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.
Brokerage Compliance Symposium
The day before F3. Every compliance issue you face - fraud exposure, carrier liability, FMCSA rules, cargo theft, insurance gaps - navigated by attorneys and operators defining best practices in a changing industry.
F3 Awards Dinner
The night before F3. FreightTech100 companies honored. FreightTech 25 and Shipper of Choice winners revealed live. Cocktail reception into dinner and live music - 300 industry leaders in one purpose-built room.
F3: Future of Freight Festival
Industry-defining keynotes, rapid-fire technology demos, and industry leaders networking in experiences across Chattanooga - plus the inaugural F3 Awards Dinner featuring the FreightTech and Shipper of Choice reveals.
The day before F3. Every compliance issue you face - fraud exposure, carrier liability, FMCSA rules, cargo theft, insurance gaps - navigated by attorneys and operators defining best practices in a changing industry.
The Signal at Chattanooga Choo Choo • Chattanooga, TN Register NowThe night before F3. FreightTech100 companies honored. FreightTech 25 and Shipper of Choice winners revealed live. Cocktail reception into dinner and live music - 300 industry leaders in one purpose-built room.
The Signal at Chattanooga Choo Choo • Chattanooga, TN Register NowIndustry-defining keynotes, rapid-fire technology demos, and industry leaders networking in experiences across Chattanooga - plus the inaugural F3 Awards Dinner featuring the FreightTech and Shipper of Choice reveals.
The Signal at Chattanooga Choo Choo • Chattanooga, TN Register Now