Evolving Regulatory Climate Signals New Potential Step for CBD Products

NEW YORK, June 4, 2019 /PRNewswire/ -- Recently, the U.S. Food and Drug Administration held its first-ever public forum on cannabis and its derivative, CBD or cannabidiol. The FDA's decision to hold the meeting comes after the government approved the U.S. Farm Bill, allowing for the possession, cultivation, and sale of hemp-derived CBD products. The FDA held the meeting in order to better understand and evaluate the efficacy of CBD, potentially allowing producers to add CBD into food and beverages as the agency has strictly stated that CBD currently cannot be added into food and beverages because it is still considered as a drug. However, given the strong public interest, the former FDA Commissioner Scott Gottlieb said that he is willing to hear opinions and research on the matter. Over a hundred speakers, which included researchers, health professionals, and politicians, voiced their opinions on the scientific background of CBD. Researchers have long argued that CBD can be effectively used to treat a variety of medical ailments such as cancer, chronic pain, Alzheimer's, Parkinson's, and notably, epilepsy. Notably, in 2018, the FDA approved the first-ever cannabis-based drug, Epidiolex, which is used to treat epilepsy among children. Following the passage of the U.S. Farm Bill, many retailers and online vendors began to sell CBD-based products. In the beginning, mostly local businesses sold these hemp-derived CBD products, but shortly after, major international corporations such as Walmart and Amazon also began to carry CBD products that are geared towards health and wellness. Looking back, regardless of concrete regulatory approval, the CBD industry has made significant progress throughout the past year. Moreover, researchers and medical institutions are continually evaluating and studying CBD in efforts to launch large scale clinical trials, potentially leading to the broader approval of CBD. According to data compiled by Ameri Research, the global legal marijuana market was valued at USD 14.3 Billion in 2016. By 2024, legal marijuana global sales are projected to reach USD 63.5 Billion while exhibiting a CAGR of 21.1% from 2017 to 2024. Pressure BioSciences, Inc. PBIO, iAnthus Capital Holdings, Inc. ITHUF IAN, 22nd Century Group, Inc. XXII, The Alkaline Water Company Inc. WTER WTER, Sorrento Therapeutics, Inc. SRNE  

The World Health Organization (WHO) has long been an advocate for CBD. The organization released a report last year which noted that CBD is safe and is not associated with any negative public health effects. Additionally, the WHO highlighted that CBD is the non-psychoactive compound found within the cannabis plant. While the Canadian Imperial Bank of Commerce analysts cited the WHO's report, they mentioned that there is still a lack of data in order to progress further. On the other hand, CIBC acknowledged that there is a strong growing demand for CBD, citing a speaker from at the hearing from that suggested there are about 65 million Americans who have tried CBD and 63% found it effective, according to MarketWatch. While many reputable CBD supporters praise the benefits of the compounds, most agree that there is still a need for testing and safety standards. CIBC said that it expects to hear more clarification from the FDA within the year. In the meantime, companies and researchers are expected to continue advancing and developing clinical trials to undermine the floating misconceptions and stereotypes regarding CBD. "Predicting the future of cannabis isn't the easiest thing to do, but there are certain things that we know for a fact will happen/change," said Arnaud Dumas de Rauly, Co-Chief Executive Officer of The Blinc Group. "The first being that Cannabis will come off Schedule 1. The majority of the industry doesn't think this will happen within the current administration but we believe it will happen sooner than later. This will lead to a more mainstream approach to compliance and the involvement of organizations like the FDA, if they are given a mandate. Then will come a regulatory framework and we'll be confronted with inconsistencies regarding state-level and federal regulations."

Pressure BioSciences, Inc. PBIO announced earlier in April that it had, "released a new, short video demonstrating the ability of the Company's proprietary Ultra Shear Technology (UST™) platform to create water-soluble CBD oil that disperses instantly, resulting in improved dosing effectiveness, enhanced absorption, and more aesthetically-pleasing products when added to carbonated soft drinks, vitamin-infused sports drinks, and beer.

Link to video: https://www.youtube.com/watch?v=gAqFQmsGHcA

In addition to superior aesthetic quality, the Company believes the resulting low nanometer-scale emulsions ("nanoemulsions") of UST-processed CBD oil should also result in optimized and reproducible bodily absorption, bioavailability, and dosing safety for CBD oil and other UST-processed materials, when compared to many of the processed CBD oils and products that are commercially available today.

Mr. Edgar Ward, President and CEO of NutraLife Biosciences NLBS, said: 'NutraLife manufactures and sells NUTRAHEMPCBD, a line of CBD-infused products that includes creams, sprays, and other products that support daily health and wellness uses. We strive to ensure that our CBD-infused products will always be of the highest quality possible; therefore, we are constantly looking for advanced technologies to continue to improve our manufacturing processes. After reviewing available data and PBI's videos, we believe methods like PBI's UST platform may enable us to offer products with superior quality and effectiveness.'

CBD is a non-psychoactive, oil-soluble compound extracted from the cannabis plant, and is typically marketed dissolved in plant oil. It has been widely reported to offer numerous health benefits from stress and anxiety relief, to decreased muscle, joint, cancer and other pain, reduced inflammation, and to nearly miraculous relief of persistent seizures. However, because CBD is an oil-based product, its ingestion typically results in poor absorption in water-based living systems. There has been enormous interest in the development of truly water-soluble CBD, to achieve efficient absorption and bioavailability from foods and beverages. The market for CBD beverages alone could achieve revenue of $260 million in just the U.S. by2022 (Bloomberg, September 27, 2018) and much more world-wide. Unfortunately, because of solubility issues, many CBD products on the market today contain an inefficient over-abundance of CBD and/or undesirable chemicals to improve and stabilize its solubility in water. PBI believes that all of these beverages and other CBD-based products could substantially benefit from PBI's Ultra Shear Technology platform, to achieve water solubility and stability from the physics of high-pressure shearing - rather than from dependency upon chemistry and reliance upon use of undesirable chemicals.

Dr. Brad Young, Chief Commercial Officer of PBI, commented: 'We are very pleased to now show (in this follow-up video) the ability of our proprietary UST platform to mix CBD oil in water and infuse carbonated soft drinks, vitamin-infused sport drinks, and beer. This latest video further highlights the power of our UST platform to make nanoemulsions and its potential to help nutraceutical and beverage manufacturers make high-quality, oil-based products. With such compelling results to rely on, and with numerous opportunities ahead of us, we intend to accelerate the development of our UST platform to better address what we believe are several multi-billion-dollar markets in nutraceuticals, cosmetics, and food & beverages.'

About Pressure BioSciences, Inc: Pressure BioSciences, Inc. PBIO is a leader in the development and sale of innovative, broadly enabling, pressure-based solutions for the worldwide life sciences industry. Our products are based on the unique properties of both constant (i.e., static) and alternating (i.e., pressure cycling technology, or PCT) hydrostatic pressure. PCT is a patented enabling technology platform that uses alternating cycles of hydrostatic pressure between ambient and ultra-high levels to safely and reproducibly control bio-molecular interactions (e.g., cell lysis, biomolecule extraction). Our primary focus is in the development of high pressure-based products for biomarker and target discovery, drug design and development, biotherapeutics characterization and quality control, food science, soil & plant biology, forensics, and counter-bioterror applications. Additionally, we are actively expanding the use of our pressure-based technologies in the following areas: (1) the use of our recently acquired protein disaggregation and refolding technology from BaroFold, Inc. to allow entry into the biologics manufacturing and contract research services sector, and (2) the use of our recently-patented, scalable, high-efficiency, pressure-based Ultra Shear Technology (UST™) platform to (i) create stable nanoemulsions of otherwise immiscible fluids (e.g., oils and water) and to (ii) prepare higher quality, homogenized, extended shelf-life or room temperature stable low-acid liquid foods that cannot be effectively preserved using existing non-thermal technologies."

For our latest "Buzz on the Street" Show featuring Pressure BioSciences, Inc. recent corporate news, please head over to: https://www.youtube.com/watch?v=wwh_rr3s3h4

iAnthus Capital Holdings, Inc. ITHUF IAN owns and operates best-in-class licensed cannabis cultivation, processing and dispensary facilities throughout the United States, providing investors diversified exposure to the U.S. regulated cannabis industry. iAnthus Capital Holdings, Inc. recently announced that its U.S. subsidiary had entered into a letter of intent to acquire CBD For Life, a top-ranked, national CBD brand in the U.S. CBD For Life has experienced an increase in interest from mainstream retailers in the first quarter of 2019 following the passage of the Farm Bill. Products are available directly to consumers online and CBD For Life is currently distributing to 750 retail locations and actively on-boarding approximately 25 new locations per week with a dedicated sales channel working with national retailers. These products are designed for self-care, beauty, and wellness; and through a partnership with iAnthus, CBD For Life plans to expand its existing wholesale and retail platform to give more consumers access to its growing range of products. "Developing a strong CBD strategy is mission critical for cannabis companies to compete on a national scale while simultaneously entering the consumer product and retail marketplace," said Hadley Ford, Chief Executive Officer of iAnthus. "With the acquisition of a name brand like CBD For Life, iAnthus is well positioned to increase our market share with greater exposure to patients and customers across the country."

22nd Century Group, Inc. XXII is a plant biotechnology company focused on technology which allows the increase or decrease in the level of nicotine in tobacco plants and the level of cannabinoids in hemp/cannabis plants through genetic engineering and plant breeding. 22nd Century Group, Inc. recently announced that the 2018 Farm Bill will greatly enhance the Company's research activities around low-THC Cannabis sativa L. Recently, President Trump signed into law the 2018 Farm Bill, including an important provision to legalize hemp, defined as Cannabis sativa L. containing not more than 0.3% THC (the compound in cannabis responsible for psychotropic effects). Cannabis plants with higher levels of THC (i.e. marijuana) remain illegal under federal law. As a Research Partner of the State of New York Department of Agriculture and Markets, and with extensive experience in plant biotechnology and genetics, 22nd Century scientists are uniquely capable of exploiting cannabis DNA. The new law will allow 22nd Century to expand the Company's research activities, to add to the Company's cannabis intellectual property portfolio, and to increase the Company's cannabis germplasm library through the legal interstate commerce of proprietary low-THC Cannabis sativa L. plants. "In ending the legal uncertainty that low-THC cannabis research has entailed, and by opening the door for legal sales of hemp across state lines, the 2018 Farm Bill will result in a vibrant and growing marketplace for 22nd Century's unique varieties," explained Dr. Paul Rushton, Vice President of Biotechnology at 22nd Century Group. "With a sizeable head-start in low-THC Cannabis sativa research in collaboration with the Company's fully licensed and accredited partners, 22nd Century is poised to take advantage of hemp's new legal status and to develop and commercialize new hemp/cannabis varieties for the medical and agricultural fields."

The Alkaline Water Company Inc. WTER WTER is a leading producer of premium bottled alkaline drinking water sold under the brand name Alkaline88®. The Alkaline Water Company Inc. recently announced that, following the passage of the Agriculture Improvement Act of 2018 (Farm Bill), the Company is well-positioned to capitalize on the opportunity to be one of the first national U.S. beverage companies to bring the true water-soluble, full-spectrum features of bioactive cannabidiol (CBD) molecules from hemp plants to U.S. consumers through its A88 Infused Beverage Division, Inc. "We are very excited that Congress has passed legislation redefining hemp to include extracts, cannabinoids and derivatives, which will permanently remove hemp from the Controlled Substances Act (CSA)," said Ricky Wright, President and Chief Executive Officer of The Alkaline Water Company. "This is a significant step forward for consumers who are looking to access CBD and CBD-infused products. As local and state legislatures, as well as the U.S. Food and Drug Administration (FDA), finalize their regulations for hemp, we are well-positioned to launch our great tasting Alkaline88® infused with natural hemp-extract formulations to become a dominant brand in this beverage category."

Sorrento Therapeutics, Inc. SRNE is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases. Sorrento Therapeutics, Inc. recently announced that it had established a new business unit to focus on the market potential for its innovative water-soluble cannabidiol (CBD) formulation technology. Cannabidiol (CBD) has been under consideration within the pharmaceutical side of Sorrento for its interesting pharmacological properties and potential clinical benefits in multiple central nervous system, autoimmune or inflammatory disease and pain-related indications. "Without distracting from our pharmaceutical business, we have the ability to leverage another Sorrento innovative technology – this time from our formulation experts – and make it available to the broader consumer market," stated Dr. Henry Ji, Chief Executive Officer and Chairman of Sorrento Therapeutics. "Longer-term, we may consider spinning off our CBD consumer business into an independently operated company if appropriate, while our research and clinical development team continues to explore the potential pharmaceutical applications of cannabidiol (CBD) for the medical markets."

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