The Public Health Institute of Chile (ISP) issued a warning recently about CBD products offered for sale online without a required sanitary registration.
Many CBD products “suddenly disappeared” from the market after the ISP news release, local sources told Marijuana Business Daily.
In recent months, the gray market had expanded considerably, according MJBizDaily’s second edition of the Latin American report.
It seems Chilean health authorities are aware of the phenomenon and are trying to enforce the rules.
The recent development is a reminder for industry players on the importance of understanding local regulations, which are often restrictive, and communicating these challenges to investors.
Several firms have rushed to publicize business initiatives in Chile in recent years, sometimes predicting millions of patients, perhaps hoping that future regulations would allow the sale of unregistered cannabis products.
While medical cannabis is legal in Chile, it largely needs to follow the traditional pharmaceutical drug development and registration route.
This requires proving efficacy and safety of products – normally through clinical trials – and registering them. This is regardless of the THC content.
“Any product” with CBD “that currently does not have a health registration granted by this Institute is a counterfeit pharmaceutical product and its quality, safety and efficacy cannot be guaranteed to the population,” Juan Roldán of the Public Health Institute of Chile said in the press release.
According to the health authority, after a “rigorous” evaluation of CBD, the institute determined that because of its therapeutic properties – analgesic, anti-inflammatory, anticonvulsant are mentioned – products with the active ingredient must obtain a premarketing sanitary registration like any other medicine.
The health authority recognizes that – unlike CBD products – hemp seed oil can be sold as food.
MJBizDaily’s Latin American report detailed a few weeks ago that:
“The ISP has rejected attempts to register CBD products as food. Although pure CBD is not a controlled substance in Chile, it is considered a psychotropic compound used in a medicine, which means products that contain it must follow the standard pharmaceutical approval route.”
In the past, the health authority granted exceptional, temporary authorizations to commercialize nonregistered medicines, but none of these have been renewed.
As of today, the only registered cannabis that appears in the health authority database is GW Pharmaceuticals’ Sativex, a medicine manufactured in the United Kingdom and rarely sold in Chile due to its high price tag.
In addition, Chile allows the direct importation by patients of nonregistered medicines if they have a special authorization to do so – typically called compassionate use in the region.
But these products cannot be imported in bulk for further distribution.