Humic acid content of hemp oil blamed for ban. The undesirability of humic acid in CBD is well known, in particular with regard to vascular damage and a possible Alzheimer’s connection. Below is an abstract from Environmental and Molecular Mutagenesis journal followed by several other references:
Humic acid (HA) in well water is associated with Blackfoot disease and various cancers. Previously, we reported that acute humic acid exposure (25–200 µg/mL for 24 hr) induces inflammation in RAW264.7 macrophages. In this study, we observed that prolonged (72 hr) HA exposure (25–200 µg/mL) induces cell-cycle arrest and apoptosis in cultured RAW264.7 cells.
We also observed that exposing macrophages to HA arrests cells in the G2/M phase of the cell cycle by reducing cyclin A/B1, Cdc2, and Cdc25C levels. Treating macrophages with HA triggers a sequence of events characteristic of apoptotic cell death including loss of cell viability, morphological changes, internucleosomal DNA fragmentation, sub-G1 accumulation. Molecular markers of apoptosis associated with mitochondrial dysfunction were similarly observed, including cytochrome c release, caspase-3 or caspase-9 activation, and Bcl-2/Bax dysregulation.
In addition to the mitochondrial pathway, HA-induced apoptosis may also be mediated through the death receptor and ER stress pathways, as evidence by induction of Fas, caspase-8, caspase-4, and caspase-12 activity. HA also upregulates p53 expression and causes DNA damage as assessed by the comet assay. These findings yield new insight into the mechanisms by which HA exposure may trigger atherosclerosis through modulation of the macrophage-mediated immune system.
Environ. Mol. Mutagen. 55:741–750, 2014. © 2014 Wiley Periodicals, Inc.
Mechanism of the toxicity induced by natural humic acid on human vascular endothelial cells http://onlinelibrary.wiley.com/doi/10.1002/tox.21819/abstract
Humic Acid Increases Amyloid β-Induced Cytotoxicity by Induction of ER Stress in Human SK-N-MC Neuronal Cells https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4463654/
UK Medicinal CBD
Included below is the text from the announcement by the UK Medicines and Healthcare Regulatory Agency from earlier this month regarding the restriction of sale of medicinal CBD products in the UK. Hemp oil, CBD isolate, this seems to apply to them all.MHRA statement on products containing Cannabidiol (CBD)
From: Medicines and Healthcare products Regulatory Agency First published: 13 October 2016
The Medicines and Healthcare products Regulatory Agency has reviewed the classification of products containing CBD and found them to meet the definition of a medicinal product.
An MHRA spokesperson said:
We have come to the opinion that products containing cannabidiol (CBD) used for medical purposes are a medicine. Medicinal products must have a product licence (marketing authorisation) before they can be legally sold, supplied or advertised in the UK, unless exempt. Licensed medicinal products have to meet safety, quality and efficacy standards to protect public health.
If you use CBD and if you have any questions, speak to your GP or other healthcare professional.
We have written to UK CBD stockists and manufacturers to inform them of our view. We can provide regulatory guidance to any company who may wish to apply for a licence.
This opinion is restricted to products containing cannabidiol (CBD).
MHRA advised manufacturers and suppliers of CBD products that we were reviewing the regulatory status of CBD products prior to this opinion being issued.
The assessment of whether a product is classified as a ‘medicinal product’ is carried out in accordance with the definition of a medicinal product and is not based on whether the product is a risk to consumers. Once a valid application is made the product will be assessed in terms of its safety quality and efficacy in the medical claims made.
Unless exempt, medicines must have a product licence (marketing authorisation) before being placed on the market. Exempt products may be supplied as ‘specials’ by an appropriate prescriber. A ‘special’ can only be supplied in order to meet the special needs of an individual patient and may not be advertised. More information about the ‘specials’ process is available on our website.
MHRA have written to 18 companies to advise them of our opinion.
MHRA is responsible for regulating all medicines and medical devices in the UK. All our work is underpinned by robust and fact-based judgments to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The Agency is an executive agency of the Department of Health. www.mhra.gov.uk
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By George Bennet,