In a joint letter, the American Herbal Products Association, Consumer Healthcare Products Association, Council for Responsible Nutrition, and United Natural Products Alliance called on Congress “to pass legislation to clarify that CBD derived from the hemp plant is a lawful dietary ingredient.”
Four trade associations representing the dietary supplement industry have united to urge Congress to provide legal clarity in the cannabidiol (CBD) product marketplace. In a joint letter, the American Herbal Products Association (AHPA), Consumer Healthcare Products Association (CHPA), Council for Responsible Nutrition (CRN), and United Natural Products Alliance (UNPA) called on Congress “to pass legislation to clarify that CBD derived from the hemp plant is a lawful dietary ingredient if the dietary supplement containing the CBD meets established product safety and quality criteria.”
These actions are urgently needed, says the letter, due to the strong consumer interest, the growth of the CBD product and their sale, and the fact that 85% of regulated U.S. hemp production in 2019 is expected to be processed for CBD and hemp extract products. While FDA is working to craft its policy on hemp-derived products, the agency has stated that establishing a legal regulatory pathway may take between three to five years, even for an expedited rule-making process. In the meantime, CBD products, safe and otherwise will continue to proliferate.
In order to classify CBD derived from the hemp plant as a lawful dietary ingredient, elaborates the letter, this would “require a limited waiver of § 201 (ff)(3)(of the Food, Drug, and Cosmetic Act (21 U.S.C. § 321(ff)(3)(B), which governs articles used in both drugs and dietary supplements. To be subject to this limited waiver, CBD would have to be derived from hemp as defined by the 2018 Farm Bill and any dietary supplement containing hemp derived CBD must fully comply with applicable requirements for new dietary ingredients under the FDCA Importantly, these products would also be required to fully comply with all other provisions of the FDCA and FDA’s implementing regulations applicable to dietary supplements, including those requiring accurate product labeling and good manufacturing practices as well as the prohibition against making any drug claims.”
The letter also urges Congress to include substantial new resources to enable effective FDA oversight of the category on top of the $2 million in the Senate appropriations bill toward “research, policy evaluation, market surveillance, issuance of an enforcement discretion policy, and appropriate regulatory activities with respect to products under the jurisdiction of the Food and Drug Administration which contain cannabidiol (CBD) and meet the definition of hemp.”