Food and Drug Administration

The Food and Drug Administration's regulations can pose challenges for importers. Customs penalty or seizure actions frequently result from failure to comply with FDA import rules, such as pre-import filing requirements.

We assist clients with general FDA issues, including license applications for foodstuffs, cosmetics and other FDA-regulated goods. Our experience includes permitting gray market imports, FDA device and manufacturer registration, halting importation of unregistered knock-offs, mitigation or elimination of FDA penalties, bioterrorism counseling, and settlement of Customs penalties issued in relation to FDA-regulated imports.

After FDA approval or clearance is obtained, we often assist importers in negotiating marketing and distribution agreements for their goods. We then stand ready to provide ongoing counsel in the event that issues arise as a result of further agency inspection, product safety recalls or business disputes.