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 June 4

June 5, 2014 by Brian Feito|FDA

The Food and Drug Administration issued its weekly Enforcement Report for June 4 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.

FDA Civil Penalty Increase to Take Effect June 18

June 5, 2014 by Brian Feito|FDA

The Food and Drug Administration confirmed that an increase in its civil penalty amounts will take effect June 18. The agency first announced the inflation-related increase in February (see 14013113). FDA is at the same time allowing FDA staff other than the Office of Chief Counsel to authorize civil monetary penalty complaints against tobacco retailers.

New and Revised FDA Import Alerts for June 3

June 4, 2014 by Brian Feito|FDA

On June 3 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 June 2

June 3, 2014 by Brian Feito|FDA

On June 2 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 May 26 - June 1

June 3, 2014 by Brian Feito|FDA

During the week of May 26 - June 1, 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:

FDA Loosens Controls on Cellulite Treatment Devices

June 3, 2014 by Brian Feito|FDA

The Food and Drug Administration is formally reclassifying powered surgical instrument for improvement in the appearance of cellulite as Class II devices that do not require premarket approval, in an order that codifies a reclassification that took effect July 12, 2013. The devices had been classified in Class III, and required the filing of a premarket approval application before distribution. FDA is reclassifying them in response to a request from Cabochon Aesthetics related to the Cabochon System. Although they will no longer need FDA approval, the devices will still be subject to certain extra "special controls" related to testing and labeling. They will not be exempt from premarket notification requirements.

New and Revised FDA Import Alerts for May 30

June 2, 2014 by Brian Feito|FDA

On May 30 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA Relaxes Requirements for Tuberculosis Detection Devices

June 2, 2014 by Brian Feito|FDA

The Food and Drug Administration is formally reclassifying some devices used for detection of tuberculosis as Class II devices that do not require premarket approval, in a final order that takes effect June 30. "Nucleic acid-based systems for mycobacterium tuberculosis complex in respiratory specimens" 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, the devices will still be subject to certain extra "special controls" related to testing and labeling, and will not be exempt from premarket notification requirements.

FDA Loosens Controls on Dengue Virus Detection Devices

June 2, 2014 by Brian Feito|FDA

The Food and Drug Administration reclassifying dengue virus serological reagents as Class II devices that do not require premarket approval, in an order issued May 30 that took effect April 8. The devices, which consist of antigens and antibodies for the detection of dengue virus in people who show symptoms, had been classified in Class III, and required the filing of a premarket approval application before distribution. The devices will be subject to premarket notification requirements as well as certain extra "special controls" related to performance characteristics, testing, and labeling.

New and Revised FDA Import Alerts for May 29

May 30, 2014 by Brian Feito|FDA

On May 29 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: