January 4, 2019

Hemp Is Now Legal, But What Does That Actually Mean?

Holland & Knight Healthcare Blog
Sara M. Klock | Michael J. Werner

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:

  • Cannabis products, hemp or otherwise, making drug claims without proper FDA drug approval are still illegal because they put patients at risk. Products claiming to diagnose, cure, mitigate, treat or prevent diseases are considered drugs by the FDA, and must go through appropriate drug approval pathways.
  • Food and dietary supplements containing added THC or CBD, regardless of whether the substances are hemp derived, cannot be legally introduced into the market because both THC and CBD are considered active ingredients in approved drugs. Since THC and CBD entered the market first as a drug, neither substance can now be added into a food or dietary supplement.
  • Hemp products not containing THC or CBD, such as hemp seed oil, may be introduced into the market as a food or dietary supplement so long as the products do not make disease claims and follow other appropriate regulatory requirements.
  • The FDA will review its approval pathways and routes for the lawful marketing of hemp and cannabis-derived products, including holding a public meeting for stakeholders to share their experiences and challenges with hemp and cannabis products.
  • Enforcement action will continue to be taken by the FDA against companies putting public health and safety at risk.

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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