Hemp/CBD

Tom Downey, JD and Sean Jennings, JD

Your patient asks you why she can find every possible variety of cannabidiol (CBD) product on the internet or at her local convenience store, but not in your pharmacy. The convoluted answer is that we’re in legal limbo period, and the on-the-ground reality is out of sync with the law, for now. 

For decades, hemp and marijuana were lumped together as a Schedule I narcotic under the Controlled Substances Act of 1970. Hemp does not have the same psychoactive ingredient, tetrahydrocannabinol (THC), that gets marijuana users “high.”

However, because hemp and marijuana are both derived from the cannabis plant, hemp was considered no different than marijuana under federal law. That meant it was illegal to grow and distribute, or to cross state lines with it in hand. It was completely illegal.

With the Farm Bill of 2018, however, hemp was decoupled from marijuana and is no longer criminalized. This applies to hemp-derived products, such as textiles and CBD.

Legal structure

While hemp and CBD are no longer criminalized, the legal structure has not yet been created for the products.

The silly analogy is ice cream. There is nothing criminal about ice cream, except for what it does to my waistline, but I can’t simply sell ice cream out of my basement. I’d need to have relevant permits, licenses, and inspections by the local health department.

For hemp, those traditional processes do not yet exist at the federal level, but rulemaking committees are working on them at both FDA and the U.S. Department of Agriculture (USDA). 

In the new world of federal regulation of the cannabis plant, FDA and USDA serve different functions. Fitting with its agency mission, USDA has primary oversight over the crop itself—hemp cultivation, farming practices, interaction with state licensing regimes, and interstate transfer and sale of hemp. 

In contrast, FDA is tasked with governing the CBD products derived from hemp—consumer safety measures, marketing requirements, and protecting public health. In this light, FDA regulations may be more relevant to end-user patients and pharmacists.

FDA process

In simplified terms, FDA’s process has two tracks. The first is a general review of CBD. The second will be assessments and potential approvals for each product infused with CBD.

The first general review could be completed by summer 2020. Approval times for individual infused products in the second phase will depend on when the applications are submitted, the nature of the product, and extent of required testing.

Once this orderly FDA structure is created, the wild west limbo period we are in now will start to come to a close. Current CBD product manufacturers will need to apply and receive approvals or cease their operations.

While the law may recognize the subtle distinction between decriminalization and legality, the CBD supply and demand markets do not. CBD products are being sold over the internet, at festivals, out of residential basements, and in stores.

During this limbo period, federal regulators are using their limited resources to curtail false or unproven medical claims. Once FDA and USDA complete their rulemaking process, we’ll have the necessary framework to provide uniformity of labeling, content, testing, and approvals.

This framework will create greater consumer protections and confidence. 

Enforcement of the new regulations will likely force consolidation of the CBD market compared with what exists today. In the near future, operators with regulatory experience, economies of scale, and distribution access are more likely to succeed.

Ultimately, the nascent industry and the public will be better off with a federal legal framework in place, and pharmacists will be able to give clear advice to their patients.