The Food and Drug Administration is proposing to codify its procedures for electronic filing of entries of FDA-regulated products in ACE. The agency’s proposed rule (here) would add new sections to the FDA regulations specifying the data elements that must or may be filed in ACE at the time of entry, and make “technical revisions” to existing FDA regulations, including an alignment of the FDA definition of owner or consignee with CBP’s definition. Comments on the proposed rule are due Aug. 30. In addition to general comments, FDA is also seeking specific input on a variety of ACE requirements FDA is proposing to codify in its regulations, including the following:

On June 28 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

The Food and Drug Administration is seeking comments on a petition to no longer allow for the use of potassium perchlorate as an additive in closure-sealing gaskets for food containers (here). The Society of the Plastics Industry submitted the petition, purporting that the substance is no longer put to that use, the FDA said. Comments on whether potassium perchlorate is still used by industry in closure-sealing gaskets for food containers, and should therefore still be allowed as an additive, are due Aug. 29.

On June 27 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On June 24 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On June 23 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

The Food and Drug Administration issued its weekly Enforcement Report for June 22 that lists the status of recalls and field corrections for food, drugs, biologics and devices (here). The report covers both domestic and foreign firms.

On June 22 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On June 21 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

The Food and Drug Administration will soon begin a pilot to test a new account management function for its Import Trade Auxiliary Communication System (ITACS), it said (here). The use of importer accounts would allow the agency to move to electronic notices of action sent out when the FDA conducts additional review of a shipment, which will allow quicker notification to the filer, importer and consignee, an FDA official recently said (see 1606100012). “Implementation of user login accounts would also allow for potential future ITACS enhancements, requested by the import trade community, that require user authentication,” the FDA said in its notice. Filers, importers of record and consignees interested in participating in the pilot should email the FDA at itacssupport@fda.hhs.gov (with ITACS Pilot Participation Request in subject line) by July 8. The FDA said it intends to begin the pilot by around July 23, and conclude it in October.