It is unsurprising that the DOH action drew such coverage. CBD is massively popular, New York City is the largest city in the United States, and the story is compelling because the DOH actually sent out agents to quarantine products, rather than simply issuing a statement. It seems to be this last point that garnered national attention based on the relative lack of coverage of a very similar story a few months ago.

On December 18, 2018, shortly before the signing of the 2018 Farm Bill, the New York State Department of Agriculture and Markets (the “Department”) issued a series of frequently asked questions (“FAQs“) and a CBD Processor Template Agreement (“CBD Agreement“) that were both focused on Hemp-CBD. Unlike the DOH, the Department did not take any enforcement action. Coverage of the FAQs and the CBD Agreement was sparse. Now that New York City is taking action, it’s time to dig into the state’s position on Hemp-CBD.

The Department oversees New York’s industrial hemp program, which was promulgated under the 2014 Farm Bill. Rather than issuing licenses or permits, the Department enters into research agreements with individuals and companies who wish to process hemp into commercial products. The Department uses a number of template agreements available online. The CBD Agreement applies to processors who wish to create Hemp-CBD products intended for human consumption.

The FAQs and the CBD Agreement make it clear that the Department is intending to treat Hemp-CBD as a dietary supplement. The FAQs state that an individual cannot “sell any item for human consumption that has CBD as an ingredient unless” the two following standards are met:

1.  The item is produced under the rigorous dietary-supplement standards described in the CBD Agreement; and
2. The item is properly labeled and packaged for sale pursuant to FDA regulations for dietary supplements.

The FAQs elaborate on its dietary supplement standard:

What is the difference between a dietary supplement and a food product?

No product for human consumption that has CBD added to it can be labeled and marketed as a food. All extracted CBD and CBD products must be manufactured pursuant to FDA dietary supplement standards and must be labeled and marketed as a dietary supplement[.]

What are “dietary-supplement standards” or “dietary supplement GMP”?

The FDA sets three levels of Good Manufacturing Practices (GMPs): one GMP standard for foods, a more rigorous GMP standard for dietary supplements, and an extremely rigorous GMP for pharmaceuticals. Products listing CBD as an ingredient must be manufactured pursuant to the dietary-supplement standards. The dietary supplement GMPs are federal, and are described here: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=111

This section is titled “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.” Any product for human consumption that lists CBD as an ingredient must be manufactured pursuant to these dietary-supplement standards.

This dietary supplement classification applies to any “product that is a combination of ready-to-eat food with additional CBD infusions or CBD extracts, such as CBD chocolate syrup or CBD soda or CBD-infused frosting drizzled cookies.” The FAQs also  apply to CBD-Hemp from other states: “products made from industrial hemp that are sold in NYS must meet NYS standards, regardless of where the product is processed or manufactured.”

It should be noted that the Department acknowledges that its jurisdiction over Hemp-CBD is limited. For example, the Department does not require businesses to apply to the Department to add pre-manufactured Hemp-CBD to another product such as a topical or to develop products using CBD is sourced from another state. There is also no requirement to obtain any authorization from the Department to sell Hemp-CBD products. However, if the product is sold anywhere in New York State, it must comply with dietary supplement standards.

You can agree or disagree with the New York City DOH’s decision to start quarantining CBD in food, however, it does seem to be consistent with the Department’s guidance. The Department is a state agency and the DOH is a city agency so DOH’s decision may be a show of deference to the Department.

Later this week, I’ll analyze the CBD Agreement and how it provides additional insight into the state’s position on Hemp-CBD.