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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 Premarket Submissions for e-Cigarettes
June 11, 2019 |FDA

The Food and Drug Administration on June 11 issued a new final guidance document on the submission of premarket tobacco product applications for electronic nicotine delivery systems (ENDS). The new guidance includes information on when premarket applications are required for e-cigarettes and other ENDS, FDA’s review polices, and what information must and should be included in applications. Premarket approval for ENDS requirements is required under a 2016 final rule that deemed ENDS and other products to be tobacco products (see 1605050011). Compliance dates for premarket approval have been pushed back to 2021 or 2022, depending on the type of product and type of submission (see 1708090020), though requirements will take effect earlier for flavored ENDS products (see 1903140023).

FDA Updates FAQs on Produce Safety Regulations
June 11, 2019 |FDA

The Food and Drug Administration updated a list of answers to frequently asked questions on the Food Safety Modernization Act to include several new topics related to its produce safety regulations, FDA said by email June 11. “The updated FAQ includes responses to many common questions that we have received through the FSMA Technical Assistance Network (TAN),” the agency said. The now 94-page document already included answers to questions on other FSMA regulations, including the Foreign Supplier Verification Program and preventive controls regulations.