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What is it? TBAs are 2,4,6-tribromoanisoles, one of a class of chemical compounds known as halogenated anisoles, which can produce a moldy or musty odor in food, drugs and other products. They can be detected by consumers even when present at parts per billion or lesser levels.
Why the buzz? Small amounts of TBAs discovered in wooden storage pallets are believed to have been responsible for the recent recall of millions of bottles of Tylenol and other medications, leading to consumer complaints about moldy or musty odors. According to the U.S. Food and Drug Administration (FDA), the smell likely came from the pallets that were used to store packaging materials. FDA says TBAs are prone to evaporate and can be absorbed by items stored nearby. Because of their volatility, it appears that even minute levels of these compounds can affect a large quantity of product. The agency says currently available data indicate that serious adverse health effects have not resulted from ingestion of drugs or foods contaminated with halogenated anisole compounds at the levels of contamination that have been reported. However, the agency says there are some reports of gastrointestinal events by consumers who also report a foul odor or taste in drug products contaminated with the typical trace levels of TBA. Even if the health effects are minimal, FDA says it is concerned that patients sensing an unusual odor that is not intrinsic to the product will stop taking their medication.
Essential Information:
FDA FAQ on Good Manufacturing Practices and Halogenated Anisoles
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