Questions before a care plan
Make the evidence answer the claim being made.
Ask for the source behind a treatment claim. Then check whether it concerns the same medicine, the same form, and the same intended use.
Keep the claim and its source together. A paper title by itself does not explain what a clinic is offering. Ask the clinician to walk through the connection in ordinary words.
What does each kind of record tell you?
Approval information as of September 26, 2026.
A facility entered in FDA (the Food and Drug Administration) records is described as registered; that entry is called registration. In the medicine list, NDC stands for National Drug Code: the product’s listing number. Neither record proves FDA approval of a medicine.
The FDA says its published problem reports do not prove that a medicine caused the reported event.
Those reports cannot tell you how often a medicine causes harm.
A warning letter is a dated warning.
An FDA warning letter tells a business what the agency believes it has done wrong. The letter is not a final finding. Later replies and discussions can change the position described.
A business without a published letter may simply not have been reviewed.
Ask what is still unknown. A useful answer can have limits. Keep those limits beside the claimed benefit when comparing the proposal.
Notes for this chapter
- FDA explanation of product listing numbers
A product number and a record of approval tell you different things.
- FDA limits on interpreting problem reports
The published reports are useful, but their limits matter.
- Search FDA warning letters
Read what the letter says, then look for later replies and letters saying the matter has been closed.
Write here, then print a copy before closing or reloading.