Bi-partisan legislation aimed at advancing clear rules for CBD and other hemp compounds has been re-introduced in the U.S. Congress.
The measure, the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021, would direct the U.S. Food and Drug Administration (FDA) to set a clear regulatory framework for hemp and hemp-derived CBD products that would protect consumers while addressing critical supply chain issues for producers.
The proposed law would address a situation in which a plethora of hemp and CBD products are available in the U.S. market in the absence of an FDA approval system. Under the proposal language in the draft bill, “hemp, cannabidiol derived from hemp, and any other ingredient derived from hemp shall be lawful for use under the Federal Food, Drug, and Cosmetic Act as a dietary ingredient in a dietary supplement.”
If enacted, the law would allow hemp and hemp derived CBD to be marketed in dietary supplements under new ingredient requirements and other policies for dietary supplements under the Food and Drug Act, including the Dietary Supplement Health and Education Act of 1994.
Sponsored by 20 representatives from both the Democratic and Republican parties, the 2021 draft law is an updated version of a bill that was proposed in 2020 which had 30 bi-partisan co-sponsors.
Stakeholders have repeatedly complained about the slow pace of progress on hemp at the FDA. “There remains an absence of substantive progress on FDA’s reported attention to creating a lawful pathway for CBD, and a similar lack of clarification from the agency that simple hemp products, such as tinctures and extracts, should be regulated the same as other herbal supplements,” said Michael McGuffin, president of the American Herbal Products Association (AHPA).
“This legislation will fill those gaps, and we see it as important for ensuring that consumers will be able to find hemp and CBD products that are clearly subject to FDA’s enforcement of the robust regulations that apply to all other herbal supplements,” McGuffin said.
FDA: Science needed
Speakers at a recent FDA conference on CBD acknowledged the growing public interest in products derived from CBD and other cannabinoids, but said the gap in science-based knowledge about health effects means extensive clinical trials are needed.
While FDA has yet to write formal rules for hemp, the agency has put forth enforcement discretion guidance for hemp products. Some companies selling CBD and other hemp extracts have encountered FDA enforcement actions, suffering stop-sale orders, fines, and product seizures.
READ: Full Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021