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The FDA keeps on reaching out for comments on CBD.
There are a few things going on with the FDA and CBD at once, so here’s the lay of the land:
First, the FDA has decided to collect public comments on CBD “indefinitely.” (Cannabis Wire reported on this decision in March.)
In July, the FDA released guidance for cannabis researchers, on which Cannabis Wire also reported. That public comment window closed this week.
Also in July, the FDA submitted to the White House its CBD enforcement policy, which is a key document that has kept the cannabis and hemp industries on their toes, as it will determine which types of products are allowed. Cannabis Wire has reported extensively on the meetings held so far with the White House and the FDA on this forthcoming guidance.
And, finally, this week, the FDA announced a two-month public comment window on another piece of guidance for those hoping to get approval for a “generic cannabidiol oral solution.” The only botanical CBD product approved to-date by the FDA has been GW Pharmaceuticals’ Epidiolex, in 2018. You can read the draft guidance here.
Bill introduced in Congress to allow “disaster relief for cannabis businesses.”
Four Congress members from Oregon – Senators Ron Wyden and Jeff Merkley, and Representatives Earl Blumenauer and Peter DeFazio – have introduced the Small Business Disaster Relief Equity Act. The bill would allow for state-legal cannabis businesses to qualify for the same programs available to other businesses.
“Cannabis businesses in Oregon hurt by the blazing wildfires or any other disaster shouldn’t be shut out from federal relief simply because the federal government is stuck in yesteryear,” Wyden said in the announcement. “These legal small businesses employ thousands of workers and support our struggling economy. If they need federal support, they should get it. Full stop.”
+ Related: California’s Department of Food and Agriculture this week published an alert, titled “Disaster-Relief Measures for Licensed Commercial Cannabis Farmers: What You Need to Know.” They write:
“The year 2020 has brought us more than 8,000 fires that have burned millions of acres across the state, and we’re still in the thick of fire season. More than 18,000 firefighters continue to work 24 hours a day, 7 days a week, battling fires throughout California, and many of these fires are wreaking havoc among our community of licensed commercial cannabis farmers. … we want to ensure our licensees are aware of the resources available to them in the event they face a fire-related emergency.”
UK Financial Conduct Authority provides clarity on cannabis stocks.
“In response to queries from cannabis-related companies interested in listing in the UK,” the FCA recently wrote on its site, it would provide some clarity on “its approach to assessing these applications.”
When it comes to non-medical cannabis companies, the answer is no. “The proceeds from recreational cannabis companies, even when they are located in those jurisdictions that have legalised it, are proceeds of crime under PoCA. We would therefore not admit the securities of such a company to the Official List.”
When it comes to medical cannabis companies within the UK, it’s slightly more straightforward. Medical cannabis has been legal, albeit in a very limited form, in the UK since 2018. Patients with permission can import certain cannabis oils, and several companies are licensed for domestic production, though the list of license-holders is not public.
“The legal position of purely UK-based medicinal cannabis companies and cannabis oil companies is clear. UK-based medicinal cannabis companies can be admitted to the Official List, if the company has the appropriate Home Office licences for their activities where they are required.”
For medical cannabis companies outside of the UK, it’s slightly more complicated. “For medicinal cannabis and cannabis oil companies with overseas activities, the company will need to satisfy us that their activities would be legal if carried out in the UK. We will also need to understand the legal basis of the company’s overseas activities, for example the nature of the local licensing and the licences the company holds.”
You can read the full FCA explanation here. It’s worth noting that more clarity is forthcoming. The FCA writes: “This is pending a guidance consultation which will follow in due course.”