There have been a lot of recent developments in legalising CBD, as the chemical science around the use of Marijuana has progressed. The developing science has shown that the obviously negative and dangerous mind-altering and hallucinatory effects of the plant extract can be separated from the medically beneficial effects by controlling the chemicals included in the preparations offered by manufacturers.
In the early 2010s, the big breakthrough was the recognition that by limiting the amount of THC, while allowing CBD in products a truly useful preparation would remain. In this way, all hallucinatory effects have been removed, and the rapid growth in the legal sale and use of therapeutic CBD has become possible throughout the USA and internationally.
The products promoted on this website comply with the 2014, US Farm Bill, which has paved the way for the current sales of all legal CBD based products, as offered here*.
In the following text (based upon a Wikipedia article) we outline how the legalisation of CBD products has progressed over the last 10 years or so. Now that an industry has grown up around providing the benefits of the supplement to a wide public, we can expect the pace of change toward greater legal clarity and open use of high-quality CBD to accelerate.
The challenge now will be for the CBD industry to bring in high-quality standards and force big improvements in the quality of all CBD products sold. If that is not achieved the CBD market will fail due to an inability of users to experience the benefits from products containing little or no CBD, despite claims to the contrary by unscrupulous manufacturers.
Sales of Food and Beverage Products Containing Cannabidiol
Food and beverage products containing cannabidiol were widely marketed in the United States as early as 2017. Hemp seed ingredients that do not naturally contain THC or CBD (but which may be contaminated with trace amounts on the outside during harvesting) were declared by the US Food and Drug Administration (FDA) as Generally recognized as safe (GRAS) in December 2018. CBD itself has not been declared GRAS, and under U.S. federal law is illegal to sell as a food, dietary supplement, or animal feed. State laws vary considerably as non-medical cannabis and derived products have been legalized in some jurisdictions in the 2010s.
Similar to energy drinks and protein bars which may contain vitamin or herbal additives, food and beverage items can be infused with CBD as an alternative means of ingesting the substance. In the United States, numerous products are marketed as containing CBD, but in reality, contain little or none. Some companies marketing CBD-infused food products with claims that are similar to the effects of prescription drugs have received warning letters from the Food and Drug Administration for making unsubstantiated health claims. In February 2019, the New York City Department of Health announced plans to fine restaurants that sell food or drinks containing CBD, beginning in October 2019.
World Anti-Doping Agency Removed CBD from its Banned Substances List
Cannabidiol has been used by professional and amateur athletes across disciplines and countries, with the World Anti-Doping Agency removing CBD from its banned substances list. The United States Anti-Doping Agency and United Kingdom-Anti-Doping Agency do not have anti-CBD policies, with the latter stating that “CBD is not currently listed on the World Anti-Doping Agency Prohibited List.
As a result, it is permitted to use in sport, though the intended benefits are unclear and not backed by clinical evidence. All other cannabinoids (including but not limited to cannabis, hashish, marijuana, and THC) are prohibited in-competition.
The intention of the regulations is to prohibit cannabinoids that activate the same receptors in the brain as activated by THC.” In 2019, the cannabis manufacturer, Canopy Growth, acquired majority ownership of BioSteel Sports Nutrition, which is developing CBD products under endorsement by numerous professional athletes. The National Hockey League Alumni Association began a project with Canopy Growth to determine if CBD or other cannabis products might improve neurological symptoms and quality of life in head-injured players. Numerous professional athletes use CBD, primarily for treating pain.
CBD as a Prescription Medicine
Prescription medicine (Schedule 4) for therapeutic use containing two percent (2.0%) or less of other cannabinoids commonly found in cannabis (such as ∆9-THC). A Schedule 4 drug under the SUSMP is a Prescription Only Medicine or Prescription Animal Remedy – Substances, the use or supply of which should be by or on the order of persons permitted by State or Territory legislation to prescribe and should be available from a pharmacist on prescription.
In June 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 60mg/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. Epidyolex was approved, for the adjunctive therapy of seizures associated with Lennox-Gastaut syndrome or with Dravet syndrome, on 18 September 2020, and added to the ARTG on 21 September 2020.
In 2020, 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.
The Legalisation of CBD Products in the US and Canada
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 in Canada on October 17, 2019, for human consumption.
As of August 2020, it is still illegal to carry cannabis and cannabis-derived products (including products containing CBD) across the Canadian border. If one carries any amount of cannabis for any purpose (including medical), it needs to be declared to the Canada Border Services Agency. Not declaring it is a serious criminal offence.
The Legalisation of CBD Products in Europe
In 2019, the European Commission announced that CBD and other cannabinoids would be classified as “novel foods”, meaning that 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 that CBD 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 a 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 Legalisation of CBD Products in New Zealand
The passing of the Misuse of Drugs (Medicinal Cannabis) Amendment Act in December 2018 means 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”.
The Legalisation of CBD Products in Sweden
Cannabidiol is classified as a medical product in Sweden. However, in July 2019, the Supreme Court of Sweden 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 Acts 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).
The Legalisation of CBD Products in the UK
Until 2017, 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, including CBD 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 foods 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 CBD after this deadline will require a fully approved application.
CBD Classification in UN Drug Treaties
Cannabidiol is not scheduled under the Convention on Psychotropic Substances or any other UN drug treaties. In 2018, the World Health Organization recommended that CBD remain unscheduled.
As of March 2020[update], 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 (with 0.3% 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) as a 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 CBD in 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 March 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 March 2020[update]. 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.
In November 2019, the FDA issued concerns about the safety of cannabidiol, stating that CBD use has potential to cause liver injury, interfere with the mechanisms of prescription drugs, produce gastrointestinal disorders, or affect alertness and mood. In March 2020, the FDA updated its safety concerns about CBD, acknowledging the unknown effects of protracted use, how it affects the developing brain, fetus or infants during breastfeeding, whether it interacts with dietary supplements or prescription drugs, whether male fertility is affected, and its possible side effects, such as drowsiness.
In February 2020, the UK FSA advised vulnerable people, such as pregnant women, breastfeeding mothers, and those already taking medication for other medical concerns not to take CBD. The FSA further recommended that healthy adults should not consume more than 70 mg CBD per day.
A 2017 analysis of cannabidiol content in oil, tincture or liquid vape products purchased online in the United States showed that 69% were mislabeled, with 43% having higher and 26% having lower content than stated on product labels.
As of September 2019, 1,085 people contacted US Poison Control Centers about CBD-induced illnesses, doubling the number of cases over the 2018 rate and increasing by 9 times the case numbers of 2017. Of cases reported in 2019, more than 33% received medical attention and 46 people were admitted to a hospital intensive care unit.
2014 and the US Farm Bill
The 2014 Farm Bill legalized the sale of “non-viable hemp material” grown within states participating in the Hemp Pilot Program which defined hemp as cannabis containing less than 0.3% of THC. Although the 2018 United States Farm 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 involve 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.
Legalising CBD Sadly Now Synonymous with False Advertising and Illegal Interstate Marketing
From 2015 to November 2019, the FDA issued dozens of warning letters to American 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 October 2019, the FDA and the Federal Trade Commission (FTC) announced a joint warning to a Florida supplements company marketing CBD products as unapproved drugs to treat childhood autism, attention-deficit hyperactivity disorder, Parkinson's disease, Alzheimer's disease, acne, and infant teething and earaches. 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. Additionally, Idaho, Nebraska, and South Dakota are the only three states as of January 7, 2020, to ban the use of CBD in any form or capacity.
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