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 USA last 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)
