Two Pivotal Issues Will Define Hemp and CBD in 2019

Hemp testing and FDA regulation of CBD will be two important issues in 2019.

In light of the 2018 Farm Bill becoming law, we can be sure that there will be a number of legal issues to address in the world of hemp and CBD. Of the emerging issues, there are two pivotal ones that will define and shape the industry in 2019. I encourage everyone with an interest in hemp and CBD to educate themselves (and their politicians and regulators), and to make their voices heard. The issues, in no particular order of priority, are hemp testing protocols and FDA regulation of CBD.

TESTING PROTOCOLS

One of the issues involves the appropriate testing protocol for measuring delta-9 THC concentrations in hemp. (I recently wrote at length about the issue here.) Since hemp is defined as cannabis with delta-9 THC concentrations that do not exceed 0.3% on a dry weight basis, coming to a proper resolution of this issue is foundational. Using the proper testing protocol is crucial to ensuring that farmers have access to an abundant variety and adequate supply of hemp strains to meet market demand.

One of the primary testing methods, gas chromatography (GC), increases levels of delta-9 THC in the sample being tested as part of the testing process. In other words, the test itself increases the very compound being measured. This alone should disqualify it from being used for hemp testing. The other method, high performance liquid chromatography (HPLC), does not modify the delta-9 THC levels and is highly reliable. It is the test that should be used for all hemp testing.

The testing issue revolves around the interpretation of a phrase in the 2018 Farm Bill regarding provisions that are required for states and Indian tribes to opt out of federal hemp regulations by creating their own regulatory plans. The provision requires plans by states and Indian tribes to have “a procedure for testing, using post- decarboxylation or other similarly reliable methods, delta-9 tetrahydrocannabinol concentration levels of hemp produced in the State or territory of the Indian tribe[.]” GC is the “post-decarboxylation” method. HPLC is the “similarly reliable” (it is actually the most reliable) method. States and the federal government should mandate that HPLC be used as the primary testing method.

FDA REGULATION OF CBD

The other issue involves how the FDA will treat CBD that is added to ingestible products. I have written about this issue here and here. The FDA released a statement (Statement) shortly after passage of the 2018 Farm Bill in which it discussed its position on CBD.

The short answer is that no one knows what the FDA will do about CBD. Its non-binding position (which is not a rule, mind you) is that CBD cannot be sold as a dietary supplement or added to food that is sold in interstate commerce. It is important to note that the FDA has held this position for approximately two years but has done nothing to enforce it. The FDA easily could have stamped out CBD before it got as big and popular as it is now. The fact that it hasn’t done so is significant in and of itself. (By way of comparison, it has taken substantial action, in the form of over 30 cease and desist letters, to stop manufacturers from making disease claims.)

The proverbial horse is out of the barn. Aside from the multitude of companies and consumers currently engaged in the industry, the multinationals are poised to jump into the fray. For example, Budweiser’s parent, InBev, is partnering with Tilray to to produce a non-alcoholic CBD beverage. A number of other multinational companies are also entering the CBD industry. I cannot imagine that the FDA will attempt to put the brakes on at this juncture. It’s too late and there is too much money and power at stake at the highest levels.

My personal belief is that one of three things will occur:

1. The FDA will utilize a little used procedure to authorize CBD as an ingredient for food, notwithstanding that it has been approved as an investigational new drug (Epidiolex). It is planning a meeting of stakeholders to consider this very thing. In fact, in the Statement it said: “While products containing cannabis and cannabis-derived compounds remain subject to the FDA’s authorities and requirements, the FDA will continue to take steps to make the pathways for the lawful marketing of these products more efficient.“

2. The FDA will continue its unofficial policy of holding its present position without enforcing it.

3. The FDA will attempt to enforce its position, in which case it may prevail, at least from the technical legal perspective. (Given CBD’s popularity, safety, and apparent efficacy for dealing with a number of health issues, it will lose catastrophically in the court of public opinion.) The battle will then move from CBD isolate to CBD in the context of “full spectrum hemp”, or even less purified CBD “isolate” (ie, purity of less than 98%). The FDA’s position is much weaker on this front and, at the very least, I believe that full spectrum will not be regulated the same as isolate.

CONCLUSION

With passage of the 2018 Farm Bill and consumer demand for CBD and hemp products continuing to ramp up, 2019 promises to be a year of explosive growth for the industry. There will be many issues that arise. Of those issues, hemp testing and FDA regulation will largely define the direction the industry takes. I intend to follow up on these issues, and many others, as they unfold.

December 26, 2018