New U.S. regulatory development paves the way for use of Isodiol’s pure, natural CBD as an approved Active Pharmaceutical Ingredient (API) for use in U.S.-based Clinical Studies and Finished Pharmaceutical Products (FPPs)
Isodiol International Inc. (CSE:ISOL) (OTC:ISOLF) (FSE:LB6A.F) (the “Company” or “Isodiol”) applauds the Drug Enforcement Administration’s (DEA) decision in the long-anticipated rescheduling of CBD following the Federal Drug Administration’s (FDA) approval of GW Pharmaceutical’s FPP, Epidiolex, for the treatment of seizures associated with two forms of epilepsy.1
The DEA announced2 today that the FDA-approved drug Epidiolex will be rescheduled in Schedule V from Schedule I,
“Epidiolex contains cannabidiol (CBD), a chemical constituent of the cannabis plant (commonly referred to as marijuana). The CBD in Epidiolex is extracted from the cannabis plant and is the first FDA-approved drug to contain a purified extract from the plant.”
This is incredibly significant as the DEA has recognized that CBD is amongst those Substances that have a low potential for abuse and health benefits, as compared to Schedule I substances, which have no currently accepted medical use in the United States, a lack of accepted safety for use, and a high potential for abuse. By rescheduling CBD to Schedule V, the DEA has recognized the benefits of API-grade CBD and its low potential for abuse.
“We believe this rescheduling of CBD places Isodiol among the best positioned companies in the market, if not in the best position, to take advantage of the increasing demand for high-quality, API-grade CBD,” stated Marcos Agramont, Isodiol International, Inc. CEO. “Isodiol is one of the only companies in the world that can supply CBD that meets the standards of the clinical studies being recognized by the DEA and FDA. We are pleased with the DEA’s latest progress in helping get API-grade CBD into the U.S. pharmaceutical market.”
Isodiol’s subsidiary, BSPG Laboratories Ltd., has received government approval at its Good Manufacturing Practice facility in the United Kingdom from the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA), in accordance with The Human Medicines Regulations 2012 (SI 2012/1916), for the manufacturing of its API-grade CBD under certificate number: UK API 48727. This API-grade CBD can be imported into Canada via Licensed Dealers (LDs) and Licensed Producers (LPs) and also into the U.S. via DEA license holders such as research universities and pharmaceutical companies.
“Isodiol believes the DEA’s decision adds substantial value to its API for clinical research and trials for FPPs in the United States,” added Agramont. “Much like GWPH’s product that went through this extensive approval process, Isodiol can supply parties interested in developing Cannabidiol-based FPPs or conducting clinical research studies with the option to utilize Isodiol’s API to forego the substantial time and resources necessary to achieve ingredient approval and develop new FPPs that are in line with the DEA’s and FDA’s objectives.”
Specifically, the agency has stated,
“‘DEA will continue to support sound and scientific research that promotes legitimate therapeutic uses for FDA-approved constituent components of cannabis, consistent with federal law,’ said Acting DEA Administrator Uttam Dhillon. ‘DEA is committed to continuing to work with our federal partners to seek ways to make the process for research more efficient and effective,’”
“‘The FDA is committed to advancing scientific research and drug development programs that properly evaluate the active ingredients contained in marijuana,’ said FDA Commissioner Scott Gottlieb, M.D. . . . ‘The FDA will continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and stand ready to work with product developers who are interested in bringing patients safe and effective, high quality products.’”
Given that the FDA’s approval and DEA’s actions on Epidiolex have raised the visibility of hemp-derived CBD products, it is even more critical that the U.S. Congress passes the 2018 Hemp Farming Act to permanently establish hemp and hemp-derived products as agricultural commodities in the United States. Isodiol encourages supporters of hemp and hemp-derived CBD to use the U.S. Hemp Roundtable’s web portal to contact their Congressmen today and urge them to support the passage of the Hemp Farming Act. CLICK HERE to send a letter to your U.S. Senators.3
For more information on Isodiol, please visit www.isodiol.com
About Isodiol International Inc.
Isodiol International Inc. is focused on the nutritional health benefits that are derived from hemp and is a product development, sales, marketing and distribution company of hemp-based consumer products and solutions.
Isodiol has commercialized a 99%+ pure, naturally isolated CBD, including micro-encapsulations, and nano-technology for quality consumable and topical skin care products. Most recently, the Company received approval for its CBD designated as an Active Pharmaceutical Ingredient for use in Finished Pharmaceutical Products, as was announced on April 26, 2018.
Isodiol’s growth strategy includes the development of over-the-counter and pharmaceutical drugs and continued international expansion into Latin America, Asia, and Europe.
ON BEHALF OF THE BOARD
Marcos Agramont, CEO & Director
Forward-Looking Information: This news release contains “forward-looking information” within the meaning of applicable securities laws relating to statements regarding the Company’s business, products and future the Company’s business, its product offerings and plans for sales and marketing. Although the Company believes that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. Readers are cautioned not to place undue reliance on forward-looking information. Such forward-looking statements are subject to risks and uncertainties that may cause actual results, performance and developments to differ materially from those contemplated by these statements depending on, among other things, the risks that the Company’s products and plan will vary from those stated in this news release and the Company may not be able to carry out its business plans as expected. Except as required by law, the Company expressly disclaims any obligation and does not intend, to update any forward-looking statements or forward-looking information in this news release. Although the Company believes that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct and makes no reference to profitability based on sales reported. The statements in this news release are made as of the date of this release.
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