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FDA Posts Draft Guidance on Unique Device Identifier Format

July 26, 2016 |FDA

The Food and Drug Administration issued a draft guidance document outlining format requirements for unique device identifiers, it said in a notice (here). The draft guidance, “Unique Device Identification System: Form and Content of the Unique Device Identifier” (here), describes “the two forms of a UDI,” clarifies the content of the UDI, and discusses “the order of the data in a UDI and UDI carrier.” FDA’s UDI rule started taking effect in September 2014 (see 13092020). The next effective date is Sept. 24, 2016, when FDA will require UDIs on the labels and packages of class II devices, data submissions for class II devices, and direct marking of certain class III devices, according to the FDA website (here).

FDA Launches New Electronic Milk Product Export Approval System

July 26, 2016 |FDA

The Food and Drug Administration launched a new electronic system for U.S. manufacturers and producers of milk products to register for lists of establishments approved for export, it said July 25 (here). Companies interested in exporting to Chile, China and the EU can use the new electronic FDA Unified Registration and Listing Systems (FURLS) Dairy Listing Module (DLM) to apply for inclusion on the applicable list for one or more of these countries, update listing information and reapply for lists as necessary, the agency said. Beginning July 25, new applications and biennial updates for currently listed firms will be processed using the DLM. To ensure a smooth transition, U.S. manufacturers and processors of milk products that are currently listed on the Chile, China or EU milk product lists should submit a new application via the DLM, FDA said. Firms currently listed on the milk product list for Chile are due for a biennial update in September 2016, it said.

New and Revised FDA Import Alerts for July 22

July 25, 2016 |FDA

On July 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 July 21

July 22, 2016 |FDA

On July 21 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 July 20

July 22, 2016 |FDA

The Food and Drug Administration issued its weekly Enforcement Report for July 20 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 July 19

July 20, 2016 |FDA

On July 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 July 18

July 19, 2016 |FDA

On July 18 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 July 15

July 18, 2016 |FDA

On July 15 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 July 14

July 15, 2016 |FDA

On July 14 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 July 13

July 14, 2016 |FDA

On July 13 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: