The Food and Drug Administration is recommending that importers and manufacturers of bottled water do not add fluoride at concentrations greater than 0.7 mg per liter, in a letter to industry dated April 27 (here). The agency recommendation does not affect the current allowable maximum of 0.8 mg of fluoride per liter in imported bottled water set in FDA’s performance standard for bottled water at 21 CFR 165, it said.

During the week of April 20-26, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination and/or surveillance of:

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

On April 24 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 April 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 April 23 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

With deadlines for regulations implementing the Food Safety Modernization Act fast approaching and importer compliance with the Foreign Supplier Verification Program required in about two years, the Food and Drug Administration is faced with the increasingly imminent challenge of getting the word out to importers and foreign suppliers tasked with new responsibilities, said FDA officials at a meeting on FSMA implementation on April 23 in Washington, D.C.

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

ORLANDO, Fla. – The upcoming Food and Drug Administration pilot to test filing and release of FDA-regulated entries in the Automated Commercial Environment will start with drugs before expanding to other products, said Domenic Veneziano, FDA director of import operations, at the annual conference of the National Customs Brokers & Forwarders Association of America April 22. The pilot, which will begin July 1, will start at three ports: Baltimore, Otay Mesa and Philadelphia, he said. The agency wants to make sure its IT systems are running smoothly before adding other FDA-regulated products to the pilot, but intends to eventually test all types of commodities before ACE cargo release becomes mandatory in November, said Veneziano. Medical devices will come after drugs in August, he said. Veneziano announced the FDA pilot would begin in July at a webinar last March (see 1503240065).

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