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EIHA CBD position paper October 2016

http://eiha.org/media/2016/10/16-10-26-EIHA-CBD-position-paper.pdf

Position paper of the European Industrial Hemp Association (EIHA) on: Reasonable regulation of cannabidiol (CBD) in food, cosmetics, as herbal natural medicine and as medicinal product Hürth (Germany), October 2016 Download this paper and further documents at: http://www.eiha.org Responsible under press legislation (V.i.S.d.P.): Michael Carus | EIHA co/ nova-Institut GmbH | Industriestraße 300 | 50354 Hürth | Germany | michael.carus@eiha.org | http://www.eiha.org Introduction to cannabidiol (CBD) Cannabidiol (CBD) is one of the non-psychotropic cannabinoids in industrial hemp. In 2016, 30,000 ha were cultivated in the European Union. The last couple of years have seen growing interest in CBD. Cannabidiol not only has a plethora of beneficial health effects, but it also has no relevant side effects, even when it is administered at high doses1 . CBD is the primary cannabinoid of industrial hemp, present in concentrations ranging from 0.5 to 4% in the upper third of the plant. Hemp extracts containing CBD as well as isolated CBD can be utilized along with hemp fibres and shives, providing extra income to farmers. Selling hemp extracts containing CBD generates additional income on top of income generated from hemp fibres and shives. CBD is increasingly used as a food supplement and in food supplement compositions, and as an ingredient in cosmetics, thereby generating new investments and creating employment in the cultivation and processing of hemp and hemp-derived products. Pharmaceutical products with CBD as an active ingredient have also been developed. Another viable application of isolated CBD is its use in electronic cigarette refills. Many citizens in Europe are already profiting from CBD in its manifold applications. Benefits and side-effects of CBD in different concentrations and applications Numerous scientific studies proved CBD’s therapeutic potential in a large number of diseases and symptoms. Just to name few: anxiety disorders (such as post-traumatic stress disorder), obesity, epilepsy, dystonia, diabetes, cancer, neurodermatitis and Alzheimer’s. Its antibacterial properties may be used to prevent infection and control inflammation: CBD is effective against staphylococci, streptococci and even against clinically relevant MRSA (Methicillin-resistant Staphylococcus aureus; van Klingeren et al., 1976, Appendino et al., 2008). Equally important as CBD’s pharmacological effects are its health-maintaining properties (physiological effects) in lower doses. These include antioxidative, neuroprotective and anti-inflammatory effects. For example, CBD is a neuroprotective antioxidant more potent than ascorbate (“Vitamin C“) or tocopherol (“Vitamin E“; Hampson et al., 1998). As a cosmetic ingredient, CBD can be used to decrease sebum / sebocytes (Oláh et al., 2014). A comprehensive review on the safety and side effects of CBD shows that even very high doses of CBD are safe and well tolerated without significant side effects. In a total of 132 reviewed publications, CBD did not induce catalepsy; it did not affect factors such as heart rate, blood pressure, body temperature, gastrointestinal transit, nor did it alter psychomotor and cognitive functions (Bergamaschi et al., 2011). Various clinical trials with a broad range of CBD doses have been performed since 2011. The studies confirmed CBD’s effectiveness in the treatment of, for instance, epilepsy and psychosis, and showed CBD’s better tolerability and milder side effects compared to classical medication for these diseases (Iffland and Grotenhermen, 2016). Legal situation – urgent need for proper legislation At the moment we see no or only a patchwork of CBDregulation. In contrast to tetrahydrocannabinol (THC), natural CBD is not psychotropic. Therefore, it is just and reasonable that CBD is not covered by the national narcotic acts or drug regulations of the 27 EU Member States (from 28 with the exception of Slovakia) and that CBD is not restricted by any EU legislation. However, regarding CBD- __________ 1 Information on toxicological effects: IVN-MUS LD50: 50 mg/kg; IVN-DOG LD50: >254 mg/kg; IVN-MKY LD50: 212 mg/kg; ORL-MKY TDL: 27 mg/kg; ORL-MUS TDL: 750 mg/kg. 2 containing hemp extracts, the situation is not as clear as for CBD as a pure substance, because they could also contain THC, which is covered by national narcotics acts in EU Member States. The European Industrial Hemp Association (EIHA) supports the development of a harmonized legislation in this field, to make sure that consumers are protected, to sustain the industry’s current double-digit growth rate, to attract new investors and to boost product development. The legislation should avoid any restrictions for CBD and clarify that extracts and preparations from industrial hemp2 are not narcotics in the EU. The European Industrial Hemp Association (EIHA) is strictly opposed to the attempts by a few pharmaceutical companies to make CBD a prescription-only drug. This only serves the interest of a few companies while damaging the young CBD industry. Such legislation would also restrict the access to CBD for many citizens, who are already profiting from CBD in food and cosmetics. It is EIHA‘s expectation that European and national authorities should not limit the use of CBD in pharmaceuticals (medicinal products) only. There is also no reason to regulate the access to CBD too rigorously, because of the wide spectrum of beneficial physiological effects of CBD and its favourable safety profile. For different doses and applications of CBD, EIHA proposes a three-tier regulation: • At high doses, CBD can be a medicinal product and should be regulated as such. • At physiological doses CBD should be regarded as an OTC-product (= over the counter) or a food supplement. This approach is already applied for many substances, such as valerian, glucosamine, chondroitin(sulfate), Ginkgo Biloba, some vitamins and iron products. • Low CBD concentrations and doses should be allowed in food products without any restrictions. • Additional aspects such as route of administration, indication area, maximum single / daily dose and pack size can be used to further fine-tune the regulation. The German BfArM3 already uses these aspects to differentiate and demarcate between prescription-only and e.g. pharmacy-only substances. CBD in high doses as a potential medicinal product with or without prescription Isolated, pure CBD and products with a high CBD concentration (intake more than 200 mg oral/day) for the average adult may be treated as medicinal products with or without prescription. CBD in medium doses should be available without prescription Products with a medium CBD concentration (intake 20 – 200 mg oral /day for the average adult) should be available in chemists and pharmacies either as (herbal) medicinal products without prescription or as food supplements (such as valerian or hop pills, silymarin, glucosamine or Gingko Biloba). Examples for medicinal products generally exempt from prescription4 in lower doses are: aciclovir, almotriptan, beclometasone dipropionate, ibuprofen, colecalciferol, as well as omeprazole and pantoprazole. So the approach we propose here is already common practice. Products – hemp extracts and tinctures in particular – should preferably be standardised to a certain CBD-concentration. The use of pure CBD in food supplements should also be investigated. Isolated CBD is in process of being enlisted in Novel Food Catalogue. Hemp extracts and tinctures with their natural CBD content shall not fall under Novel Food framework, because CBD is a natural constituent in hemp food which has been used in Europe for 2,000 years. The European Commission stated on 18 December 1997 that food containing parts of the hemp crop is not considered “novel food”. In the same vein, hop extracts, used for example for beer brewing instead of hop flowers, were never recognized as novel food. CBD products can contain traces of THC, the main psychotropic cannabinoid of hemp. The THC level should be regulated, but not as strictly as for food, because of the much lower daily intake of food supplements. Low CBD concentrations allowed in food products Low CBD concentrations (intake less than 20 mg/day for the average adult) should be allowed in food products without any restrictions. CBD in other applications such as cosmetics Cannabidiol has been listed in CosIng with 4 functional claims: “antioxidant, skin conditioning, skin protecting, and antisebhorrhoeic” without any restrictions as per Annex II/III of Regulation 1223/2009. __________ 2 Any cultivar listed in “Common Catalogue of Varieties of Agricultural Plant Species” as per Art. 10 of COMMISSION REGULATION (EC) No 1120/2009. 3 http://www.bfarm.de/DE/Arzneimittel/Pharmakovigilanz/Gremien/Verschreibungspflicht/antragVerkaufsabgrenzung.html, accessed on October 12th 2016. 4 Prescription requirement for medicinal products is up to the responsibility of national authorities in the EU and may differ from country to country. 3 References and further literature on pharmacological and physiological effects of CBD Ali, E. M., Almagboul, A. Z., Khogali, S. M., & Gergeir, U. M. (2012): Antimicrobial activity of Cannabis sativa L. Chinese Medicine, 3(1), 61. Appendino, G., Gibbons, S., Giana, A., Pagani, A., Grassi, G., Stavri, M., Smith, E. & Rahman, M. M. (2008): Antibacterial cannabinoids from Cannabis sativa: a structure-activity study. Journal of natural products, 71(8), 1427-1430. Bergamaschi, M. M., Queiroz, R. H. C., Zuardi, A. W. & Crippa, J. A. S. (2011): Safety and side effects of cannabidiol, a Cannabis sativa constituent. Current drug safety, 6(4), 237-249. Best, W. (2016): Personal communication, Wim Best, Inspectie voor de Gezondheidszorg (www.igz.nl). Booz, G. W. (2011): Cannabidiol as an emergent therapeutic strategy for lessening the impact of inflammation on oxidative stress. Free Radical Biology and Medicine, 51(5), 1054-1061. Borges, R. S., Batista, J., Viana, R. B., Baetas, A. C., Orestes, E., Andrade, M. A., Honorio, K. M. & da Silva, A. B. (2013): Understanding the molecular aspects of tetrahydrocannabinol and cannabidiol as antioxidants. Molecules, 18(10), 12663- 12674. Drysdale, A. J., Ryan, D., Pertwee, R. G., & Platt, B. (2006): Cannabidiolinduced intracellular Ca 2+ elevations in hippocampal cells. Neuropharmacology, 50(5), 621-631. Hampson, A. J., Grimaldi, M., Axelrod, J., & Wink, D. (1998): Cannabidiol and (-−) Δ9-tetrahydrocannabinol are neuroprotective antioxidants. Proceedings of the National Academy of Sciences, 95(14), 8268-8273. Iffland, K. & Grotenhermen, F. (2016): Safety and Side Effects of Cannabidiol – A review of clinical data and relevant animal studies on chronic CBD administration. NovaInstitute, Hürth (will be available online at the end of October). Oláh, A., Tóth, B. I., Borbíró, I., Sugawara, K., Szöllõsi, A. G., Czifra, G., Pál, B., Ambrus, L., Kloepper, J., Camera, Em., Ludovici, M., Picardo, M., Voets, T., Zouboulis, C. C., Paus, R. & Bíró, T. (2014): Cannabidiol exerts sebostatic and antiinflammatory effects on human sebocytes. The Journal of clinical investigation, 124(9), 3713-3724. Van Klingeren, B., & Ten Ham, M. (1976): Antibacterial activity of Δ9-tetrahydrocannabinol and cannabidiol. Antonie van Leeuwenhoek, 42(1-2), 9-12

 


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The European Industrial Hemp Association (EIHA) this week criticized “a few pharmaceutical companies” for leading a fight for legislation that would make CBD a prescription-only drug, on the heels of recent developments in Germany and the UK.

http://hemptoday.net/eiha-lashes-out-at-pharma-firms/

The European Industrial Hemp Association (EIHA) this week criticized “a few pharmaceutical companies” for leading a fight for legislation that would make CBD a prescription-only drug, on the heels of recent developments in Germany and the UK. The Association called for “urgent” action to overcome what it sees at present as “only a tenuous patchwork of CBD-regulation(s)” currently on the books.

While good for medical CBD players, the situation threatens current CBD companies promoting and selling low-content CBD products as food and health supplements.
“This only serves the interest of a few (pharmaceutical) companies while damaging the young CBD industry,” EIHA said in a statement, noting, “such legislation would also restrict the access to CBD for many citizens, who are already profiting (benefitting – ed.) from CBD in food and cosmetics.” British CBD vaporizer company MediPen and publicly-traded GW Pharmaceuticals have openly pushed for the medical designation on CBD, which is derived from low-THC hemp. GW is also based in the UK.

‘Favorable safety profile’

“It is EIHA’s expectation that European and national authorities should not limit the use of CBD (to) pharmaceuticals only,” the Association noted, adding “there is also no reason to regulate the access to CBD too rigorously, because of the wide spectrum of beneficial physiological effects of CBD and its favourable safety profile.” The developments in Europe threaten to set in motion an even wider cascade of blows to the nascent worldwide CBD industry that started with a clampdown in the USAlast year over what government regulators called dubious health claims being made by some CBD vendors.

The first warning sign in Europe came Oct. 1 in Germany, where an amendment to the federal Regulation on Prescription Medicines essentially designated basically all CBD-laced products as prescription-only without any consideration for dosages or administration methods. That amendment was based on an earlier recommendation by an expert group from Germany’s Federal Institute for Drugs and Medical Devices, according to EIHA.

Three-tier framework

CBD advocates have generally suggested a three-tier regulatory framework that places high doses of CBD in a medicinal, prescription-only category, but which frees CBD-laden products with lower percentages to be sold on the open market over the counter as food and health supplements. Such a three-level approach already governs such substances as Ginkgo Biloba and some vitamin and iron products, EIHA noted.

“Regrettably there was complete disregard (for) the fact that substantial pharmacological effects of orally administered CBD cannot be observed at dosages under approx. 200 mg per day for an average adult, and that CBD is very well tolerated even at much higher dosages,” EIHA said of the situation in Germany, underscoring the substance’s safety at all levels, and noting “the chance to benefit from the versatile beneficial health effects of CBD at different dosage regimes was missed.”

Missed opportunity

Three days later the UK government’s Medicines and Healthcare products Regulatory Agency (MHRA) released a “review” that found CBD has a “restoring, correcting or modifying” effect on certain “physiological functions” — essentially tagging it as a medicine requiring a prescription. MHRA then issued a raft of letters to UK CBD suppliers advising them that CBD is being designated as a medicine, and that sale of CBD products must stop as of Nov. 1, after which time suppliers will have to obtain either a “marketing authorisation” or a “traditional herbal registration” from the MHRA to sell the products.

Most of the UK CBD vendors who received letters from the MHRA have said they will cease trading, according to EIHA, but several of the largest CBD suppliers said they’ve yet to be notified and will continue their business until they receive notice of the regulatory changes. The UK Cannabis Trade Association (UKCTA) is to meet with MHRA Nov. 3, EIHA added.

The Association has drafted a full position paper, “Reasonable regulation of cannabidiol (CBD) in food, cosmetics, as herbal natural medicine and as a medicinal product” which it is asking CBD users to sign.

BACKGROUNDER: CBD (Cannabidiol) is one of the non-psychotropic cannabinoids in industrial hemp. In 2016, 30,000 ha were cultivated in the European Union. The last couple of years have seen growing interest in CBD. Cannabidiol not only has a plethora of beneficial health effects, but it also has no relevant side-effects, even when it is administered at high doses. CBD is increasingly used as a food supplement and in food supplement compositions, and as an ingredient in cosmetics, thereby generating new investments and creating employment in the cultivation and processing of hemp and hemp-derived products. Pharmaceutical products with CBD as an active ingredient have also been developed. (EIHA)


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The European Industrial Hemp Association (EIHA) published a position paper to overcome the patchwork of CBD-regulation in the European Union

http://news.bio-based.eu/urgent-need-for-a-reasonable-regulation-of-cannabidiol-cbd-in-food-cosmetics-as-herbal-natural-medicine-and-as-medicinal-product/
26 Oktober 2016

Urgent need for a reasonable regulation of cannabidiol (CBD) in food, cosmetics, as herbal natural medicine and as medicinal product

The European Industrial Hemp Association (EIHA) published a position paper to overcome the patchwork of CBD-regulation in the European Union

Cannabidiol (CBD) is one of the non-psychotropic cannabinoids in industrial hemp. In 2016, 30,000 ha were cultivated in the European Union. The last couple of years have seen growing interest in CBD. Cannabidiol not only has a plethora of beneficial health effects, but it also has no relevant side-effects, even when it is administered at high doses. CBD is increasingly used as a food supplement and in food supplement compositions, and as an ingredient in cosmetics, thereby generating new investments and creating employment in the cultivation and processing of hemp and hemp-derived products. Pharmaceutical products with CBD as an active ingredient have also been developed.

At the moment there is only a tenuous patchwork of CBD-regulation. Just two examples from the last weeks:

On the 4th October, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) started issuing letters to CBD suppliers advising them that CBD is being designated as a medicine and that sale of CBD products must stop within 28 days; effectively banning sale of CBD from the 1st November. The implication of these letters is that for CBD to be sold in future, suppliers will have to obtain either a ‘marketing authorisation’ or a ‘traditional herbal registration’ from the MHRA.  Most of the companies contacted by the MHRA have said they will cease trading, but several of the largest CBD suppliers have stated they have not received any letter from the MHRA and will continue their business until they receive notification of a change in law. The UK Cannabis Trade Association (UKCTA) has secured a meeting with MHRA on 3rd November.
In Germany, as of 1st October, 2016, CBD-containing medicinal products became prescription-only-medicines without any restriction as to dosages or administration routes. This was by an amendment to the Regulation on Prescription Medicines (“AMVV”), following a previous recommendation by an expert group of the Federal Institute for Drugs and Medical Devices (BfArM). Regrettably there was complete disregard to the fact that substantial pharmacological effects of orally administered CBD cannot be observed at dosages under approx. 200 mg per day for an average adult, and that CBD is very well tolerated even at much higher dosages. The chance to benefit from the versatile beneficial health effects of CBD at different dosage regimes was missed.
The European Industrial Hemp Association (EIHA) supports the development of a harmonized legislation in this field, to make sure that consumers are protected, to sustain the industry’s current double-digit growth rate, to attract new investors and to boost product development. The legislation should avoid any restrictions for CBD and clarify that extracts and preparations from industrial hemp are not narcotics in the EU.
The European Industrial Hemp Association (EIHA) is strictly opposed to the attempts by a few pharmaceutical companies to make CBD a prescription-only drug. This only serves the interest of a few companies while damaging the young CBD industry. Such legislation would also restrict the access to CBD for many citizens, who are already profiting from CBD in food and cosmetics. It is EIHA‘s expectation that European and national authorities should not limit the use of CBD in pharmaceuticals (medicinal products) only. There is also no reason to regulate the access to CBD too rigorously, because of the wide spectrum of beneficial physiological effects of CBD and its favourable safety profile.
For different doses and applications of CBD, EIHA proposes a three-tier regulation: At high doses, CBD can be a medicinal product and should be regulated as such. At physiological doses CBD should be regarded as an OTC-product (= over the counter) or a food supplement. This approach is already applied for many substances, such as valerian, glucosamine, chondroitin(sulfate), Ginkgo Biloba, some vitamins and iron products. Low CBD concentrations and doses should be allowed in food products without any restrictions.
Additional aspects such as route of administration, indication area, maximum single / daily dose and pack size can be used to further fine-tune the regulation. The German BfArM already uses these aspects to differentiate and demarcate between prescription-only and e.g. pharmacy-only substances.

The full position paper of the European Industrial Hemp Association (EIHA) on: “Reasonable regulation of cannabidiol (CBD) in food, cosmetics, as herbal natural medicine and as medicinal product” (October 2016) can be found, signed and supported here: www.eiha.org/cbd-support

EIHA asks all patients and citizen profiting from CBD products to sign the position paper.

Source: European Industrial Hemp Association, press release, 2016-10-27.


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CBD Oil – concentrated form of cannabidiol.

CBD Oil – What is it?

CBD Oil – What is it?

CBD Oil can be defined as a product with the concentrated form of cannabidiol. In the dietary world, it is popularly known as a supplement and a good source of nutrients. The product comes in various forms, including liquid oil, thick paste, sublingual sprays/drops, topical salves, candy/gum and vapor for e-cigarettes. There are a huge range of CBD oil benefits.

The oil is derived from Cannabidiol which is an active compound in cannabis. The compound is a major phytocannabinoid, forming 40% of the plant’s extract. CBD is quite different from another major compound of the same plant known as THC. It is non-psychoactive and offers a myriad of medical benefits. It is legal and safe for both young & adult persons.

CBD Oil has numerous therapeutic properties

According to the British Journal of Clinical Pharmacology, the oil can heal or ease a number of health conditions. It can fight inflammation, remove free radicals as an anti-oxidant and reduce nausea & prevent vomiting as an antiemetic product. It can also help with depression and psychotic conditions.

CDB Oil is a natural pain killer
Several studies show that the oil activates areas of brain that control synaptic transmission in painful parts of the body. It acts as a neuromodulator for many physiological processes, including pain sensation. According to rheumatologists, the oil can be used to reduce pain caused by arthritis. Its strong analgesic properties can make it a good option for many pain killers that cause adverse side effects.

CBD Oil is a natural neuroprotective agent
Many researches show that the oil acts a neuroprotective agent that can effectively prevent neurodegradation and reduce oxidative stress. It can also prevent a number of oxidation-associated diseases such as rheumatoid arthritis, gastric ulcer & Crohn’s disease. In addition, it can help with CNS disorders such as Parkinson’s disease and Alzheimer’s disease. Other researches confirm that the oil inhibits the production of glutamate and attenuates its toxicity. This means that it can protect brain cells and reduce the risk of ischemic.

CBD Oil is a great skin product
First, it inhibits the production of sebum and therefore can be used to keep acne in check. Second, it controls the formation of sebocytes which are types of sebaceous cells that secrete sebum. Third, it has antiproliferative effects which means that it can be used to control the spread of skin cancer and other types of malignant.

CBD Oil dosing
The dosage varies with the brand, cannabidiol concentration and disease to be treated. Some brands recommend too much serving while others recommend small doses. When it comes to concentration, oils with a high amount of the compound are available in small doses and vice versa. Concerning the disease to be treated, the dosage can be as small as 2.5 mg for up to 25 days for chronic pain or as high as 1,280 mg for up to 5 months for schizophrenia.

How to use CBD Oil
There are a number of ways that the oil is administered, with orally being the most common way. Other methods include taking it through the skin and via inhalers and vaporizers.

Side effects of CBD Oil
This cannabis product does not cause any major side effects. Some people may get minor digestive problems when using it while others may experience a dry sensation in the mouth. Other side effects include: susceptibility to bacterial infections and mild blood clotting problems.

 


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Cancer Patient Given 18 Months to Live is Cured by Cannabis Oil

October 21, 2016 David Hibbitt had been told he only had 18 months to live but now he’s looking forward to life with his new bride after being given the all clear. The 33-year-old, from Stoke-on-Tr…

Source: Cancer Patient Given 18 Months to Live is Cured by Cannabis Oil


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Cannabidiol

Cannabidiol is an ingredient of the hemp plant.

According to section 1 subsection 1 BtMG (Narcotics Act) narcotics are defined as all substances and preparations which are listed in Annexes I to III of the BtMG. Substances that are not listed in the Annexes are, as a result, not subject to the provisions of the BtMG.

Cannabidiol is not explicitly listed in the Narcotics Act (BtMG).

In contrast to the provisions of the AMG (Medicinal Products Act) on the prescription requirement, there is no catch-all definition which automatically includes new agents in the BtMG.

Thus, it is a fact that cannabidiol is not considered a narcotic so far. As a result, the provisions of the BtMG are not applicable.