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 July 24

July 25, 2014 by Brian Feito|FDA

On July 24 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 23

July 25, 2014 by Brian Feito|FDA

The Food and Drug Administration issued its weekly Enforcement Report for July 23 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.

FDA Loosens Controls on Two Gastroenterology-Urology Devices

July 25, 2014 by Brian Feito|FDA

The Food and Drug Administration is reclassifying implanted blood access devices (here) and implantable transporstatic tissue retractor systems (here) as Class II devices that do not require premarket approval, in two separate final orders issued July 25. Reclassification of the former takes effect July 25, while the latter's reclassification went into effect Sept. 13, 2013. The devices had been classified in Class III, and required the filing of a premarket approval application before distribution. Although they will no longer need FDA approval, both types of devices will still be subject to certain extra "special controls". They will not be exempt from premarket notification requirements.

FDA Signs Cooperation Agreement With Mexican Government

July 25, 2014 by Brian Feito|FDA

The Food and Drug Administration on July 24 signed a statement of intent with its regulatory counterparts in Mexico to cooperate more closely on produce safety efforts, said FDA Deputy Commissioner for Foods Michael Taylor in a blog post. The two-page document sets out a strategy to work with Mexico to identify practices to prevent contamination during the growing, harvesting, packing, holding and transportation of fresh fruits and vegetables, as well as verification measures to ensure prevention is working, said Taylor. It also provides for the exchange of information between the two countries, enhanced collaboration on traceback activities, and the development of education and outreach materials to help companies comply with produce safety standards, he said.

New and Revised FDA Import Alerts for July 23

July 24, 2014 by Brian Feito|FDA

On July 23 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 22

July 23, 2014 by Brian Feito|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, 2014 by Brian Feito|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:

Other Modified FDA Import Alerts for the Week of July 14-20

July 22, 2014 by Brian Feito|FDA

During the week of July 14-20, 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 and/or surveillance of:

New and Revised FDA Import Alerts for July 18

July 21, 2014 by Brian Feito|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 17

July 18, 2014 by Brian Feito|FDA

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