Chapter F · Words in an offer
Look past the reassuring words.
An offer may say “FDA registered,” “purity tested” or “research use only.” Find out what each phrase tells you about the product.
What do these words actually prove?
FDA is the US medicine regulator. Compare each phrase with the explanation below. Ask what the phrase proves about the exact product.
Words in an offer
“FDA registered”
A statement about registration. Ask what was registered: a place, an ingredient, or a product listing.
“Purity tested”
A test showing what share of the sample consists of the named ingredient. Ask what the test did and did not measure.
“Research use only”
A label marking the product for research. Ask why it is being offered to treat a person.
What the words can prove
Registration does not prove approval
Under the rule checked September 26, 2026, registering with FDA or listing a product does not mean FDA has approved it. [a]
A listed product can be identified by its National Drug Code (NDC); that code still does not establish FDA approval. [b]
Purity is a limited result
FDA’s July 2026 KPV review found that most test certificates gave only a purity result, leaving out test results and allowed amounts for unwanted substances. [c]
A test certificate lists test results. A batch is a group of product made together. Ask for the certificate for the batch you would receive. Ask which unwanted substances were checked, how much was found and how much was allowed.
Read the treatment claims too
In letters reviewed September 26, 2026, FDA rejected research-only labels when the surrounding website showed products were intended for human use. [d]
If a website says “research only” and also offers treatment, ask the clinician to explain why the two descriptions disagree.
Ask for the missing document
Bring the exact offer to the visit. Ask which studies support the proposed treatment, what the ingredient’s full name is, and which pharmacy will make it.
If the reply is just “FDA registered” or “purity tested,” ask again for the studies, full ingredient name and pharmacy details.
Questions to take into a visitNotes for this page
A · What registration and listing mean under the federal rule.
eCFR · registration and listingB · The limits of a product code.
FDA · the product-code directoryC · The test-certificate findings in FDA’s KPV review.
FDA · the KPV reviewD · FDA’s reasoning about intended human use despite research labels.
FDA · research labels and intended use