FDA proposes e-filing requirements to facilitate product imports.

  • FDA and the U.S. Customs and Border Protection Agency (CBP) work together to facilitate the admission of imported products into the U.S.  The Automated Commercial Environment (ACE) is a commercial trade processing system operated by CBP that helps automate and expedite the processing of imports and exports.
  • Earlier this month, FDA issued a proposed rule to establish requirements for the electronic filing of FDA-regulated products in ACE (or any CBP-authorized electronic filing system).  The proposed rule would require certain data elements to be submitted at the time of entry, with such elements falling generally into two categories:  (1) those that identify the article offered for import; and (2) those that identify the person(s) seeking to import the article.  The proposed rule would impose submission requirements related to the importation of foods, food-contact substances, and other FDA-regulated products.
  • FDA’s stated goal is for these requirements to facilitate effective and efficient admissibility review by the Agency and an improved ability to focus FDA’s limited resources on higher-risk imports.  Interested stakeholders are invited to submit comments on the proposed rule by August 30, 2016.