DEA Statement on CBD, Hemp and “Farm Bill”
“Media attention has focused on a derivate of marijuana that many refer to as ‘Charlotte’s Web’ or ‘CBD oil.’ At present, this material is being illegally produced and marketed in the United States in violation of two federal laws: The Controlled Substances Act (CSA) and the Federal Food, Drug, and Cosmetic Act (FDCA). Because it is illicitly produced by clandestine manufacturers, its actual content is uncertain and will vary depending on the source of the material. However, it is generally believed that the material is an extract of a variety of the marijuana plant that has a very high ratio of cannabidiol (CBD) to tetrahydrocannabinols (THC). Because this extract is a derivative of marijuana, it falls within the definition of marijuana under federal law. Accordingly, it is a Schedule I controlled substance under the CSA.
“As with all controlled substances, it is illegal under the CSA to produce or distribute ‘Charlotte’s Web’/CBD oil (or any other marijuana derivative) except by persons who are registered with DEA to do so. Because ‘Charlotte’s Web’/CBD oil is not an FDA-approved drug:
- It is a schedule I controlled substance under the CSA;
- It is unlawful under the FDCA for any practitioner to provide the material to human beings under the guise of ‘research’ without first submitting an Investigational New Drug (IND) application to the FDA;
- The CSA requires that any person seeking to conduct research with the material obtain a registration with DEA authorizing such research;
- The CSA further requires that the researcher obtain the schedule I material from a legally authorized producer.
“All of these requirements (submission of the IND to FDA, obtaining a DEA research registration, and obtaining the material from a lawful source) are essential to protecting human research subjects from the potential dangers of using an experimental drug and are essential to the scientific integrity of the research. Because ‘Charlotte’s Web’ is reportedly being administered to pediatric research subjects, the potential dangers are even more pronounced, making compliance with the FDA IND requirement even more crucial.
“It is important to correct a misconception that some have about the effect of the Agricultural Act of 2014 (which some refer to as the ‘farm bill’) on the legal status of ‘Charlotte’s Web’/CBD oil. Section 7606 of the Agricultural Act of 2014 authorizes institutions of higher education (e.g., universities) and state Departments of Agriculture to grow and cultivate ‘industrial hemp’ (defined under the Act as marijuana with a THC content of 0.3 percent or less) for agricultural research purposes where permitted under state law. However, the Agricultural Act of 2014 does not permit such entities, or anyone else, to produce non-FDA-approved drug products made from cannabis. Thus, the CSA and FDCA restrictions mentioned above remain in effect with respect to the production of ‘Charlotte’s Web’/CBD oil for human consumption.”