The provinces and territories are responsible for determining how cannabis is distributed and sold within their jurisdictions.
CBD and products containing CBD, such as cannabis oil, may only be sold by a:
Growing cannabis plants containing CBD for commercial sale
CBD can be found in different varieties of the cannabis plant, including hemp.
Hemp-seed oil is marketed in Canada in:
The flowering heads, branches and leaves may only be imported or exported by a licence holder under the Cannabis Regulations:
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.
Below we summarize some of the key US trade compliance considerations for companies seeking to import or export these products. Because every export from the United States by definition involves an import into another country, there will always be at least one other jurisdiction’s import laws to consider.
Even where a product appears to be EAR99 based on a self-classification, there still may be benefit to obtaining a formal CCATS from BIS. First, this could avoid questions from US Customs and Border Protection (“CBP”), which enforces US export control laws at the border and which might question whether the products are described in an ECCN on the CCL. Second, it could be helpful to have a CCATS on hand to provide to other parties involved in the transaction that may want assurances that the export is in compliance with US export control laws, such as banks, intermediaries, and customers.
Exports from the United States to embargoed territories (Crimea, Cuba, Iran, North Korea, Syria) are prohibited without licenses from BIS and/or the Office of Foreign Assets Control (“OFAC”) in the US Treasury Department. (While OFAC is the primary sanctions enforcement agency, BIS and OFAC have overlapping jurisdiction in some cases, so it is always important to consider both agencies’ licensing requirements.) There are narrow licensing programs for products that qualify as agricultural commodities, medicines, and medical devices, with eligibility requirements and licensing policies that vary depending on the sanctions program. We recommend working with knowledgeable trade compliance counsel to determine whether the products might be eligible for these licenses. If so, companies should develop procedures to ensure compliance with the terms and conditions of the relevant licenses. Companies should always watch out for red flags that a customer might divert products to a sanctioned territory without the required licenses.
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.
Except for certain low-value shipments, information on exports from the United States must generally be provided to the US Census Bureau in a filing known as the Electronic Export Information (“EEI”) based on requirements set out in the Foreign Trade Regulations (“FTR”). For instance, the EEI filing must identify the “Schedule B” number (a 10-digit number used in the United States to classify physical goods for export to another country based on the Harmonized System of classification codes), the ultimate consignee, and the country of ultimate destination, among others. Aside from being used for statistical purposes, EEI filings are reviewed by agencies such as BIS and OFAC for enforcement and export controls purposes.
How should you ensure compliance?
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.
26. Can approved human drugs containing CBD or synthetic THC be used extralabel in animals?
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?
We are aware that state and local authorities are fielding numerous questions about the legality of CBD. There is ongoing communication with state and local officials to answer questions about requirements under the FD&C Act, to better understand the landscape at the state level, and to otherwise engage with state/local regulatory partners.
FDA continues to be concerned at the proliferation of products asserting to contain CBD that are marketed for therapeutic or medical uses although they have not been approved by FDA. Often such products are sold online and are therefore available throughout the country. Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective. This deceptive marketing of unproven treatments also raises significant public health concerns, because patients and other consumers may be influenced not to use approved therapies to treat serious and even fatal diseases.