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