Legal status of CBD.
Prescription Medicine (Schedule 4) for therapeutic use containing two percent (2.0%) orless of other cannabinoids commonly found in cannabis (such as ∆9-THC).A Schedule 4 drug under the SUSMP isa Prescription Only Medicine, or Prescription Animal Remedy – Substances, the use or supply of which should be by or on the order of persons permitted byState or Territory legislation to prescribe and should be available from pharmacist on prescription.
InJune 2020, the Australian Therapeutic Goods Administration (TGA) published a consultation on a proposal to pave the way to make "low dose" CBD available to consumer/patients via pharmacists only through moving products from Schedule 4 to 3. Any products sold would need to have their safety,quality and efficacy pre-assessed by the TGA and be formally approved for sale(details to be outlined by TGA). They would be made available to over 18s only,with the maximum daily dose of 60 mg/day, up to 2% THC finished product allowed, 30-day maximum supply, plant-derived or synthetic. This proposal is based on an initial literature review on the safety of low dose CBD published by the TGA in April 2020. Epidiolex was approved, for the adjunctive therapy of seizures associated with Lennox-Gastautsyndrome or with Dravet syndrome,on 18 September 2020, and added to the ARTG on 21 September 2020.
In2020, Bulgaria became the first country in the European Union to allow retail sales of food products and supplements containing CBD, despite the ongoing discussion within the EU about the classification of CBD as a novel food.But there exists a legal gap because of the lack of a legally permissible minimum amount of THC in the products containing cannabinoids.
In October 2018, cannabidiol became legal for recreational and medical use by the federal Cannabis Act. As of August 2019, CBD products in Canada could only be sold by authorized retailers or federally licensed medical companies, limiting their access to the general public. The Canadian government states that CBD products "are subject to all of the rules and requirements that apply to cannabis under the Cannabis Act and its regulations." It requires "a processing licence to manufacture products containing CBD for sale, no matter what the source of the CBD is, and that CBD and products containing CBD, such as cannabis oil, may only be sold by an authorized retailer or licensed seller of medical CBD.” Edible CBD products were scheduled to be permitted for sale inCanada on October 17, 2019 for human consumption.
As of August 2020, it is still illegal to carry cannabis and cannabis-derivedproducts (including products containing CBD) across the Canadian border. If one carries any amount of cannabis for any purpose (including medical), it need to be declared to the Canada Border Services Agency. Not declaring it is a serious criminal offence.
In 2019, the European Commission announced that CBD and other cannabinoids would be classified as "novel foods", meaningthat CBD products would require authorization under the EU Novel Food Regulation stating that because "this product was not used as a food or food ingredient before May 15, 1997, before it may be placed on the market in the EU as a food or food ingredient, a safety assessment under the Novel Food Regulation is required." The Recommendation – applying to CBD extracts, synthesized CBD, and all CBD products, including CBD oil – was scheduled for a final ruling by the European Commission in March 2019. If approved, manufacturers of CBD products would be required to conduct safety tests and prove safe consumption, indicating thatCBD products would not be eligible for legal commerce until at least 2021. In December 2020, the European Commission concluded that CBD should not be considered as drug and can be qualified as food.
Cannabidiol is listed in the EU Cosmetics Ingredient Database (CosIng). However, the listing of an ingredient, assigned with an INCI name,in CosIng does not mean it is to be used in cosmetic products or is approved for such use.
Several industrial hemp varieties can be legally cultivated in Western Europe.A variety such as "Fedora 17" has a cannabinoid profile consistently around 1%, with THC less than 0.3%.
In 2017, the government made changes to the regulations so that restrictions would be removed, which meant a doctor was able to prescribe cannabidiol to patients.
The passing of the Misuse of Drugs(Medicinal Cannabis) Amendment Act in December 2018means cannabidiol is no longer a controlled drug in New Zealand, but is a prescription medicine under the Medicines Act, with the restriction that"the tetrahydrocannabinols (THCs) and specified substances within the product must not exceed 2 percent of the total CBD, tetrahydrocannabinol (THC)and other specified substances.".
According to a document received in response to an appeal to the Ministry of Internal Affairs of the Russian Federation, measures of state control in the Russian Federation regarding CBD have not been established. However, there is also a response from the Ministry of Health of the Russian Federation indicating that CBD can be considered as an isomer of restricted THC.But in this case, the THC isomer is also, for example, progesterone,which is freely sold in pharmacies. On February 17, 2020,the deputy of the Moscow City Duma Darya Besedina sentan official request to the Prime Minister of the Russian Federation Mikhail Mishustin with a request to eliminate that legal ambiguity by publishing official explanations and, if necessary, making required changes in the corresponding government decree.
Cannabidiol Is classified as a medical product in Sweden. However, in July 2019, Supreme Court ofSweden ruled that CBD oil with any concentration of THC falls under the narcotic control laws.
While THC remains illegal, cannabidiol is not subject to the Swiss Narcotic Act Because this substance does not produce a comparable psychoactive effect. Cannabis Products containing less than 1% THC can be sold and purchased legally.
Cannabidiol,in an oral-mucosal spray formulation combined with Delta-9-tetrahydrocannabinol,is a product available (by prescription only until 2017) for the relief of severe spasticity due to multiple sclerosis (where other anti-spasmodics have not been effective).
Until2017, products containing cannabidiol marketed for medical purposes were classed as medicines by the UK regulatory body,the Medicines and Healthcare products Regulatory Agency (MHRA) and could not be marketed without regulatory approval for the medical claims. As of 2018, cannabis oil is legal to possess, buy, and sell in the UK, providing the product does not contain more than 1 milligram of THC and is not advertised as providing a medicinal benefit.
In January 2019, the UK Food Standards Agency indicated it would regard CBD products, includingCBD oil, as a novel food having no history of use before May 1997, and stated that such products must have authorisation and proven safety before being marketed. The deadline for companies with existing products to submit a full and validated novel food application with the FSA is 31 March 2021; failure to do so before this date will exclude those companies from selling CBD. New products containing CBDafter this deadline will require a fully approved application.
Cannabidiol is not scheduled under the Convention onPsychotropic Substances or any other UN drug treaties.In 2018, the World Health Organization recommended that CBD remain unscheduled.
As of October 2020, cannabidiol extracted from marijuana remains a Schedule I Controlled Substance, and is not approved as a prescription drug or dietary supplement or allowed for interstate commerce in the United States. CBD derived from hemp (with0.3% THC or lower) is legal to sell as a cosmetics ingredient, but cannot be sold under federal law as an ingredient in food, dietary supplement, or animal food. It is a common misconception that the legal ability to sell hemp (which may contain CBD) makes CBD legal.
In September 2018, following its approval by the FDA for rare types of childhood epilepsy, Epidiolex was rescheduled (by the Drug Enforcement Administration) asa Schedule V drug to allow for its prescription use. This allows GW Pharmaceuticals to sell Epidiolex, but it does not apply broadly and all other CBD-containing products remain Schedule I drugs. Epidiolex still requires rescheduling in some states before it can be prescribed in those states.
In 2013, a CNN program that featured Charlotte's Web Cannabis brought increased attention to the use of CBDin the treatment of seizure disorders. Since then, 16 states have passed laws to allow the use of CBD products with a physician's recommendation (instead of a prescription) for treatment of certain medical conditions. This is in addition to the 30 states that have passed comprehensive medical cannabis laws, which allow for the use of cannabis products with no restrictions on THC content.Of these 30 states, eight have legalized the use and sale of cannabis products without requirement for a physician's recommendation. As of October 2020, CBD was not an FDA-approved drug eligible for interstate commerce, and the FDA encouraged manufacturers to follow procedures for drug approval.
Some Manufacturers ship cannabidiol products nationally, an illegal action which the FDA did not enforce in 2018, with CBD remaining the subject of an FDA investigational new drug evaluation, and is not considered legal as a dietary supplement or food ingredient, as of October 2020. Federal illegality has made it difficult historically to conduct research on CBD. CBD is openly sold in head shops and health food stores in some states where such sales have not been explicitly legalized.
State and local governments may also regulate cannabidiol. For example, the Massachusetts Department of Agricultural Resources issued a rule in June 2019 aligning state CBD regulations with FDA regulations. This means that although recreational marijuana is legal in the state, CBD cannot legally be sold in food or as a dietary supplement under state law.
2018 Farm Bill and hemp
The 2014 Farm Bill legalize the sale of "non-viable hemp material" grown within states participating in the Hemp Pilot Program which defined hemp cannabis containing less than 0.3% of THC. Although the 2018 United StatesFarm Bill led some states to interpret the bill as enabling private farmers to grow hemp for extraction and retail of CBD, federal agencies – including the FDA and DEA –retained regulatory authority over hemp-derived CBD as a Schedule I Substance. By federal law, private enterprises developing hemp-derived CBD are obligated to cultivate hemp exclusively for industrial purposes, which involves the fiber and seed, but not the flowering tops which contain THC and CBD. Hemp CBD products may not be sold into general commerce, but rather are allowed only for research. The 2018 Farm Bill requires that research and development of CBD for a therapeutic purpose would have to be conducted under notification and reporting to the FDA.
FDA Warning letters
From 2015to December 2020, the FDA issued dozens of warning letters toAmerican manufacturers of CBD products for false advertising and illegal interstate marketing of CBD as an unapproved drug to treat diseases, such as cancer, osteoarthritis,symptoms of opioid withdrawal,Alzheimer's disease, and pet disorders.The FDA said that the letters were issued to enforce action against companies that were deceiving consumers by marketing illegal products for which there was insufficient evidence of safety and efficacy to treat diseases. In July 2019, the FDA stated: "Selling unapproved products with unsubstantiated therapeutic claims — such as claims that CBD products can treat serious diseases and conditions — can put patients and consumers at risk by leading them to put off important medical care. Additionally, there are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD."
In December 2020, the Federal Trade Commission (FTC) initiated a law enforcement crackdown on American companies marketing CBD products as unapproved drugs. The warning also applied to hemp CBD capsules and oil that were being marketed illegally while not adhering to the federal definition of a dietary supplement.