What does a source actually prove?

What does an approval record tell me?

Food and Drug Administration (FDA) approval concerns a particular drug product and its stated uses.

Does the source name the same medicine? Is it about the same kind of shot or tablet, used to treat the same problem?

FDA’s directory lists drug products. A product is identified there by its National Drug Code (NDC).

As of September 2026, FDA says having that code does not mean the product has approval.

If an offer shows an NDC number or a database entry, ask for the approval record as well.

What does registration tell me?

Federal rules checked for September 2026 distinguish approval from registration of a facility or listing of a drug. Neither entry means FDA approval.

As of September 2026, FDA also does not approve doctors’ offices or laboratories.

Ask: “Does this record show registration, or does it show approval of this exact medicine?”

What does a report of harm prove?

Sending FDA a problem report does not establish the medicine as the cause.

It does not show that a medical professional has checked the information in the report.

The frequency of a problem among medicine users cannot be worked out from these reports.

Ask what was reported and what is still unknown. A report is a reason to ask about a problem, not proof of its cause.

What does a letter from FDA prove?

In a warning letter, FDA sets out its concerns about a company as they stood when it wrote. The letter is not a final finding.

Later replies or action by the company may change how FDA treats the concerns raised in the letter.

Ask for the latest reply or follow-up record. A letter alone cannot tell you whether the problem was fixed or the medicine can now be sold.

Finding no warning letter does not mean a company passed a check; FDA may never have reviewed it.

How do I ask about treatment evidence?

Was the work done in people? Did it study this exact product? What was measured? Does the finding address the problem I brought to the visit?

Ask your treating clinician what the source demonstrates, which questions remain unanswered, and what it means for your care.