The Evolution of the CBD Regulatory Landscape

No federal agency has taken charge of regulating cannabidiol products, leaving decisions up to the individual states.

At best, the regulation of cannabidiol (CBD) in the United States can be described as patchwork. On a federal level, any part or constituent of Cannabis sativa plants, more commonly known as cannabis or marijuana, is a Schedule I controlled substance. Hemp—defined as Cannabis sativa containing less than 0.3% Δ-9-tetrahydrocannabinol (THC) and the basis for CBD product—was exempted from this scheduling by the Agriculture Improvement Act of 2018 (Farm Bill).1

Enactment of the Farm Bill removed hemp from Schedule I of the Controlled Substances Act and launched a surge in hemp growing and a boom in the production of CBD products derived from now-legal hemp—and created confusion for regulators and pharmacists.

“I checked the landscape legally before I got involved,” said Tim Kotschwar, PharmD, owner of Alliance Community Pharmacy in Alliance, Nebraska. “I talked with the local police chief, the state patrol, our prosecuting attorney, even a local judge. I was basically told it’s not officially legal in Nebraska, but you can buy CBD in Bed, Bath & Beyond or just about any gas station.

“I was still nervous, so I talked with the state board of pharmacy and the Nebraska Pharmacists Association. They all said it’s not officially legal yet, but it belongs in the pharmacy. That guy in the gas station isn’t going to be able to talk about the long list of CBD-drug interactions or [adverse] effect profiles,” Kotschwar continued. “The FDA says we can’t call OTC CBD a drug, but pharmacists are the people trained to...counsel buyers about the drug-like qualities of CBD.”

Federal Inaction

The text of the Farm Bill set the upper allowable limit of THC in hemp as less than 0.3% by dry weight of plant material but said nothing about THC or other constituents in products derived from hemp products, including CBD. The bill also underlined the authority of the FDA to regulate hemp, said Al Carter, PharmD, MS, RPh, executive director and secretary of the National Association of Boards of Pharmacy. The problem, he explained, is that the FDA is largely avoiding CBD regulation outside the 2018 approval of cannabidiol (Epidiolex) for certain seizures.2

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