June 25, 2019

Wyden Presses FDA to End the Uncertainty, Promptly Update Regulations on CBD, Other Hemp-based Derivatives

“The regulatory confusion and uncertainty surrounding CBD cannot continue . . .”

Washington, D.C.— U.S. Sen. Ron Wyden, D-Ore., today urged the Food and Drug Administration (FDA) to promptly issue guidance that ensures the regulatory pathway Congress intended for the lawful use of hemp-derived cannabidiol (CBD) as a food additive and as a dietary ingredient in dietary supplements.

In a letter to Department of Health and Human Services (HHS) Secretary Alex Azar and FDA Acting Commissioner Ned Sharpless, Wyden urged the FDA to issue its formal enforcement discretion policy by August 1, 2019. He also requested that – pending publication of a permanent final rule – the agency initiate rulemaking to allow the manufacturing and sale of products containing hemp-derived CBD under the existing statutory and regulatory frameworks applicable to food and dietary supplements. Additionally, Wyden expressed his strong support for the FDA undertaking a process to make lawful a safe level for foods and dietary supplements containing hemp-derived CBD.

“I fully embrace FDA’s commitment to the promotion and protection of public health and understand that, with respect to hemp-derived CBD, the agency will be examining a number of health and safety considerations. Given these and other factors, I certainly acknowledge the challenges that FDA faces in expeditiously creating a legal pathway for hemp-derived CBD in foods and dietary supplements, especially since the agency has never used these rulemaking authorities before,” Wyden wrote.

“However, I, and many in the CBD industry, find FDA’s indication that it may take three to five years to issue a final regulation authorizing the lawful use of hemp-derived CBD in foods and dietary supplements fully unacceptable. The regulatory confusion and uncertainty surrounding CBD cannot continue for that length of time.”

Congress established hemp as a legal agricultural commodity and authorized the production, consumption and sale of hemp and hemp-derived products, including hemp-derived cannabidiol (CBD), when it passed Wyden’s Hemp Farming Act as a provision included in the 2018 Farm Bill. Since then, the U.S. Department of Agriculture issued a legal opinion through the agency’s Office of the General Counsel recognizing, among other things, the federal legality of hemp extract. FDA inaction on the issue, however, continues the uncertainty and confusion for hemp producers.

“I am pleased the USDA has signaled – in the latest unified regulatory agenda – that it intends to issue an interim final rule to establish the regulatory framework for commercial hemp production in August 2019,” Wyden wrote. “This will give hemp farmers a measure of certainty, but the FDA’s current inaction with respect to regulating hemp-derived CBD in manufactured products has caused confusion and uncertainty for hemp producers.”

A full copy of the letter can be found here.