76 percent of products anaylsed in a new study from Johns Hopkins Medicine contained concentrations of CBD that differed from what was stated on the label.
In a new study, Johns Hopkins Medicine researchers tested more than 100 topical cannabidiol (CBD) products available online and at retail stores, finding significant evidence of mislabelling CBD content.
The study also revealed that some of these nonprescription products contained amounts of THC, the main active ingredient in cannabis that can cause a “high,” including some products that claimed to be free of THC.
The study, published yesterday (20 July) in JAMA Network Open, also found that some of the CBD products made therapeutic claims not approved by the US Food and Drug Administration (FDA). To date, the FDA has only approved one prescription CBD product to treat seizures associated with rare epilepsy disorders and two prescription THC products for nausea and vomiting associated with chemotherapy and for loss of appetite and weight loss associated with HIV/AIDS.
“Misleading labels can result in people using poorly regulated and expensive CBD products instead of FDA-approved products that are established as safe and effective for a given health condition,” said study lead author Tory Spindle PhD, assistant professor of psychiatry and behavioural sciences at the Johns Hopkins University School of Medicine.
CBD and THC are the most commonly known compounds in the plant cannabis sativa. A key difference between the two is that THC can produce a psychoactive “high” effect at high doses, whereas CBD doesn’t.
Under the Agriculture Improvement Act of 2018 (the Farm Bill), CBD products that contain less than 0.3 percent of THC are not considered federally illegal substances.
This has made CBD products popular and widely available to consumers virtually anywhere in the country, but it also makes it difficult for the FDA to address unapproved claims and mislabelled CBD content.
However, Spindle noted: “Recent research has shown that people who use CBD products containing even small amounts of THC could potentially test positive for cannabis using a conventional drug test.” This has not been determined for topical CBD products, but the authors are currently studying it.
For the study, the research team purchased 105 CBD topical products — including lotions, creams and patches — online and at brick-and-mortar retail locations in Baltimore, Maryland, in July and August 2020.
Products were tested using a technology called gas chromatography-mass spectrometry to identify the actual amount of CBD and THC they contained.
Only 89 (85 percent) of the 105 tested products listed the total amount of CBD in milligrams on the label. Of the 89 products, 16 (18 percent) contained less CBD than advertised, 52 (58 percent) contained more CBD than advertised and 21 (24 percent) were accurately labelled.
On average, the in-store products contained 21 percent more CBD than advertised and the online products contained 10 percent more CBD than advertised, though CBD label accuracy varied widely across products.
THC was detected in 37 (35 percent) of the 105 products, though all were within the legal limit of 0.3 percent. Four of those 37 were labelled as “THC free,” 14 (38 percent) stated they contained less than 0.3 percent THC and 19 (51 percent) did not reference THC on the label.
Of the 105 products, 29 made a therapeutic claim, mostly about pain/inflammation, 15 made a cosmetic/beauty claim, such as alleviating wrinkles, and 49 noted they were not FDA approved.
The other 56 products made no reference to the FDA. “It’s important to note that the FDA has not approved CBD products to treat any of the conditions advertised on the products we tested,” said Spindle, who also is a faculty member at the Johns Hopkins Cannabis Science Laboratory.
“The variability in the chemical content and labelling found in our study highlights the need for better regulatory oversight of CBD products to ensure consumer safety,” said Ryan Vandrey PhD, professor of psychiatry and behavioural sciences at the Johns Hopkins University School of Medicine and the study’s senior author.C
Such regulation, the authors believe, would ensure CBD products meet established standards for quality assurance and prevent CBD mislabelling so consumers can make informed decisions about product selection and are not misled by unproven therapeutic or cosmetic claims.
The study authors also caution that people should check with their health care practitioner before starting any CBD regimen.
The research was supported by the Substance Abuse and Mental Health Services Administration (SAMHSA).
Panaxia to expand its Malta production plant with $6m investment
Panaxia’s investment in the country is a “milestone” for Malta’s medical cannabis industry, says Minister for the Environment, Energy and Enterprise.
Israel-based Panaxia is set to expand its medical cannabis production facility in Malta and will export its first products to Germany in the coming weeks.
Panaxia is set to deepen its connection with Malta as it plans a further expansion to its local production plant now the company has obtained its EU-GMP licence.
The company received an official license from the health authorities in Malta to manufacture finished medical cannabis products in May, 2022.
The news of Panaxia’s $6m (~£4.95m) investment was announced during a visit to Panaxia’s Ħal Far plant by Malta’s Minister for the Environment, Energy and Enterprise Miriam Dalli.
Panaxia aims to enrich the Maltese production portfolio with products aimed for both Europe and Latin American markets. To do this, its Malta facility will diversify into an array of products ranging from the production of tablets, oil and extracts, as well as carrying out clinical trials, stability experiments and research and development.
Minister Miriam Dalli described Panaxia as an early success story for one of Malta’s newest economic niches.
Minister Dalli commented: “Malta Enterprise has been in discussions with Panaxia since the early days after the enacted legislation in 2018. Today, Panaxia is only marking the start of its actual production, but it is already planning an expansion in its facilities.
“This is another milestone reached for our medical cannabis industry – an industry which further enriches our wider pharmaceutical sector. Malta is the ideal location for such operations, whereby specialised products are developed for the global healthcare supply chain.”
CEO of Panaxia, Dadi Segal, commented: “I am impressed with the role of Malta Enterprise in their support to our Malta team at Panaxia on various levels, not just the financial assistance but also the constant communication and facilitation.
“We had to build this facility from scratch and the process was long but soothed through Malta Enterprise’s constant guidance.”
Panaxia also operates from locations within the United States, Canada and South Africa, and is currently in the process of registering products in Portugal, Greece, Poland and Brazil amongst others. Its range of pharmaceutical products, over 60 in all, are mainly based on cannabis plant extracts and treat a variety of ailments including nausea, anxiety and depression.
Groundbreaking agreement to supply Czech patients with cannabis extracts
The agreement will enable Czech pharmacies to prepare personalised medicines for patients.
Prague-based pharmaceutical company, Motagon, will be the first company in the Czech Republic to supply medical cannabis extracts to patients.
Motagon has secured the agreement with Europe’s biggest indoor cannabis producer and one of the first cannabis extracts and formulations producers Phcann International.
Phcann International is an EU-GMP vertically integrated, multinational pharmaceutical cannabis company headquartered in Warsaw, Poland with an established footprint portfolio of countries like UK, Germany, Poland, Italy, Israel, Portugal, Australia and Brazil.
Through the agreement, Czech cannabis patients will now be able to access Motagon’s dried cannabis flowers and extracts to treat a number of health conditions including neuropathic pain, spasticity in multiple sclerosis, chronic pain, vomiting and nausea in the context of conventional cancer treatment, complex palliative care, or treatment of symptoms in neurological diseases such as Parkinson’s.
Additionally, Czech doctors are extended the option to work with an effective form of cannabis medicines, namely standardised extracts with more precise doses of CBD and THC cannabinoids.
With the extracts, pharmacies will be able to prepare personalised medicines for specific patients, including creams and gels for topical application, oils and capsules for oral consumption and rectal and vaginal suppositories.
Motagon’s chairman and executive director of Heaton, Motagon’s parent company, Jaromír Frič, commented: “We are extremely pleased that in a relatively short period of time we have managed to commence the import, sale and distribution of high-quality medical cannabis to pharmacies in the form of dried flowers, but our aim from the start was to offer more effective forms such as extracts to Czech patients as soon as possible.
“I believe that doctors and especially patients will appreciate this fundamental change, as well as the fact that there will be a broad extracts portfolio with a wide array of THC-CBD formulations, targeting a wider range of patients.
“I would also like to express my great appreciation to our team at Motagon who have successfully managed to comply with all the legislative requirements of the regulatory authorities.”
Motagon CEO Jan Mehner, has stated that the range of extracts on offer should cover the needs of the vast majority of cannabis patients in the Czech Republic:.
Mehner commented: “We plan to immediately introduce extracts with high THC content and a group of balanced THC-CBD extracts, allowing us to target patient populations that aren’t responding to treatments from existing traditional medicines.
“We’ll then broaden our portfolio (and patient base) to include high CBD and balanced products with a slight predominance of THC or, conversely, CBD.”
Phcann International CEO, Zlatko Keskovski, commented: “The agreement with Motagon will provide both companies with the first mover advantage in the Czech market where we will be able to set and implement the highest standards of quality and consistency that will meet expectations of the Czech patients.”
The first cannabis extracts are expected to be available in Czech pharmacies as early as September 2022.
Swiss CBD investment company secures £26.23m funding
Pharma Tech Holding has obtained a capital commitment agreement from LDA Capital.
Pharma Tech Holding SA has secured a CHf30m (£26.23m) investment from global investment group LDA Capital Ltd – with expertise in cross-border transactions including the agriculture, Agri-tech, and CBD industries – which will support its portfolio investments.
Pharma Tech Holding SA invests in innovative businesses with high technological value and scalability potential, mainly in Switzerland and Europe, with a focus on the health-tech, agri-tech, and functional food.
The CHf30m investment from LDA Capital will allow the company to invest and support its portfolio company Blue Sky Swisse SA, which focuses on the extraction of natural active principles from vegetable matrices, vegetable waste, and renewable sources to deliver B2B products under the form of CBD oil, terpenes and waxes.
The factory, located in Biasca, will be built with state of art of extraction technology using supercritical CO2, and will be self-sufficient through the use of solar photovoltaic panels and district heating.
CEO at Pharma Tech Holding, Sabina Del Nigro, commented: “We’re thrilled with this partnership and are so glad that LDA Capital recognises the value of Pharma Tech Holding and its portfolio company, with the aim of creating one of the most innovative hubs for health-tech, agri-tech and functional food.”
Blue Sky Swisse will make high-quality CBD due to a proprietary extraction process, starting from the farming, performed under strict control and culminating with the immediate freezing of the flowers after harvest.
It will also sell “all natural” formulations to increase bioavailability and will invest in the agricultural raw material chain, as well as creating an aeroponic greenhouse in Ticino, to deliver a high-quality GMP pharmaceutical CBD oil.
LDA Capital agreed to commit an amount of up to CHf30m in cash within a maximum of three years. This Capital Commitment will be released based on drawdowns by Pharma Tech Holding, which Pharma Tech Holding has the right to exercise at its sole discretion.