Doing a little law CE this morning (because pharmacists have to know pharmacy and medicine law), I came across this nugget, the Farm Bill of 2018 and thought I would share. I didn't know anything about this until I read this. (note: delta-9-tetrahydrocannabinoid, or THC, is abbreviated several different ways in the following paragraphs. They all mean the same thing. Also, Epidiolex is a CBD-derived pharmaceutical that is on the market for two very rare pediatric seizure disorders. Final note, Marinol is synthetic d-9-THC and has been on the market since the 80s. No one uses it.)
Farm Bill
A highly significant event that affected the regulatory status of cannabinoids was the 2018 Farm Bill (Agriculture Improvement Act of 2018). Its goal is to encourage agricultural production of hemp to be used in commercial products. The 2018 Farm Bill removes “hemp” as defined in the bill from the CSA definition of marijuana, and expressly excludes THC from “hemp” from scheduling and control under the CSA (i.e., any THC extracted from the legally defined hemp, but not THC from legally defined marijuana).38 The 2018 Farm Bill conforms to the definition of “industrial hemp” under the Agricultural Act of 2014 and defines hemp as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol [“THC”] concentration of not more than 0.3 percent on a dry weight basis.” A Cannabis plant or product with a THC level exceeding 0.3 percent is considered marijuana, which remains classified as a Schedule I controlled substance regulated by DEA under the CSA.
This general framework carries over to CBD and other cannabinoids as well (see more details below). Cannabinoids derived from plants or parts that fall under the definition of hemp (less than 0.3% THC) are no longer controlled. Those derived from plants not defined as hemp (i.e., where the THC content exceeds 0.3%) are still Schedule I substances. To put it simply, if CBD is derived from a plant producing less than 0.3% THC, it is not an illegal substance. However, the 2018 Farm Bill did not “legalize” CBD per se; it removes products derived from “hemp” from the CSA but does not speak to individual substances obtained from Cannabis sativa. Moreover, the DEA rule states that “a cannabis derivative, extract, or product that exceeds the 0.3% ?9-THC limit is a schedule I controlled substance, even if the plant from which it was derived contained 0.3% or less delta-9-THC on a dry weight basis.” So, even if the plant contains less than 0.3% d-9-THC, if the product exceeds this level during processing, DEA will consider it illegal.
In 2021, the U.S. Department of Agriculture (USDA) issued a Final Hemp Rule that addresses other issues such as licensing requirements, recordkeeping requirements for maintaining information about the land where hemp is produced, procedures for testing the THC concentration levels for hemp, procedures for disposing of non-compliant plants, and procedures for handling violations.
More significantly, DEA issued an Interim Final Rule regarding hemp in August 2020 to comply with the 2018 Farm Bill. It limited the definition of “Marihuana Extract” to extracts "containing greater than 0.3 percent delta-9-tetrahydrocannabinol on a dry weight basis." It also stated that the drug code for tetrahydrocannabinols in the controlled substances list does not include tetrahydrocannabinols in hemp. In other words, it formally recognized that substances obtained from legally defined hemp are excluded from DEA enforcement. However, the interim rule clarifies that "synthetically derived tetrahydrocannabinols" remain scheduled substances regardless of their d9THC content, although it has not yet defined “synthetically derived”. In addition, the new rule descheduled Epidiolex ( formerly C-V).
Even though cannabinoids derived from hemp may no longer be illegal controlled substances, it does not mean there are no restrictions on their sale. Cannabinoids promoted as medicines remain under FDA’s jurisdiction, and FDA has noted that the 2018 Farm Bill “explicitly preserved FDA’s authority to regulate products containing cannabis or cannabis-derived compounds” under the Food Drug and Cosmetic Act (FDCA). FDA’s position is that even if a cannabinoid product meets the definition of "hemp" under the 2018 Farm Bill, it still must comply with the FDCA.40 FDA has been consistently unfavorable towards CBD products that are touted as having health benefits and FDA has also been concerned with their quality control.
An example of this policy is CBD. FDA approved the Epidiolex formulation of CBD which went through the normal (statutory) drug approval process. FDA has been clear that this is the only approved CBD product and the only 1 to meet its requirements to be legally marketed. FDA has issued warning letters to other manufacturers selling OTC CBD advising them that they are illegally marketing their products. Moreover, FDA has warned manufacturers not to add CBD to an existing OTC product even if it lists it as an “inactive” ingredient.
FDA has also taken the position that CBD (or THC) products may not be sold as dietary supplements, even if derived from hemp. CBD and THC are active ingredients in drugs that have already been the subject of a previously approved IND and an FDA-approved drug (Epidiolex). The Food, Drug and Cosmetic Act (FDCA) prohibits the introduction of previously approved drug ingredients into the food supply or marketing as a dietary supplement. FDA has indicated that this prohibition applies across the board to food products (including animal food) that contain an active drug ingredient. [At the time this continuing education activity was being prepared, a bill, the Hemp Access and Consumer Safety Act, was introduced to Congress which would provide a regulatory pathway for CBD to be approved as a supplement.]
Farm Bill
A highly significant event that affected the regulatory status of cannabinoids was the 2018 Farm Bill (Agriculture Improvement Act of 2018). Its goal is to encourage agricultural production of hemp to be used in commercial products. The 2018 Farm Bill removes “hemp” as defined in the bill from the CSA definition of marijuana, and expressly excludes THC from “hemp” from scheduling and control under the CSA (i.e., any THC extracted from the legally defined hemp, but not THC from legally defined marijuana).38 The 2018 Farm Bill conforms to the definition of “industrial hemp” under the Agricultural Act of 2014 and defines hemp as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol [“THC”] concentration of not more than 0.3 percent on a dry weight basis.” A Cannabis plant or product with a THC level exceeding 0.3 percent is considered marijuana, which remains classified as a Schedule I controlled substance regulated by DEA under the CSA.
This general framework carries over to CBD and other cannabinoids as well (see more details below). Cannabinoids derived from plants or parts that fall under the definition of hemp (less than 0.3% THC) are no longer controlled. Those derived from plants not defined as hemp (i.e., where the THC content exceeds 0.3%) are still Schedule I substances. To put it simply, if CBD is derived from a plant producing less than 0.3% THC, it is not an illegal substance. However, the 2018 Farm Bill did not “legalize” CBD per se; it removes products derived from “hemp” from the CSA but does not speak to individual substances obtained from Cannabis sativa. Moreover, the DEA rule states that “a cannabis derivative, extract, or product that exceeds the 0.3% ?9-THC limit is a schedule I controlled substance, even if the plant from which it was derived contained 0.3% or less delta-9-THC on a dry weight basis.” So, even if the plant contains less than 0.3% d-9-THC, if the product exceeds this level during processing, DEA will consider it illegal.
In 2021, the U.S. Department of Agriculture (USDA) issued a Final Hemp Rule that addresses other issues such as licensing requirements, recordkeeping requirements for maintaining information about the land where hemp is produced, procedures for testing the THC concentration levels for hemp, procedures for disposing of non-compliant plants, and procedures for handling violations.
More significantly, DEA issued an Interim Final Rule regarding hemp in August 2020 to comply with the 2018 Farm Bill. It limited the definition of “Marihuana Extract” to extracts "containing greater than 0.3 percent delta-9-tetrahydrocannabinol on a dry weight basis." It also stated that the drug code for tetrahydrocannabinols in the controlled substances list does not include tetrahydrocannabinols in hemp. In other words, it formally recognized that substances obtained from legally defined hemp are excluded from DEA enforcement. However, the interim rule clarifies that "synthetically derived tetrahydrocannabinols" remain scheduled substances regardless of their d9THC content, although it has not yet defined “synthetically derived”. In addition, the new rule descheduled Epidiolex ( formerly C-V).
Even though cannabinoids derived from hemp may no longer be illegal controlled substances, it does not mean there are no restrictions on their sale. Cannabinoids promoted as medicines remain under FDA’s jurisdiction, and FDA has noted that the 2018 Farm Bill “explicitly preserved FDA’s authority to regulate products containing cannabis or cannabis-derived compounds” under the Food Drug and Cosmetic Act (FDCA). FDA’s position is that even if a cannabinoid product meets the definition of "hemp" under the 2018 Farm Bill, it still must comply with the FDCA.40 FDA has been consistently unfavorable towards CBD products that are touted as having health benefits and FDA has also been concerned with their quality control.
An example of this policy is CBD. FDA approved the Epidiolex formulation of CBD which went through the normal (statutory) drug approval process. FDA has been clear that this is the only approved CBD product and the only 1 to meet its requirements to be legally marketed. FDA has issued warning letters to other manufacturers selling OTC CBD advising them that they are illegally marketing their products. Moreover, FDA has warned manufacturers not to add CBD to an existing OTC product even if it lists it as an “inactive” ingredient.
FDA has also taken the position that CBD (or THC) products may not be sold as dietary supplements, even if derived from hemp. CBD and THC are active ingredients in drugs that have already been the subject of a previously approved IND and an FDA-approved drug (Epidiolex). The Food, Drug and Cosmetic Act (FDCA) prohibits the introduction of previously approved drug ingredients into the food supply or marketing as a dietary supplement. FDA has indicated that this prohibition applies across the board to food products (including animal food) that contain an active drug ingredient. [At the time this continuing education activity was being prepared, a bill, the Hemp Access and Consumer Safety Act, was introduced to Congress which would provide a regulatory pathway for CBD to be approved as a supplement.]
