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 Issues July Interstate Certified Shellfish Shippers List

July 10, 2012 by Brian Feito|FDA

The Food and Drug Administration (FDA) issued the July Interstate Certified Shellfish Shippers List (ICSSL). The ICSSL is published monthly for the information and use by food control officers, the seafood industry and other interested persons. The shippers listed have been certified by regulatory authorities in the United States, Canada, Chile, Korea, Mexico and New Zealand under the uniform sanitation requirements of the National Shellfish Program.

New and Revised FDA Import Alerts for July 6

July 9, 2012 by Brian Feito|FDA

On July 6 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 5

July 6, 2012 by Brian Feito|FDA

On July 5 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 5

July 6, 2012 by Brian Feito|FDA

The Food and Drug Administration issued its weekly Enforcement Report for July 5 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.

Highlights of FDA's Proposed Rule to Require Unique Identifiers on Medical Devices

July 6, 2012 by Brian Feito|FDA

The Food and Drug Administration issued its proposed rule to require unique device identifiers (UDIs) on the labels of medical devices and device packages, with certain exceptions. The proposed rule, which would implement requirements added to the Federal Food, Drug, and Cosmetic Act by Section 226 of the Food and Drug Administration Amendments Act of 2007, is scheduled to be published in the July 10 Federal Register. Comments on the FDA’s proposed rule are due by about Nov. 7. Comments on new information collection requirements contained in the proposed rule are due by Sept. 10.

New and Revised FDA Import Alerts for July 3

July 5, 2012 by Brian Feito|FDA

On July 3 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA Amends Requirements for Two Red Dyes Used in Drugs & Cosmetics

July 5, 2012 by Brian Feito|FDA

The Food and Drug Administration amended its requirements for D&C Red No. 6 and D&C Red No. 7 by replacing the current specification for “Ether-soluble matter” with a maximum limit of 0.015 percent for the recently identified impurity 1-[(4-methylphenyl)azo]-2-naphthalenol, in response to a petition filed by Sun Chemical Corp, it said in a final rule. The rule is effective August 7, 2012, except for any provisions that may be stayed by the filing of proper objections. Such objections and requests for hearings may be submitted by August 6, 2012.

FDA Requires Premarket Approval for Permanent Pacemaker Electrodes by Oct. 4

July 5, 2012 by Brian Feito|FDA

A premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) will be required for cardiovascular permanent pacemaker electrodes, said the Food and Drug Administration in a final rule.

New and Revised FDA Import Alerts for July 2

July 3, 2012 by Brian Feito|FDA

On July 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 June 25 - July 1

July 3, 2012 by Brian Feito|FDA

During the week of June 25 - July 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 of: