August 18, 2023

Given FDA’s public health mission and existing expertise in products marketed as food, dietary supplements, and drugs, we urge Congress to provide the agency with additional authority and funding to oversee the safety and marketing of CBD products. [...] Accordingly, this letter identifies gaps and challenges in FDA’s existing food and dietary supplements authorities and highlights the authorities that should be conferred to the agency in order to safely regulate CBD products. [...] CBD edibles share many attributes and risks with food and dietary supplements, so the new regulatory framework should ensure that existing policies that provide for safety and accurate labeling of food and dietary supplements be applied to CBD products, either by regulating these products as a subcategory of foods, or by creating a separate regulatory framework that incorporates similar basic requ. [...] Existing Authorities for Food and Dietary Supplements Should Serve as a Foundation for CBD Products Regardless of whether CBD products are considered to be a subset of foods or are provided a separate and distinct regulatory framework from foods, the misbranding and marketing provisions that currently apply to foods and supplements should serve as a basis for regulating these products. [...] If CBD is allowed in foods and dietary supplements, agencies and industry should be given clear guidance on who has authority to regulate the different types of CBD products and how the products are to be regulated.