The American Herbal Products Association (AHPA) urged the Food and Drug Administration (FDA) last week to protect consumers by quickly taking specific actions to clarify the regulatory status of hemp and hemp-derived ingredients used in dietary supplements and foods that contain cannabidiol (CBD).
“We strongly believe the existing regulations for dietary supplements and foods are sufficiently robust to address issues for hemp-derived ingredients used in these product categories,” said AHPA President Michael McGuffin. “FDA should act promptly to protect consumers by issuing a regulation permitting hemp-derived CBD as a lawful ingredient in dietary supplements and foods to enable FDA to vigorously enforce dietary supplement and food requirements against firms marketing any CBD-containing supplement or food product."
In comments submitted to FDA, AHPA requested that FDA use its statutory authority to issue a regulation permitting hemp-derived CBD as a lawful ingredient in dietary supplements and foods, preferably using an interim final rule process. If FDA is unable to issue this regulation promptly, AHPA encouraged FDA to promptly issue guidance to state the agency’s intent to exercise formal enforcement discretion with respect to the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) on which FDA bases its position that CBD-containing supplements and foods are unlawful.
AHPA also requested FDA acknowledge that simple hemp-derived products that contain naturally-occurring levels of hemp’s botanical constituents do not trigger prior-drug exclusion provisions in the FD&C Act.
“FDA should revise its public statements to reflect the appropriate and precise scope of its interpretations of the prior-drug exclusion provisions as applied to CBD to provide much-needed clarity to consumers, industry, and state and local governments that have relied on FDA’s insufficiently nuanced statements to date,” McGuffin said.
AHPA’s comments address several specific questions included in FDA’s request for information on “Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds” published in an April 3, 2019 Federal Register notice. In these answers, AHPA covers several subjects, including health and safety risks, manufacturing and product quality, and marketing, labeling and sales.
“AHPA encourages FDA to take swift action to ensure access to safe and well-manufactured supplements and foods, while preserving the federal government’s ability to efficiently and effectively protect consumers from unsafe and unlawful products.”