Earlier this month, the Food and Drug Branch of the California Department of Public Health (CDPH) updated an FAQ document relative to regulation of cannabidiol (CBD), a non-psychoactive derivative of cannabis, which has been in the news most recently relative to FDA’s approval of a CBD drug to treat rare forms of epilepsy. CBD is also widely sold in many states, labeled as a food or dietary supplement.
In the FAQ document, CDPH recited the definition of “food” as
- (a) Any article used or intended for use for food, drink, confection, condiment, or chewing gum by man or other animal.
- (b) Any article used or intended for use as a component of any article designated in subdivision (a). [citation omitted]
The CDPH points out that the definition of “food” does not include products containing cannabis, which is legal in California and regulated by the CDPH Manufactured Cannabis Safety Branch. Further, CDPH appears to discard the position held by many in the CBD industry that the 2014 Farm Bill, which legalized growing of industrial hemp by state departments of agriculture or institutions of higher education for research purposes, supports broader legalization of CBD derived from industrial hemp.
Rather, CDPH relies on federal law – including the federal Food, Drug and Cosmetic Act and the status of cannabis and CBD as a Schedule I narcotic under the Controlled Substances Act – in determining that, although California allows manufacturing and sale of cannabis products (including edibles), the use of industrial hemp as a source of CBD in food products (foods, food ingredients, food additives, or dietary supplements) is prohibited. Further, CDPH states that this will remain the policy until FDA rules that industrial hemp-derived CBD oil and CBD products can be used as a food or California determines that they are safe to use for human and animal consumption.
It is unclear if this revision is intended to clarify California law and align it with FDA’s position that CBD is not a food or a dietary supplement (FDA has issued several warning letters stating this), particularly in the wake of FDA’s approval of CBD-based Epidiolex. Further, nothing is said about product that is already on the market or whether CDPH intends to engage in enforcement relative to such products. In short, the practical impact of this change is an open question.