Numerous other legal requirements apply to dietary supplement products, including requirements relating to Current Good Manufacturing Practices (CGMPs) and labeling. Information about these requirements, and about FDA requirements across all product areas, can be found on FDA’s website.
Information from adverse event reports regarding cannabis use is extremely limited; the FDA primarily receives adverse event reports for approved products. General information on the potential adverse effects of using cannabis and its constituents can come from clinical trials that have been published, as well as from spontaneously reported adverse events sent to the FDA. Additional information about the safety and effectiveness of cannabis and its constituents is needed. Clinical trials of cannabis conducted under an IND application could collect this important information as a part of the drug development process.
17. Does the FDA object to the clinical investigation of cannabis for medical use?
A. FDA is aware that unapproved cannabis or cannabis-derived products are being used for the treatment of a number of medical conditions including, for example, AIDS wasting, epilepsy, neuropathic pain, spasticity associated with multiple sclerosis, and cancer and chemotherapy-induced nausea.
5. Why hasn’t FDA approved more products containing cannabis or cannabis-derived compounds for medical uses?
The 2014 Hemp Farming Bill created a framework for the legal cultivation of industrial hemp without requiring a permit from the DEA. Four years later, the passage of the Hemp Farming Act of 2018 which was signed into law by President Donald Trump in November 2018, introduced a new legal channel through which certain types of CBD can be considered legal. The measure removed industrial hemp plants from its earlier status as a controlled substance, shifting oversight from the DEA to the FDA.
According to the DEA, these categories are based upon the drug’s abuse or dependency potential as well as its acceptable medical use. However, it’s important to note that this classification system has frequently been called into question by people who are concerned that law enforcement uses the CSA to overly criminalize substances that may not actually be as dangerous as the DEA states.
State laws are the other consideration when it comes to the legal status of CBD. Currently, hemp-derived CBD is legal in most states. As a result, it is increasingly easy to find CBD products in many cities and states despite the technicalities of federal law. Additionally, in certain states with medical marijuana legalization, CBD products containing THC are also permitted for qualifying patients. CBD products with more than .3% THC are also legalized in states with adult-use programs in place.
In the United States, the Drug Enforcement Agency (DEA) classifies different controlled substances drugs by grouping them into five separate categories, or “schedules.” These five schedules were a result of the Federal Controlled Substances Act (CSA), a part of the Comprehensive Drug Abuse Prevention and Control Act of 1970, which was signed into law by former President Richard Nixon.
To date, researchers have identified several health benefits and possible therapeutic uses of CBD, including anti-inflammatory, anti-anxiety, and numerous neuroprotective qualities.
My job is to shed light. Most specifically on the great intricacies of cannabis law, policy, and regulation. The past several years have seen extensive debate about the legal status of cannabidiol (CBD). Is it legal? Was it ever a controlled substance? How is it regulated? Lawyers, industry professionals, and learned scholars debate this with so much vigor that it creates confusion, if not a misstatement of the facts. It hurts my ears and burns my eyes to hear or see an argument that identifies CBD as a controlled substance, because the law is quite clear in this regard.
First, let’s look at the definition of marijuana with an “H” (marihuana), which is indeed scheduled. This comprises all parts of the Cannabis Sativa L. plant, excluding non-viable seeds stock and fiber, but including the resins and the remainder of the plant. CBD, of course, is present within the marijuana plant. If you derive CBD from the marijuana plant, it would in fact be controlled, because it came from a controlled substance. This is known as the “source rule” — the source of the material dictates its legality. But what if CBD and other non-psychoactive cannabinoids are derived from a legal source, such as the 25 other plant species that contain levels of cannabinoids or industrial hemp?
Hemp-derived CBD oil
The only cannabinoid mentioned in the CSA is tetrahydrocannabinol, THC, the psychoactive compound in cannabis. While it is specifically scheduled, courts have disagreed on whether THC needs to be synthetically or naturally derived to fall within the definition of tetrahydrocannabinol under the CSA. Six years ago, industrial hemp was for the first time ever defined separately from marijuana as holding less than 0.3 Δ9-THC percent by dry weight. The 2014 Farm Bill specifically authorized the use of industrial hemp as a legal substance for purposes of market, scientific, and agricultural-based research. The CBD industry exploded because of the “market-based research exception” — one could only study the plant with a viable market in place for its products. This position was litigated in 2018 in HIA v. DEA III and the restrictions were removed by the 2018 Farm Bill.
For something to be a controlled substance under the Federal Controlled Substances Act (CSA), it must be specifically scheduled and assigned one of five scheduling criteria. Schedule I is the most restrictive, which indicates that this controlled substance has no medicinal value and a high potential for abuse. Schedule V, the least restrictive, indicates a drug with currently accepted medical uses and treatments in the United States and a low potential for abuse. Schedule V drugs typically consist of preparations containing limited quantities of certain narcotics, but not always. When one combs through the CSA, the word “cannabidiol” or “CBD” is nowhere to be found — not in the code of federal regulations or in the enacting legislation. One must look deeper to find out what is scheduled and what is not.