WASHINGTON — Retailers, manufacturers and farmers in the hemp-derived cannabidiol (CBD) space have long expressed frustration three years after the passing of the 2018 Farm Bill that the U.S. Food and Drug Administration (FDA) still has not issued a pathway to legal bring ingestible CBD products to market.
Last month, a bipartisan bill was introduced by Sens. Ron Wyden (D-Ore.), Rand Paul (R-Ky.) and Jeff Merkley (D-Ore.) to address the FDA’s lack of action, reported by Marijuana Moment.
“CBD products are legally being used and produced across the nation,” Sen. Wyden said in a separate statement. “Yet because the FDA has failed to update its regulations, consumers and producers remain in a regulatory gray zone. It’s long past time for the FDA to get with the program, for the sake of American consumers and farmers.”
Titled the Hemp Access and Consumer Safety Act, the proposed bill would exempt “hemp, hemp-derived cannabidiol or a substance containing any other ingredient derived from hemp” from certain restrictions that have kept CBD-infused foods, beverages and dietary supplements in a legal gray area while the FDA determines how to regulate CBD products.
“Hemp-derived CBD products and businesses have earned their recognition in the marketplace, but the FDA, unfortunately, hasn’t treated them like any other food additive or dietary supplement,” said Sen. Paul.
“Hemp-derived CBD products are already widely available,” said Sen. Merkley. “We all need FDA to issue clear regulations for them just like they do for other foods, drinks and dietary supplements.”
The proposed bill also states that the FDA may “establish labeling and packaging requirements” for CBD products, but not that it must do so.
Attorney Jonathan Havens, a partner in Washington, D.C., and Baltimore-based Saul Ewing Arnstein & Lehr LLP, noted the differences between the language of this bill and the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act currently pending in the U.S. House of Representatives. The House bill—co-sponsored by Rep. Kurt Schrader (D-Ore.) and Rep. Morgan Griffith (R-Va.)—would only allow CBD products that comply with the FDA’s requirements for a dietary supplement containing a new dietary ingredient. Havens described the Wyden bill as “more passive” when it comes to the FDA.
“The Wyden bill says FDA could issue regulations, but I think there's a lower barrier to entry for industry if that bill becomes law,” he told CSP Daily News. “On the other hand, the Schrader bill leaves a burdensome hurdle in the industry’s path: Proving to FDA the safety of a new dietary ingredient (i.e., CBD).”
While the bill in the Senate may be more preferable to the hemp/CBD industry, Havens expressed concerns about the likelihood it actually passes given the current 50-50 party split.
"Like most everything else in the Senate right now, I am not sure how likely the Wyden CBD bill is to pass unless it’s attached to must-pass legislation, or unless the co-sponsor list grows to 60-plus,” he said.