Why CBG (Cannabigerol) May Have a Promising Role to Play in FDA Drug Approvals

Why CBG (Cannabigerol) May Have a Promising Role to Play in FDA Drug Approvals

PR Newswire

PALM BEACH, Florida, July 14, 2020

Financialnewsmedia.com News Commentary

PALM BEACH, Florida, July 14, 2020 /PRNewswire/ -- The CBD craze was a long time coming and its presently full steam ahead. 2019 was the year of cannabidiol (CBD) in the cannabis industry. CBD continued to make its way into countless consumer products, from sodas to sports bras. A recent legal article on the Canna Law Blog said: "Recently, another cannabinoid has begun getting a lot of buzz inside the cannabis industry, much like CBD before it. That cannabinoid is CBG (cannabigerol). Like CBD, CBG is among the 100+ molecules in the cannabis plant. From a scientific perspective, CBG is unique for the "precursor" role it plays in synthesizing other cannabinoids–including THC and CBD–and in synthesizing the overall chemical composition of the plant. From a regulatory perspective, the legal status of CBG products may be less problematic than CBD products. It continued: "It is illegal to add CBD to many products, in FDA's view, due to the "drug exclusion rule." According to FDA, products containing CBD cannot be sold as dietary supplements because CBD was investigated and approved by FDA as a new drug (Epidoex). If something is a non-exempt "drug" it cannot be placed in the food stream under the Food Drug & Cosmetic Act. Mentioned in today's commentary include:  Aphria Inc. (NASDAQ: APHA) (TSX: APHA), Rapid Therapeutic Science Laboratories, Inc. (OTCPK: RTSL), Cronos Group Inc. (NASDAQ: CRON) (TSX: CRON), cbdMD, Inc. (NYSE: YCBD), Village Farms International, Inc. (NASDAQ: VFF) (TSX: VFF).

The article continued:  Unlike CBD, CBG has not been approved as a drug, and FDA itself has acknowledged that "parts of the cannabis plant that do not contain THC or CBD might fall outside the scope of the [drug exclusion rule]." If CBG is approved as a drug at some point down the line, it also seems likely that the drug exclusion rule would not apply: this is because the rule contains an exception for substances marketed as foods or dietary supplements prior to any FDA clinical investigation. People are already marketing CBG products as foods and dietary supplements. This domestic legal framework, alongside the fact that CBG can be lawfully produced and extracted from hemp under the 2018 Farm Bill, seemingly gives CBG a viable legal runway. Of course, everything here is conditioned on manufacturers and sellers steering clear of unapproved health claims."

Rapid Therapeutic Science Laboratories, Inc. (OTCPK: RTSL)  Breaking News:  Rapid Therapeutic Completes Delivery of Additional 6,000 Units of its Proprietary Metered Dose Inhalers - Rapid Therapeutic Science Laboratories (the "Company" or "RTSL"), a SEC fully-reporting, growth-oriented manufacturing and marketing company focused on employing FDA-approved Metered Dose Inhaler (MDI) technology to deliver aerosolized cannabinoids, such as CBD, CBG, and THC, announced today that it has delivered an additional 6,000 units (8,000 total) under its previously announced 100,000 unit order that was recently expanded to 250,000 units.

The Company has leased a state-of-the-art lab tested to ISO 6 standards and maintains general facility/process controls in its environmentally filtered operations, as part of compliance with FDA Good Manufacturing Practices (GMP) related to ISO 13485.  This lab will allow the company to pursue RTSL's stated goal of FDA registration of all RTSL products.

Rapid Therapeutic Science Laboratories, Inc. Chairman and CEO, Donal R. Schmidt, Jr. stated, "This 6,000-unit lot was the last production run before we relocated to our new ISO 13485 lab. Our new lab allows us to manufacture a higher-quality product more quickly, and with less waste than we could previously."

Mr. Schmidt continued, "With an estimated gross margin of approximately $20 per unit, this order for 250,000 units, by itself, could represent up to $5,000,000 in gross profit for the Company.  Our RxoidTM CBD Inhalers are currently being sold through doctors' offices and in pharmacies across the United States." Read the full Press Release and more for RTSL at:  https://www.financialnewsmedia.com/news-rtsl

In other active company news in the markets this week: 

Aphria Inc. (NASDAQ: APHA) (TSX: APHA) a leading global cannabis company, recently announced that it has issued 1,658,375 common shares (the "Settlement Shares") to Emblem Cannabis Corporation ("Emblem"), a wholly owned subsidiary of Aleafia Health Inc.  as part of a settlement agreement entered into between the parties and previously disclosed on June 25, 2020 .

The Settlement Shares were issued in Canada by way of a prospectus supplement to Aphria's base shelf prospectus dated November 22, 2019 and in reliance on Regulation S under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"). Copies of the prospectus supplement and base shelf prospectus are available under Aphria's profile on SEDAR

Cronos Group Inc. (NASDAQ: CRON) (TSX: CRON) announced that it will hold its 2020 Second Quarter Earnings Conference Call on Thursday, August 6, 2020 at 8:30 a.m. EDT. Cronos Group's senior management team will discuss the Company's financial results and will be available for questions from the investment community after prepared remarks.  A live audio webcast of the earnings call will be available on the Company's website. The webcast of the call will be archived for replay on the Company's website.

Participants may also listen via telephone by dialing (866) 795-2258 toll-free from the U.S. and Canada, or (409) 937-8902 if dialing from outside the U.S. and Canada (passcode:9993888). If joining by phone, please dial into the call 15-20 minutes earlier to avoid any long hold times.

cbdMD, Inc. (NYSE: YCBD) recently announced that it has filed a new patent application with the U.S. Patent and Trademark Office which will allow it to pursue patented protection in several key areas, including novel formulations and delivery systems, as well as methods of manufacturing and use. The recent submission by the company is part of its ongoing intellectual property strategy to ensure appropriate protection around its product lines and to be forward-thinking as to the direction of the CBD market.

"cbdMD has always been a leader of innovation the CBD industry. Pursuing intellectual property will remain a priority for us as we continue to strengthen and grow the company's assets within a fiscally disciplined mindset," said Martin A. Sumichrast, Chairman and co-CEO at cbdMD, Inc. "The filing of this new patent application furthers supports our mission of being a preeminent science-based company in a currently congested CBD marketplace. Continued research and development for real world applications drives innovation and protecting those proprietary technologies and ideas is consistent with cbdMD's business plan. We look forward to our future innovation and continuing to pursue additional IP protection."

Village Farms International, Inc. (NASDAQ: VFF) (TSX: VFF) recently announced that it has executed a definitive agreement with DutchCanGrow Inc. ("DCG"), a Netherlands-based cannabis enterprise, to become one of six equal shareholders in DCG owning just under 16% each, with a seventh shareholder owning 5%.  DCG is pursuing the opportunity to become one of a limited number of licensed cannabis growers (up to a maximum of 10) when the Dutch government permits the first legal recreational cannabis market in Europe under its 10-city Experiment to Investigate Closed Cannabis Supply Chains (the "WECG").

If successful in receiving a license from the Dutch government when awarded later this year, DCG plans to construct and operate a specialized cannabis greenhouse facility in the Netherlands and develop, produce and market a variety of safe, high-quality cannabis products to supply this new legalized market. Since 1976 in the Netherlands, a cannabis policy has been in effect regarding cannabis, under which the sale of cannabis at "coffee shops" is tolerated but the cultivation of cannabis is illegal. In 2019, in response to concerns around product safety (ingredients, additives, contaminants) and increasing criminal involvement related to cannabis cultivation, the Netherlands' House of Representatives approved the WECG as an intermediary step to address the lack of quality standards and societal impact of crime related to cannabis.

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