PROPOSED RULE COULD FORCE IMPORTERS TO HOLD GOODS FOR SIX MONTHS
Under a new rule proposed by U.S. Customs for the Food and Drug Administration, importers would be required to hold goods for six months after importation, or risk paying “liquidated damages” of three times the value of the goods.
The new regulation would extend the conditional release period from 30 days to 180 days for all FDA-regulated goods, including food, drugs, medical devices, cosmetics and some electronic products.
A Federal Register notice said the rule change is needed “to provide a reasonable period of time for the FDA to perform its enforcement functions,” explaining that, under present law, the FDA must act within 30 days of release.
“The notice does not mention that current law also allows the FDA to extend that period indefinitely by a variety of actions,” said Lee Sandler, an attorney with Sandler, Travis & Rosenberg in Miami.
“The proposed rule appears impractical from the point of view of importers,” Sandler said. “How many of them can hold goods in inventory for six months?”
Comments on the proposed rule are due by Aug. 6.