Pubdate: Thu, 31 Mar 2016
Source: Portland Mercury (OR)
Column: Cannabuzz
Copyright: 2016 The Portland Mercury
Author: Josh Jardine


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 
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.
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MAP posted-by: Jay Bergstrom