On December 20, 2018, President Donald Trump signed the Agricultural Improvement Act of 2018 (the 2018 Farm Bill) into law. The 2018 Farm Bill contains several provisions that change the regulatory framework for the cultivation and production of hemp in the United States and the commercialization of hemp-derived products. Importantly, these provisions redefine "hemp" and amend the Controlled Substances Act (CSA) to exclude hemp, under this revised definition, from the CSA definitions of marijuana and tetrahydrocannabinol (THC). Therefore, hemp, under this revised definition, is not subject to control under the CSA.
It has been widely reported that the 2018 Farm Bill "legalizes" hemp and hemp-derived products such as cannabidiol (CBD). Although the Farm Bill explicitly allows for the sale of hemp-derived products, hemp products will still have to comply with state and U.S. Department of Agriculture (USDA) regulatory programs. The hemp provisions of the 2018 Farm Bill do not alter the Food and Drug Administration's (FDA's) authority over the use of hemp-derived ingredients in FDA-regulated products, including drug products, foods, dietary supplements, and cosmetics. As discussed further below, FDA has consistently taken the position that CBD, whether derived from hemp or marijuana, is prohibited from use as an ingredient in food and dietary supplements under the exclusionary clauses of the Federal Food, Drug, and Cosmetic Act (FFDCA). FDA's regulatory authority over these products would remain unchanged.1 For these reasons, it is paramount for companies seeking to market FDA-regulated products that contain hemp-derived ingredients to seek advice from their FDA regulatory counsel prior to doing so.
After the Farm Bill was passed, FDA Commissioner Scott Gottlieb issued a public statement reaffirming this position, but also acknowledged FDA has the authority to promulgate a regulation to allow the use of a pharmaceutical ingredient in a food or dietary supplement, and that the agency is currently evaluating whether to pursue such a process. In addition, on the same day the Farm Bill was signed, FDA announced it had completed its review of three generally recognized as safe (GRAS) notifications for hemp seed oil, hulled hemp seed, and hemp seed protein, and that the agency had no questions regarding the company's conclusion that the use of these ingredients as described in the notices is safe.2
The 2018 Farm Bill, by expanding the definition of hemp derivatives that are removed from control under the CSA, shifts the regulatory and enforcement burden for FDA-regulated products from the Drug Enforcement Agency (DEA) to FDA. FDA may face more pressure to use its authority under the FFDCA.
The Farm Bill provides that the cultivation of hemp will be subject to regulation by states, or, if a state does not wish to be the primary regulator of hemp production in its jurisdiction, by the USDA. While this measure will undoubtedly open the market for hemp cultivation and the production of hemp-derived products, significant work remains ahead for both federal and state regulators to establish these programs and promulgate the necessary regulations to monitor and implement these programs. Until these programs are established, the cultivation and production of hemp-derived products may only be performed in accordance with an agricultural pilot program, as established under section 7606 of the Agricultural Act of 2014 (7 U.S.C. 5940). Section 7606 sunsets one year after the USDA establishes its plan under the new subtitle.
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Footnotes
1 CBD also is marketed in topical products as a "cosmetic." It is unclear if FDA would concur CBD may be incorporated into cosmetic ingredients.
2 See FDA Constituent Update, FDA Responds to Three GRAS Notices for Hemp Seed-Derived Ingredients for Use in Human Food, available here.
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