The Food and Drug Administration on Sept. 6 issued a final rule (here) listing 19 ingredients used in consumer antibacterial soaps, including triclosan and triclocarban, as not generally recognized as safe and effective. Effective Sept. 6, 2017, these 19 consumer antiseptic wash drug products are considered by FDA to be misbranded, and are new drugs for which applications are required for marketing, FDA said. The final rule covers these ingredients only when used in consumer antiseptic washes, it said. Other rulemakings are currently ongoing for ingredients of healthcare antiseptics, consumer antiseptic rubs, first aid antiseptics and antiseptics used by the food industry.

On Sept. 1 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 Aug. 31 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 Aug. 31 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On Aug. 30 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On Aug. 29 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On Aug. 26 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On Aug. 25 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 Aug. 24 that lists the status of recalls and field corrections for food, drugs, biologics and devices (here). The report covers both domestic and foreign firms.

The Food and Drug Administration is seeking comments (here) on new information it says it will have to collect in order to implement a user account management function in its Import Trade Auxiliary Communications System (ITACS). The new function, which is the subject of a pilot FDA plans to conclude by October (see 1606220042), would allow FDA to distribute Notices of FDA Action electronically, enable users to access Notices of FDA Action within ITACS, and allow users to view the details of specific FDA information requests in ITACS. “ITACS user account management functionality would also allow for potential future ITACS enhancements, requested by the import trade community, that require user authentication,” FDA said. FDA would have to ask users to enter “basic information such as the person's name, their employer's name, a contact email address, an account password, etc., into ITACS via the user account management function interface,” it said. That should take users about 30 minutes each, it said. Comments are due Oct. 25.