How Truthe is made
Made and tested. Here is what that means.
Every Truthe nutrition product carries four short lines about how it was made. This page is where those lines lead. It says where our products are made, the rule they are made under, what gets tested and when, and where the ingredients come from, in plain words, with a mark of our own over each line and nothing implied that the documents do not support.
We publish the whole label, and we hold the claims about the label to the same standard: nothing here goes further than the documents behind it.
Where it is made
Truthe nutrition products are made in FDA registered facilities in the United States.
That line means exactly one thing. Any facility that manufactures, packs or holds food for sale in the United States, and dietary supplements are regulated as food, must register with FDA and is subject to FDA inspection. Registration is a legal requirement, not an award, and it is not an approval of the facility or of any product made in it. FDA does not approve dietary supplements.
How it is made
Every Truthe product is made under FDA current Good Manufacturing Practice for dietary supplements, the federal rule at 21 CFR Part 111.
Part 111 is not a marketing standard. It requires a written master manufacturing record for every product, a batch record for every lot, identity testing of every dietary ingredient before it is used, controls on the components, packaging and labels that go into a product, and a quality control unit with the authority to approve or reject each batch. The rule binds every supplement manufacturer in the country. FDA does not certify compliance with it; it inspects for it.
What is tested, and when
Ingredients are tested before they enter production. Independent laboratories test them for identity, purity and potency, so that what goes into the blender is what the formula says.
Finished lots are tested for potency, to confirm the label amounts, and for microbial safety. Those are the two things a finished-lot certificate shows, and they are the only two things this page claims. We do not list contaminant classes we have not seen a certificate for.
Where the ingredients come from
Truthe products are manufactured in the USA with domestic and imported ingredients. We say it that way on purpose. An unqualified Made in the USA claim requires that all or virtually all of a product be of domestic origin, and some of the best ingredients are not.
The clearest example is the whey in Nutrition Blend, which is sourced from New Zealand. Where an ingredient's origin matters to the formula, the product page names it.
The four lines
What we put on every product, and what each line rests on
The marks are ours. FDA keeps its name and logo for its own use and issues nothing for facility registration, no agency issues a cGMP logo, and the marks certification programs issue belong to the facilities that hold them, not to us. So the four marks are Truthe’s, set in one style, and the line under each one is worded to carry its own limit.
FDA REGISTERED
Made in an FDA registered manufacturing facility.
MANUFACTURED IN USA
Made with domestic and imported ingredients.
INDEPENDENTLY TESTED
Ingredients and finished lots tested by independent labs for potency and microbial safety.
cGMP MANUFACTURING
Made under FDA current Good Manufacturing Practice for dietary supplements, 21 CFR Part 111.
Five terms, explained
The words on supplement labels, and what they actually mean
- cGMP
- Current Good Manufacturing Practice. For dietary supplements it is the federal rule at 21 CFR Part 111, covering personnel, facilities, equipment, written procedures, ingredient testing, batch records and quality control. Every US supplement manufacturer must follow it. Nobody is “cGMP certified” by FDA; FDA inspects for compliance.
- Registered versus certified
- Registered means a facility has filed with FDA, which the law requires. Certified means an outside body audited the facility against a written standard and issued a certificate. The two words are not interchangeable, and a certification held by a manufacturing facility is not a claim about any single product made there. No Truthe product is individually certified by any third-party program, and we do not show any certifier’s mark.
- Certificate of analysis
- A document from a laboratory reporting what it tested in a specific lot and what it found: for a finished supplement, typically the potency of the labeled ingredients and a microbial panel. A certificate speaks for one lot, not for a product line.
- Third-party tested
- Testing performed by a laboratory that is not owned by the manufacturer or the brand. The phrase says who did the testing. It does not say what was tested for, which is why this page names the analytes it can stand behind and no others.
- ISO/IEC 17025
- The international standard that accredits testing laboratories. When a laboratory is 17025 accredited, an outside body has checked that its methods, equipment and staff are competent for the tests it reports. It is a statement about the lab, not about the product it tested.
Questions about how a specific product is made or tested? Ask us. If the answer is not on this page, we would rather tell you than imply it.