In the presence of other people, he often felt uncomfortable and physically tense, according to a post by a user who calls himself Peter500. To change this, he bought cannabidiol (CBD) oil, dripped one to three drops a day under his tongue, and felt better after 15 to 30 minutes. In other words: more relaxed. “The difference was like day and night,” reports the young man on the website of a well-known drugstore, “I can only advise anyone suffering from social anxiety to try CBD once in a while.” Other consumers are no less euphoric about the oil.
CBD is a substance of the hemp plant Cannabis Sativa L. It can be bought not only in the form of oils and tablets but also as chewing gum, chocolate and gummy bears. The Handelsblatt reports that even the Coca-Cola Group is already thinking about recipes with the hemp substance.
In the United States, the restaurant sector has also started to surf the CBD wave. West Coast Ventures Group Corp. (OTC: WCVC) is America’s first CBD restaurant stock, and their flagship Illegal Burger franchise is experiencing continuous growth. In their first year of operations alone in 2018, the company recorded a revenue of $3,054.623 and it is set to grow even higher. In the first quarter of 2019, the revenue growth has risen by 21.55 percent and is expected to top that in the second quarter. In other words, the CBD business is booming.
In Germany, more and more people are asking about the effects of CBD at the Independent Patient Advice Centre (UPD) and are hoping that the substance will have “spectacular effects,” reports Johannes Schenkel, Medical Director of UPD.
But is the substance really such a miracle cure? Are there any problematic side effects—and is the purchase of CBD dietary supplements legal at all? The fact is that the supervising authorities of some countries cannot check all the products currently available on the market, and the legal situation is complicated.
CBD is prescription-only as a medicine
In fact, a comprehensive review by the World Health Organization (WHO) in 2018 confirms that CBD has many therapeutic properties that could help treat epilepsy, dizziness, insomnia and anxiety. “CBD acts via various receptors or other biological mechanisms in the human body and can thus influence our metabolism and our immune system,” explains pharmacologist Gerd Glaeske of the University of Bremen, who is also a member of the MedWatch advisory board.
In the USA, the U.S. Food and Drug Administration (FDA) has approved the CBD-containing drug Epidiolex from GW Pharmaceutical 2017 for the treatment of children with Dravet and Lennox-Gastaut syndrome, two severe forms of epilepsy. Pharmaceutical companies such as Zynerba Pharmaceuticals or Echo Pharmaceuticals are also currently trying to develop drugs with CBD. According to the WHO, CBD, unlike tetrahydrocannabinol (THC), which is also found in hemp, is neither “high” nor addictive.
That sounds promising. Nevertheless, it should not be forgotten that CBD research is still in its infancy. A study conducted by King’s College in London in 2018 showed that people with schizophrenia who took 1,000 milligrams of CBD in addition to their standard medication had fewer hallucinations and thoughts of suicide than the comparison group who received only a placebo. However, a study by Yale University in the U.S., where patients with schizophrenia received a slightly lower dose of 600 milligrams per day, found no improvement in symptoms.
Many CBD studies are also based on animal models or cell cultures, the results of which are not easily transferable to humans. Further clinical trials in humans are therefore needed to check whether CBD helps against anxiety, sleep disorders and mental illness—and in what specific dosage. People like Peter500, who have the feeling that the substance helps them to overcome their social fears, could therefore also be subjectively experiencing the placebo effect, says Glaeske.
Of course, an “imaginary effect” would not be harmful—and indeed, according to the WHO review, CBD seems to be relatively well-tolerated. Interactions with other medications or drugs, however, are not excluded. In Germany, the Committee of Experts on Prescription Obligations (Sachverständigen-Ausschuss für Presprespflicht) has therefore already spoken out in 2015 in favor of making CBD subject to prescription obligation. According to the committee, CBD is to be regarded as a substance “which, if used without medical supervision, could directly or indirectly endanger human health, even if used as directed.” Since October 2016, the substance has therefore been officially included in the Ordinance on the Prescription of Medicinal Products (AMVV). This means that CBD is only available on prescription as a medicinal product.
Is the sale of “novel” CBD-containing food legal?
But why are drugstores or online shops allowed to sell CBDs in the form of oils and chocolate without the substance having been precisely researched?
For one, “The prescription requirement,” explains Annekathrin Schrödl from UPD, “only applies to drugs that have already been approved.” The sale of CBD medicines outside the pharmacy is therefore punishable by law. However, the oils, chocolate bars and chewing gums with CBD currently on the market are usually marketed by manufacturers as foods or dietary supplements. The decision as to whether these are marketable is decided by the countries governing them, who also decide whether CBD preparation is to be classified under food or medicine.
Moreover, the basic requirement that food containing hemp may be sold in countries like Germany for example is that, according to the Narcotics Law, the processed cannabis plants originate from the cultivation of a country of the European Union (EU) with certified seeds, and that their THC content does not exceed the limit of 0.2 percent.
According to the Novel Food Regulation of the European Union, foods containing CBD are also regarded as so-called “novel foods.” Before they are approved for sale, the European Food Safety Authority (EFSA) must check their safety. The regulation defines “novel” as all foods that were not used for “human consumption” in the EU on a “significant scale” before May 15, 1997. Foods which are derived from hemp and therefore naturally contain CBD and which were frequently sold and consumed in EU countries before the deadline are excluded from this rule. These include hemp seeds, hemp seed oil, hemp seed meal, and fat-free hemp seed protein.
However, producers and sellers seem to ignore the fact that EFSA approval is required for the sale of CBD-enriched foods. According to the Federal Office of Consumer Protection and Food Safety (BVL), not a single manufacturer has filed an application for approval. According to the BVL, CBD foods are therefore not marketable in Germany.
This is an assessment that is actually shared by the competent supervisory authorities of the Länder. The consumer protection ministry of Schleswig-Holstein, for example, has already “informed the local authorities responsible for food monitoring that CBD-containing products are not marketable and asked them to carry out appropriate inspections,” reports press spokesman Oliver Breuer on request.
In Saxony-Anhalt, individual foodstuffs were tested with CBD. In some cases, the products were taken from the market, since the responsible authorities classified the samples as medications. In other cases, proceedings were still ongoing.
In Munich, in the Ebersberg and Dachau districts and Baden-Württemberg, the police also searched 17 shops selling CBD products. The operators must answer now before the court. Elsewhere the substance is not under special observation. There are currently no known sales activities or consumer complaints about such products—checks have therefore not yet taken place.
Food monitoring does not function sufficiently
And this is precisely the problem: supervisory authorities cannot test every product currently on the market. The investigations are “random” and “risk-oriented.” For the food authorities to inspect a product, there must therefore be a suspicion that it poses an acute risk to the health of consumers. If there is no such suspicion, the decision is obviously made by chance. In addition, there is no central authority responsible for food monitoring in the federal states; instead, there is an institution responsible for this task in almost all administrative districts and cities.
In the federal state of Hesse, for example, 26 authorities in administrative districts and independent cities are responsible for inspection, and in the federal state of Berlin, almost every one of the 12 districts has its own veterinary and food supervisory authority. Health scientist Glaeske sees a consumer protection problem in this federal structure. The fact that each individual administrative district or each individual district sets its own priorities means that there is no uniform procedure. “The mere fact that so many food supplements containing CBD continue to be offered shows that food monitoring does not function sufficiently,” criticises Glaeske.
The fact that the control of CBD foods is not a top priority for the authorities is probably also due to the fact that there are no known cases in which their consumption would have severely endangered a person’s health.
As long as the CBD dietary supplements do not exceed the guideline value of 0.2 percent THC and are not combined with other drugs, their intake is probably not harmful to healthy people, confirms Glaeske. In terms of CBD, however, he is concerned with the legal classification of active substances—and in many cases, this is not complied with. Jörg Förster of the Saxon State Ministry for Social Affairs and Consumer Protection therefore points out that food companies are primarily responsible for the “safety and legal conformity of their products.”
Finding ways to sell CBD
However, companies seem to interpret the legal situation differently. Although the drugstore chain “dm” has stopped selling CBD oil at short notice, CBD products can currently be ordered in the online shop. Managing Director Sebastian Bayer simply says: “We decided to take the CBD oils off the market as a precaution. After a successful review, the company decided to resell products containing five percent CBD oil.” There was no answer to the question as to exactly what was investigated during the review.
The Veganz supermarket offers CBD in the form of chocolate. How can this be when there is no Novel Food approval? “As a precaution, our specialist department has now stopped the sale of the product,” MedWatch says in response to an initial enquiry. Together with the manufacturer, however, the company later came to the conclusion that the CBD chocolate violated “no food regulations.” According to the manufacturer, the CBD oil contained in the product comes mainly from hemp seed oil with a THC content of less than 0.2 percent—and according to the current assessment of the EFSA, this is legal. The product is now sold again by Veganz.
The operators of Nordicoil.de are also of the opinion that the products distributed by them do not fall under the Novel Food Regulation. The European Industrial Hemp Association (EIHA), which also represents them, is already taking legal action against the Federal Office of Consumer Protection and Food Safety (BVL). In a lawyer’s letter to the BVL, the organisation tries, among other things, to prove that CBD was already consumed before the deadline of May 15, 1997. In addition, it accuses the BVL of presenting the CBD in a factually and legally undifferentiated manner and points out that the “Novel Food” catalogue is merely a “non-binding guide.”
In its letter, the EIHA even sets April 26, 2019 as the deadline for the Federal Office to change the information on CBD provided on its website. The BVL obviously cannot understand the accusations—at least the information has not yet been changed. The BVL press office confirms that the “Novel Food” catalogue is “not legally binding.” However, the classification as a novel food was the result of coordination between the Member States and the European Commission, which is why it could be assumed that in the vast majority of cases the competent authorities in the Member States would also act in accordance with the Novel Food Catalogue—“after all, the respective wording in the Novel Food Catalogue was agreed between them.”
For health scientist Glaeske, this is a farce: instead of manufacturers of food supplements having their products checked, they went “the easy way and simply offer,” he criticises. “The monitoring authorities of the federal states are running behind.”
Many of the products contain too much THC
The situation is similar to the application for the products, for the control of which the Länder are also responsible. The online shop Herbano announces that its CBD oils could help against diseases such as acne, type 1 diabetes, multiple sclerosis and even cancer. However, disease-related advertising for food and dietary supplements is only permitted in Germany if it is approved under the so-called Health Claims Regulation. Such claims are published on a Union list. “For CBD, however, this is currently not the case,” reports Christiane Manthey of Verbraucherzentrale Baden-Württemberg. Advertising claims that the substance helps against diabetes and cancer not only lack any scientific evidence, they are also banned. When asked by Herbano why they nevertheless advertise their CBD products with such promises, no answer has yet been forthcoming.
Many of the food supplements offered on the Internet are also produced abroad and are not always dosed as the product description indicates. In order to find out how safe CBD products sold on the internet are, scientists analysed 84 CBD food and dietary supplements from 31 different companies. The result: a good two out of five products were underdosed and around one in four overdosed. In 18 cases, even a THC dose was found which could cause poisoning. Also in Bavaria, an online shop operator must answer before the court, because the CBD oil sold contained more THC than the law permits.
Susanne Weg-Remers of the Cancer Information Service (KID) advises patients to always discuss the use of CBD products with the treating physician and to have them be prescribed as medicines. This not only saves the 30 to 50 euros that some products cost, but also ensures that the product really contains the ingredients that are noted on the packaging.
(Featured image by DepositPhotos)
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