Keep the claim attached to its evidence
Which product and which use?
FDA is the Food and Drug Administration, the US drug agency. It reviews evidence for a particular medicine and use before approving it.
Request the exact medicine name, whether it comes as a tablet, injection or another form, and why it is being suggested. A broad claim about an ingredient leaves those questions unanswered.
Is the claim about a reviewed product or a preparation?
A compounded medicine is made to order. Before such a medicine is sold, FDA does not check its quality, its safety or how well it works. Rule checked September 26, 2026.
According to FDA, a claim misleads people if it says studies prove a made-to-order medicine gives the same health results as an approved drug. Guidance checked September 26, 2026.
Is a report being treated as proof?
Reporting a problem after using medicine does not establish that the medicine was the cause. FDA also says a count of these reports cannot tell you how common a problem is.
To judge how common a problem is, you need more than the report count. You need to compare problems with how many people used the medicine. Reports alone do not give that comparison.
Ask what the evidence can answer and what it leaves uncertain.
Is a drug code being treated as approval?
A product's identifying number in FDA drug records is its National Drug Code, abbreviated NDC. Having that number does not mean FDA approved the medicine. Rule checked September 26, 2026.
Ask for the actual approval record rather than a code alone.
A useful sentence to ask for
Try: “Please explain what this evidence means for the medicine and use we are discussing.”
Write down the limits as well as the hoped-for result. Bring that note back if the product or plan changes.
Read about review and reported problems
- FDA on approval claims
Read to check what an approval statement actually covers.
- FDA's public medicine-problem reports
The FDA Adverse Event Monitoring System (AEMS), formerly FAERS, shows reports of medicine problems. Read why a report count has limits.
- FDA's drug-code directory explanation
Read when an entry in drug records or a drug code is offered as proof of approval.