§ I International information

Edition · MMXXVI

Swiss Vitalis LLC · Newark, DE · USA

Hemp-derived CBD Made in the USA Informational page

Swiss Vitalis.
U.S.-made CBD,
for international
patients.

Information for international patients. Swiss Vitalis is a U.S.-based manufacturer of hemp-derived CBD products. This page provides general information for patients abroad, including those in Brazil, who wish to learn about our composition, our manufacturing standards, and the way our products can be accessed from outside the United States.

Read the information → View lab results (COA)

Manufactured in the USA

Hemp-derived · Δ9-THC < 0.3%

Third-party lab tested

U.S. manufacture

Rec · MMXXVI

Third-party
tested, lot by lot.

Vol · 01

U.S. manufacturing

2018 Farm Bill

Lab testing

COA by lot

Hemp-derived CBD manufactured in the United States Less than 0.3% Δ9-THC under the 2018 U.S. Farm Bill Third-party lab testing certificate of analysis by lot Informational page for international patients No direct sales to Brazil informational content only Individual import patient responsibility under RDC 660/2022 Hemp-derived CBD manufactured in the United States Less than 0.3% Δ9-THC under the 2018 U.S. Farm Bill Third-party lab testing certificate of analysis by lot Informational page for international patients No direct sales to Brazil informational content only Individual import patient responsibility under RDC 660/2022

§ II About our products

Hemp-derived CBD,
manufactured in
the United States.

U.S.-made hemp-derived CBD products, with independent third-party testing and a certificate of analysis issued at lot level.

II.a · Product standards i.

About our products

Swiss Vitalis manufactures hemp-derived CBD products in the United States in compliance with applicable U.S. federal regulations, including the 2018 Farm Bill.

Our products contain less than 0.3% Δ9-THC by dry weight. Lot-level certificates of analysis (COAs) from SC Labs, an independent laboratory accredited to ISO/IEC 17025, are published on our lab results page and updated as new lots are released. Three of the four certificates sit on the laboratory’s own portal, where we cannot edit them after the fact.

The facility where the products are made holds a Certificate of Conformity to 21 CFR Part 111, issued by Eurofins Healthcare Assurance. The manufacturing practice, the certificate number and how to check a specific lot are on How it is made.

Origin

United States

Framework

Farm Bill 2018

THC limit

< 0.3% dry wt.

Testing

By lot

Manufactured in the USA Hemp-derived · less than 0.3% Δ9-THC Independent third-party testing Lot-level traceability

View certificates of analysis swissvitalisusa.com/lab-results

§ III International access

How international patients
access our products.

Swiss Vitalis does not ship directly to Brazil and does not operate a sales network in Brazil. The section below explains how the individual personal-import pathway works.

III.a · Individual import pathway ii.

How international patients access our products

We sell our products in the United States, at wholesale and through licensed resellers. We do not ship directly to Brazil.

Patients located in Brazil who wish to import cannabis-derived products for personal use must obtain an individual import authorization (Anuência de Importação) from ANVISA under RDC 660/2022, based on a valid prescription issued by a licensed Brazilian physician. The patient is the importer of record in any such transaction.

Swiss Vitalis is not involved in the authorization process and does not provide medical, regulatory, or legal advice. Patients are encouraged to consult their physician and, if desired, an independent import-assistance service of their own choosing.

Direct shipping to Brazil

None

Importer of record

The patient

Authorization

ANVISA · RDC 660/2022

U.S. fulfillment

Novus Byzantium LLC

U.S.-side fulfillment of shipments to international patients, including Brazilian patients who have individually obtained an Anuência de Importação from ANVISA under RDC 660/2022, is handled by Novus Byzantium LLC, a Wyoming limited liability company that distributes Swiss Vitalis hemp-derived CBD products in the United States. Novus Byzantium LLC operates independently of Swiss Vitalis LLC, is not a Brazilian entity, does not operate commercially in Brazil, and does not replace the patient’s role as the importer of record on any shipment.

III.b · ANVISA reference listing iii.

ANVISA reference listing

Swiss Vitalis CBD is included in ANVISA’s published reference of cannabis-derived products eligible for the individual personal-import procedure under RDC 660/2022, Art. 5º §3º. The reference names Swiss Vitalis LLC, of Delaware, United States.

Reference document, current edition

Nota Técnica nº 40/2026/SEI/COCIC/GPCON/DIRE5/ANVISA

Annex

Signed

27 May 2026

Process

25351.927642/2021-31

SEI doc.

4283964

The reference is re-issued as the list grows; the listing was already present in the edition of April 2026 (Nota Técnica nº 19/2026) and is carried in the current one. The document is published at the same ANVISA address each time, linked below, and the edition in force is the one that counts.

Patients located in Brazil who hold a valid prescription issued by a licensed Brazilian physician may apply directly to ANVISA, through the Federal Government Services Portal (gov.br), for individual import authorization (Anuência de Importação) for personal use, in accordance with the procedure established by RDC 660/2022. The Nota Técnica states that for products on its list the approval of that registration is automatic; for products not on the list, the request goes to ANVISA’s technical review.

Important · ANVISA statement

ANVISA expressly states in the same Nota Técnica that products listed in this reference are not registered with ANVISA and have not had their efficacy, quality or safety evaluated by the Agency. Inclusion in the reference does not constitute registration, approval, endorsement, recommendation, or commercial authorization. ANVISA further states that these products may not be imported, stored, distributed, or resold by legal entities in Brazil and must be imported exclusively by the natural-person patient for strictly personal, non-transferable use, with delivery to third parties prohibited, under Art. 15 of RDC 660/2022.

Swiss Vitalis makes no claim about what any product does. These statements have not been evaluated by the Food and Drug Administration, and the products are not intended to diagnose, treat, cure, or prevent any disease.

View ANVISA reference document (Nota Técnica, current edition) gov.br/anvisa

§ IV Regulatory notes

Regulatory and
legal notes.

Jurisdiction, responsibility, and the scope of the information provided on this page.

IV.a · Legal notes iv.

Regulatory and legal notes

Swiss Vitalis CBD is included in ANVISA’s published reference of products eligible for the individual personal-import procedure under RDC 660/2022 (Nota Técnica nº 40/2026, Annex I).

Scope of inclusion

Inclusion in ANVISA's reference does not constitute ANVISA registration, commercial authorization, or approval. ANVISA expressly states that listed products have not had their efficacy, quality or safety evaluated, and that they may not be imported, stored, distributed, or resold by legal entities in Brazil.

Swiss Vitalis products are manufactured and sold in the United States. No representation is made that any product is registered, approved, or authorized by ANVISA, the FDA, or any other regulatory authority for the treatment, diagnosis, cure, or prevention of any disease.

Swiss Vitalis LLC (Delaware, USA) is the manufacturer of the product; Novus Byzantium LLC (Wyoming, USA) is the U.S. distributor that handles outbound fulfillment to international personal-import patients. Neither entity is registered with ANVISA, and neither entity operates commercially in Brazil.

Any import of our products into Brazil by an individual patient is the sole responsibility of that patient and must comply with Brazilian law, including RDC 660/2022 and any applicable ANVISA requirements.

Swiss Vitalis does not solicit sales, maintain distributors, or advertise to the Brazilian public. Inquiries from international patients are answered on an informational basis only.