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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, update January 2017
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Introduction to cannabidiol (CBD)
inflammation: CBD is effective against staphylococci,
streptococci and even against clinically relevant MRSA
(Methicillin-resistant
Staphylococcus aureus; van Klingeren
Cannabidiol (CBD) is one of the non-psychotropic and
et al., 1976, Appendino et al., 2008).
non-intoxicating cannabinoids in industrial hemp. In
2016, 30,000 ha were cultivated in the European Union.
Equally important as CBD’s pharmacological effects are
The last couple of years have seen growing interest in CBD.
its health-maintaining properties (physiological effects) in
Cannabidiol not only has a plethora of beneficial health
lower doses. These include antioxidative, neuroprotective
effects, but it also has no relevant side effects, even when
and anti-inflammatory effects. For example, CBD is a
it is administered at high doses1.
neuroprotective antioxidant more potent than ascorbate
("Vitamin C“) or tocopherol ("Vitamin E“; Hampson et
CBD is the primary cannabinoid of industrial hemp,
al., 1998). As a cosmetic ingredient, CBD can be used to
present in concentrations ranging from 0.5 to 4 % in
decrease sebum / sebocytes (Oláh et al., 2014).
the upper third of the plant. Hemp extracts containing
CBD as well as isolated CBD can be utilized along with
A comprehensive review on the safety and side effects of
hemp fibres and shives, providing extra income to farmers.
CBD shows that even very high doses of CBD are safe and
Selling hemp extracts containing CBD generates additional
well tolerated without significant side effects. In a total of
income on top of income generated from hemp fibres and
132 reviewed publications, CBD did not induce catalepsy;
shives.
it did not affect factors such as heart rate, blood pressure,
body temperature, gastrointestinal transit, nor did it
CBD is increasingly used as a food supplement and in
alter psychomotor and cognitive functions (Bergamaschi
food supplement compositions, and as an ingredient
et al., 2011). Various clinical trials with a broad range of
in cosmetics, thereby generating new investments and
CBD doses have been performed since 2011. The studies
creating employment in the cultivation and processing
confirmed CBD’s effectiveness in the treatment of, for
of hemp and hemp-derived products. Pharmaceutical
instance, epilepsy and psychosis, and showed CBD’s better
products with CBD as an active ingredient have also been
tolerability and milder side effects compared to classical
developed. Another viable application of isolated CBD is
medication for these diseases (Iffland and Grotenhermen,
its use in electronic cigarette refills.
2016).
Many citizens in Europe are already profiting from CBD in
Legal situation – urgent need for
its manifold applications.
proper legislation
Benefits and side-effects of CBD
At the moment we see no or only a patchwork of CBD-
in different concentrations and
regulation. In contrast to tetrahydrocannabinol (THC),
applications
natural CBD is not psychotropic and non-intoxicating.
Therefore, it is just and reasonable that CBD is not covered
by the national narcotic acts or drug regulations of the 27
Numerous scientific studies proved CBD’s therapeutic
EU Member States (from 28 with the exception of Slovakia)
potential in a large number of diseases and symptoms. Just
and that CBD is not restricted by any EU legislation.
to name few: anxiety disorders (such as post-traumatic
However, regarding CBD-containing hemp extracts, the
stress disorder), obesity, epilepsy, dystonia, diabetes,
situation is not as clear as for CBD as a pure substance,
cancer, neurodermatitis and Alzheimer’s. Its antibacterial
because they could also contain THC, which is covered by
properties may be used to prevent infection and control
national narcotics acts in EU Member States.
__________
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.
1
The European Industrial Hemp Association (EIHA)
products without prescription or as food supplements
supports the development of a harmonized legislation in
(such as valerian or hop pills, silymarin, glucosamine or
this field, to make sure that consumers are protected, to
Gingko Biloba). Examples for medicinal products generally
sustain the industry’s current double-digit growth rate, to
exempt from prescription4 in lower doses are: aciclovir,
attract new investors and to boost product development.
almotriptan, beclometasone dipropionate, ibuprofen,
The legislation should avoid any restrictions for CBD and
colecalciferol, as well as omeprazole and pantoprazole.
clarify that extracts and preparations from industrial
hemp2 are not narcotics in the EU.
So the approach we propose here is already common
practice. Products – hemp extracts and tinctures in
The European Industrial Hemp Association (EIHA) is
particular – should preferably be standardised to a certain
strictly opposed to the attempts by a few pharmaceutical
CBD-concentration. Hemp extracts and tinctures with
companies to make CBD a prescription-only drug.
their natural CBD content shall not fall under Novel
This only serves the interest of a few companies while
Food framework, because CBD is a natural constituent
damaging the young CBD industry. Such legislation
in hemp food which has been used in Europe for 2,000
would also restrict the access to CBD for many citizens,
years. The European Commission stated on 18 December
who are already profiting from CBD in food and cosmetics.
1997 that food containing parts of the hemp crop is not
EIHA expects European and national authorities to not
considered “novel food”. In the same vein, hop extracts,
limit the use of CBD to only pharmaceuticals (medicinal
used for example for beer brewing instead of hop flowers,
products). There is also no reason to regulate the access
were never recognized as novel food.
to CBD too rigorously, because of the wide spectrum of
beneficial physiological effects of CBD and its favourable
A plethora of papers exist which show that substantial
safety profile.
pharmacological activity of CBD in clinical studies is not
observed under approx. 200 mg oral/d for an average adult.
For different doses and applications of CBD, EIHA proposes
These references also highlight, that starting from ca. 20
a three-tier regulation:
mg CBD per day to ca. 200 mg CBD exerts physiological
effects (Devinsky et al., 2014, dos Santos et al., 2014, Food
• At high doses, CBD can be a medicinal product and
Standards Australia P1042; Friedman et al., 2015; Hill et al.,
should be regulated as such.
2012, Iffland et al., 2016; Schubart et al., 2013.)
• At physiological doses CBD should be regarded as an
CBD products can contain traces of THC, the main
OTC-product (= over the counter) or a food supplement.
psychotropic cannabinoid of hemp. The THC level should
This approach is already applied for many substances,
be regulated, but not as strictly as for food, because of the
such as valerian, glucosamine, chondroitin(sulfate),
much lower daily intake of food supplements.
Ginkgo Biloba, some vitamins and iron products.
EIHA also urges the industry to not make any unwarranted
• Low CBD concentrations and doses should be allowed
health claims when using CBD-rich extracts or tinctures
in food products without any restrictions.
in food supplements.
• Additional aspects such as route of administration,
Low CBD concentrations allowed in food
indication area, maximum single / daily dose and pack
products
size can be used to further fine-tune the regulation.
The German BfArM3 already uses these aspects to
Low CBD concentrations (intake less than 20 mg/day for
differentiate and demarcate between prescription-only
the average adult) should be allowed in food products
and e.g. pharmacy-only substances.
without any restrictions.
CBD in high doses as a potential medicinal
Having no restrictions for CBD levels below 20 mg per
product with or without prescription
day, can be justified because studies as early as the one
by Belgrave and colleagues (1979), showed in a placebo-
Isolated, pure CBD and products with a high CBD
controlled, randomized, double-blind study that a single
concentration (intake more than 200 mg oral/day) for the
dose of 22.4 mg CBD per 70 kg body weight, did neither
average adult may be treated as medicinal products with
elicit psychomotor effects nor showed any interaction
or without prescription.
with concomitant alcohol administration.
CBD in medium doses should be available
CBD in other applications such as cosmetics
without prescription
Cannabidiol has been listed in CosIng with 4 functional
Products with a medium CBD concentration (intake 20 -
claims: “antioxidant, skin conditioning, skin protecting,
200 mg oral /day for the average adult) should be available
and antisebhorrhoeic” without any restrictions as per
in chemists and pharmacies either as (herbal) medicinal
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.
2
References and further literature on
Food Standards Australia New Zealand: Supporting Document 2,
pharmacological and physiological
Cannabidiol hazard profile – Proposal P1042, and cit.
effects of CBD
lit. (www.foodstandards.gov.au/code/proposals/Pages/
P1042LowTHChemp.aspx; accessed on January 10th,
2017).
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Antimicrobial activity of Cannabis sativa L. Chinese
Friedman, D., & Devinsky, O. (2015): Cannabinoids in the treatment
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