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FDA Enforcement Report on Recalls & Field Corrections for Feb. 24

February 26, 2016 |FDA

The Food and Drug Administration issued its weekly Enforcement Report for Feb. 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.

New and Revised FDA Import Alerts for Feb. 24

February 25, 2016 |FDA

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

FDA Meeting Scheduled on FSMA Planning, FSVP Rules for Food Importers

February 25, 2016 |FDA

The Food and Drug Administration scheduled a March 21 meeting to discuss import safety regulations and programs, the agency said in a notice (here). Topics will include the Foreign Supplier Verification Program final rule for importers (see 1511130006), the agency said. The agency also plans to discuss "comprehensive planning effort for the next phase of the FDA Food Safety Modernization Act implementation relating to import safety programs, which includes establishing the operational framework for these programs and plans for guidance documents, training, education, and technical assistance," it said. Comments are due March 7 and early registration by March 14 is "strongly recommended," said FDA (here).

New and Revised FDA Import Alerts for Feb. 23

February 24, 2016 |FDA

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

FDA Extends Comment Period for Proposed 'Gluten-Free' Recordkeeping Requirements

February 23, 2016 |FDA

The Food and Drug Administration is extending until April 25 the period for comments on proposed requirements for manufacturers of hydrolyzed and fermented foods bearing “gluten-free” claims. FDA’s Nov. 18 proposed rule would require manufacturers keep records that prove their hydrolyzed and fermented foods labeled “gluten-free” comply with certain thresholds, by showing the food or any ingredient is below the limit before fermentation or hydrolysis occurs (see 1511180013). Comments on the proposed rule were originally due Feb. 16.

New and Revised FDA Import Alerts for Feb. 22

February 23, 2016 |FDA

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

FDA Publishes Small Business Guide on Omega-3 Food Labeling Claims

February 23, 2016 |FDA

The Food and Drug Administration on Feb. 19 announced (here) a new guide (here) to help small businesses comply with regulations that recently took effect on omega-3 fatty acid content claims in food labeling. A FDA final rule issued in 2014 prohibits statements on labels that a food is “high in,” “rich in” or an “excellent source of” the omega-3 fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), and restricts similar claims for alpha-linolenic acid (ALA) (see 14042829). The final rule took effect Jan. 1, 2016.

FDA Posts List of Valid ACE Unit of Measure Codes

February 23, 2016 |FDA

The Food and Drug Administration recently posted a list of valid unit of measure codes for filings in the Automated Commercial Environment (here) to its ACE/ITDS webpage (here). Use of a code not included on the list will result in an ACE entry rejection, said FDA. Each level of packaging should be declared, and the same code cannot be declared more than once, it said. The list also includes examples for each commodity type.

Topics:Automated Commercial Environment (ACE)

New and Revised FDA Import Alerts for Feb. 19

February 22, 2016 |FDA

On Feb. 19 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

New and Revised FDA Import Alerts for Feb. 18

February 19, 2016 |FDA

On Feb. 18 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: