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FDA Issues Guidance on Use of Fruit and Vegetable Juices as Food Color Additives

December 14, 2016 |FDA

The Food and Drug Administration on Dec. 13 issued guidance on the use of fruit and vegetable juices as color additives in food, it said (here). The guidance document (here) includes a list of juices and FDA’s position on whether they are allowed as color additives in food under FDA’s regulations.

New and Revised FDA Import Alerts for Dec. 12

December 13, 2016 |FDA

On Dec. 12 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

Investigational Drug Establishments Not Required to Register, FDA Says

December 13, 2016 |FDA

The Food and Drug Administration is correcting a final rule it issued in August to clarify drug establishment registration requirements for manufacturers of investigational drugs, it said (here). The original final rule setting electronic registration requirements for human and animal drug and biologics establishments included an incorrect statement that establishments that make investigational drugs must register. FDA now says “manufacturers, repackers, relabelers, or salvagers who manufacture, repack, relabel, or salvage drugs solely for use in research, teaching, or chemical analysis and not for sale are exempt from the establishment registration requirement” if they’re not required to register due to other activities.

New and Revised FDA Import Alerts for Dec. 9-10

December 12, 2016 |FDA

On Dec. 9-10 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA Issues Guidance on Illegitimate Products in Drug Supply Chain

December 12, 2016 |FDA

The Food and Drug Administration issued a new guidance document to assist members of the drug supply chain in complying with the Drug Supply Chain Security Act, it said (here). The guidance (here) “is intended to aid certain trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product and specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain,” FDA said. It also describes how trading partners under the law should notify FDA of illegitimate products and how to terminate such notifications, it said. Comments are due Feb. 7.

New and Revised FDA Import Alerts for Dec. 8

December 9, 2016 |FDA

On Dec. 8 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA Enforcement Report on Recalls & Field Corrections for Dec. 7

December 9, 2016 |FDA

The Food and Drug Administration issued its weekly Enforcement Report for Dec. 7 that lists the status of recalls and field corrections for food, drugs, biologics and devices (here). The report covers both domestic and foreign firms.

New and Revised FDA Import Alerts for Dec. 7

December 8, 2016 |FDA

On Dec. 7 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FSVP Import Alerts to Present New Challenges for Importers, Former FDA Official Says

December 8, 2016 |FDA

Importers will have to be even more wary of import alerts once the Foreign Supplier Verification Program takes effect in May 2017, according to Domenic Veneziano, an independent consultant representing EAS Consulting. Import alerts associated with FSVP could lose business for importers when their suppliers, still able to get their products in, turn elsewhere, while import alerts issued on suppliers could raise FDA scrutiny on importers, Veneziano said, speaking at the Food and Drug Law Institute Enforcement, Litigation and Compliance Conference on Dec. 7 in Washington.

New and Revised FDA Import Alerts for Dec. 6

December 7, 2016 |FDA

On Dec. 6 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: