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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 Issues Guidance on Latex-Free Claims in Medical Product Labeling
December 1, 2014 |FDA

The Food and Drug Administration posted new guidance on the labeling of products that do not contain natural latex (here). FDA says some companies are labeling their drugs, devices and biologics as “latex free” or “does not contain latex.” However, there is currently no test that can back up a claim that a product is completely latex-free, said the agency. Instead, companies should label their products as “not made with natural rubber latex.” If a company wants to say a specific product or part isn’t made with natural latex, it should say “the [product] is not made with natural rubber latex,” said FDA. Although FDA said the guidance is not binding, the agency told manufacturers that currently include statements like “latex-free” or “does not contain latex” to update their labeling to show FDA’s recommended labeling statement, or consider removing any such statements altogether.

FDA Issues Draft Guidance on Drug Supply Chain Traceability Data Standards
November 26, 2014 |FDA

The Food and Drug Administration on Nov. 26 issued a draft guidance on standards for data exchange under the Drug Supply Chain Security Act (here). The year-old law requires an interface between FDA and drug manufacturers, wholesalers, repackagers, and dispensers that would allow for the electronic exchange of product and transaction information to enable verification of the legitimacy of drug products and improved efficiency of recalls (see 13121725). Comments on the proposed standards are due by Jan. 27.

Other Modified FDA Import Alerts for the Week of Nov. 17-23
November 25, 2014 |FDA

During the week of Nov. 17-23, 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: