FDA is proposing to establish action levels for lead in foods intended for babies and young children. A draft guidance released by the agency on Jan. 24 would set a lead action level at 10 parts per billion for fruits, vegetables (except single-ingredient root vegetables), mixtures (including grain and meat-based mixtures), yogurts, custards/puddings and single-ingredient meats; 20 ppb for single-ingredient root vegetables; and 20 ppb for dry cereals. If the guidance is finalized, though not binding, "the FDA would consider these action levels, in addition to other factors, when considering whether to bring enforcement action in a particular case," the agency said in a news release. Comments are due March 27, FDA said in a notice released Jan. 24.

On Jan. 20, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On Jan. 18-19, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA has issued its Enforcement Report for Jan. 18, listing the status of recalls and field corrections for food, cosmetics, tobacco products, drugs, biologics and devices. The report covers both domestic and foreign firms.

On Jan. 17, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On Jan. 13, the FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On Jan. 12, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA on Jan. 12 signed a Mutual Recognition Agreement with Switzerland’s Agency for Therapeutic Products (Swissmedic) that will allow the U.S. and Switzerland to rely on each other’s inspections of pharmaceutical and veterinary drug facilities, avoiding the need for duplicate inspections, FDA said in a statement that day. Prior to the MRA’s entry into force, FDA still must “determine whether Swissmedic is capable of conducting inspections that meet U.S. requirements, and Swissmedic must make a similar determination with respect to the FDA meeting Swiss requirements,” FDA said. The MRA includes privisons on when the regulators intend to accept official good manufacturing practice documents from the other; how regulators will transmit the documents; and the establishment of two committees “to facilitate the effective functioning of the MRA,” said a release from the Office of the U.S. Trade Representative, which also signed the agreement.

On Jan. 10-11, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA has issued its Enforcement Report for Jan. 11, listing the status of recalls and field corrections for food, cosmetics, tobacco products, drugs, biologics and devices. The report covers both domestic and foreign firms.