In late May 2019, the Food and Drug Administration held a landmark hearing regarding a regulatory framework for CBD products. By July, Congress was already becoming impatient with the lack of progress. It is now January 2020, and the FDA does not appear to be much closer to releasing its long-anticipated regulations. Congress’s impatience has now turned into action.
The FDA’s concern, according to a recent article in Politico, is the lack of reliable data on the safety of CBD and early indications that perhaps there are legitimate safety issues. According to FDA Principal Deputy Commissioner Amy Abernathy, the FDA has “this incredible blank space that we need to start to fill in” and there are simply not the usual means to fill it with sufficiently reliable scientific data. Additionally, the “information that we do have signals that there’s some real safety concern,” according to Abernathy. For instance, Abernathy indicated that the FDA has reviewed some data indicating that high concentrations of CBD pose a risk of liver damage.
The solutions, according to Abernathy, need to be creative. The FDA generally does not collect its own data, but given the public urgency on this issue, it is reaching out to companies, including pharmaceutical companies, with data. Abernathy further indicated that the FDA will continue to roll out information as it is developed. “As we have developed reasonably solid conclusions about a particular category or space, we’ve tried to get that information out to the public as quickly as possible,” she said.
These comments cannot be reassuring to the CBD industry, which remains in limbo. With no guiding regulations from the FDA and widely variable state regulations and enforcement, less scrupulous actors have become entrenched in the CBD space with lower-quality products and potentially misleading health claims. More scrupulous actors, meanwhile, are unable to viably compete in that marketplace and are awaiting a more robust regulatory regime that the FDA has so far not provided.
Congress may be ready to take action. On Monday January 13, 2020, U.S. Representative Collin Peterson (D-MN) introduced a bill (H.R. 5587) to amend an exclusionary clause in the Dietary Supplement Health and Education Act. The exclusionary clause currently states that any product that was investigated as a drug prior to coming to market as a dietary supplement or as part of a food remains a drug and is subject to the jurisdiction of the FDA. CBD was initially investigated as a drug, and that provides the bases for the FDA’s jurisdiction. Rep. Peterson’s bill would add a parenthetical excluding “hemp-derived cannabidiol or a hemp-derived cannabidiol containing substance.” In other words, if passed in its current form, the bill will remove the basis upon which the FDA has been able to prohibit use of CBD and hemp oil in dietary supplements. The bill was introduced on a bipartisan basis with two Republican congressmen from hemp-producing Kentucky in support.
We anticipate that Rep. Peterson’s bill will increase the pressure on the FDA. If the FDA won’t move on this issue, then perhaps Congress will. Keep checking out our blog for further information on this and other topics impacting the cannabis industry.