Although there is no meaningful toxicological data on TBA at these levels, the health risks appear to be minimal. Currently available data indicate that serious adverse health effects have not resulted ingestion of drugs or foods contaminated with halogenated anisole compounds at the levels of contamination that have been reported. However, there are some reports of gastrointestinal events by consumers who also report sensing a foul odor, or taste, in drug products contaminated with the typical trace levels of TBA. Even if the health effects are minimal, FDA is concerned that patients sensing an unusual odor that is not intrinsic to the product will stop taking their medication.
