FDA issues reiterative statement on legal hemp12.21.18
In our blog post yesterday about the federal legalization of hemp in the United States, we pointed out that such legalization does not unsettle the U.S. Food and Drug Administration's (FDA) position that hemp-derived CBD oil (cannabidiol) is prohibited from use as a food ingredient or dietary supplement, meaning that the current CBD consumer products market is not likely to experience significant changes as a result of federal legalization.
Almost on cue, FDA Commissioner Scott Gottlieb issued a statement concerning the FDA’s position regarding the regulation of products containing cannabis and cannabis-derived compounds (e.g., CBD).
In our view, the statement is merely reiterating the FDA’s position on the topic, which the agency had already polished up when it approved GW Pharma’s Epidiolex seizure medication (which contains CBD). The FDA’s non-binding Q&A on the topic, which effectively provides guidelines as to which kinds of food, cosmetic or medical cannabis products the FDA might regulate, can be found here. Mr. Gottlieb’s statement also contains a reminder that the FDA has authority to take enforcement action against cannabis companies, in order to protect public health.
In perhaps the only new development, the statement also indicates that “pathways remain available for the FDA to consider whether there are circumstances in which certain cannabis-derived compounds might be permitted in a food or dietary supplement … [but] the FDA would only consider doing so if the agency were able to determine that all other requirements in the FD&C Act are met, including those required for food additives or new dietary ingredients.”
Indeed, it will be interesting to see if the FDA creates a special set of rules relating to hemp-derived products, or if it will simply continue to enforce its rules through the processes seen before yesterday’s legalization of hemp.