Federal Regulations
Impact on Cannabis
The CSA makes cannabis illegal on a federal level, classified as a Schedule I substance. It does not differentiate between different types of cannabis, such as hemp or marijuana. This means that all forms of cannabis and its extracts are deemed illegal.
The Tenth Amendment in the Bill of Rights of the United States Constitution establishes that any power not given to the Federal government in the Constitution is given to the States or the people. Since the CSA is not a Constitutional amendment and only a Federal Regulation, States can choose to overrule that regulation. As a result, many states have decided to create their own cannabis regulations, allowing for medical and/or adult recreational use. For example, the Connecticut legislature effectively reschedules cannabis to Schedule II.
The DEA is currently in the process of rescheduling Cannabis to Schedule III based on recommendations from the Department of Health and Human Services (HHS) after reviewing the FDA study in August 2023. This will impact nearly every facet of the cannabis industry. This means that the federal government is giving cannabis medicinal value and establishing the basis for legal cannabis prescriptions.
The 2018 Farm Bill separates Hemp from Marijuana in the definition of cannabis, which is referenced in the CSA as a Schedule I substance. This effectively legalizes Hemp, protecting the agriculture hemp industry but also influencing the hemp drug market. Since the bill explicitly states “∆9-THC” in the definition, THC analogs, such as THCA and isomers like ∆8-THC, are being sold in products on the basis that they are classified as hemp due to the ∆9-THC content. Furthermore, the DEA’s bill interpretation fails to include “dry weight” in the definition, allowing ∆9-THC infused beverages and gummies to be sold because they are less than 0.3% ∆9-THC by net weight.
The Farm, Food, and National Security Act of 2024 is an amendment to the 2018 Farm Bill currently pending in federal courts. It distinguishes cannabinoid drug hemp from industrial fiber hemp. It also revises the hemp and marijuana definitions to include all THC analogs and derivatives, contributing to the total THC limit of 0.3% by dry weight. States that have not taken legislative measures to address this will now be subject to the regulations, potentially disrupting a multi-million dollar black market for THCA and ∆8-THC products. It also establishes a synthetic cannabinoid category that is made illegal. This would remove some more uncommon products from the market, such as THC-O-acetate, a semisynthetic derivative that is three times as potent as ∆9-THC.
The FDCA gives the FDA regulatory power over food, drugs, and cosmetics. It creates a drug approval process with clinical trials and prohibits manufacturers from making unsubstantiated health claims. This means that even though the DEA may be granting cannabis medical value, the product sold as medical prescriptions must still be FDA-approved. It also prohibits manufacturers from making health claims on dietary supplements with CBD until the FDA has clinical trials to support them.