Personalized medicine: Certificates of analysis for cannabis
In recent years, the cannabis industry has presented multiple and significant advances at a global level. One of the sectors with the greatest development has been personalized medicine. At ICAN we know that Mexico already has products such as CBD or hemp oils and drops. Do you have any doubts about this? In this blog we explain how to interpret some documents to know the authenticity of these products.
Well-regulated markets offer security and reliability to consumers, who can access products without the worry of not having the necessary requirements endorsed by the responsible authorities. In turn, a market that complies with the respective regulations (primarily sanitary) allows users to have access to truthful, clear, verified and updated information.
As we have reported in several articles, each country has authorities responsible for certifying the origin and components of goods. This allows consumers to be alerted when a product does not meet regulatory criteria. The guardianship and certification is mandatory for the various sectors involved in the cultivation, manufacture, distribution and marketing of cannabis: from agriculture to textiles and pharmaceuticals.
While the accelerated development has highlighted the potential of the cannabis industry the cannabis industryThe risks should not be underestimated, especially when there is no comprehensive, explicit regulation that is known to most of us. In the specific case of our country, the delay in the issuance of the regulation has favored the growth and strengthening of the illicit market.
In 2019, Mexican authorities warned that some brands were marketing CBD products without a health registration. These companies designed marketing dynamics in social networks, chat rooms and home sales platforms. In addition to the advertising violations, the seriousness of these activities lies in the fact that there is a high probability that these goods have been smuggled across the northern border or that they have been produced in the country with low-quality production techniques. In other words: The content of the products could be highly harmful to the consumer. [1, 2] If you are interested in going deeper into this topic, we suggest you to review in more detail our blog dedicated to the pyramid schemes.
It is very important to measure and propose solutions, because in addition to violating the right to health, the black market has negative effects on our right to information. For this reason, we offer you a series of tools and strategies that can be very useful for health professionals who are interested in personalized medicine and treatments based on medical cannabis.
The first thing you should know: Consumers are subjects of law.
Not all cannabis products found in the country are apocryphal. Although the production of cannabis is not allowed within the national territory, there are companies specialized in importing the raw material. Personalized medicine is a practice that can provide functional alternatives with CBD.
According to the Federal Consumer Protection Law: Consumers have the following rights:
Right to information: all information on the good or service must be timely, complete, clear and truthful.
Right to education: consumers must know their rights and how the law protects them in order to learn how to consume better and more intelligently.
Right to safety and quality: the good or service must comply with safety and quality standards and regulations.
Requires Certificate of Analysis
Companies dedicated to the preservation and improvement of health have a social commitment. Suppliers are obliged to provide access to the Certificate of Analysis ( COA ) . This document must be issued by the responsible official authority or by an authorized private laboratory. In this regard, the Ministry of Foreign Affairs (SRE) stipulates: [5].
"A certificate of analysis is the document that certifies the content of a product or raw materials, where the results of the analyses carried out on the materials are noted.
#FriendlyReminder: In the particular case of cannabis, laboratories are located abroad and must be certified by experts in the analysis of the plant.
How to read a certificate of analysis: Checklist in seven basic facts
As a consumer you should pay attention to the following data:
Customer data.
2. Type of sample, lot number and date of analysis.
3. Summary sheet of the analyzed product:
4. Analysis of cannabinoids.
5. Analysis of pesticides and heavy metals.
6. Microbiological analysis.
7. Certification and verification code.
The batch number, date and customer data (1 and 2) is information that will allow the consumer to corroborate that the raw material with which the formula was prepared corresponds to what is reported by the CA. Additionally, the invoice may be required to validate that it is the same purchase.
The product summary sheet (3) groups data such as sample type and main properties of the sample. The type of sample (whether it is resin, oil, ointment or drops; whether it has CBD or THC) and physicochemical characteristics are highlighted.
In the analysis of cannabinoids (4) shows a list of the cannabinoids analyzed, as well as the amounts found in the sample. The abbreviations vary according to the laboratory. We suggest you look up their meaning.
Some products that - in their labeling - advertise to be CBD drops may not contain CBD or may be below the indicated amount, or may contain CBD but also THC. There is a risk that these products exceed the allowed values (usually between 0.3 and 1 %) and cause unwanted psychotropic effects.
At a minimum, all cannabis-derived products must have the above-mentioned points (1 to 4), plus the verification code and certification (7). Ideally, they should also have pesticide, heavy metal and microbiological analyses (5 and 6) to determine that they are safe for consumption.
Don't forget: When laboratories did not perform one or more tests, you will find the abbreviation NT or the words "Not tested".
In the analysis of pesticides and heavy metals (5) the different components and their range of presence in the substance are listed. It is preferable that the analyzed sample does not contain these substances, but if it does, they should not exceed the reference values indicated by the laboratory, otherwise there is a risk of intoxication and cancer. The latter depends on the amount ingested, the time of consumption and the sensitivity of the person. In very severe cases, excessive intake of pesticides and heavy metals can cause death. [6,7]
Microbiological analysis (6) provides information on a number of bacteria, fungi and toxins that could be found in the product and, through consumption, lead to disease.
Finally, we find the verification code, the signature of the person in charge, the slogan and the seal of the company specialized in cannabis analysis that certified the laboratory (7). The code is usually a QR code that can be scanned to access a web page with the summary of the analysis.
At ICAN we are aware that many patients require cannabis-based medicines, so part of our commitment is to provide tools to make more informed decisions regarding cannabis products on the market.
References
[1] Sánchez, A. (20 de septiembre de 2019). Venden cannabidiol de forma ilegal. Reforma. Recuperado de <sitio web>, última consulta el 24 de febrero de 2020.
[2] González, L. (2019). Cofepris revoca lineamientos para comercializar derivados de cannabis. El Economista. Recuperado de <sitio web>, última consulta el 25 de febrero de 2020.
[4] Ley Federal de Protección al Consumidor (24 de diciembre de 1992). Diario Oficial de la Federación, México. Recuperada de <pdf>, última consulta el 6 de marzo de 2020.
[5] SRE. (s.f.). Visado a certificado de análisis. Recuperado de <sitio web>, última consulta el 6 de marzo de 2020.
[6] Luna Saucedo, B.E., Rodríguez Rodríguez, A.C., Quevedo Alvarez, O. Cabrera Rabí, L. (2007). Determinación de Metales Pesados en un Suplemento Nutricional de Origen Natural con Propiedades Antioxidantes. Lat. Am. J. Pharm. 26 (5): 760-4. Recuperado de <sitio web>, última consulta 6 de marzo 2020.
[7] Doménech, J. (2004). Plaguicidas. Offarm. 23(7), 108-114. Recuperado de <sitio web>, última consulta el 6 de marzo 2020.
[8] Cerra, H., Fernández, M.C., Horak, C., Lagomarsino, M., Torno, G., Zarankin, E. (2013). MANUAL DE MICROBIOLOGÍA APLICADA A LAS INDUSTRIAS FARMACÉUTICA, COSMÉTICA Y DE PRODUCTOS MÉDICOS. Recuperado de <sitio web>, última consulta el 6 de marzo 2020.
[9] Gómez Ayala, A. E. (2007) Alimentos y micotoxinas. Farmacia Profesional, 21(8), 49-53. Recuperado de <Sitio web>, última consulta el 6 de marzo 2020.
