Pubdate: Thu, 31 Mar 2016 Source: Portland Mercury (OR) Column: Cannabuzz Copyright: 2016 The Portland Mercury Contact: http://www.portlandmercury.com/ Details: http://www.mapinc.org/media/1174 Author: Josh Jardine FDA V CBD: DAWN OF WTF The FDA's New Rules for CBD Are Confused-and Confusing IT'S BEEN A HELL of a month in the canna world. It started on March 15, when the Oregon Health Authority (OHA) shocked a room full of 500-plus cannabis-business owners at an Oregon Cannabis Association meeting. Suddenly, making and selling extracts was illegal. That seems to be all sorted out-see my colleague Vince Sliwoski's Ask a Pot Lawyer column. But as soon as the dust settled on that, Facebook and other stellar sources of dependable and non-alarmist information began exploding with the news that the US Food and Drug Administration (FDA) had "outlawed" cannabidiol (CBD). Online shrieking and hysterical ranting commenced in full force. "THE FDA IS GOING TO OUTLAW CBD!" wrote one thoughtful and well-informed person in my feed. "BIG PHARMA IS GOING TO OWN ALL CANNABIS! NOW IS THE TIME FOR REVOLUTION!" posted another. It was unclear if said revolution would involve multiple angry-face emojis and "Share If You Like" posts, much like our forefathers battled the tyrant King George III. ("Thomas Jefferson and 55 other founding fathers suggest you like the page 'We the People.'") So for the second time in as many weeks, let's take a collective calming breath and do something all too rare: read and comprehend the facts of an issue. As explored in past columns, CBD is a cannabinoid found in both industrial hemp plants and in marijuana, particularly the flowering plants you tried, and failed, to grow with a desk lamp in college. CBD has gained widespread interest for its potential health benefits, perhaps most famously as a possible treatment for pediatric epilepsy. (Google "Charlotte's Web CBD oil" for details on its most well-known case.) Unlike THC, CBD is not psychoactive, and people are using it for pain, stress relief, reduction of inflammation, and numerous other health issues. CBD As CBD is not on the feds' list of controlled substances, products made with it can be shipped across state lines-also unlike THC products. Last month, the FDA sent out warning letters to some companies who manufacture products that contain CBD. The letters warned against labeling these products with drug claims-for example, claims that the product can cure, mitigate, treat, or prevent disease. Manufacturers were warned to revise product labeling and remove any such claims. The feds went on to say that CBD products may no longer be marketed as supplements, as it is now being considered a "new drug." The FDA writes: "New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA.... FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective." The Hemp Industries Association (HIA) weighed in on these two matters with a statement that read, in part, "It is the position of the HIA that legal hemp products containing CBD were marketed as foods and dietary supplements long before cannabidiol formulations were submitted to the FDA for testing as a 'new drug.' As such, CBD products are exempt from laws that preclude CBDs from product status as dietary supplements pending 'new drug' approval by the FDA." While that was playing out at the federal level, Oregon managed to get into the CBDrama Game as well. As of March 1, Oregon dealt a blow to industrial hemp producers, stating that dispensaries may no longer accept and sell products made with industrial-hemp-derived CBD. (Don't worry-hemp clothing is still legal.) But it's okay if the CBD was extracted from "marijuana." So that topical you're so fond of using to treat your bum knee now must be made from a marijuana plant, not a hemp plant. Why? No idea. I'm not sure why the OHA is making many of the decisions it has of late. It seems we would want to support the burgeoning hemp industry in Oregon, not place senseless restrictions on it. And this particular restriction seems to only apply to existing medical dispensaries, not the forthcoming recreational ones, which seems unfair-not to mention difficult to enforce. I don't need a hemp bracelet. I need to provide pain relief to the patients I work with. And I could use something right now to deal with this headache of regulatory overreach. - --- MAP posted-by: Jay Bergstrom