With the enactment of the Agriculture Improvement Act of 2018 (Farm Bill) on Dec. 20, 2018, hemp and cannabis derivatives with extremely low concentrations of Tetrahydrocannabinol (THC) – less than 0.3 percent on a dry weight basis – are no longer illegal substances under the Controlled Substances Act. While this means that these products can be legally produced and marketed in the United States, it does not mean that marijuana is legal or that the U.S. Food and Drug Administration (FDA) no longer has regulatory authority over hemp and other cannabis-derived products.
In the FDA's official statement and Q&A following the signing of the Farm Bill, the agency acknowledged "the growing public interest" in cannabis and cannabis-derived products, including cannabidiol (CBD). However, the FDA also stated that these products are "subject to the same authorities and requirements as FDA-regulated products containing any other substances." Thus, for hemp products to legally be on the market as a food, dietary supplement or drug, they must follow the FDA's regulatory authority and approval pathways.
In its statement, the FDA tried to clarify the regulatory treatment of hemp and cannabis products by stressing the following:
Overall, the removal of hemp from the Controlled Substances Act does not merit immediate excitement for companies manufacturing and distributing hemp and cannabis-derived products, as there is relatively little change regarding the FDA's regulatory authority and enforcement policy. However, the agency has committed to taking steps to ensure hemp and cannabis-derived products can be legally and safely on the market. This is an ever-changing regulatory environment and it will be critical to monitor the FDA's actions.
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