In April 2015, we commented on how FDA cancelled Import Alert 16-08 (Detention without Physical Examination of Swordfish for Methyl Mercury). This alert instructed FDA to automatically detain all swordfish imports unless the manufacturer was on FDA’s Green List. Though the alert had been in place for almost 30 years, FDA removed it without any explanation about the Agency’s expectation for future shipments of swordfish.
Reflecting back, it appears that the removal of Import Alert 16-08 might mark the close of FDA’s long history of interactions with methyl mercury in swordfish, which dates back to the 1970s. FDA indicated that the alert was removed because there appeared to be no more need for it –there were few instances of non-compliant product for some time.
On top of that, FDA is not enforcing the historical 1ppm action level for methyl mercury – it appears that there is insufficient health evidence to justify this action level while FDA considers establishing a new action level. Or perhaps, this issue will no longer be a priority and FDA will never establish a new action level.
However, this matter may not be entirely closed as FDA’s Compliance Policy Guide (last updated in 2007) still contains the 1ppm action level, and the field – unaware of what has taken place – relies on the Compliance Policy Guide to seek enforcement action.
For further comment on the status of swordfish regulation, or for questions on importing any FDA-regulated product, contact FDAImports.com today.
