What does the evidence prove?

Registration

A company can be registered with the FDA, meaning it is recorded in the agency’s records. A medicine can also appear on its product list. Neither fact means the FDA approved the business or medicine.

NDC

National Drug Code is the full name of NDC. This number identifies a medicine listed in the FDA’s product records.

Having this number does not establish FDA approval for the medicine.

A custom version

Be wary of a claim that a made-to-order medicine was tested in people and works just like the approved product. The FDA says that claim is false or misleading.

Advisory committee

The FDA keeps a list of certain raw ingredients that ordinary pharmacies may use for made-to-order medicines. This is one way an ingredient can qualify. It still needs required quality records and must come from an FDA-registered maker.

A committee advises the FDA about this list, but a vote does not change it. The FDA must invite people’s views and complete a new rule before it changes the list.

Problem reports

A problem report by itself cannot prove cause or tell you how often a medicine causes harm.

An enforcement letter

A warning letter from the FDA sets out the concerns the agency had at the time of sending it. Later replies from the company and further FDA review may change the agency’s view of the problem.

The letter states a concern; it is not a final decision that the company broke a rule.

Finding no letter does not mean the FDA cleared a product or business.