Ukraine has kept its THC level at 0.08% (for seed and fiber production), and Slovakia is the only country in the European Union where CBD and THC are still illegal. Only the cultivation of industrial hemp varieties approved by the EU and with less than 0.2% THC is legal in Slovakia, and it cannot be cultivated to extract CBD. The local pharmaceutical business is also seeking approval for the development and manufacture of cannabinoid-based drugs in both states.
Italians are not alone in this novel practice. Following the novel food change, many European companies approached the issue by relabelling their products. Austrian biotech company CannHelp recalled all of its CBD-based oils, foods, and cosmetics. The company has relabelled the oils so they are now categorized as “aromatic products” and, as such, placed back on the shelves.
In April 2019, the Spanish Agency for Consumer Affairs, Food Safety and Nutrition (AECOSAN) issued guidance that stated CBD oils, regardless of whether its origin is natural or synthetic, as well as extracts and other parts of the plant Cannabis sativa L. (flowers, leaves, and stems) are considered novel food.
Romania: Under criminal law
In practice, to avoid leaves and flowers being left in the ‘grey area’ and to escape further regulatory confusion, some Italian companies started registering CBD hemp flower products as animal feed. However, registering pure cannabinoids such as CBD extracts as animal feed is not permitted. CBD for pet food is also forbidden.
In Great Britain, the biggest CBD market in Europe, THC is listed as a controlled substance under the Misuse of Drugs Act 1971. CBN (Cannabinol) and CBDV (Cannabidivarin) are also class B controlled substances. Only CBD isolated in its pure form is not listed as a controlled substance. Growing your own cannabis and hemp is allowed with a license from the UK Home Office for licensed medical distributors or companies that sell nutritional supplements. CBD products sold as nutritional supplements must be labeled in accordance with The Food Supplements Regulations from 2003. The sale of hemp flowers and buds is prohibited. CBD extracts and other derived products are considered novel foods and need to gain authorization. As we are informed by the Food Standards Agency (FSA), currently there are no CBD extract products authorized as novel foods in the UK, and the products on the market are in contravention of the novel food regulations.
Not all EU member states have announced the enforcement of novel food catalog guidelines on CBD, and there are unconfirmed reports that Bulgaria recently issued a license that would permit the sale of CBD food products.
CBD in Europe – Legislation at the EU and National Levels: In January 2019, the European Commission changed the entry in the novel foods catalog for cannabinoids. Novel Food is defined as food that had not been used for human consumption to a significant degree in the European Union before 15th May 1997. Previously to this decision, only enriched CBD was considered novel food. Now a new entry Cannabinoids was created, and it states all hemp extracts to be novel. Also, the entry of Cannabis sativa L. was changed and now only seed-derived products are considered food. The leaves and flowers are left in a ‘grey zone’.
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.
A. To date, the agency has not approved a marketing application for cannabis for the treatment of any disease or condition. FDA has, however, approved one cannabis-derived and three cannabis-related drug products. These approved products are only available with a prescription from a licensed healthcare provider.
1. What are cannabis and marijuana?
The 2018 Farm Bill, however, explicitly preserved FDA’s authority to regulate products containing cannabis or cannabis-derived compounds under the FD&C Act and section 351 of the Public Health Service Act (PHS Act). FDA treats products containing cannabis or cannabis-derived compounds as it does any other FDA-regulated products — meaning they’re subject to the same authorities and requirements as FDA-regulated products containing any other substance. This is true regardless of whether the cannabis or cannabis-derived compounds are classified as hemp under the 2018 Farm Bill.
A. The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA), permits veterinarians to prescribe extralabel uses of approved human and animal drugs for animals under certain conditions. Extralabel use must comply with all the provisions of AMDUCA and its implementing regulation at 21 CFR § 530. Among other limitations, these provisions allow extralabel use of a drug only on the lawful order of a licensed veterinarian in the context of a valid veterinarian-client-patient relationship and only in circumstances when the health of an animal is threatened or suffering, or death may result from failure to treat.
Many advocates applaud Leader McConnell for his stewardship of these hemp provisions into the Farm Bill and his leadership on the legislation overall. That assessment is accurate. Without Mr. McConnell’s efforts, the hemp provisions would never had found their way into the legislation initially. And although his position as Senate leader gave him tremendous institutional influence over the legislation, he went a step further by appointing himself to the conference committee that would bring the House and Senate together to agree on a final version.
Third, the law outlines actions that are considered violations of federal hemp law (including such activities as cultivating without a license or producing cannabis with more than 0.3 percent THC). The law details possible punishments for such violations, pathways for violators to become compliant, and even which activities qualify as felonies under the law, such as repeated offenses.
The Farm Bill has no effect on state-legal cannabis programs. Over the past 22 years, 33 states have legalized cannabis for medical purposes, and over the past six years, 10 states have legalized cannabis for adult use. Every one of those programs is illegal under federal law, with no exceptions, and the Farm Bill does nothing to change that. That said, many in the advocacy community hope that the reforms to hemp policy under the Farm Bill serve as a first step toward broader cannabis reform. (Although I would argue that a soon-to-be-sworn-in Democratic House majority alongside a president with a record of pro-cannabis reform rhetoric is the more likely foundation for broader cannabis reform.)
Deputy Director – Center for Effective Public Management
Under the 2018 Farm Bill hemp is treated like other agricultural commodities in many ways. This is an important point. While there are provisions that heavily regulate hemp, and concerns exist among law enforcement—rightly or wrongly—that cannabis plants used to derive marijuana will be comingled with hemp plants, this legislation makes hemp a mainstream crop. Several provisions of the Farm Bill include changes to existing provisions of agricultural law to include hemp. One of the most important provisions from the perspective of hemp farmers lies in section 11101. This section includes hemp farmers’ protections under the Federal Crop Insurance Act. This will assist farmers who, in the normal course of agricultural production, face crop termination (crop losses). As the climate changes and as farmers get used to growing this “new” product, these protections will be important.
One big myth that exists about the Farm Bill is that cannabidiol (CBD)—a non-intoxicating compound found in cannabis—is legalized. It is true that section 12619 of the Farm Bill removes hemp-derived products from its Schedule I status under the Controlled Substances Act, but the legislation does not legalize CBD generally. As I have noted elsewhere on this blog CBD generally remains a Schedule I substance under federal law. The Farm Bill—and an unrelated, recent action by the Department of Justice—creates exceptions to this Schedule I status in certain situations. The Farm Bill ensures that any cannabinoid—a set of chemical compounds found in the cannabis plant—that is derived from hemp will be legal, if and only if that hemp is produced in a manner consistent with the Farm Bill, associated federal regulations, association state regulations, and by a licensed grower. All other cannabinoids, produced in any other setting, remain a Schedule I substance under federal law and are thus illegal. (The one exception is pharmaceutical-grade CBD products that have been approved by FDA, which currently includes one drug: GW Pharmaceutical’s Epidiolex.)
One of the goals of the 2014 Farm Bill was to generate and protect research into hemp. The 2018 Farm Bill continues this effort. Section 7605 re-extends the protections for hemp research and the conditions under which such research can and should be conducted. Further, section 7501 of the Farm Bill extends hemp research by including hemp under the Critical Agricultural Materials Act. This provision recognizes the importance, diversity, and opportunity of the plant and the products that can be derived from it, but also recognizes an important point: there is a still a lot to learn about hemp and its products from commercial and market perspectives. Yes, farmers—legal and illegal—already know a lot about this plant, but more can and should be done to make sure that hemp as an agricultural commodity remains stable.
For a little bit of background, hemp is defined in the legislation as the cannabis plant (yes, the same one that produces marijuana) with one key difference: hemp cannot contain more than 0.3 percent of THC (the compound in the plant most commonly associated with getting a person high). In short, hemp can’t get you high. For decades, federal law did not differentiate hemp from other cannabis plants, all of which were effectively made illegal in 1937 under the Marihuana Tax Act and formally made illegal in 1970 under the Controlled Substances Act—the latter banned cannabis of any kind.