Blog

Posted on behalf of Elise de Gandiaga.

Overview

On December 20, 2018, the Agricultural Act of 2018, also known as the 2018 farm bill, was signed into law. The updated bill amends the Controlled Substances Act’s definition of marijuana to exclude hemp, ensures crop insurance is available for hemp and lifts restrictions currently in place on cultivating hemp. Prior to the 2018 farm bill, hemp was lawfully cultivated under the auspices of institutions of higher education and authorized state pilot programs, which issue research permits to allow farmers to grow industrial hemp. The 2018 farm bill reduces barriers that hinder cultivation and marketing of hemp and hemp-derived ingredients, including cannabidiol (CBD). Nonetheless, the FDA maintains its position that the two hemp-derived ingredients, CBD and tetrahydrocannabinol (THC), cannot lawfully be included in foods or dietary supplements. THC is the reported psychoactive component of marijuana, which is associated with recreational use, whereas CBD is considered nonpsychoactive and is thought to have therapeutic properties to treat ailments such as anxiety, insomnia, and arthritis. The FDA has to date limited its public enforcement regarding CBD to issuing warning letters to a handful of companies making therapeutic claims related to serious disease conditions. However, the FDA could alter its enforcement in light of the 2018 farm bill as the interest in and market for hemp-derived products continue to expand (Law 360 1/1/19).

Historical Perspective

Hemp is a variety of the Cannabis sativa L. plant which is grown specifically for the industrial uses of its derived products such as hemp seeds, oil, or CBD. Although both cannabis and hemp are derived from the Cannabis sativa L. plant and contain THC, hemp contains lower concentrations of THC and higher concentrations of CBD. For decades, federal law has not differentiated hemp from other cannabis plants, and similar to marijuana, it was made illegal by the 1937 Marihuana Tax Act and the 1970 Controlled Substances Act (CSA), until the passage of the Agricultural Act of 2014 – the 2014 farm bill. The 2014 farm bill (section 7606) enabled the lawful cultivation of industrial hemp defined as “the plant Cannabis sativa L. and any part of such plant, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis,” (7 U.S.C. § 5940) by either an institution of higher education or a state department of agriculture for limited research purposes under the auspices of an “agricultural pilot program” developed under state law. The 2014 farm bill distinguished industrial hemp from marijuana based on its concentration of THC. In contrast, the CSA distinguishes industrial hemp from marijuana based on the part of the plant from which the product is derived. Reconciling these two definitions as applied to a given product remains significant, as marijuana is classified by the U.S. Drug Enforcement Administration (DEA) as a Schedule I controlled substance. Moreover, in 2016, the DEA issued new guidance regarding its classification of marijuana extracts including CBD, in which it stated that “scientific literature indicates [that] cannabinoids, such as ... 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” and that “[a]ccording to scientific literature, cannabinoids are not found in the parts of the cannabis plant that are excluded from the CSA definition of marijuana. ...” (US DOJ). In other words, the DEA’s position was that CBD could not be extracted from the exempt portions of the cannabis plant, leaving CBD illegal under federal law (Law 360 12/20/18).

Changes with the 2018 Farm Bill

The 2018 farm bill attempts to address the uncertainties from the 2014 farm bill regarding industrial hemp and its derivatives, by creating a clear regulatory structure for the commercial development and legal protection of hemp and hemp-based CBD. The bill specifically amends the CSA to provide that the legal term “marihuana” explicitly “does not include hemp.” Consequently, the legal definition of hemp and hemp-based CBD and its distinction from marijuana should now be clear, enabling the commercial development of these products (Law 360 12/20/18).

Of note, the legal protections are only applicable to hemp and hemp-based CBD which is grown in accordance with the provisions of the 2018 farm bill. In other words, the 2018 farm bill does not grant legal status or legal protection to those hemp products currently on the market, as none have, or could have been, developed and grown in accordance with the bill’s requirements. Additionally, it will be some time before any lawful cultivation can occur, since the bill seeks an entirely new system for the regulation of industrial hemp at both the state and the federal levels (Law 360 12/20/18). Therefore, a state (and/or Indian tribe) is now required to submit a plan to the U.S. Secretary of Agriculture which includes the (i) monitoring and regulation of the production of industrial hemp; (ii) procedure for testing industrial hemp for THC levels; (iii) procedure for the effective disposal of the plants; (iv) enforcement procedures (e.g., inspections and random sampling of hemp producers); (v) certification regarding resources and personnel necessary to carry out these directives; and, (vi) procedures for submitting this information to the secretary (Section 297B of the 2018 Agricultural Act). In other words, new regulatory programs and related funding need to be developed by each state, and then submitted for the secretary’s review and approval, before lawful cultivation of hemp under the new bill (Law 360 12/20/18). The 2018 farm bill also provides for the parallel development of a federal program for the oversight and regulation of hemp if a state opts not to develop its own program (Section 297C of the 2018 Agricultural Act).

It is also noteworthy that although the 2018 farm bill amended the definition of marijuana under the CSA, it explicitly specified that nothing in the bill shall affect or modify the Federal Food, Drug and Cosmetic Act (FDCA) or the authority of the Commissioner of Food and Drugs (FDA) to enforce the FDCA (Section 297D of the 2018 Agricultural Act). As determined by the FDA, section 301(II) of the FDCA prohibits the introduction into interstate commerce of any food (including beverages) to which CBD has been added. Similarly, CBD is not generally recognized as safe by the FDA as a lawful food additive, which further prevents the inclusion of hemp-based CBD in food or beverage products (Law 360 12/20/18).

It is likely that the 2018 Farm Bill will encourage companies to produce hemp-based products for various applications. Cardno ChemRisk scientists have extensive professional experience evaluating the possible hazards posed by chemicals in consumer products and foods. For more information on Cardno ChemRisk's capabilities, please contact Elise de Gandiaga.

The full 2018 Farm Bill can be found here: https://www.congress.gov/bill/115th-congress/house-bill/2