§ I Manufacturing standard
Edition · MMXXVI
Swiss Vitalis LLC · Newark, DE · USA
Hemp-derived CBD Made in the USA Informational page

Swiss Vitalis.
U.S.-made CBD,
verified
lot by lot.

How the products are made and verified. Swiss Vitalis LLC is a U.S.-based manufacturer of hemp-derived CBD products. This page describes where they are made, the standard they are made to, and how anyone can check a specific lot against the laboratory’s own record. It is not an offer of sale.

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
§ II About the 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 the products

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

The products contain not more than 0.3% Δ9-THC by dry weight, which is the threshold the Farm Bill sets for hemp. The oils carry the extract in MCT. On the current full-spectrum lot, Δ9-THC measured 0.1844% by weight, 52.980 mg in a 30 mL bottle; on the broad-spectrum lot it is reported as not detected, at a limit of detection of 0.002 mg/g.

The Swiss name and the alpine terpene profile are brand identity and a formulation choice. No part of the manufacture happens in Switzerland, and we would rather write that here than let it come up during due diligence.

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 Manufacturing practice

Made under
certified practice.

Nutritional Good Manufacturing Practice with a documented process, batch record and release, at a facility whose certificate was issued by somebody other than us.

III.a · Manufacturing practice ii.

Good Manufacturing Practice

Manufacture under nutritional Good Manufacturing Practice, with a documented process, a documented batch record and a documented release.

Upstream of the extractor, the raw material is handled under Good Agricultural and Collection Practice, so the plant material arrives with a record of its own. That is a practice we operate to, and it is not covered by the manufacturing certificate below, whose scope is 21 CFR Part 111.

The manufacture is certified, and by somebody other than us. The facility where these products are manufactured holds a Certificate of Conformity from Eurofins Healthcare Assurance, a certification body accredited by ANAB to ISO/IEC 17065, against 21 CFR Part 111, Good Manufacturing Practices for Dietary Supplements, with no authorised exclusions. The certified product categories are gummy, ingestible oil, powder and softgel; the certified operations run from liquid formulation and mixing to molding, packaging and labelling, bulk and primary packaging, and warehousing.

Reference document
Certificate of Conformity · Eurofins Healthcare Assurance · 21 CFR Part 111
Certificate
FSS2019082908_1
Issued
Expires
Accreditation
ANAB · ISO/IEC 17065
Important · what the certificate names

That certificate names the plant, not Swiss Vitalis. It is held by the contract manufacturer, which is why the document itself is not published here: naming the plant is their call to make and not ours. The number above is published so the claim can be checked, and a qualified buyer gets the certificate under a confidentiality agreement.

Open an enquiry Certificate under NDA
III.b · Independent verification iii.

Independent verification

Analysis by SC Labs, an independent laboratory accredited to ISO/IEC 17025 (PJLA accreditation number 87168).

Three of the four certificates are published by lot on the laboratory’s own client portal, which means they sit on their server rather than ours and cannot be edited by us after the fact. The gummies certificate is served from this site instead.

Each of the four SKUs has a certificate on the lab results page. They do not carry the same panels, and each block there names the ones its certificate does not have.

Laboratory
SC Labs
Accreditation
ISO/IEC 17025
PJLA no.
87168
Published
By lot

How to check a specific lot

  1. Read the lot number printed on the carton.
  2. Find that lot on the lab results page and open the certificate on the SC Labs portal from there.
  3. If the lot number on your carton is not the one published, ask the seller for the certificate of the lot you actually have. A certificate for a different lot is a document about a different product.

Five checks, in order, and what each one catches: how to read a certificate of analysis.

© MMXXVI Swiss Vitalis LLC · Newark, DE, USA Volumen MMXXVI · Manufacturing standard · reviewed U.S. hemp · 2018 Farm Bill