How to read a medical claim.

What approval tells you

The US agency responsible for medicine reviews is the Food and Drug Administration, often called FDA.

FDA approval belongs to a particular product and named uses.

Compounded drugs are medicines prepared to order.

The FDA does not review them before marketing for safety, quality or whether they work.

Ask whether the study tested the exact medicine you would receive. Was it the same drug ingredient, the same amount in each dose, and made in the same way?

What a report can tell you

An adverse event is an unwanted experience reported during the use of a medical product.

A report can raise a concern without showing that the medicine caused the event.

FDA cautions that the frequency of a problem cannot be worked out from these reports.

Report guidance as of September 17, 2026.

If an advert gives a count of problems, ask where that count came from: a study or reports sent in by patients and others.

A count of reports cannot show how common a problem is.

What registration and letters tell you

FDA registration puts a drug-making or drug-handling business in the agency's records. It does not show FDA approval of that business or its medicines, or that the drugs may legally be sold.

Ask what FDA actually checked and request the exact medicine's approval record.

A warning letter records FDA concerns at a point in time.

It is not FDA's final decision. Later replies between FDA and the company can change the status of the concerns.

Search FDA's letters by the company's name. Look for a reply or a closeout letter about the concerns, and check the dates.

A closeout letter tells you FDA has closed the concerns in that letter. If no later answer is shown, ask whether there is a newer FDA update.

The absence of a letter is not proof that a company was reviewed.

Letter guidance as of September 17, 2026.

Questions that test a claim

• Which product did the evidence concern?
• Was the claim about a medicine, a way of making it, or a business licence?
• Does the source say that, or does the advert add more?
• What date was the status or price checked?
• What remains uncertain?