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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New and Revised FDA Import Alerts for March 27

March 28, 2017 |FDA

On March 27 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 March 24-25

March 27, 2017 |FDA

On March 24-25 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 March 23

March 24, 2017 |FDA

On March 23 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 March 22

March 24, 2017 |FDA

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

New and Revised FDA Import Alerts for March 22

March 23, 2017 |FDA

On March 22 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 March 21

March 22, 2017 |FDA

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

Former FDA Commissioners Oppose Drug Importation Proposals in Letter to Congress

March 22, 2017 |FDA

Four former commissioners of the Food and Drug Administration warned Congress that allowing personal importation of drugs would lead to a surge in counterfeit and substandard pharmaceuticals, in a letter posted to the Duke University Margolis Center for Health Policy website on March 17 (here). There's some “renewed debate” on allowing personal importation as a means to reduce the cost of prescription medicines, but addressing the serious issue of access to affordable drugs will “not be such a straightforward task,” said the letter, signed by former commissioners Robert Califf, Margaret Hamburg, Mark McClellan and Andrew von Eschenbach.

New and Revised FDA Import Alerts for March 20

March 21, 2017 |FDA

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

FDA Extends Period for Comments on Limit for Carcinogen in Smokeless Tobacco

March 21, 2017 |FDA

The Food and Drug Administration is extending until July 10 the period for comments on its proposal to establish a limit on N-nitrosonornicotine (NNN) in finished smokeless tobacco products, it said (here). The proposed limit would apply to smokeless tobacco products manufactured, imported, distributed or sold beginning three years after the publication date of the final rule (see 1701200031). Comments were originally due April 10.

FDA Adds Functionality in ACE ABI for Product Code Builder

March 21, 2017 |FDA

The Food and Drug Administration recently deployed a web service that will allow importers and customs brokers to access FDA’s product code builder database through the ACE Automated Broker Interface (ABI), CBP said in a CSMS message (here). The product code builder application program interface released March 20 will allow software developers to build a user interface for the product code builder in ABI, FDA said (here). “This does not replace the current online Product Code Builder but compliments it by providing trade a method to program existing software to query and verify FDA Product Codes,” it said.