Sen. Ron Wyden (D-OR), a co-author of the hemp provisions included in the 2018 Farm Bill, sent letters to Food and Drug Administration (FDA) Commissioner Ned Sharpless and Health & Human Services (HHS) Secretary Alex Azar urging the agencies to promptly create a regulatory pathway to use cannabidiol (CBD) as a food additive and as a dietary ingredient in dietary supplements.
"The passage of the 2018 Farm Bill is Congress’s clear intent to further advance and support the domestic production and sale of hemp and hemp derivatives like CBD," Sen. Wyden states in the letter. "Hemp growers and producers in states like Kentucky and Oregon are poised to make significant economic gains from hemp and its derivatives, but only if the federal regulatory system ensures the lawful and safe use of these recently liberated products."
Sen. Wyden asked the agencies to issue guidance announcing a formal enforcement discretion policy by August 1, 2019, and – pending publication of a permanent final rule – issue an interim final rule that ensures a regulatory pathway for lawful use of CBD as a food additive and as a dietary ingredient in dietary supplements.
Sen. Wyden's request aligns with the advocacy efforts of the American Herbal Products Association (AHPA) as recently promoted by AHPA President Michael McGuffin at a public meeting held by FDA on May 31 to gather scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.
“AHPA is extremely pleased to see Senator Wyden showing leadership in advocating for the Secretary of the Health & Human Services and the Commissioner of the Food & Drug Administration to move promptly to resolve the current regulatory uncertainty surrounding CBD," McGuffin said. "At the same time, the approach outlined by the Senator ensures that these agencies’ commitment to public health is fully maintained.”