The Ministry of Health and Wellness has sent out a release stating that it has not approved Psilocybin Mushroom containing products for use on the Jamaican market.
According to Chief Medical Officer, Dr Jacquiline Bisasor McKenzie, “It is never the intention of the ministry to erect a barrier to access to healthcare products.
However, the ministry must ensure that any product offered to the public for use must meet the establishedstandards within the respective legislative framework.”
“The Standards and Regulation Division (SRD) of the Ministry of Health and Wellness has the authority under the Food & Drugs Act 1964 (FDA) and the corresponding Regulation of 1975 (FDR) to regulate healthcare products including psilocybin containing products.
Further, Jamaica is signature to the 1971 Psychotropic Convention and is required to regulate thepsilocybin / psilocin moiety as a controlled substance,” added the CMO
Medicinal preparations made from the psilocybin containing mushroom, whether in its natural state or by processing, that are intended for treatment (relief of depression/ menstrual pain), are consequently and automatically regulated as a “drug” by the Minister of Health and Wellness under the FDA and FDR as they satisfy the definition of a drug under the FDA, Section 2, which states the following:
“Drugs” means any substance or mixture of substances manufactured, sold or represented for use in – (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state or the symptoms thereof in man or animal; (b) restoring, correcting or modifying organic functions in man oranimal;
Acting Chief Technical Director, Standards & Regulation, Cynthia Lewis Graham also noted that “under the jurisdiction of the Minister of Health & Wellness, a drug is to be licensed (registered), subject to strict assessment of efficacy, safety and quality by the Standards and Regulations Division with core functions to assess and evaluate drugs for the safe use by the public and be permitted for use, importation and trade.
Further Regulation 40 (1) of the FDR states that: A person shall not manufacture, import or distribute a drugunless – (a) that drug has been registered with the Ministry of Health.”
The public is advised that this drug and its byproducts can be dangerous to one’s health.
