Although naturally produced cannabis has enjoyed legalization in certain states, it remains, on the whole, widely illegal at the federal level. Understanding the basic regulations for cannabis is important for companies looking to remain compliant and successfully bring their products to market. This requires not only knowing which governmental agencies are involved in regulating cannabis, but also being familiar with different state, federal, and local laws. We’ll address federal and state here.
The Federal Level
Cannabis is more heavily restricted at the federal level, and federal agencies consider the majority of cannabis products to be illegal due to the federal Controlled Substances Act (CSA). This generally classifies Tetrahydrocannabinol (THC), a component of cannabis, as a Schedule I substance and places it in the most restrictive class of drugs reserved for products with a “high potential for abuse” and “no currently accepted medical use.” While a variety of federal agencies have jurisdiction, the primary federal agencies responsible for overseeing cannabis regulation include the FDA and the Drug Enforcement Agency (DEA).
Under these agencies, cannabis that makes drug-like claims would be subject to the FDA’s jurisdiction and would likely need to demonstrate safety, efficacy, and that it is not adulterated or misbranded. Accordingly, each indication for “medical cannabis” unsupported by “substantial evidence” would render the medical cannabis adulterated and misbranded. To date only Epidiolex, a purified drug substance derived from marijuana, has met this standard and is approved for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. As a consequence, many cannabis products remain illegal at the federal level and the FDA has generally practiced enforcement discretion in choosing not to prosecute most individuals along the cannabis distribution chain.
The State Level
Guidelines for cannabis at the state level are more relaxed. Many states have legalized the use of cannabis for medical or recreational purposes. Of the states that have legalized cannabis, the majority of states permit cannabis to be used for medical purposes—meaning that cannabis can be used if a physician has recommended it to treat one of a predetermined list of medical conditions.
Despite growing state cannabis legalization, companies still face potential fines and penalties if they do not remain properly compliant. Repeat offenses and sales can end up in even harsher sentences. This is why it remains important for companies in the cannabis industry to reach out to an attorney to ensure that they are meeting state and federal laws.