Released Cannabis Monograph
Established in 1995, the American Herbal Pharmacopoeia (AHP) is a non-profit 501(c)(3) California- based organization with a mission to promote the responsible use of herbal products and herbal medicines. The AHP produces critically reviewed documents called monographs that outline the quality control criteria needed for ensuring the identity, purity, and quality of botanical raw materials.
Each monograph also presents a complete and critical review of the traditional and scientific literature regarding the efficacy and safety of herbal medicines and includes information on specific products such as tinctures and extracts. In 2011, the AHP began the development of a Cannabis Monograph and a Therapeutic Compendium for Cannabis. The first edition of the Cannabis Monograph was released in 2013 and provides scientifically valid standards for companies engaged in laboratory analysis of cannabis, cannabis-derived products and hemp products with regards to:
- Ensuring the identity, quality, purity, and potency of cannabis, cannabis-derived and hemp products;
- Reporting, analytic equipment calibration and method validation;
- And, ensuring product safety by identifying safe levels of pesticides, metals, and microbial limits.
Cannabis Monograph Q&A
Since 1995, AHP has been developing standards of identity, purity, quality, and therapeutic and safety reviews for botanical ingredients. The overall goal of AHP is to promote the quality, safety, and integrity of herbal medicine.
The primary focus of all monographs is to provide testing standards that provide scientifically valid ways for ensuring the identity, purity, potency, and quality of botanical raw materials.
Every monograph contains a suite of identification and quality tests including botanical, macroscopic, microscopic, and chemical characterizations. Specific chemical tests will include thin layer chromatography, which can be used for identification purposes; and high performance liquid chromatography (HPLC) and gas chromatography (GC) used to quantify key cannabinoids. Additionally, the monograph will include guidance regarding pesticides, metals, and microbial limits and testing.
Multiple methods allow for a variety of stakeholders to employ scientifically valid techniques from ensuring identity, purity, and quality whether in the field, dispensary, a patient, product manufacturer, or regulator. Also, different techniques assess different things and so a multiple of tests is always better than simply employing one.
The selection of tests include are formal tests included in every pharmacopoeia (compendium of drug products) worldwide. The chemical tests included have been in use for more than 30 years. One set of tests comes from the peer –reviewed scientific literature and was used as part of the formal drug enforcement agency (DEA) program for testing Cannabis samples; another test is used as part of a United Nations program for drug evaluation.
There is never one technique or method that is best for all things all the time and technology is always changing. What is most important is to establish methodologies that give reproducible and consistent results, which these methods do. The monograph will establish a scientifically valid baseline of accurate reporting of analytical results. Thereafter, other methods can be compared against the AHP method.
Currently in the Cannabis analytical world, different analysts are using different technologies and methods and reporting their results, such as quantitation of THC, in different ways that are often not scientifically valid. They then use those analytical results to claim some level of superiority, such as higher THC values, which dispensaries and patients or product manufacturers use to influence buying decisions. However, every technology and method gives different results so the values being reported are not consistent and so buying choices are often made on inaccurate information. Adherence to a monograph standard ensures that results are consistent and findings are accurate.
The Therapeutic Compendium is a comprehensive review of the totality of the available medical literature for Cannabis. It includes historical and traditional herbal medicine experience along with a review of modern scientific literature encompassing indications, contraindications, side effects, dosing, preparations, safety, use in pregnancy, and interactions with conventional medications.
Most popular information is generated from inaccurate or imprecise extrapolations of the benefit or potential benefit of Cannabis as reflected in pharmacological research. Much of this research is exploratory and may not have any relevance to human clinical use. Additionally, reporting biases heavily influence many sources of information, popular and scientific. Pro-Cannabis reporting often exaggerate the potential benefits of the botanical, while anti-Cannabis reporting will often negate any potential benefit. The truth is usually somewhere in the middle. A key element of the AHP Therapeutic Compendium is that it will be reviewed by multi-disciplinary groups of reviewers representing herbal and naturopathic medicine on the traditional use side and medical doctors, pharmacists, pharmacologists and toxicologists on the science side. When completed the Therapeutic Compendium will represent one of the most comprehensive and balanced reviews of the totality of the Cannabis literature anywhere in the world.
The Standards of Identity, Quality, and Testing monograph will be released first, with a target time of fourth quarter 2013. We expect the Therapeutic Compendium can be released within 4–6 months after that.