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What Does the Farm Bill Mean for CBD/Hemp Products?

The recently enacted Farm Bill amends the Controlled Substances Act so that  hemp and CBD products containing trace amount of THC are not classified as Schedule 1 controlled substances.    While many are excited about this amendment, the law does not change FDA’s regulatory requirements for CBD-containing products under its regulatory jurisdiction.

At the end of 2018, Congress passed and President Trump signed the bipartisan Agricultural Improvement Act of 2018 (also known as the “Farm Bill”).  The focus of the $867 billion legislation is to extend major programs for income support, food and nutrition, land conservation, trade promotion, rural development, research, forestry, horticulture, and other miscellaneous programs.  Included in the lengthy bill was the rescheduling of some cannabis products from the Controlled Substances Act (CSA).  However, the Farm Bill does not affect the Food and Drug Administration’s (FDA) authority to regulate Cannabidiol (CBD) or other hemp products, nor does it change the FDA’s regulatory requirements for CBD-containing products under its regulatory jurisdiction.

Notably, section 12619 of the Bill (“Conforming changes to the Controlled Substances Act”) modifies the federal Controlled Substances Act of 1970 so to make clear that industrial hemp products are not considered marijuana.  In addition, the bill amends the CSA to make clear that such products containing no more than 0.3 percent delta-9 tetrahydrocannabinol (THC) are no longer classified as Schedule I controlled substances.

A meaningful understanding of the Farm Bill requires an examination of the differences and similarities between hemp and marijuana. Both hemp and marijuana are each a type of cannabis plant. That said, marijuana contains up to 30 percent THC, whereas hemp generally contains less than 0.3 percent THC, and instead contains a larger percentage of CBD, a compound credited with having medicinal benefits. THC is the cannabinoid contained in marijuana that produces psychoactive effects in humans. The Farm Bill recognizes the differences between the two cannabis types, thereby loosening the restrictions previously placed on hemp.

The Farm Bill removes hemp from the CSA’s definition of “cannabis” and excludes THC found in hemp from scheduling under the CSA. The Farm Bill defines hemp as “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 [“THC”] concentration of not more than 0.3 percent on a dry weight basis.” Unlike marijuana, hemp is an agricultural commodity that can be used in the production of a variety of consumer products, including rope, paper, clothing, and shampoos. In removing hemp from the definition of marijuana, the government purportedly intends to foster the farming of hemp and manufacture of hemp products in the United States.

In the first instance and by default, the United States Department of Agriculture (“USDA”) shall exercise primary regulatory control over hemp production in the United States. However, states and Indian tribes wishing to exercise primary regulatory control over hemp production are able to submit regulatory plans to the USDA for review.

Importantly, although the Farm Bill lifts the restrictions on the production of hemp and manufacture of hemp goods, such goods remain within the purview of the Food and Drug Administration.  The FDA addressed any uncertainty surrounding its position on hemp and CBD in a December 20, 2018 Statement. Here, the FDA underlines the fact that Congress has preserved its existing authority to regulate products containing cannabis or cannabis derived compounds, including CBD, under both the Federal Food, Drug, and Cosmetic Act and section 351 of the Public Health Service Act. The FDA’s continued view is that it is unlawful to introduce into interstate commerce food containing added CBD or THC, or to market CBD or THC products “as, or in, dietary supplements, regardless of whether the substances are hemp-derived.”

The FDA has stated, however, that it recognizes the intense public interest in this matter, as well as the evident interest of Congress in supporting the development of certain hemp products. As such, the FDA intends to hold a public meeting where stakeholders may share experiences and opinions regarding hemp products, with a goal of improving the efficiency and predictability of existing “lawful pathways by which products containing cannabis or cannabis-derived compounds can be marketed.” 

Takeaway: Questions undoubtedly remain as to how exactly the Farm Bill and the legalization of hemp will play out in a practical sense. As discussed above, in the wake of its planned public meeting on the matter, the FDA may make changes to existing policies and procedures regarding the regulation of hemp products. Manufacturers and marketers involved in the hemp and CBD industries should, however, keep in mind FDA’s current position regarding such products, which are not modified by the new law. 

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