Signs that your pet may be suffering adverse effects from ingesting cannabis may include lethargy, depression, heavy drooling, vomiting, agitation, tremors, and convulsions.
The agency has and will continue to monitor the marketplace and take action as needed to protect the public health against companies illegally selling cannabis and cannabis-derived products that can put consumers at risk and that are being marketed for therapeutic uses for which they are not approved. At the same time, FDA recognizes the potential therapeutic opportunities that cannabis or cannabis-derived compounds could offer and acknowledges the significant interest in these possibilities. FDA continues to believe that the drug approval process represents the best way to help ensure that safe and effective new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy. The Center for Drug Evaluation and Research (CDER) is committed to supporting the development of new drugs, including cannabis and cannabis-derived drugs, through the investigational new drug (IND) and drug approval process (see Question #16).
A. The FDA is aware that several states have either passed laws that remove state restrictions on the medical use of cannabis and its derivatives or are considering doing so. It is important to conduct medical research into the safety and effectiveness of cannabis products through adequate and well-controlled clinical trials. We welcome the opportunity to talk with states who are considering support for medical research of cannabis and its derivatives, so that we can provide information on Federal and scientific standards.
Children and Pregnant/Lactating Women
24. I’ve seen cannabis products being marketed for pets. Are they safe?
4. Aside from Epidiolex, are there other CBD drug products that are FDA-approved? What about the products I’ve seen in stores or online?
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.
A. It depends, among other things, on the intended use of the product and how it is labeled and marketed. Even if a CBD product meets the definition of “hemp” under the 2018 Farm Bill (see Question #2), it still must comply with all other applicable laws, including the FD&C Act. The below questions and answers explain some of the ways that specific parts of the FD&C Act can affect the legality of 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.
With different forms of cannabis being legalized on both a state and federal level, CBD’s class schedule continues to be complex and confusing for some. All the while,, the CBD market continues to skyrocket as more and more companies produce, distribute, and sell CBD products, and as consumers across the world buy CBD products in increasing numbers.
Overview of the Schedule I classification
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.
According to the FDA, CBD derived from hemp plants is still not approved for use in medicinal products or in food and drink products. In September 2018, prior to the passage of the 2018 Hemp Farming Bill, the DEA released a statement announcing that CBD products that had been approved by the U.S. Food and Drug Administration (FDA) and contain less with THC levels below .1% would be classified as a Schedule V substance.
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?
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.
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
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.