Regulatory evolution of medicinal Cannabis and the new legal framework for hemp in cosmetic and food applications in Peru

Maritza Reátegui
Estudio Rodrigo, Lima
Mreategui@estudiorodrigo.com

Cecilia Alarcón Galarza
Estudio Rodrigo, Lima
Calarcon@estudiorodrigo.com

Introduction

Peru has emerged as a dynamic market in Latin America for the regulation and commercialisation of medicinal cannabis and hemp-derived products. The country’s regulatory authorities have implemented progressive frameworks that support innovation, patient access and industrial development.

The enactment of Law No. 32195 in December 2024 marked a pivotal moment, establishing the legal basis for the agricultural and industrial use of non-psychoactive cannabis (hemp), with broad applications in cosmetics, food, textiles and construction.

Development of the Peruvian market in regard to marketing authorisation and compounding

Peru has made significant strides in regard to the regulation and commercialisation of medicinal cannabis, particularly through making use of the marketing authorisation pathways contemplated in its national regulatory framework. One of the most effective mechanisms involves the registration of cannabis-based products under the category of natural products, as permitted by the General Directorate of Medicines, 

Supplies and Drugs (Dirección General de Medicamentos, Insumos y Drogas or DIGEMID). The use of this pathway has enabled the commercialisation of cannabis derivatives without requiring full pharmaceutical registration, provided that such products comply with the country’s established safety, efficacy and quality standards.

In parallel, compounding practices have gained relevance, particularly in the context of therapeutic cannabis. These preparations are formulated by authorised pharmaceutical establishments pursuant to a medical prescription, tailored to the specific needs of individual patients. The regulatory flexibility surrounding compounding has fostered responsible medical use of use substances and has expanded the therapeutic options available, especially for patients with chronic conditions.

Up-to-date information available on DIGEMID’s official website indicates that, as of mid-2025, 27 marketing authorisations have been granted for cannabis-related products in Peru. Of these, four correspond to medicines, while 23 are registered under the category of natural products. This distribution highlights the strategic use of the natural product pathway contemplated in the Peruvian regulatory framework, which has facilitated market access to cannabis derivatives. It also reflects the growing maturity and adaptability of Peru’s regulatory system in responding to innovation and public health needs.

These developments position Peru as a regional leader in cannabis regulation, combining technical rigor with regulatory adaptability. The increasing number of authorisations and the expansion of the compounding practices being carried out demonstrate Peru’s dynamic and responsive regulatory system that supports innovation, while safeguarding public health.

Law No. 32195: the legal framework for industrial hemp

Law No. 32195 establishes the legal framework for the agricultural development of industrial hemp, defined as cannabis with less than one per cent tetrahydrocannabinol (THC) on a dry-weight basis. This threshold excludes hemp from the scope of controlled substances and enables its use in a wide range of industrial applications, including cosmetics, food, textiles and construction.

Following the enactment of the Law, the draft regulation has already been published, providing detailed procedures and technical requirements for the production, transformation and commercialisation of industrial hemp. The regulation confirms that hemp derivatives may be used in the manufacture of food and cosmetic products, provided that they comply with the applicable safety, traceability and quality standards.

In the case of cosmetics, the regulation introduces a specific authorisation process that will be managed by the DIGEMID, which complements the regional framework established by Decision 833 of the Andean Community. While Decision 833 provides harmonised criteria for cosmetic ingredients, Peru requires additional national authorisation for the use of hemp-derived substances. The regulation outlines the procedures for obtaining such authorisation, including the submission of a manufacturing plan, traceability documentation and compliance with good manufacturing practices.

For food applications, the regulation aligns with international standards, such as the Codex Alimentarius and standards set by the United States Food and Drug Administration, which recognise hemp seeds and oils as safe ingredients. The Peruvian framework now enables the incorporation of hemp derivatives into processed foods, beverages, supplements and additives, subject to gaining the applicable sanitary authorisation from the DIGESA. Establishments must demonstrate compliance with Hazard Analysis Critical Control Points (HACCP) plans, allergen controls and provide analytical verification of the product’s THC levels.

The publication of the draft regulation marks a critical step in the journey towards the full implementation of Law No. 32195. It provides legal certainty and operational clarity for stakeholders across the hemp value chain, from agricultural producers to industrial manufacturers. Once finalised, the regulation is expected to unlock new opportunities for innovation and investment in Peru’s life sciences and agribusiness sectors.

Beyond cosmetics and food, the regulation also envisions the use of hemp in textiles, construction materials, animal feed, bioplastics and other industrial transformations. These applications are detailed in the draft regulation, which defines the technical and sanitary requirements for processing, manufacturing and commercialisation of industrial hemp.

Furthermore, the regulation promotes hemp as an alternative crop, which would be achieved through coordinated efforts by the National Commission for Development and Life without Drugs (Comisión Nacional para el Desarrollo y Vida sin Drogas or DEVIDA) and the Ministry of Agricultural Development and Irrigation (Ministerio de Desarrollo Agrario y Riego or MIDAGRI), particularly in regions affected by illicit coca cultivation. This policy supports rural development, the formalisation of agricultural activities and social inclusion, while fostering sustainable economic alternatives.

Conclusion

Peru’s regulatory evolution in terms of the use of cannabis and hemp reflects a positive trajectory towards innovation, public health protection and industrial diversification. The combination of robust marketing authorisation systems, growing compounding practices and the new legal framework for hemp positions Peru as a regional leader in responsible cannabis regulation. The anticipated regulation will not only enable the use of hemp in cosmetics and food, but will also catalyse broader applications across other industries, fostering sustainable development and economic growth.