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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 Considering End to Exemption From Device Labeling Requirements for Medical Procedure Kits
January 5, 2016 |FDA

The Food and Drug Administration is seeking comments by April 4 on a proposed policy change that would subject certain medical procedure kits to unique device identifier data submission and labeling requirements, it said (here). Outlined in a draft guidance released on Jan. 4 (here), FDA’s new draft definition for medical device “convenience kits,” which are currently exempt from some UDI requirements, would exclude kits containing devices that are meant to be reused or replaced.

FDA Removes Chemicals Used in Paper Goods from List of Allowable Indirect Food Additives
January 4, 2016 |FDA

The Food and Drug Administration removed three perfluoroalkyl ethyl containing food-contact substances used as oil and water repellants for paper and paperboard, it said in a final rule that takes effect Jan. 4 (here). The rule removes the additives -- diethanolamine salts of mono- and bis, pentanoic acid, and perfluoroalkyl substituted phosphate ester acids -- from the agency's regulations for indirect food additives.