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Client Alert- DEA Issues Implementing Rules on Hemp Provisions of 2018 Farm Bill Including a Potentially Controversial Position on Synthetics

Aug 25, 2020
  • FisherBroyles News

The U.S. Drug Enforcement Agency (DEA) issued an interim final rule (IFR) implementing conforming changes to DEA’s regulations necessitated by the Agricultural Improvement Act of 2018 (“Farm Bill”), specifically, the hemp provisions. While the IFR notes that it does not create any additional regulatory requirements and merely conforms regulations to the existing statutes that have been in effect since 2018, critics of the changes have noted that DEA appears to have imposed restrictions on certain synthetic tetrahydrocannabinols, including so called “Delta-8 THC”, a cannabinoid derived from hemp.

The conforming changes, per the text of the IFR:

  • Modify the definition of tetrahydrocannabinols (THC) to exclude “any material, compound, mixture, or preparation that falls within the definition of hemp.”
  • Remove from control under Schedule V a drug product in finished dosage formulation that has been approved by FDA that contains cannabidiol (CBD) derived from cannabis [with] no more than 0.1% … residual tetrahydrocannabinols.
  • Remove certain import and export controls over over drug products in finished dosage formulations that have been approved by FDA that contains CBD.
  • Modify DEA’s regulation defining “Marijuana Extract” is limited to extracts “containing greater than 0.3 percent” THC on a dry weight basis.

The language of the IFR is concerning as it redefines synthetic in a manner which is broad for the DEA and could have great impact on limitations of producing cannabinoid isolate products.  Also, take note that every instance regarding CBD has the preface of approved by the FDA.  This only includes approved FDA drugs containing CBD, so this does not include products, such as tinctures, dummies, and creams which contain CBD isolate.   It is imperative for all concerned to file objections and comments to the proposed rule, but the deadline in October.

The FisherBroyles Pharmacy and Health Care Law team is pleased to keep those in the industry updated on topics of interest. Questions regarding the subject matter of this alert may be directed to any of the following attorneys:

Brian E. Dickerson  [email protected]    202.570.0248

Anthony J. Calamunci  [email protected]   419.376.1776

Nicole Hughes Waid  [email protected]   202.906.9572

Amy L. Butler  [email protected]   419.340.8466

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