Contemporary CBD Issues in the United StatesContemporary CBD Issues in the United States
In the United States, federal and state laws regarding the sale of CBD are confusing; brands selling CBD supplement face risk, as DEA and FDA have issues with the cannabinoid compound.
March 13, 2018
Cannabaceae is a family of flowering plants. The family includes about 170 species, grouped into 11 genera. These include botanicals such as: Cannabis (hemp and marijuana), Humulus (hops) and Celtis (hackberries).
Some articles state the genus Cannabis has three recognized species: Cannabis sativa, C. indica, C. ruderalis. However, based on morphological, anatomical, phytochemical and genetic studies, it is generally legally accepted that there is only a single species: C. sativa L., with C. indica and C. ruderalis being varieties. Both “marijuana” and “industrial hemp” refer to the same plant, C. sativa.
The cannabis plant is made up of hundreds (at least 113) of cannabinoid compounds. The plant’s two most prominent cannabinoids are tetrahydrocannabinol (THC) and cannabidiol (CBD). CBD is non-psychoactive, while THC has the well-known psychoactive effect on users. All cannabis plants contain cannabinoids, albeit in different concentrations.
CBD gained national attention when CNN covered the story of Charlotte Figi, a pediatric, epilepsy patient in Colorado. Figi was 5 years old and having 300 seizures a week. She had a dramatic reduction in seizures after she tried cannabis oil. So, Figi's parents went to the Stanley Brothers for help to find a strain of cannabis that was high in CBD and low in THC. The Stanley Brothers developed a strain they named "Charlotte's Web" after the girl.
U.S. Federal Law and the Controlled Substance Act (CSA)
The Controlled Substances Act (CSA) is the statute that establishes federal U.S. drug policy under which the manufacture, importation, possession, use, and sale and distribution of certain substances are regulated. It was passed by the 91st United States Congress as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970.
The CSA controls psychoactive substances or others with abuse potential as well as all stages of the manufacturing and supply chain, and all users, such as patients. The CSA places all substances which are regulated into one of five schedules. This placement is based on the substance’s medical use, potential for abuse and safety or dependence liability (21 USC 812). The general rule indicates a substance and products derived from that substance are in the same schedule.
No prescriptions may be written for Schedule I substances, and such substances are subject to production quotas imposed by DEA. Schedule I substances can only be utilized as a part of a federally approved research program (basically, banned from commerce).
Marijuana is on Schedule I of the CSA, even though 29 states and Washington D.C. have legalized medical marijuana.
According to Title 21 United States Code (USC) Controlled Substances Act, the current legal definition of marijuana is:
“The term ‘marihuana’ means all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin. Such term does not include the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil or cake, or the sterilized seed of such plant which is incapable of germination (21 USC 802(d) (16)).
Stalks and products derived from those stalks are not illegal because they are not marijuana. This distinction allowed for legal use and importation of hemp products, even though marijuana remains federally illegal.
CBD itself is not specifically listed on the CSA.
Cannabis was listed in the U.S. Pharmacopeia (USP) from 1850 through 1941, when it was removed.
1937—The Marijuana Tax Act made hemp and marijuana illegal for any use.
1976—The U.S. federal government created the investigational new drug (IND) compassionate use research program, allowing patients to receive up to 9 pounds of cannabis from the government each year.
2001—The DEA attempted to ban the manufacture, sale or import of food and cosmetics made from agricultural hemp seeds produced overseas, arguing these products contained trace amounts of THC, even though they didn’t make anyone high.
2004—The Ninth Circuit Court of Appeals ruled hemp products derived from the parts of the hemp plant exempt from the CSA are legal to import. The court ruled the presence of THC does not alone make a product a controlled substance.
2014—The Agricultural Act (also known as the “Farm Bill”) Section 7606 (7 USC 5940) legalized the growing and cultivating of industrial hemp for research purposes in states “where such growth and cultivation is legal under State law, notwithstanding existing Federal statutes that would otherwise criminalize such conduct.” Industrial hemp is defined to mean “the plant Cannabis sativa L. and any part of such plant, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.” The term “research” was not defined.
2016—DEA issued a rule (Establishment of a New Drug Code (7350) for Marihuana Extract) defining “marihuana extracts” to include extracts “containing one or more cannabinoids from any plant of the genus Cannabis.” This rule went into effect on Jan. 13, 2017. The rule re-defined the definition of marijuana to include extracts from any part of the plant.
DEA is creating a new Administration Controlled Substances Code Number for "Marihuana Extract." This code number will allow DEA and DEA-registered entities to track quantities of this material separately from quantities of marihuana. This, in turn, will aid in complying with relevant treaty provisions.
Under international drug control treaties administered by the United Nations, some differences exist between regulatory controls pertaining to marihuana extract versus those for marihuana and THC. DEA has previously established separate code numbers for marihuana and THC, but not for marihuana extract. To better track these materials and comply with treaty provisions, DEA is creating a separate code number for marihuana extract with the following definition: "Meaning an extract containing one or more cannabinoids that has been derived from any plant of the genus Cannabis, other than the separated resin (whether crude or purified) obtained from the plant." Extracts of marihuana will continue to be treated as Schedule I controlled substances.
2017—DEA issued a Clarification of the New Drug Code (7350) for Marijuana Extract, and made the following clarification:
The new drug code (7350) established in the Final Rule does not include materials or products excluded from the definition of marijuana set forth in the CSA.
The new drug code includes only those extracts that fall within the CSA definition of marijuana.
If a product 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).
Current CBD Status
Litigation continues, and the marketplace is changing.
Currently, DEA maintains CBD is a Schedule I substance under the federal CSA, indicating it currently has no accepted medical use. It states that, under U.S. law (the CSA), the definition of marijuana includes all parts of the cannabis plant that are the source of cannabinoids. The CSA definition of marijuana also includes “every compound, manufacture, salt, derivative, mixture or preparation” of such parts of the cannabis plant—and CBD produced from the cannabis plant clearly falls within this category. Thus, CBD, being a derivative of marijuana, is marijuana under U.S. law (and hemp is marijuana). Accordingly, because marijuana is a Schedule I controlled substance under the CSA (as set forth in 21 U.S.C. § 812(c), Schedule I(c)(10)), CBD is a Schedule I controlled substance under the CSA.
However, CBD is not listed on the federal schedule of controlled substances. CBD cannot have a delta-9 THC concentration of more than 0.3 percent on a dry weight basis—per 2014 Farm Bill. But, DEA states CBD still cannot be sold, as it is a controlled substance. CBD only made from mature stalks, fibers, cake or seeds (sterilized) apparently are OK, according to the above revised DEA clarification, which excludes it from being a “marihuana extract.” This is contrary to DEA’s stated position.
Anyone selling hemp-derived CBD (or hemp oil extracts) should also make sure its products come from imported hemp (and the correct part of the plant). Why? Because the rules in the 2014 Farm Bill, regarding how hemp can be grown in the United States, declare it illegal to grow hemp for commercial purposes (only for research purposes).
Via many warning letters, FDA made its position that CBD may not lawfully be sold in dietary supplements, or added to food, even if no health claims are being made. FDA’s reasoning is based on the Federal Food, Drug, and Cosmetic Act (FD&C), which defines “dietary supplement” to exclude products that contain an FDA-approved drug or a substance that has been authorized for investigation as a new drug. FDA concluded CBD falls within this category because of the clinical research recently conducted on Epidiolex and Sativex. In October 2017, GW Pharmaceuticals PLC (operates in United States as Greenwich Biosciences) announced they had completed the submission of a new drug application (NDA) to FDA for Epidiolex®. The CBD drug has been studied to treat two forms of epilepsy: Lennox-Gastaut syndrome (LGS) and Dravet syndrome.
If Epidiolex gets approved by FDA as a drug, the selling of CBD as a non-drug may possibly become illegal. It really will be a matter of enforcement discretion on FDA’s part as to whether producers of CBD formulations will be allowed to continue to operate.
Regardless, supplement brands cannot legally make claims of treatments or cures when marketing, selling or labeling CBD. Only drugs can make such claims, since they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure or function of the body.
If CBD becomes classified as a drug:
There is potential, due to a clause in the FD&C Act, for substances marketed in a dietary supplement or a conventional food, before an IND is authorized, to continue use of the supplement in non-drug products. Based on evidence available to FDA, the agency concluded this is not the case for CBD. Some disagree, noting hemp oil was marketed prior to GW Pharma’s application.
The cannabis plant is made up of hundreds of cannabinoid compounds. Creating a product with another specific cannabinoid or a blend of cannabinoids, rather than CBD, might be the way around the main CBD component in Epidiolex.
FDA may choose to allow CBD to be sold as a non-drug substance.
Litigation may eventually resolve the legal issue on the selling of CBD.
Congress can choose to make CBD legal.
Is CBD legal? Federally, no. In some states, yes. In the United States, federal and state laws regarding the medical use of cannabis and cannabinoids are confusing and at odds with each other. Many states allow cannabis products high in cannabidiol and low in THC to be sold for medical use. CBD cannot be sold across state lines (interstate commerce).
So far, FDA has not shut down the sale of CBD and has concentrated on sellers making non-allowed claims. Brands selling CBD supplement still face risk, since both DEA and FDA have issues with CBD.
Robin Koon is executive vice president at Best Formulations (bestformulations.com), and has more than 35 years of pharmaceutical experience in clinical pharmacy, as a retail drug chain executive, in managed-care and in manufacturing.
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