For hemp-seed oil to be exempted from the Cannabis Act, no phytocannabinoid including THC and CBD may be added or concentrated by processing.
There is increasing interest, both in Canada and worldwide, in CBD. CBD is a compound found in the cannabis plant. It is regulated in Canada under the Cannabis Act.
The Cannabis Act and its regulations do not distinguish between CBD derived from industrial hemp and CBD derived from cannabis with greater than 0.3% THC.
CBD and prescription drugs
As a result, CBD and products containing CBD are subject to all of the rules and requirements that apply to cannabis under the Cannabis Act and its regulations. This includes CBD derived from industrial hemp plants, as well as CBD derived from other varieties of cannabis.
All phytocannabinoids, with several exceptions, are listed on the Prescription Drug List. If you wish to manufacture and sell a health product containing CBD that makes a health claim, you require approval for the product as a prescription drug under the Food and Drug Regulations.
Hemp producers may not extract the CBD themselves, unless they also have a cannabis processing or research licence.
To cultivate any cannabis plants that you intend to sell, you must have a federal licence issued under the Cannabis Act.
As the market for hemp derived CBD has exploded, there is increasing interest in international trade in these products and the materials used to make them, including in the United States. For example, a US-based manufacturer of hemp-derived CBD edibles might import the active ingredient for manufacturing and then export the finished product overseas. US-based companies could also be interested in importing or exporting raw materials such as industrial hemp, hemp seeds, or other hemp-derived products.
If the products otherwise comply with US law, there is nothing under US customs laws that would prohibit importing them into the United States. In particular, CBP has confirmed publicly that hemp seeds can be imported into the United States. As with any other types of products, anything imported into the United States must be “classified” in the Harmonized Tariff Schedule of the United States (“HTSUS”). Based on the HTSUS code, and the customs value and the country of origin of the good, the appropriate duties, if any, need to be paid. Importers can self-classify the products or submit an administrative ruling request to CBP prior to importation.
What should you know about US export controls and economic sanctions?
US trade laws are subject to robust enforcement, frequently resulting in significant fines, reputational damage, and settlement agreements that impose compliance program obligations on companies. It is safe to assume that imports and exports of these products could receive greater scrutiny by the US regulators, at least for the time being while the industry matures. In order to mitigate the risk of violations, companies interested in importing or exporting legal hemp and CBD products should develop and maintain compliance programs designed to ensure compliance with US export controls, sanctions, and customs laws and regulations. This includes procedures for product classification, licensing determinations, and restricted party screening processes.
The first step in determining whether a particular export is permissible under US export controls laws is determining whether the product is described in an export control classification number (“ECCN”) set out in the Commerce Control List (“CCL”) in Part 774 of the Export Administration Regulations (“EAR”). The EAR are enforced by the Bureau of Industry and Security (“BIS”) in the US Commerce Department. The ECCN can be determined in one of several ways, including by self-classifying the product based on a review of the CCL, or by asking BIS for a formal commodity classification ruling referred to as a “CCATS”. Products that are not described on the CCL are assigned a catch-all classification of EAR99, which means they generally do not require a BIS license for export to most destinations. It seems unlikely to us that a hemp or CBD product would be described on the CCL. However, reaching an ECCN determination requires a detailed understanding of a product’s technical parameters, so this review should be conducted by knowledgeable trade compliance counsel with input from product experts at the company.
What should you know about US customs laws?
Notwithstanding the legality of these products, there continue to be reports of seizures of legal CBD products imported into the United States. This may be due to the difficulty of distinguishing legal (i.e., hemp-derived) CBD from illegal (i.e., marijuana-derived) CBD without extensive laboratory analysis, and/or it could be due to confusion on the part of CBP officials about what is permitted. For example, in a lawsuit filed in US District Court for the Central District of California, a US-based CBD company alleged that CBP had illegally seized four shipments of Spanish-origin hemp between 2015 and 2018. Three of the shipments are alleged to have been destroyed in part because CBP improperly determined the imports contained controlled substances, notwithstanding documentation from the Spanish growers that the hemp had less than 0.3% THC, making it legal under federal law. The lawsuit has since been settled.
The existence of substantial clinical investigations regarding THC and CBD have been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex. (See Sativex Commences US Phase II/III Clinical Trial in Cancer Pain )
A. With the exception of products such as the hemp seed ingredients discussed in Question #12, which have been evaluated for safety, it is important to protect children from accidental ingestion of cannabis and cannabis-containing products. FDA recommends that these products are kept out of reach of children to reduce the risk of accidental ingestion. If the parent or caregiver has a reasonable suspicion that the child accidentally ingested products containing cannabis, the child should be taken to a physician or emergency department, especially if the child acts in an unusual way or is/feels sick.
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.
With respect to products labeled to contain “hemp” that may also contain THC or CBD, as mentioned above it is a prohibited act under section 301(ll) of the FD&C Act to introduce or deliver for introduction into interstate commerce any animal food to which THC or CBD has been added.
While the agency is aware of reports of pets consuming various forms of cannabis, to date, FDA has not directly received any reports of adverse events associated with animals given cannabis products. However, adverse events from accidental ingestion are well-documented in scientific literature. If you feel your animal has suffered from ingesting cannabis, we encourage you to report the adverse event to the FDA. Please visit Reporting Information about Animal Drugs and Devices to learn more about how to report an adverse event related to an animal drug or for how to report an adverse event or problem with a pet food.