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 June 23

June 24, 2014 by Brian Feito|FDA

On June 23 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 June 16-22

June 24, 2014 by Brian Feito|FDA

During the week of June 16-22, 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 Proposes Non-Enforcement of Controls on Medical Device Data Systems

June 24, 2014 by Brian Feito|FDA

The Food and Drug Administration intends to adopt a non-enforcement stance for controls on medical device data systems, it said in a draft guidance posted June 20 (here). Under the policy, if adopted, FDA would not “enforce compliance with the regulatory controls, including registration and listing, premarket review, postmarket reporting and quality system regulation for manufacturers of these types of devices,” it said. Comments on the draft guidance are due Aug. 25, according to a concurrent Federal Register notice (here).

New and Revised FDA Import Alerts for June 20

June 23, 2014 by Brian Feito|FDA

On June 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 Comment Period on Proposed Cigar and e-Cigarette Restrictions

June 23, 2014 by Brian Feito|FDA

The Food and Drug Administration is allowing more time for comments on its proposal to extend its current restrictions on cigarettes and smokeless tobacco so they also apply to electronic “e-cigarettes,” cigars, pipe tobacco, nicotine gels, hookah tobacco, and nicotine dissolvables. The proposed rule issued by FDA in April would set requirements for registration, FDA review, and health warning labels on e-cigarettes and other tobacco products (see 14042426). Comments are now due Aug. 8.

New and Revised FDA Import Alerts for June 19

June 20, 2014 by Brian Feito|FDA

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

Correction: FDA Loosens Controls on Hemostatic Sponges

June 20, 2014 by Brian Feito|FDA

Correction: The Food and Drug Administration is loosening controls on nonabsorbable expandable hemostatic sponges for temporary internal use by reclassifying them as Class II medical devices (see 14061615).

New and Revised FDA Import Alerts for June 18

June 19, 2014 by Brian Feito|FDA

On June 18 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 June 18

June 19, 2014 by Brian Feito|FDA

The Food and Drug Administration issued its weekly Enforcement Report for June 18 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 June 17

June 18, 2014 by Brian Feito|FDA

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