Note regarding this rule – In light of questions that the Drug Enforcement Administration has received from members of the public following the publication of the Final Rule establishing a new Controlled Substance Code Number (drug code) for marijuana extract, DEA makes the following clarification:
As explained in the Final Rule, the creation of this new drug code was primarily intended to give DEA more precise accounting to assist the agency in carrying out its obligations to provide certain reports required by U.S. treaty obligations. Because the Final Rule did not add any substance to the schedules that was not already controlled, and did not change the schedule of any substance, it was not a scheduling action under 21 U.S.C. §§ 811 and 812.
Clarification of the New Drug Code (7350) for Marijuana Extract
The new drug code is a subset of what has always been included in the CSA definition of marijuana. By creating a new drug code for marijuana extract, the Final Rule divides into more descriptive pieces the materials, compounds, mixtures, and preparations that fall within the CSA definition of marijuana. Both drug code 7360 (marijuana) and new drug code 7350 (marijuana extract) are limited to that which falls within the CSA definition of marijuana.
Because recent public inquiries that DEA has received following the publication of the Final Rule suggest there may be some misunderstanding about the source of cannabinoids in the cannabis plant, we also note the following botanical considerations. As the scientific literature indicates, cannabinoids, such as tetrahydrocannabinols (THC), cannabinols (CBN) and cannabidiols (CBD), are found in the parts of the cannabis plant that fall within the CSA definition of marijuana, such as the flowering tops, resin, and leaves. 2 According to the scientific literature, cannabinoids are not found in the parts of the cannabis plant that are excluded from the CSA definition of marijuana, except for trace amounts (typically, only parts per million) 3 that may be found where small quantities of resin adhere to the surface of seeds and mature stalk. 4 Thus, based on the scientific literature, it is not practical to produce extracts that contain more than trace amounts of cannabinoids using only the parts of the cannabis plant that are excluded from the CSA definition of marijuana, such as oil from the seeds. The industrial processes used to clean cannabis seeds and produce seed oil would likely further diminish any trace amounts of cannabinoids that end up in the finished product. However, as indicated above, if a product, such as oil from cannabis seeds, consisted solely of parts of the cannabis plant excluded from the CSA definition of marijuana, such product would not be included in the new drug code (7350) or in the drug code for marijuana (7360), even if it contained trace amounts of cannabinoids. 5
A. A cosmetic is defined in 201(i) as “(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.”
To date, FDA has not approved a marketing application for cannabis for the treatment of any disease or condition and thus has not determined that cannabis is safe and effective for any particular disease or condition. The agency has, however, approved one cannabis-derived and three cannabis-related drug products (see Question #2).
 Hayatbakhsh, et al. Birth Outcomes associated with cannabis use before and during pregnancy. Pediatric Research. 2012; 71 (2): 215-219.
Questions and Answers
3. Has FDA approved any medical products containing cannabis or cannabis-derived compounds such as CBD?
A. Information for patients on Right to Try (RTT) is available on our website. RTT is designed to facilitate access to certain investigational drugs through direct interactions between patients, their physicians and drug sponsors – FDA is not involved in these decisions. Sponsors developing drugs for life-threatening conditions are responsible for determining whether to make their products available to patients who qualify for access under RTT. If you are interested in RTT, you should discuss this pathway with your licensed physician. Companies who develop drugs and biologics, also known as sponsors, can provide information about whether their drug/biologic is considered an eligible investigational drug under RTT and if they are able to provide the drug/biologic under the RTT Act.
13. What is FDA’s position on cannabis and cannabis-derived ingredients in cosmetics?
In addition, under 21 CFR 530.20, extralabel use of an approved human drug in a food-producing animal is not permitted if an animal drug approved for use in food-producing animals can be used in an extralabel manner for the use. In addition, under 21 CFR 530.20(b)(2), if scientific information on the human food safety aspect of the use of the approved human drug in food-producing animals is not available, the veterinarian must take appropriate measures to ensure that the animal and its food products will not enter the human food supply.
For more information on extralabel use of FDA approved drugs in animals, see Extralabel Use of FDA Approved Drugs In Animals.
Under federal law, CBD that is derived from cannabis plants with more than .3% THC is considered illegal, as the intoxicating cannabinoid remains a Schedule I substance. If the cannabis plant has more than .3% THC, then all substances derived from it — including any CBD extracted from the plant — are considered by the DEA to be a federally restricted Schedule I substance.
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.
Interestingly, recent research seems to back up the position that CBD is not a drug in this sense that it isn’t normally detected during a drug screening. Most U.S. employers, for instance, abide by the guidelines set forth by the Substance Abuse and Mental Health Services Administration (SAMHSA), which includes detection for THC but not for CBD. Most employment drug tests specifically look for the presence of THC or THC metabolites, but it’s highly unlikely that CBD oil will show up on a drug test.
Is CBD a Schedule 1 drug?
Two of the most abundant cannabinoids produced by the cannabis plant are THC, which produces the plant’s renowned intoxicating effects, and CBD, which is a non-intoxicating compound and appears to provide many therapeutic and medicinal qualities. This combination of cannabis compounds are also key in understanding how the Schedule I classification applies to CBD products.
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.
To meet federal legal criteria, CBD oil must contain no more than 0.3 percent THC. Photo by: Gina Coleman/Weedmaps
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.