Key Takeaways from Intoxicating Cannabinoids: The Science and the Law Webinar

By Catie Wightman, Shawn Hauser

Jun 16, 2022

The 2018 Farm Bill federally legalized hemp nearly four years ago, but the FDA still hasn't developed regulations for finished hemp products. Because the FDA has failed to act, hemp-derived products with high levels of intoxicating cannabinoids (such as delta-8 and delta-9 THC) are becoming increasingly popular in consumer markets and are the subject of much debate in the cannabis industry.

VS hemp and cannabinoids attorneys Shawn Hauser and Andrea Golan recently hosted a webinar on this very topic with a stellar group of panelists. The session featured Will Woodlee, an FDA regulatory attorney with Kleinfeld, Kaplan & Becker LLP; Darwin Millard, aka the "Spock of Cannabis," a volunteer member of ASTM International Technical Committee D37 on Cannabis; Dr. Jacqueline Jacques, chief research officer at Thorne HealthTech; and Christina Phelps, head of U.S. regulatory affairs at Cronos Group. The panel discussed how "intoxicating" consumer products are generally regulated, how these principles may be applied to cannabis, what the science says, and the potential future regulatory landscape for intoxicating hemp-derived products.

Below are key takeaways from this timely and informative discussion:

FDA Regulation of Intoxicating Cannabinoids

  • The FDA takes the position that CBD and Delta-9 THC may not be added to food or beverages. This position is based on the prior drug exclusion rule and does not extend to other cannabinoids.

  • The FDA has limited issuing warning letters to companies that make egregious medical claims about CBD and other hemp products, stating that such claims make these products unapproved new drugs. The FDA noted that it cannot move forward with additional enforcement actions against these companies without the Center for Drug Evaluation and Research's cooperation.

  • To be lawfully marketed under FDA laws and regulations, cannabinoids added to food must be Generally Recognized as Safe (GRAS). The GRAS process involves numerous safety studies.

  • To be lawfully marketed as a dietary supplement, cannabinoids must go through the FDA's New Dietary Ingredient (NDI) process. This process also involves extensive safety studies.

  • Whether the FDA deems a product safe depends on the particular ingredient, the ingredient's amount, and the use conditions. An ingredient safe at one dose would not necessarily be deemed safe at a higher dose.

  • It is unlikely that the FDA would approve an NDI notification or consider a product GRAS if the product is intoxicating in a way that alters the consumer's behavior or perception. FDA has been slow to act in regulating hemp products. The FDA has made clear that if it is going to create an exception to the prior drug exclusion rule, it must be highly confident in the safety profile of the extensive range of products that could contain CBD. The agency has also told Congress that it needs more authority to regulate cannabis-based products. Because of this, solutions will likely have to come from Congress. States are stepping in to fill the gap, but the state patchwork is impracticable.

State Approaches to the Regulation of "Intoxicating Cannabinoids"

  • Some states prohibit the sale of "intoxicating" cannabinoids without defining "intoxicating."

  • Other states define THC to include Delta-8 THC and other THC isomers, effectively limiting the combined amount of all THCs to 0.3%. This approach does not account for other intoxicating cannabinoids that are not THC isomers.

  • Several states prohibit cannabinoids that are "synthetic" or created through isomerization. "Synthetic" is often not defined; when it is, definitions are often unclear and subject to differing interpretations. A growing number of states are defining "synthetic" as applied to cannabinoids. In addition, this approach does not account for cannabinoids directly extracted from the plant that may be considered "intoxicating."

  • Other states, such as Colorado, have chosen to develop a task force to evaluate the best approach to regulating "intoxicating" cannabinoids. This approach allows for input from stakeholders and scientists to assess the best way forward.

Defining "Intoxicating"

  • As discussed above, several states have passed legislation to prohibit "intoxicating" cannabinoids.

  • There is no standard definition in the law for the term "intoxicating." States have not defined in legislation or regulation, leaving the term open to interpretation. This may not be an appropriate regulatory term.

  • "Intoxicating" is difficult to define. There are cannabinoids (CBD) and other substances (caffeine) that affect the brain which would not be considered intoxicating. Defining "intoxicating" to differentiate between these substances and those that are actually impairing is difficult. The common definition of "intoxicating" (to excite or stupefy by alcohol or a drug especially to the point where physical and mental control is markedly diminished) may not encompass all impairing cannabinoids.

  • Other terms, such as "psychoactive," are also problematic. Many substances are "psychoactive" (affect the brain) but do not cause a person to become impaired.

  • Appropriate definitions need to be created to capture substances that alter behavior or perception

For a deeper dive, watch the replay of "Intoxicating Cannabinoids: The Science and the Law." If you have questions about this subject, please contact Shawn Hauser.

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