July 15 2018

Authored By: Rod Kight

The California Department of Public Health (CDPH), Food and Drug Branch (FDB), released a new FAQ, Industrial Hemp and Cannabidiol (CBD) in Food Products on July 6, 2018 (FAQ). The FAQ specifically states that CBD may not be introduced into food products:

[A]lthough California currently allows the manufacturing and sales of cannabis products (including edibles), the use of industrial hemp as the source of CBD to be added to food products is prohibited. Until the FDA rules that industrial hemp-derived CBD oil and CBD products can be used as a food or California makes a determination that they are safe to use for human and animal consumption, CBD products are not an approved food, food ingredient, food additive, or dietary supplement.

This position appears to be in response to the FDAs June 25, 2018 press release (which I discuss here) about its approval of Epidiolex, a CBD medication, in which it stated (inaccurately):

Under the Controlled Substances Act (CSA), CBD is currently a Schedule I substance because it is a chemical component of the cannabis plant.

I dont lightly assert that the FDA is inaccurate. As a lawyer it is critical that I distinguish between what the law is (including a reasonable interpretation of it based on sound evidence and legal principles) and what it should be. However, in this instance, the FDAs blanket categorization of CBD as a Schedule I substanceis simply and plainly wrong. CBD is not listed in the CSA. The FDA impliedly acknowledges this by supporting its statement with a reference to the fact that CBD is a chemical component of the cannabis plant. That, in and of itself, is not dispositive of the issue since cannabisis not a controlled substance. (Marijuanais.) In fact, the FDAs statement is in direct opposition to the Ninth Circuit Court of Appeals’ April 30, 2018 ruling in the HIA v DEA case, in which it found that [t]he Agricultural Act contemplates potential conflict between the Controlled Substances Act and preempts it.” (Note: The Agricultural Actis the Courts term for the industrial hemp provisions of the Agricultural Act of 2014, commonly known as the Farm Act” or “Farm Bill.) In other words, cannabis that falls under the industrial hemp provisions of the Farm Act is not controlled under the CSA.

The FDA statement is also in direct opposition to multiple DEA statements on the matter over the past year and half, including:

-The March 14, 2017 Clarification (which I wrote about here), that states: If a product consisted solely of parts of the cannabis plant excluded from the CSA definition of marijuana, such product would not be included in the new drug code (7350) or in the drug code for marijuana (7360).” As determined by the Ninth Circuit and the Farm Act itself (and California law (see below)), industrial is excluded from the definition of marijuana.

-Its June 2, 2017 brief to the Ninth Circuit in the HIA v DEA case (which I wrote about here), in which it stated: To the extent that a product consisting solely of exempt parts of the cannabis plant contained trace amounts of cannabinoids, such product would not be included in the new drug code.” (P.27) “DEAs Rule does not control cannabinoids in their own right.” (P.25) “DEA is not seeking to schedule cannabinoids.” (P.29)

-The May 22, 2018 Internal Directive (which I wrote about here), that states: The mere presence of cannabinoids is not itself dispositive as to whether a substance is within the scope of the CSA; the dispositive question is whether the substance falls within the CSA definition of marijuana.

In other words, and contrary to both the FDA and the CDPH, CBD is not a controlled substance unless it is derived from marijuana. By definition, industrial hemp is not marijuana.

That being said, and in line with what I have been telling my clients, we are quickly approaching a time when CBD isolate may be treated differently from hemp extract. This is because full spectrum(also known as broad spectrum) hemp extract containing naturally occurring CBD, along with the other phytonutrients in the hemp plant, is different from CBD isolate, which is typically 99+% pure CBD. Given the FDAs approval of Epidiolex, a pure CBD oral solution from marijuana, it would not surprise me if the FDA began enforcing its position that the practice of enriching consumable products with CBD violates the Food, Drug & Cosmetic Act. (In number 13 of its FAQ page, “FDA and Marijuana: Questions and Answersthe FDA asserts, it is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which THC or CBD has been added.“)

The same analysis does not apply to non-enriched full spectrum hemp extract, which merely contains the naturally occurring CBD contained in the hemp plant and dozens (hundreds?) of other compounds. Hemp extract is not “CBD” (or Epidiolex, for that matter), even if it contains it. For this reason, the CDPHs FAQ is best interpreted as restricting consumable products that contain CBD isolate, but not restricting products that are composed of hemp extract. (This interpretation does not completely let the CDPH off the hook since the FDAs rationale for restricting CBD from being used to enrich consumable products is its improper contention that it is a Schedule I controlled substance.)

To be clear, in a subsection of #1 of its FAQ, the CDPH asserts that [h]emp oil that is not derived from industrial hemp seedsis not allowed in food. I do not think that the CDPH took the time to tease out the subtle but important distinctions between CBD isolate and hemp extract with naturally occurring CBD. Also, and despite the distinction, the CDPH position is contrary to Californias industrial hemp statute, which contains no such prohibition. In fact, the California Health and Safety Code specifically removes industrial hempfrom its list of controlled substances , including the resin extracted from any part of the plant; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin produced therefrom.That being said, this FAQ demands modification to avoid conflict with California law, not to mention the inevitable confusion it will create regarding the status of consumable industrial hemp products containing naturally occurring CBD. If you live in California I encourage you to contact your local legislative representative today.