FDA Commissioner Announces Steps Toward Regulation Of Cannabis Products

There has been an ever-growing public interest in cannabis-derived therapies and products in recent years, and the trend only shows signs of getting stronger as the cannabidiol (CBD) industry is projected to grow to over $2 billion by 2020.

In December, the passage of the 2018 Farm Bill legalized hemp and hemp-derived CBD, though the Food and Drug Administration (FDA) was quick to announce that they would be retaining their authority to regulate it as they do other food and drugs in the United States.

At the time, FDA Commissioner Scott Gottlieb issued a statement explaining the agency’s approach to cannabis products and their next course of action.

Currently, the FDA does not permit interstate commerce of THC or CBD edibles or the marketing of them as dietary supplements.

On Tuesday the FDA announced that it would be taking several important new steps to help advance the agency’s consideration of a framework for the regulation of the lawful marketing of “appropriate cannabis and cannabis-derived products.”

“We treat products containing cannabis or cannabis-derived compounds as we do any other FDA-regulated products,” said Gottlieb. “Among other things, the FDA requires a cannabis product (hemp-derived or otherwise) that’s marketed with a claim of therapeutic benefit to be approved by the FDA for its intended use before it may be introduced into interstate commerce.”

As part of the FDA’s plan, the agency will be hosting a ten-hour public hearing on May 31 to gather scientific data, personal experiences, and other information from stakeholders regarding manufacturing, labeling, sale, safety, and quality of products that contain cannabis compounds. An opportunity for written public comment will also be available until July 2.

The FDA also intends to form a high-level internal agency working group to research possible avenues for dietary supplements and food items containing CBD to be lawfully marketed. The group will consider what regulatory and statutory changes might need to be made, as well as their possible impact.

Updates will be made to the FDA website’s frequently asked questions page to help the public understand how the rules apply to cannabis products.

The FDA also plans to issue multiple warning letters as well to companies that market CBD products with unfounded claims that are aimed at vulnerable populations.

FDA Public Hearing
May 31, 2019
8:00 a.m. – 6:00 p.m.
FDA’s White Oak Campus
Building 31, Room 1503 – Great Room
10903 New Hampshire Avenue
Silver Spring, Maryland 20993

A webcast link for the hearing will be made available on the FDA website prior to the meeting date.

Electronic comments must be submitted to Docket FDA-2019-N-1482 by July 2, 2019.