Approval claims
Does registration prove approval?
The Food and Drug Administration (FDA) is the U.S. federal drug agency.
As of September 2026, registering with FDA or listing a drug does not mean that FDA approved it or that it can legally be sold.
Ask what the registration covers. Ask for the approval record for the actual product.
Source · Federal rule on registration and listing
What if a product has a drug code?
A National Drug Code marks a product’s entry in a directory kept by the government.
As of September 2026, FDA says that code does not establish approval.
A code answers a different question from whether the finished product is approved.
Source · FDA on National Drug Codes
What does a warning letter establish?
An FDA warning letter sets out concerns the agency had about a particular business at the time of writing.
A later response or review may change the position described in the letter.
Read the date on the letter. Look for the company’s reply and later FDA updates about the concerns in that letter.
Source · FDA’s letter search
Limits of advice and reports
Can committee advice change the rules?
As of September 2026, advice from an FDA advisory committee cannot by itself alter the rules for compounding ingredients.
Ask for the final rule or approval document that the treatment claim relies on.
Source · FDA’s process for compounding ingredients
Does a report prove a medicine caused harm?
A report of a problem during medicine use does not establish that the medicine was the cause.
Those reports cannot be used to calculate how often the problem occurs.
Ask what kind of evidence supports a claim about how often something happens.