Do I have to include all my inactive ingredients?

Answer:

The FDA is not requiring all inactive ingredients to be listed but is requesting the data be provided. If there is a UNII code for an inactive ingredient, it is expected that you include that in the Product Data Elements section. If you do not list all the inactive ingredients that have UNIIs associated and receive an error, you must inform the FDA via email and request a manual override if an error occurs. If an inactive ingredient is listed on the label image but not in the data element section, the FDA could contact the company to inquire about the discrepancy.