Cannabis Newsletter – February 2023

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PERU: NEW REGULATIONS

Supreme Decree No. 004-2023-SA approved a new regulation on cannabis for medicinal use that provides new opportunities for those interested in this market.

This approved regulation repeals the previous regulation and enters into force within six (6) months.

Some of the main points are:

Licenses

• The licenses for cannabis activities (psychoactive and non-psychoactive) are maintained, which are research, production, importation, commercialization of cannabis and its derivatives, and artisanal production of cannabis derivatives with associative cultivation.
• Licenses that have been obtained under the provisions of the Regulation approved by Supreme Decree No. 005-2019-SA, must be adapted to the provisions mentioned in the new regulation.
• The rule establishes conditions for the modification of production licenses with or without cannabis cultivation and security protocols.

Commercialization and production

• The commercialization of cannabis seeds produced in the country is allowed to those who have a license for the production of cannabis derivatives with cultivation.
• Pharmaceutical laboratories engaged only in conditioning and reconditioning are licensed for production that does not include cultivation.
• For the importation of cannabis, cannabis derivatives whose content is predominantly cannabidiol and less than 1% of tetrahydrocannabinol (non-psychoactive Cannabis), the DIGEMID issues a document of no objection for importation, a requirement for customs clearance.

Use

Medical prescriptions for the use of cannabis and its derivatives for medicinal and therapeutic purposes are included in the benefits financed by the Essential Health Insurance Plan (PEAS) and its complementary plans.

https://busquedas.elperuano.pe/download/url/decreto-supremo-que-aprueba-el-reglamento-que-regula-el-uso-decreto-supremo-n-004-2023-sa-2155611-1

COLOMBIA: FOODS WITH CANNABIS APPROVED BY INVIMA

The National Institute for Drug and Food Surveillance (INVIMA) has authorized the sanitary registration of four (4) foods and beverages with cannabis.

For this type of products the THC concentration allowed is less than 0.2%.

https://www.invima.gov.co/web/guest/cuatro-productos-entre-alimentos-y-bebidas-a-base-de-cannabis-ya-cuentan-con-registro-sanitario-invima?redirect=%2F

COLOMBIA: COSMETICS WITH CANNABIS

The National Institute for Drug and Food Surveillance (INVIMA) of Colombia has issued External Circular No. 1000-001-23 informing about the additional requirements for obtaining Mandatory Health Notifications (NSO) for cosmetics containing cannabis.

In addition to compliance with Decision No. 833, it must demonstrate that the THC content is less than 0.2%, report the concentration of the cannabis-derived ingredient in the formulation and its certificate of analysis, among other requirements.

https://www.invima.gov.co/documents/20143/2624625/CIRCULAR+EXTERNA+%282%29.pdf

USA: CANNABIDIOL

According to a communication posted on its website, the FDA has stated that the current regulatory framework for food is not appropriate for regulating the use of CBD. The FDA has indicated that it will work in collaboration with the U.S. Congress to develop an interagency strategy that will allow for the proper regulation of these products.

https://www.fda.gov/news-events/press-announcements/fda-concludes-existing-regulatory-frameworks-foods-and-supplements-are-not-appropriate-cannabidiol

https://www.fda.gov/food/cfsan-constituent-updates/fda-issues-response-three-citizen-petitions-related-cbd-and-dietary-supplements