Alibi V.29 No.11 • March 12-18, 2020 

Baked Goods

Talking But Saying Nothing

FDA reports on CBD progress

Baked Goods logo (with correct glasses!)

Last week, the US Food and Drug Administration finally got around to updating Congress on the progress it has made on developing CBD regulations, but it doesn't seem to say anything new.

In its report to the US House and Senate Committees on Appropriations, the FDA pointed out that CBD “is not a risk-free substance.” The agency says that during public clinical trials for Epidiolex, CBD was associated with risks “including liver injury, drug-drug interactions, drowsiness that may affect driving, and the possibility of male reproductive toxicity.”

The report states that the FDA is still seeking data concerning long-term effects of sustained use of the drug. The agency says that before it can come up with effective regulations, it needs to answer these “key questions”: What happens if you use CBD daily for sustained periods of time? What level of intake triggers the known risks associated with CBD? How do different methods of exposure affect intake? What is the effect of CBD on the developing brain? What are the effects of CBD on an unborn child or breastfed newborn? How does CBD interact with herbs and botanicals? Does CBD cause male reproductive toxicity in humans, as has been reported in studies of animals? Are there differing safety concerns for use in certain animal species, breeds or classes? Are any residues formed in edible tissues of food-producing animals?

The update also says the FDA has been monitoring gray market CBD sales and is concerned about products that are being sold using unproven medical claims. “Some of these products are marketed for serious diseases and conditions like cancer, Alzheimer’s disease, and opioid use disorder,” the report says. And it doesn't look like the agency has any plans to stop enforcing the rules. “FDA intends to continue monitoring the marketplace, and to initiate and expand appropriate compliance and enforcement action against unlawful CBD products that pose the greatest risk of harm to the public. As we move forward, FDA intends to continue taking action to address violations we identify that put the public at risk.”

And that's really all we got out of it. Instead of any real progress with regulations, we got the assurance that the FDA is looking to fund more research into CBD and that they're going to keep penalizing companies that sell CBD products that make unwarranted medical claims.

Earlier this month, newly-appointed FDA Commissioner Stephen Hahn said attempting to ban CBD would be a “fool's game” and suggested that the agency was taking a more positive stance on the drug's efficacy.

Banks Support SAFE Act

Banking associations from 49 states and Puerto Rico are urging lawmakers to advance a bill that would protect financial institutions that service cannabis businesses.

In a letter written to Sens. Mike Crapo and Sherrod Brown—the chairman and ranking member of the Senate Banking Committee—the Joint State Bankers Association said that while they might not support legalizing cannabis, they do support passing the Secure and Fair Enforcement (SAFE) Banking Act.

Financial institutions are currently barred by federal law from knowingly working with criminal enterprises. Since marijuana is still federally illegal, banks aren't allowed to work with marijuana companies.

“As a result, this segment of our local economies is forced to operate on an all-cash basis, which creates serious public safety, revenue administration, and legal compliance concerns in the communities we serve,” wrote the association. “The impact on our local economies could also prove significant, as revenue paid to unrelated industries that provide products and services to state-authorized cannabis businesses such as law firms, accountants and contractors is technically money derived from illegal activities, and thus could be considered money laundering.”

The SAFE Banking Act would change all that by blocking federal authorities from penalizing banks that work with cannabis companies that operate in states where the drug is legal. And—as the association points out—the SAFE Banking Act is a “banking-specific solution that would address the reality of the current marketplace” without affecting current cannabis laws.

Near the end of February, Sen. Cory Gardner reportedly said that lawmakers are “close to finding common ground to getting everyone signed off to move this forward.”

Reciprocity Rules to Start in July

New Mexico Department of Health Secretary Kathyleen Kunkel has reportedly signed off on a rule change allowing nonresidents enrolled in other states' medical cannabis programs to purchase, possess and consume cannabis in New Mexico. Under the new rules, out-of-state patients can go to any dispensary in New Mexico and register as a reciprocal patient.

According to NM Political Report, Dr. Dominick Zurlo, the Medical Cannabis Program Director, confirmed that the rule change goes into effect July 1. He said the the rule change is being delayed while state's seed-to-sale tracking software is upgraded. “We’re actually doing a much broader upgrade … that is going to have a much greater impact for patients in improving the system and improving how patients actually get registered in the program,” Zurlo said. The new system will reportedly include an online portal where some patients will be able to register and have their applications approved by providers online.

He also said we'll start to see consumption areas—which reciprocal patients will need to consume their meds—start to open between now and July, but those rules have not yet been approved. “Those are still being reviewed but I anticipate very soon that we’ll actually have those promulgated as well,” Zurlo said.

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