Farm Bill Amendments to Enable CBD Oil and Hemp IndustryJune 28, 2018

On June 27th, the Senate published the latest version of amendments to the Farm Bill which contain updates to the regulatory framework for hemp and derived products including CBD (cannabidiol) oil. Cannabidiol oil has documented health benefits such as effectiveness in treating certain types of seizures, and the U.S. Department of Health and Human Services holds a patent to the use of  cannabinoids as antioxidants and neuroprotectants.

However, the existing regulatory framework for cannabidiol comes with baggage from its plant parent – it is a chemical component of the plant species Cannabis sativa, which includes varieties of marijuana permitted to be used for recreational purposes in some states. Under Federal Law in the Controlled Substances Act, marijuana and derivatives including CBD oil are Schedule 1 substances illegal to transport or possess, along with heroin. Despite this classification, on June 25th, the FDA approved cannabidiol as a pharmaceutical. The FDA was clear to point out the therapeutic distinction between cannabidiol and marijuana, stating that “CBD does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC). It is THC (and not CBD) that is the primary psychoactive component of marijuana.” The availability of cannabidiol and other hemp products could be enabled through the Senate’s June 27th version of the Farm Bill, which updates the regulatory framework. The fundamental basis for these changes in the Farm Bill is the proposed definition of “hemp”, which explicitly adds cannadinoids and other derivatives to the definition, and requires that hemp contain not more than 0.3% THC:

 ‘‘HEMP.—The term ‘hemp’ means the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.”

Other changes of note in the June 27th Farm Bill amendments include enabling the transport of seeds across state lines and allowing farmers to grow hemp as a crop on a broader basis, an amendment to the Controlled Substances Act removing the newly defined hemp from the controlled substances list, a review system for State programs, and adding hemp to the list of crop insurance eligible crops.

These amendments would remove the Federal restriction on these products, thereby facilitating access to banking, permitting lawful interstate movement of materials for research and sales, and removing restrictions on intellectual property protection. The USPTO will not register marks if goods or services covered involve a per se violation of federal law, such as activities prohibited under the Controlled Substances Act. These Farm Bill amendments would permit federal trademark registration and facilitate identifiable brand standards for hemp products, including CBD oil.

There is no timeline on a final vote for the Farm Bill, but if the current proposed amendments go through as drafted it may result in a crop with environmental benefits being more broadly available for U.S. farmers to plant, and a more cost-effective plant-derived treatment compared to the FDA’s newly approved drug, for patients who benefit from CBD oil.

Cassie J. Edgar, Patent Attorney and Chair of the Regulatory Law practice group, advises clients in intellectual property, regulatory law, crisis management, compliance, stewardship, lobbying, and matters with USDA, FDA, EPA, and FTC. She will be eating French food tonight and suggests to avoid going here. For additional information, please visit MVS or contact Cassie directly via email at cassie.edgar@ipmvs.com .

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