On September 17, Senate Majority Leader Mitch McConnell proposed language that directs the U.S. Food and Drug Administration (“FDA”) to issue policies on regulating and enforcing regulations on the use hemp-derived cannabidiol (“CBD”) in products. This language would be inserted into a congressional spending report and would direct the FDA to provide a report to congress within 90 days, stating the FDA’s “progress” towards analyzing data to determine its policy of enforcement discretion. Secondly, the language would direct the FDA to issue a policy on that enforcement discretion concerning “certain products containing CBD meeting the definition of hemp[.]” Though this has been reported as clearing a path for CBD products, that is not necessarily the case.
The FDA’s Current Position on CBD
When the Farm Bill passed late last year, then-FDA Commissioner Scott Gottlieb issued a press release stating that it is unlawful to sell food or dietary supplements containing hemp-derived CBD, mainly because it is an active ingredient in the FDA-approved drug Epidiolex. This position was reiterated earlier this year and remains the agency’s current position. The FDA did have a public hearing on May 31, 2019, to discuss these products, and there have been rumors of the FDA may loosen this position in the future. But until that occurs, companies selling these products do so at risk of enforcement action from the federal government (and from local and state government), particularly if they do so while making medical claims about the products.
The Proposed Language
The proposed language does not specify which products the FDA will issue a policy on; it merely uses the term “products.” Presumably the FDA will have to issue a policy for both food and dietary supplements. Currently, the FDA is not scrutinizing cosmetics that contain hemp-derived CBD. What’s most important to note in this language is that it directs the FDA to determine a “policy of enforcement discretion,” which is quite vague. The FDA could simply implement its current policy of prohibiting food and dietary supplements containing hemp-derived CBD.
The language also states,
FDA is encouraged to consider existing and ongoing medical research related to CBD that is being undertaken pursuant to an Investigation New Drug (IND) application in the development of a regulatory pathway for CBD in products under the jurisdiction of FDA and to ensure that any future regulatory activity does not discourage the development of new drugs.
Existing and ongoing medical research is generally showing CBD to be potentially beneficial for a number of different diseases. But that doesn’t mean that it can, or should, be used in food or dietary supplement. The language just doesn’t seem narrow enough to direct the FDA one way or the other.
But this proposed language should be taken in the context of other congressional pressure on the FDA. Last week, two representatives (from both political parties) circulated a letter to the House urging their colleagues to demand the FDA establish regulations that would allow the use of hemp-derived CBD in food and dietary supplements. The letter points out that though CBD is currently classified as a drug (Epidiolex), it has the authority to classify lower doses of CBD in food and dietary supplements as allowable.
This is on top of a budget amendment approved in June setting aside funds for the FDA to set a “safe level for conventional foods and dietary supplements containing cannabidiol (CBD).” While this amendment still needs to be approved by the whole House and by the Senate, the FDA may take these signs and move to regulate CBD products in a less strict manner than its current position.
Potential for Preemption?
When the FDA does issue final regulations on food and dietary supplements containing hemp-derived CBD, questions will remain as to whether those rules will trump state laws already passed on the subject. The Supremacy Clause of the U.S. Constitution states that when federal and state laws conflict, or where the federal government has clearly laid out a regulatory field for itself, conflicting state law will be invalidated. This will likely be an issue for CBD laws.
Take California for example, where AB 228 is currently winding its way through the legislature, and states that food containing CBD regulated by state law will not be considered adulterated. Many other states have similar laws already, including Colorado, Maine, New Mexico, and Wisconsin. Will these laws be preempted by FDA policy? They likely will, which will then set up yet another conflict between federal and state law and leave open the question of whether the states will have an appetite to openly defy the federal government (like states have done by legalizing cannabis), and whether the federal government will in turn have an appetite to enforce federal law.