The FDA held a “stakeholders” call on May 25 to present information on how it reached its present stance concerning CBD and to answer a few questions. FDA’s presentation included its assessment of survey data concluding that the predominant uses of CBD are ingestion resulting in multiple adverse health effects. Based on its findings, FDA concluded that the safety profile for CBD ingestion does not fit into the definition of a food additive, but requires a health safety/”harm reduction” analysis, and tossed this politically charged hot potato to Congress.
FDA is telling Congress to carve out a new regulatory pathway for CBD, FDA is looking for something short of drug approval and akin to dietary supplements. FDA does not anticipate the new regulatory category to be “food,” leaving in serious doubt whether manufacturers will be permitted to use it as a food additive. On the bright side for industry, FDA is not considering any premarket approval requirement.
FDA’s position is that the Farm Bill merely removed hemp from the controlled substances prohibition leaving it to other agencies to determine how it may be used. In this regard, FDA flatly refutes that “CBD is legal” or that “Delta-8 THC is federally legal.” Nonetheless, FDA is clearly resigned to CBD eventually having a regulatory pathway to the marketplace, its comments regarding higher concentration THC products termed “intoxicants” are another matter entirely.