Legal basis for the commercial sale of Hemp-CBD


The 9th circuit ruling in the case of HIA v. DEA (2004) established that the DEA cannot regulate naturally occurring amounts of THC that may be found in hemp-containing food and cosmetic products being sold in the United States.

Manufacturers of hemp products have taken this to mean that other naturally occurring non-psychoactive Cannabinoids, such as Cannabidiol (CBD), are also exempt from DEA regulation, and have started making concentrated CBD products from hemp that are being marketed as "dietary supplements".

Such manufacturers are being closely monitored by the DEA and the FDA, and any attempts at claiming medical use for these Hemp-CBD products are being swiftly sanctioned.


Intended uses of Hemp-CBD


So, what is Hemp-CBD being used for ?  Polishing shoes ?  Waxing surfboards ?

Obviously not.  People are using Hemp-CBD with the intent of reducing inflammation, anxiety, and seizures, and fighting cancer, all of which are medical uses.

Selling imported Hemp-CBD as a "dietary supplement" is merely an attempt to bypass state law and the FDA drug approval process, and results in patients being exposed to a drug substance that is not being regulated for medical use.  

Remember, Hemp-CBD cannot be marketed for medical use because it is not approved for medical use, which means that its use by a healthcare professional to treat medical conditions would constitute medical fraud.


CBD is still a Schedule I Controlled Substance


The controlled substance classification of CBD can be understood by reviewing the state and federal definitions of "Marijuana".

"The term "marihuana" means all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin.  Such term does not include the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination."

So, the only things not included in the definition of marijuana are the stalks and stalk fiber, infertile seeds, and seed oil.  And it doesn't matter whether it's a Cannabis variety being used to grow flowers for medical use or a variety with a THC concentration of 0.3% or less that is being used to grow seeds and stalks, both are members of the Cannabis genus.  

But what is resin ?  There is no state or federal definition of "resin", so we must turn to the Single Convention, which provides the following: "“Cannabis resin” means the separated resin, whether crude or purified, obtained from the cannabis plant."  Which would lead us to conclude that resin really means hash, or the oily trichomes that have been removed from the surface of the Cannabis flower by means of manual extraction.

Chemicals removed from the Cannabis plant by other means, such as solvent extraction, must therefore fall under the "every compound" provision of the marijuana definition.

Currently, the only way for patients in Hawaii to legally possess and utilize CBD for medical use at the state level is under Hawaii's Medical Use of Marijuana Law (HRS 329, Part IX), which allows patients to produce Marijuana for personal medical use under the supervision of a Physician.

Dispensaries will also be able to sell CBD for medical use, as long as they comply with state law and follow the same Good Manufacturing Practices that apply to the manufacture of FDA approved drug products, and as long as the DEA and FDA continue to follow DOJ's policy of NOT enforcing the Schedule I status of CBD.


DEA's POSITION


The DEA initially weighed in on this subject in 2011, when it issued a notice of proposed rulemaking to notify the public that it was considering a new code for "Marijuana Extract".  This was followed five years later with the recent release of a final rule creating a separate category in order to track such extracts and to comply with international drug treaties.

21 CFR 1308.11(d)(58) Marihuana Extract - 7350: ‘‘Meaning an extract containing one or more cannabinoids that has been derived from any plant of the genus Cannabis, other than the separated resin (whether crude or purified) obtained from the plant.’’

If we take resin to mean hash, then anything else removed from the Cannabis plant by means of a chemical method, such as alcohol or CO2 extraction, would be considered a marijuana extract, which would still be a Schedule I controlled substance.

Because of confusion that still surrounds this new extract rule, the DEA issued additional clarification on the classification of extracted cannabinoids:

"Because recent public inquiries that DEA has received following the publication of the Final Rule suggest there may be some misunderstanding about the source of cannabinoids in the cannabis plant, we also note the following botanical considerations.  As the scientific literature indicates, cannabinoids, such as tetrahydrocannabinols (THC), cannabinols (CBN) and cannabidiols (CBD), are found in the parts of the cannabis plant that fall within the CSA definition of marijuana, such as the flowering tops, resin, and leaves."


HIA's POSITION


The Hemp Industries Association (HIA) feels that the new DEA Marijuana Extract rule violates the federal Controlled Substances Act and the right of hemp manufacturers to produce whatever kind of Cannabinoid products they want, and have filed a petition for judicial review in the Ninth Circuit Court of Appeals in San Francisco.


State Scheduling of CBD


The Governor's Office, the Department of Public Safety, and the Department of Health all refuse to disclose the scheduling status of CBD in Hawaii or do anything about the current situation with unregulated Hemp-CBD being sold in many of our health food stores and smoke shops.

Next stop: Office of Consumer Protection.