November 27, 2021

Volume XI, Number 331

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In Light of 2018 Farm Bill, FDA Issues Statement on Use of CBD in Food; Completes Evaluation of 3 Hemp-Related GRASNs

The Agriculture Improvement Act (also known as “the 2018 Farm Bill”) was signed into law on December 20, 2018.  Among other things, the law changes certain federal authorities relating to the production and marketing of hemp, defined as cannabis (Cannabis sativa L.), and derivatives of cannabis (e.g., CBD) with extremely low (less than 0.3% on a dry weight basis) concentrations of THC.  The changes include removing hemp from the Controlled Substances Act, which means it will no longer be an illegal substance under federal law.

However, as previously reported, the 2018 Farm Bill does not affect FDA’s authority to regulate CBD or other hemp products, or change the regulatory requirements for such materials in FDA-regulated products like food, dietary supplements, cosmetics, or drugs.  Indeed, Congress explicitly preserved FDA’s current authority to regulate products containing cannabis or cannabis-derived compounds under the FD&C Act and section 351 of the Public Health Service Act.  FDA released a statement clarifying their position on the use of cannabis or cannabis-derived compounds in food and dietary supplements.  In sum, it is still illegal to sell a food or dietary supplement that contains added CBD or THC in interstate commerce.

In their statement, FDA acknowledged that there is significant public interest in this area and FDA plans to evaluate whether they should issue a regulation allowing the use of a drug ingredient in food or dietary supplements.  FDA intends to hold a public meeting for stakeholders and based on input provided at the meeting, FDA will consider the lawful pathways for such products to be marketed, and how FDA can make those pathways more predictable and efficient.

Relatedly, FDA also announced that the agency had completed their evaluation of three GRASNs related to hulled hemp seeds (GRN 765), hemp seed protein (GRN 771), and hemp seed oil (GRN 778).  FDA had no questions regarding the companies’ conclusions that the uses of such products are safe.  Thus, the products can be legally marketed in human foods.  As mentioned by FDA, some substances that are derived from hemp may not contain CBD or THC (or contain de minimis levels), such as those substances at the focus of the GRASNs.  Thus, their addition to foods do not raise the same issues as the addition of substances that contain CBD or THC.

© 2021 Keller and Heckman LLPNational Law Review, Volume IX, Number 2
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About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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