EAPA Litigation

Under the Enforce and Protect Act, CBP investigates whether a company is evading particular antidumping and countervailing duty orders. Litigation on determinations made under the relatively new statute have centered on due process protections for respondents, CBP's evidentiary basis for its decisions and the interplay of decisions made on the scope of the applicable AD/CVD orders from both CBP and the Commerce Department. The Court of Appeals for the Federal Circuit issued a key decision for all EAPA cases in Royal Brush Manufacturing v. United States, when it found CBP to have violated a respondent's due process protections by failing to provide it with access to the business proprietary information used in the proceeding.

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FDA Enforcement Report on Recalls & Field Corrections for Aug. 22

August 23, 2012 by Brian Feito|FDA

The Food and Drug Administration issued its weekly Enforcement Report for Aug. 22 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.

New and Revised FDA Import Alerts for Aug. 21

August 22, 2012 by Brian Feito|FDA

On Aug. 21 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 Aug. 20

August 21, 2012 by Brian Feito|FDA

On Aug. 20 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

Other Modified FDA Import Alerts for the Week of Aug. 13-19

August 21, 2012 by Brian Feito|FDA

During the week of Aug. 13-19, 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 of:

FDA Asks for Comments on Dietary Supplement Labeling Requirements

August 21, 2012 by Brian Feito|FDA

The Food and Drug Administration is asking for comments on the burden of its dietary supplement labeling requirements under the Dietary Supplement and Nonprescription Drug Consumer Protection Act. The Act requires the label of a dietary supplement marketed in the U.S. to include a domestic address or domestic telephone number through which the product’s manufacturer, packer or distributor may receive a report of a serious adverse event associated with the dietary supplement. FDA expects 1,460 respondents will prepare 3.8 new labels per year for a total of 5,560 new labels, which will require an average of 0.2 hours per label, for a total of 1,112 annual burden hours. Comments are due Sept. 21.

New and Revised FDA Import Alerts for Aug. 17-19

August 20, 2012 by Brian Feito|FDA

On Aug. 17-19 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA Issues Q&A for Guidance on Salmonella Prevention in Eggs

August 20, 2012 by Brian Feito|FDA

The Food and Drug Administration issued a guidance entitled “Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation.” The guidance contains questions and answers on FDA’s July 9, 2009, final rule requiring shell egg producers to implement measures to prevent Salmonella Enteritidis from contaminating eggs on the farm and from further growth during storage and transportation, and requiring these producers to maintain records concerning their compliance with the final rule and to register with FDA. The final rule became effective Sept. 8, 2009.

New and Revised FDA Import Alerts for Aug. 16

August 17, 2012 by Brian Feito|FDA

On Aug. 16 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 Aug. 15

August 16, 2012 by Brian Feito|FDA

On Aug. 15 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 Aug. 15

August 16, 2012 by Brian Feito|FDA

The Food and Drug Administration issued its weekly Enforcement Report for Aug. 15 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.