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cbd oil schedule 1

5. Why hasn’t FDA approved more products containing cannabis or cannabis-derived compounds for medical uses?

A. Expanded access is a potential pathway for a patient with a serious or life-threatening disease or condition to try an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when there are no comparable or satisfactory therapies available. Manufacturers may be able to make investigational drugs available to individual patients in certain circumstances through expanded access, as described in the FD&C Act and implementing regulations.

FDA Communications

A. No. There are no other FDA-approved drug products that contain CBD. We are aware that some firms are marketing CBD products to treat diseases or for other therapeutic uses , and we have issued several warning letters to such firms. Under the FD&C Act, any product intended to have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug. Drugs must generally either receive premarket approval by FDA through the New Drug Application (NDA) process or conform to a “monograph” for a particular drug category, as established by FDA’s Over-the-Counter (OTC) Drug Review. CBD was not an ingredient considered under the OTC drug review. An unapproved new drug cannot be distributed or sold in interstate commerce.

A. The agency has received reports of adverse events in patients using cannabis or cannabis-derived products to treat medical conditions. The FDA reviews such reports and will continue to monitor adverse event reports for any safety signals, with a focus on serious adverse effects. Consumers and healthcare providers can report adverse events associated with cannabis or cannabis-derived products via the FDA’s MedWatch reporting system, either online or by phone at 1-800-FDA-1088. For more information, please see the FDA’s webpage on MedWatch.

As discussed above (see Question #2), the 2018 Farm Bill removed hemp from the CSA. This change may streamline the process for researchers to study cannabis and its derivatives, including CBD, that fall under the definition of hemp, which could speed the development of new drugs.

Federal classification of CBD is one of the biggest areas of confusion still surrounding CBD, CBD oil, and other CBD-infused products, leaving some to wonder: Is CBD or CBD oil a Schedule I drug?

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.

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After the 2018 Farm Bill was signed, FDA Commissioner Scott Gottlieb issued a statement confirming that the agency would oversee and regulate hemp-derived CBD products under the Federal Food Drug & Cosmetic Act (FD&C Act) and that only “cosmetic” CBD products would be allowed. According to the FDA, cosmetics are defined as “articles intended to be rubbed, poured, sprinkled, or sprayed” on the human body, a description that fits many hemp-derived CBD products.

Cannabidiol (CBD) has seen explosive growth in popularity over the past few years. Despite this, there is still a lot of confusion regarding the legal status of CBD, including CBD’s class schedule and whether CBD or CBD oil is a Schedule I drug.

On the other hand, if your definition of the word “drug” refers to an intoxicating substance that alters your central nervous system, perception, mood, consciousness, or generates mind-altering effects, then most experts would say that no, CBD is not a drug.

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.

Hemp-derived CBD oil

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?

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.

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.