Delays in imports via RDC 660 reveal stricter US enforcement and non-compliance with above-limit THC

The importation of cannabis-based products into Brazil through RDC 660 faces a scenario of delays and increased operational complexity. A Sechat investigation with industry companies indicates that recent changes in the United States — the main origin of these shipments — have directly impacted logistical flows, affecting delivery times for patients.

One of the main factors behind this scenario is the increase in shipments blocked at origin or during transit, many associated with irregularities involving THC levels above the allowable limit.

Stricter enforcement at origin

In the United States, enforcement by agencies such as Customs and Border Protection (CBP) and the Drug Enforcement Administration (DEA) has intensified over recent months. Companies report an increase in inspections, holds, and, in some cases, seizure of shipments.

Even products with THC levels within the federal limit of 0.3% are undergoing more detailed checks. The use of detector dogs and the analysis of the characteristic odor of cannabis have begun to prompt a more cautious approach by authorities.

THC levels above allowable limit stall operations

Industry sources point out that a significant portion of the problems is related to sending non-compliant products. There are records of companies attempting to export items to Brazil with THC content above 0.3%, which is not permitted under the RDC 660 model.

These shipments end up being blocked, detained, or returned, creating a cascade effect across the entire operation. As a result, the level of inspection increases for all shipments, including those in full compliance.

In practice, this trend has directly contributed to stalling the flow of RDC 660, extending timelines and creating logistical uncertainty for companies and patients.

Documentation becomes decisive

Documentary compliance has become the primary factor for enabling shipments. Among the required items are:

• Complete and traceable Certificate of Analysis (COA)
• Safety Data Sheet (SDS)
• Production and manufacturing licenses in the United States
• "Known shipper" registration with the TSA
• Packaging with QR Code, origin identification, and address

Companies report that incomplete or inconsistent COAs are among the main reasons for detention. Since October of last year, there has been an increase in strictness and review of these documents.

Airlines increase requirements

Air freight continues to operate, but with higher requirements. Airlines such as LATAM and American Airlines now make boarding conditional on rigorous documentation checks.

Shipments with any inconsistency are not accepted. Fear of fines and operational delays — which can generate high costs, estimated at around US$ 700 per hour of grounded aircraft — has led companies to adopt a more conservative stance.

Reduced flight availability worsens delays

The reduction in the international flight network also contributes to this situation. Rising fuel costs, driven by geopolitical tensions, and route redistribution have reduced flight availability between the United States and Brazil.

With less capacity available, cargo that is more sensitive from a regulatory standpoint faces greater difficulty in boarding, extending transit times.

Impacts in Brazil

In Brazil, delays are also related to regulatory review times. Companies report that processes at Anvisa can take months, and in case of denial, returning cargo can further prolong the logistics cycle, affecting product shelf life.

This scenario puts pressure on RDC 660 operations, which are currently responsible for serving a large number of patients through direct importation.

“Issues related to logistics have always been present in direct imports by patients (RDC 17, 335, and 660). Therefore, it is essential for all companies involved in the import process — both those in Brazil assisting the patient and logistics providers — to perform a prior and consistent review of documentation, whether of the patient (the Anvisa authorization) or the exact match of the prescribed product to what is being shipped to Brazil,” evaluates Leonardo Navarro, legal director at ICR (Instituto Conexão e Regulação)