This week Aurora Cannabis Inc. (ACB) announced that its High CBD Oil Drops have been approved for use in Ireland.
The approval came under Ireland’s new Medical Cannabis Access Program (MCAP), which was authorized in June by Irish Minister of Health Simon Harris and is scheduled to last for five years.
Aurora’s High CBD Oil Drops are now part of a regulatory schedule by the Irish Minister of Health that enables importation, prescription and supply. The company says that its CBD Oil Drops are one of only two products to receive such an approval.
Under the (MCAP), patients can receive medical cannabis prescriptions for any of the following medical conditions: spasticity associated with multiple sclerosis; intractable nausea and vomiting associated with chemotherapy; and severe, refractory (treatment-resistant) epilepsy.
“Aurora is pleased to be able to assist patients who are seeking treatment with high quality EU-GMP (good manufacturing practice) certified pharmaceutical-grade medical cannabis in Ireland,” says Dr Shane Morris, Chief Product Officer at Aurora.
“We are very proud to be one of the first approved suppliers of medical cannabis under the MCAP. We want to acknowledge the efforts made by many people, especially the patients and doctors who have campaigned for access to these medicines.
“We look forward to more of Aurora’s high-quality medicines being approved, so that more patients can benefit from the MCAP in Ireland. We will continue to work closely with all parties and state agencies to facilitate further availability.”
Ireland’s approval coincides with FDA warning against CBD
Just as Aurora announced its CBD product approval from Ireland, back is the U.S. the FDA updated its stance on the cannabidiol compound, warning that “CBD has the potential to harm you.”
CBD has had a fast rise to fame, making headlines across product categories such as: food, beverage, cosmetics, skin and body care, etc. These products can be found in states where cannabis is not recreationally or medically legal, and even in major retail chains such as CVS Health, Walgreens, Boots Alliance, and Rite Aid.
Thus far, the FDA has only approved one drug utilizing the compound, and that’s Epidiolex from GW Pharmaceuticals PLC (GWPH), a treatment for severe forms of childhood epilepsy.
The FDA says that because there is a lack of scientific information, they cannot conclude that CBD is “generally recognized as safe among qualified experts for use in human and animal food,” adding that 15 companies in the U.S. have been warned that they were illegally selling products containing CBD.
CBD “can cause” liver damage, affect other drugs, and when combined with alcohol or other depressants can increase the risk of sedation or drowsiness, according to the FDA’s revised consumer update. The update details other potential side effects such as drowsiness, gastrointestinal distress and changes in mood.
The regulatory agency also acknowledges that many aspects of CBD remain unknown. For example, not much is known about the long-term effects of taking CBD daily for extended periods, or the effects on a developing brain, or how it interacts with herbs and botanicals.
Aurora Cannabis Inc. (ACB) was unchanged in after-hours trading Tuesday. Year-to-date, ACB has declined %, versus a 16.46% rise in the benchmark S&P 500 index during the same period.
About the Author: Eric Bowler
Eric Bowler is an accomplished journalist providing in-depth insights for more than two decades. Over the past several years his focus has been on the marijuana industry, with a special interest in cannabis growth stocks. His daily coverage of the industry keeps him on top of the key trends with the goal of helping investors make well-informed decisions.